A Phase 2 interventional study of TALAZOPARIB in Early Breast Cancer, sponsored by Pfizer. Terminated at 97 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-11-09.
Sponsored by Pfizer · Phase 2, Interventional, and Treatment
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Among 22 studies testing talazoparib in Breast Neoplasms — 5 open to participants now, 7 under way, none of them phase 3. talazoparib · Breast Neoplasms.
Among the 22 studies testing talazoparib in Breast Neoplasms, this one is the 9th largest by enrollment, is the only one that started in 2018, is one of 12 in phase 2, and was the 11th registered.
14,829 studies on the registry are indexed under Breast Neoplasms; 3,320 are open to participants now.
Browse Breast Neoplasms studies →5 of the 22 studies testing talazoparib in Breast Neoplasms are open now, in 4 countries. Recruiting first, the newest first:
Massachusetts General Hospital · Sites in United States
Ages 18+ · Women only
Seoul National University Hospital · Sites in Korea, Republic of
Ages 19+ · Women only
National University Hospital, Singapore · Sites in Singapore
Ages 18–99
Erasmus Medical Center · Sites in Netherlands
Ages 18+
QuantumLeap Healthcare Collaborative · Sites in United States
Ages 18+
By country, each count listing its studies:
talazoparib: first FDA approval 2018 (TALZENNA), first EMA approval 2019. What it is approved for, and how studies give it, is on its page →
Of the 2,399 Breast Neoplasms studies recruiting now, 1,570 (65%) set no upper age limit and 592 (25%) stop at 75 or younger; 103 take children under 18; 215 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
22 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 9 · Phase 2 15 · Phase 3 1
First in 2010; this study’s year is marked. 1 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 61 is below the median of 72 across 10,903 interventional studies indexed under Breast Neoplasms.
Median enrollment 33 across the 22 interventional studies. Of the 11 that completed or were terminated, 9 (82%) have results posted.
This tab as a report to print or save as PDF → With an account.
5 of 22 have an industry lead sponsor. The 10 most frequent:
Pfizer is the lead sponsor of 3,337 studies on the registry; 150 are open to participants now.
Of its 601 completed or terminated interventional studies of FDA-regulated products, 392 (65%) have results posted.
182 studies in Breast Neoplasms by Pfizer: 6 open now, 26 under way, 7 of them phase 3. Of 145 finished, 94 (65%) have results posted.
Among the 182 studies in Breast Neoplasms by Pfizer, this one is the 70th largest by enrollment of the 121 interventional ones that give a count, is one of 6 that started in 2018, is one of 43 in phase 2, and was the 105th registered.
Pfizer’s Breast Neoplasms studies by the year they started, since 1998.
4 of the studies testing talazoparib in Breast Neoplasms that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03990896Massachusetts General HospitalEvaluation of Talazoparib, a PARP Inhibitor, in Patients With Somatic BRCA Mutant Metastatic Breast Cancer: Genotyping Based Clinical Trial | 2027-03-31 |
| NCT03964532Georgetown UniversityTALAVE: Induction Talazoparib Followed by Combination of Talazoparib and Avelumab in Advanced Breast Cancer | 2027-04 |
| NCT04892693Seoul National University HospitalTalazoparib in Advanced Breast Cancer Patients With Homologous Recombinant Deficiency | 2027-05-31 |
| NCT05035745National University Hospital, SingaporeSelinexor & Talazoparib in Advanced Refractory Solid Tumors; Advanced/Metastatic Triple Negative Breast Cancer (START) | 2027-11 |
Add all 4 to your calendar (.ics) → With an account.
Among the 22 studies testing talazoparib in Breast Neoplasms, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among Pfizer’s 182 in Breast Neoplasms:
This tab as a report to print or save as PDF → With an account.
A PHASE 2, NON RANDOMIZED, OPEN LABEL, SINGLE ARM, MULTI CENTER STUDY OF TALAZOPARIB FOR NEOADJUVANT TREATMENT OF GERMLINE BRCA1/2 MUTATION PATIENTS WITH EARLY HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 NEGATIVE BREAST CANCER
TALAZOPARIB (PARP INHIBITOR) FOR NEOADJUVANT TREATMENT OF GERMLINE BRCA1/2 MUTATION PATIENTS WITH EARLY HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 NEGATIVE BREAST CANCER. THIS IS A MONOTHERAPY TREATMENT FOR 24 WKS FOLLOWED BY SURGERY TO EVALUATE PATHOLOGICAL COMPLETE RESPONSE.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
SINGLE ARM, NON-RANDOMIZED
Drug: TALAZOPARIB
Talazoparib 1mg/day
Percentage of Participants Achieving Pathological Complete Response (pCR) as Per Independent Central Review (ICR) in Evaluable Analysis Set as Per ICR With 80% Confidence Interval (CI)
pCR was defined as the absence of residual invasive cancer in the breast and axillary lymph nodes on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy (ie, ypT0/Tis ypN0 in the current American Joint Committee on Cancer \[AJCC\] staging system). pCR rate by ICR was defined as the percentage of participants achieving pCR by ICR after talazoparib treatment for 24 weeks, followed by surgery, among all participants in the evaluable population (Evaluable Analysis Set as per ICR). The exact CI was calculated using the Blaker's method.
Time frame: Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)
Percentage of Participants Achieving pCR as Per ICR in Evaluable Analysis Set as Per ICR With 95% CI
pCR was defined as the absence of residual invasive cancer in the breast and axillary lymph nodes on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy (ie, ypT0/Tis ypN0 in the current AJCC staging system). pCR rate by ICR was defined as the percentage of participants achieving pCR by ICR after talazoparib treatment for 24 weeks, followed by surgery, among all participants in the evaluable population (Evaluable Analysis Set as per ICR). The exact CI was calculated using the Blaker's method.
Time frame: Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)
Percentage of Participants Achieving pCR as Per ICR in Intention-to-Treat (ITT) Analysis Set With 80% CI
pCR was defined as the absence of residual invasive cancer in the breast and axillary lymph nodes on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy (ie, ypT0/Tis ypN0 in the current AJCC staging system). pCR rate by ICR in ITT Analysis Set was defined as the percentage of participants achieving pCR by ICR after talazoparib treatment for 24 weeks, followed by surgery, among all participants in the ITT Analysis Set. The exact CI was calculated using the Blaker's method.
Time frame: Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)
Percentage of Participants Achieving pCR as Per ICR in ITT Analysis Set With 95% CI
pCR was defined as the absence of residual invasive cancer in the breast and axillary lymph nodes on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy (ie, ypT0/Tis ypN0 in the current AJCC staging system). pCR rate by ICR in ITT Analysis Set was defined as the percentage of participants achieving pCR by ICR after talazoparib treatment for 24 weeks, followed by surgery, among all participants in the ITT Analysis Set. The exact CI was calculated using the Blaker's method.
Time frame: Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)
Percentage of Participants Achieving pCR as Per Investigator in Evaluable Analysis Set as Per Investigator
pCR was defined as the absence of residual invasive cancer in the breast and axillary lymph nodes on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy (ie, ypT0/Tis ypN0 in the current AJCC staging system). pCR rate by investigator was defined as the percentage of participants achieving pCR by investigator review after talazoparib treatment for 24 weeks, followed by surgery, among all participants in the evaluable population (Evaluable Analysis Set as per Investigator). The exact CI was calculated using the Blaker's method.
Time frame: Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)
Percentage of Participants Achieving pCR as Per Investigator in ITT Analysis Set
pCR was defined as the absence of residual invasive cancer in the breast and axillary lymph nodes on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy (ie, ypT0/Tis ypN0 in the current AJCC staging system). pCR rate by investigator in ITT Analysis Set was defined as the percentage of participants achieving pCR by investigator review after talazoparib treatment for 24 weeks, followed by surgery, among all participants in the ITT Analysis Set. The exact CI was calculated using the Blaker's method.
Time frame: Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)
Percentage of Participants Achieving pCR in Breast Only as Per Investigator in Evaluable Analysis Set as Per Investigator
pCR in breast was defined as the absence of residual invasive cancer in the breast and axillary lymph nodes on hematoxylin and eosin evaluation of the complete resected breast specimen following completion of neoadjuvant therapy with talazoparib. pCR rate in breast by investigator was defined as the percentage of participants achieving pCR in breast by investigator review after talazoparib treatment for 24 weeks, followed by surgery, among all participants in the evaluable population (Evaluable Analysis Set as per Investigator). The exact CI was calculated using the Blaker's method.
Time frame: Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)
Percentage of Participants Achieving pCR in Breast Only as Per Investigator in ITT Analysis Set
pCR in breast was defined as the absence of residual invasive cancer in the breast and axillary lymph nodes on hematoxylin and eosin evaluation of the complete resected breast specimen following completion of neoadjuvant therapy with talazoparib. pCR rate in breast by investigator in ITT Analysis Set was defined as the percentage of participants achieving pCR in breast by investigator review after talazoparib treatment for 24 weeks, followed by surgery, among all participants in the ITT Analysis Set. The exact CI was calculated using the Blaker's method.
Time frame: Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)
Percentage of Participants Achieving pCR in Breast Only as Per ICR in Evaluable Analysis Set as Per ICR
pCR in breast was defined as the absence of residual invasive cancer in the breast and axillary lymph nodes on hematoxylin and eosin evaluation of the complete resected breast specimen following completion of neoadjuvant therapy with talazoparib. pCR rate in breast by ICR was defined as the percentage of participants achieving pCR in breast by ICR after talazoparib treatment for 24 weeks, followed by surgery, among all participants in the evaluable population (Evaluable Analysis Set as per ICR). The exact CI was calculated using the Blaker's method.
Time frame: Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)
Percentage of Participants Achieving pCR in Breast Only as Per ICR in ITT Analysis Set
pCR in breast was defined as the absence of residual invasive cancer in the breast and axillary lymph nodes on hematoxylin and eosin evaluation of the complete resected breast specimen following completion of neoadjuvant therapy with talazoparib. pCR rate in breast by ICR in ITT Analysis Set was defined as the percentage of participants achieving pCR in breast by ICR after talazoparib treatment for 24 weeks, followed by surgery, among all participants in the ITT Analysis Set. The exact CI was calculated using the Blaker's method.
Time frame: Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)
Percentage of Participants With Residual Cander Burden (RCB) as Per ICR in Evaluable Analysis Set as Per ICR
The RCB is a continuous index derived from the following: primary tumor dimensions; cellularity of the tumor bed; axillary nodal burden. Residual cancer burden by ICR is reported as a categorical variable with four classes (categories): RCB 0 (pCR), I (minimal RCB), II (moderate RCB), III (extensive RCB). Participants who had progressive disease or was unable to be assessed for RCB due to missing required axillary specimen were counted in the "Missing" category. The simultaneous exact CI was calculated using Goodman's method.
Time frame: Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)
Percentage of Participants With RCB as Per ICR in ITT Analysis Set
The RCB is a continuous index derived from the following: primary tumor dimensions; cellularity of the tumor bed; axillary nodal burden. Residual cancer burden by ICR is reported as a categorical variable with four classes (categories): RCB 0 (pCR), I (minimal RCB), II (moderate RCB), III (extensive RCB). Participants who had progressive disease or was unable to be assessed for RCB due to missing required axillary specimen were counted in the "Missing" category. The simultaneous exact CI was calculated using Goodman's method.
Time frame: Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)
Probability of Being Event-Free at 3 Years in Evaluable Analysis Set
Event-Free Survival (EFS) is defined as the time from surgery date to first documentation of local or distant recurrence or death or initiation of antineoplastic therapy before documentation of first relapse. Participants discontinuing study before documentation of first relapse or death, but after surgery were censored observations for EFS. EFS at 3 years is defined as the probability of being event free at 3 years after surgery using Kaplan Meier methods.
Time frame: 3 years after surgery
Probability of Being Alive at 3 Years in Evaluable Analysis Set
Overall Survival (OS) is defined as the time from first dose of talazoparib to death due to any cause. Participants not known to have died at the time of the analysis were right censored on the date they were last known to be alive before the analysis data cutoff date. OS at 3 years is defined as the probability of being alive at 3 years after first dose of talazoparib using Kaplan Meier methods.
Time frame: 3 years after first dose of talazoparib
Probability of Being Alive at 3 Years in ITT Analysis Set
OS is defined as the time from first dose of talazoparib to death due to any cause. Participants not known to have died at the time of the analysis were right censored on the date they were last known to be alive before the analysis data cutoff date. OS at 3 years is defined as the probability of being alive at 3 years after first dose of talazoparib using Kaplan Meier methods.
Time frame: 3 years after first dose of talazoparib
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with study treatment. TEAEs=AEs that occurred between first dose of study drug and up to 28 days after the last dose that were absent before treatment or worsened relative to pretreatment state. Grades of AEs were defined by National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 4.03. Grade 1=asymptomatic/mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2=minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activity of daily living (ADL); Grade 3=severe or medically significant but not immediately life-threatening, hospitalization of prolongation of hospitalization indicated; disabling limiting self-care ADL; Grade 4=events with life-threatening consequences, urgent intervention indicated; Grade 5= death related to AE.
Time frame: Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months)
Number of Participants With Serious Adverse Events (SAEs)
An SAE was any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect. Treatment-related SAEs were determined by the investigator.
Time frame: Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months)
Number of Participants With TEAEs Leading to Permanent Discontinuation of Study Drug
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with the study treatment. TEAEs were AEs that occurred between first dose of study drug and up to 28 days after the last dose that were absent before treatment or that worsened relative to pretreatment state.
Time frame: Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months)
Number of Participants With TEAEs Leading to Temporary Discontinuation of Study Drug
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with the study treatment. TEAEs were AEs that occurred between first dose of study drug and up to 28 days after the last dose that were absent before treatment or that worsened relative to pretreatment state.
Time frame: Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months)
Number of Participants With TEAEs Leading to Dose Reduction of Study Drug
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with the study treatment. TEAEs were AEs that occurred between first dose of study drug and up to 28 days after the last dose that were absent before treatment or that worsened relative to pretreatment state.
Time frame: Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months)
Number of Participants With Laboratory Abnormalities
Laboratory parameters included hematology, serum chemistry, urinalysis and coagulation. Grades of laboratory abnormalities were defined according to NCI CTCAE version 4.03. Participants with laboratory test abnormalities meeting specified criteria (\>upper limit of normal \[ULN\] or \<lower limit of normal \[LLN\]) (without regards to baseline abnormality) are reported.
Time frame: Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months)
Number of Participants With Hematology Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline
Hematology laboratory parameters included hematocrit, hemoglobin, mean corpuscular volume, red blood cells, platelets, white blood cells with differential (neutrophils, lymphocytes, monocytes, eosinophils, basophils). Grades of lab results were defined by NCI CTCAE version 4.03. Grade 1(mild)=asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2(moderate)=minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activity of daily living (ADL); Grade 3=severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated; disabling limiting self-care ADL; Grade 4=life-threatening consequences, urgent intervention indicated; Grade 5=death related to AE. This outcome measure was based only on laboratory data. As Grade 4 anemia cannot be assessed based only on laboratory data, it was not applicable for analysis in this outcome measure.
Time frame: Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months)
Number of Participants With Chemistry Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline
Chemistry laboratory parameters included albumin, total protein, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, total bilirubin, blood urea nitrogen, creatinine, non-fasting glucose, bicarbonate, calcium, chloride, magnesium, phosphate, potassium, sodium, and lactate dehydrogenase. Grades of laboratory results were defined by NCI CTCAE version 4.03. Grade 1 (Mild) = asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2 (Moderate ) = minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activity of daily living (ADL); Grade 3 = severe or medically significant but not immediately life-threatening, hospitalization of prolongation of hospitalization indicated; disabling limiting self-care ADL; Grade 4 = events with life-threatening consequences, urgent intervention indicated; Grade 5 = death related to AE.
Time frame: Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months)
Trough Plasma Concentration (Ctrough) of Talazoparib in Cycles 2, 3 and 4 in PK Analysis Set
Time frame: Pre-dose on Day 1 of Cycles 2, 3, 4
Within-Participant Average Ctrough of Talazoparib at Steady State in PK Analysis Set
Within-participant average Ctrough of talazoparib at steady state for each participant was defined as the average (mean) value of the steady state Ctrough values (Cycle 2 Day 1, Cycle 3 Day 1 and Cycle 4 Day 1 trough concentrations) for each individual participant.
Time frame: Pre-dose on Day 1 of Cycles 2, 3, 4
Ctrough of Talazoparib in Cycles 2, 3 and 4 in Dose-Compliant PK Analysis Set
Time frame: Pre-dose on Day 1 of Cycles 2, 3, 4
Within-Participant Average Ctrough of Talazoparib at Steady State in Dose-Compliant PK Analysis Set
Within-participant average Ctrough of talazoparib at steady state for each participant was defined as the average (mean) value of the steady state Ctrough values (Cycle 2 Day 1, Cycle 3 Day 1 and Cycle 4 Day 1 trough concentrations) for each individual participant.
Time frame: Pre-dosing on Day 1 of Cycles 2, 3, 4
Number of Participants Who Achieved Definitive Deterioration in Global Health Status (GHS)/Quality of Life (QoL) Per European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-30)
EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes (PROs), consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the GHS/QoL scale, participants rated their overall health and quality of life within the past week. A 10 point change from baseline was used to indicate clinically meaningful change. Definitive deterioration was defined as ≥10 point decrease from baseline without any subsequent \<10 point decrease.
Time frame: Baseline to End of Treatment visit (assessed for maximum of 33 weeks)
Kaplan-Meier Estimate of Time to Definitive Deterioration in GHS/QoL Per EORTC QLQ-30
EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the GHS/QoL scale, participants rated their overall health and quality of life within the past week. A 10 point change from baseline was used to indicate clinically meaningful change. Definitive deterioration was defined as ≥10 point decrease from baseline without any subsequent \<10 point decrease.
Time frame: Baseline to End of Treatment visit (assessed for maximum of 33 weeks)
Probability of Not Achieving Definitive Deterioration in GHS/QoL Per EORTC QLQ-C30 at 3 and 6 Months
EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all to 4=very much). For the GHS/QoL scale, participants rated their overall health and quality of life within the past week. A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best. A 10 point change from baseline was used to indicate clinically meaningful change. Definitive deterioration was defined as ≥10 point decrease from baseline without any subsequent \<10 point decrease. Probability of not achieving definitive deterioration (being event-free) at specified time points (3 and 6 months post-baseline) using the Kaplan Meier method were reported.
Time frame: 3 months and 6 months post-baseline
Number of Participants Who Achieved Definitive Deterioration in Nausea and Vomiting Symptoms Per EORTC QLQ-C30
EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the nausea and vomiting symptoms scale, participants self-rated how much they had felt nauseated and/or vomited during the past week. A 10 point change from baseline was used to indicate clinically meaningful change. Definitive deterioration was defined as ≥10 point increase from baseline without any subsequent \<10 point increase.
Time frame: Baseline to End of Treatment visit (assessed for maximum of 33 weeks)
Kaplan-Meier Estimate of Time to Definitive Deterioration in Nausea and Vomiting Symptoms Per EORTC QLQ-C30
EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the nausea and vomiting symptoms scale, participants self-rated how much they had felt nauseated and/or vomited during the past week. A 10 point change from baseline was used to indicate clinically meaningful change. Definitive deterioration was defined as ≥10 point increase from baseline without any subsequent \<10 point increase.
Time frame: Baseline to End of Treatment visit (assessed for maximum of 33 weeks)
Probability of Not Achieving Definitive Deterioration in Nausea and Vomiting Symptoms Per EORTC QLQ-C30 at 3 and 6 Months
EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, with 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores (1=very poor to 7=excellent); other items have 4 possible scores (1=not at all to 4=very much). For the nausea and vomiting symptoms scale, participants self-rated how much they had felt nauseated and/or vomited during the past week. A linear transformation was applied to raw scores so that transformed scores lie between 0 to 100, with 0 being the best and 100 being the worst for this symptom scale. A 10 point change from baseline was used to indicate clinically meaningful change. Definitive deterioration was defined as≥10 point increase from baseline without any subsequent \<10 point increase. Probability of not achieving definitive deterioration (being event-free) at specified time points (3 and 6 months post-baseline) using Kaplan Meier method were reported.
Time frame: 3 months and 6 months post-baseline
Change From Baseline in Global QoL Per EORTC QLQ-C30
EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the GHS/QoL scale, participants rated their overall health and quality of life within the past week. Negative change from baseline indicates deterioration in GHS/QoL and positive change indicates improvement.
Time frame: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)
Change From Baseline in Physical Functioning Per EORTC QLQ-C30
EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the physical functioning scale, participants self-rated levels of difficulty in doing strenuous activities, taking a walk, how much they needed to stay in bed or a chair, or needed help with eating, dressing, bathing, using the toilet. Negative change from baseline indicates deterioration in physical functioning and positive change indicates improvement.
Time frame: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)
Change From Baseline in Role Functioning Per EORTC QLQ-C30
EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the role functioning scale, participants self-rated how much they were limited in doing work or daily activities, or in pursuing hobbies or other leisure time activities during the past week. Negative change from baseline values indicates deterioration in role functioning and positive change indicates improvement.
Time frame: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)
Change From Baseline in Emotional Functioning Per EORTC QLQ-C30
EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the emotional functioning scale, participants self-rated how much they felt tense, worried, irritable or depressed during the past week. Negative change from baseline values indicates deterioration in emotional functioning and positive change indicates improvement.
Time frame: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)
Change From Baseline in Cognitive Functioning Per EORTC QLQ-C30
EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the cognitive functioning scale, participants self-rated the extent of difficulty in concentrating on things or remembering things during the past week. Negative change from baseline values indicates deterioration in cognitive functioning and positive change indicates improvement.
Time frame: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)
Change From Baseline in Social Functioning Per EORTC QLQ-C30
EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the social functioning scale, participants self-rated how much their physical condition or medical treatment interfered with their family life and social activities during the past week. Negative change from baseline values indicates deterioration in social functioning and positive change indicates improvement.
Time frame: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)
Change From Baseline in Fatigue Symptoms Per EORTC QLQ-C30
EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the fatigue symptoms scale, participants self-rated how much they had felt weak, tired or needed to rest during the past week. Negative change from baseline values indicates improvement of fatigue symptoms and positive change indicates deterioration.
Time frame: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)
Change From Baseline in Nausea and Vomiting Symptoms Per EORTC QLQ-C30
EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the nausea and vomiting symptoms scale, participants self-rated how much they had felt nauseated and/or vomited during the past week. Negative change from baseline values indicates improvement of nausea and vomiting symptoms and positive change indicates deterioration.
Time frame: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)
Change From Baseline in Pain Symptoms Per EORTC QLQ-C30
EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the pain symptoms scale, participants self-rated the extent of pain and how much the pain interfered with daily activities during the past week. Negative change from baseline values indicates improvement of pain symptoms and positive change indicates deterioration.
Time frame: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)
Change From Baseline in Dyspnoea Symptoms Per EORTC QLQ-C30
EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the dyspnoea symptoms scale, participants self-rated the intensity of shortness of breath during the past week. Negative change from baseline values indicates improvement of dyspnoea symptoms and positive change indicates deterioration.
Time frame: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)
Change From Baseline in Insomnia Symptoms Per EORTC QLQ-C30
EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the insomnia symptoms scale, participants self-rated the intensity of shortness of breath during the past week. Negative change from baseline values indicates improvement of insomnia symptoms and positive change indicates deterioration.
Time frame: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)
Change From Baseline in Appetite Loss Symptoms Per EORTC QLQ-C30
EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the appetite loss symptoms scale, participants self-rated the extent of lack of appetite during the past week. Negative change from baseline values indicates improvement of appetite loss symptoms and positive change indicates deterioration.
Time frame: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)
Change From Baseline in Constipation Symptoms Per EORTC QLQ-C30
EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the constipation symptoms scale, participants self-rated the intensity of constipation during the past week. Negative change from baseline values indicates improvement of constipation symptoms and positive change indicates deterioration.
Time frame: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)
Change From Baseline in Diarrhea Symptoms Per EORTC QLQ-C30
EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the diarrhea symptoms scale, participants self-rated the intensity of diarrhea during the past week. Negative change from baseline values indicates improvement of diarrhea symptoms and positive change indicates deterioration.
Time frame: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)
Change From Baseline in Financial Difficulties Per EORTC QLQ-C30
EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the symptom scale of financial difficulties, participants self-rated how much their physical condition or medical treatment caused financial difficulties. Negative change from baseline values indicates improvement of financial difficulties and positive change indicates deterioration.
Time frame: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)
Change From Baseline in Body Image Per EORTC QLQ Breast Cancer Quality of Life Questionnaire (EORTC QLQ-BR23)
EORTC-QLQ-BR23 is a 23-item breast cancer module developed as a supplement for the EORTC-QLQ-C30 to assess the quality of life of participants with breast cancer, consisting of 2 functional scales, 3 symptoms scales, and 3 single-item scales. Each scale has 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the functional scale of body image, participants self-rated how much they felt physically less attractive or less feminine, difficult to look at themselves naked, or dissatisfied with their body during the past week. Negative change from baseline indicates worsening of self-rated body image and positive change indicates improvement.
Time frame: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)
Change From Baseline in Sexual Functioning Per EORTC QLQ-BR23
EORTC-QLQ-BR23 is a 23-item breast cancer module developed as a supplement for the EORTC-QLQ-C30 to assess the quality of life of participants with breast cancer, consisting of 2 functional scales, 3 symptoms scales, and 3 single-item scales. Each scale has 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the sexual functioning scale, participants self-rated to what extent they were interested in sex and were sexually active (with or without intercourse) during the past 4 weeks. Negative change from baseline values indicates worsening of sexual functioning and positive change indicates improvement.
Time frame: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)
Change From Baseline in Sexual Enjoyment Per EORTC QLQ-BR23
EORTC-QLQ-BR23 is a 23-item breast cancer module developed as a supplement for the EORTC-QLQ-C30 to assess the quality of life of participants with breast cancer, consisting of 2 functional scales, 3 symptoms scales, and 3 single-item scales. Each scale has 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the functional scale of sexual enjoyment, participants self-rated to what extent sex was enjoyable for them during the past 4 weeks. Negative change from baseline values indicates worsening of sexual enjoyment and positive change indicates improvement.
Time frame: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)
Change From Baseline in Future Perspective Per EORTC QLQ-BR23
EORTC-QLQ-BR23 is a 23-item breast cancer module developed as a supplement for the EORTC-QLQ-C30 to assess the quality of life of participants with breast cancer, consisting of 2 functional scales, 3 symptoms scales, and 3 single-item scales. Each scale has 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the functional scale of future perspective, participants self-rated how much they were worried about their health in the future. Negative change from baseline values indicates worsening of future perspective and positive change indicates improvement.
Time frame: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)
Change From Baseline in Systemic Therapy Side Effects Per EORTC QLQ-BR23
EORTC-QLQ-BR23 is a 23-item breast cancer module developed as a supplement for the EORTC-QLQ-C30 to assess the quality of life of participants with breast cancer, consisting of 2 functional scales, 3 symptoms scales, and 3 single-item scales. Each scale has 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the systemic therapy side effects scale, participants self-rated the intensity of symptoms of dry mouth, unusual taste, pain and irritation of eyes, hair loss, feeling ill or unwell, hot flushes and headaches during the past week. Negative change from baseline= improvement of these side effects, positive change = deterioration.
Time frame: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)
Change From Baseline in Breast Symptoms Per EORTC QLQ-BR23
EORTC-QLQ-BR23 is a 23-item breast cancer module developed as a supplement for the EORTC-QLQ-C30 to assess the quality of life of participants with breast cancer, consisting of 2 functional scales, 3 symptoms scales, and 3 single-item scales. Each scale has 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the breast symptoms scale, participants self-rated how much they had pain or skin problems (e.g. itchy, dry, flaky) on or in the area of affected breast, and how much this area was swollen or oversensitive during the past week. Negative change from baseline indicates improvement of breast symptoms and positive change indicates deterioration.
Time frame: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)
Change From Baseline in Arm Symptoms Per EORTC QLQ-BR23
EORTC-QLQ-BR23 is a 23-item breast cancer module developed as a supplement for the EORTC-QLQ-C30 to assess the quality of life of participants with breast cancer, consisting of 2 functional scales, 3 symptoms scales, and 3 single-item scales. Each scale has 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the arm symptoms scale, participants self-rated how much they had pain in the arm or shoulder, how much the arm or hand was swollen, and difficulty in raising the arm or moving it sideways. Negative change from baseline indicates improvement of arm symptoms and positive change indicates deterioration.
Time frame: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)
Change From Baseline in Upset by Hair Loss Per EORTC QLQ-BR23
EORTC-QLQ-BR23 is a 23-item breast cancer module developed as a supplement for the EORTC-QLQ-C30 to assess the quality of life of participants with breast cancer, consisting of 2 functional scales, 3 symptoms scales, and 3 single-item scales. Each scale has 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the upset by hair loss scale, participants self-rated how upset they were due to loss of hair during the past week. Negative change from baseline values indicates improvement of upset by hair loss and positive change indicates deterioration.
Time frame: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)
Number of Participants With Deterioration in Nausea/Vomiting Symptoms
EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the nausea and vomiting symptoms scale, participants self-rated how much they had felt nauseated and/or vomited during the past week. A 10 point change from baseline was used to indicate clinically meaningful change. Deterioration in nausea and vomiting symptoms was defined as a 10 point or more increase from baseline for that specific time point.
Time frame: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)
Number of Participants With Improvement in Nausea/Vomiting Symptoms
EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the nausea and vomiting symptoms scale, participants self-rated how much they had felt nauseated and/or vomited during the past week. A 10 point change from baseline was used to indicate clinically meaningful change. Improvement in nausea and vomiting symptoms was defined as a 10 point or more decrease from baseline for that specific time point.
Time frame: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)
Number of Participants With No Change in Nausea/Vomiting Symptoms
EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all to 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the nausea and vomiting symptoms scale, participants self-rated how much they had felt nauseated and/or vomited during the past week. A 10 point change from baseline was used to indicate clinically meaningful change. No change in nausea/vomiting symptoms=having neither deterioration (≥10 point increase from baseline) nor improvement (≥10 point decrease from baseline) for the time point.
Time frame: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)
Number of Participants With Missed Expected Menstrual Periods Per Patient Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Missed expected menstrual period was assessed electronically using the PRO CTCAE questionnaire, a PRO measure developed to evaluate symptomatic toxicity in patients on cancer clinical trials. This objective captures the concept of fertility preservation through PRO, since there is a possible fertility sparing effect of talazoparib versus chemotherapy.
Time frame: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)
| Milestone | Talazoparib 1 mg QD |
|---|---|
| Started | 61 |
| Completed | 45 |
| Not completed | 16 |
| Withdrew: Adverse event | 3 |
| Withdrew: Progressive disease | 10 |
| Withdrew: Other | 1 |
| Withdrew: Withdrawal by subject | 2 |
| Milestone | Talazoparib 1 mg QD |
|---|---|
| Started | 49 |
| Received treatment | 0 |
| Completed | 49 |
| Not completed | 0 |
| Milestone | Talazoparib 1 mg QD |
|---|---|
| Started | 58 |
| Received treatment | 0 |
| Completed | 0 |
| Not completed | 58 |
| Withdrew: Death | 2 |
| Withdrew: Study terminated by sponsor | 55 |
| Withdrew: Withdrawal by subject | 1 |
pCR was defined as the absence of residual invasive cancer in the breast and axillary lymph nodes on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy (ie, ypT0/Tis ypN0 in the current American Joint Committee on Cancer \[AJCC\] staging system). pCR rate by ICR was defined as the percentage of participants achieving pCR by ICR after talazoparib treatment for 24 weeks, followed by surgery, among all participants in the evaluable population (Evaluable Analysis Set as per ICR). The exact CI was calculated using the Blaker's method.
| Percentage of participants | Talazoparib 1 mg QD |
|---|---|
| Percentage of Participants Achieving Pathological Complete Response (pCR) as Per Independent Central Review (ICR) in Evaluable Analysis Set as Per ICR With 80% Confidence Interval (CI) | 45.8 (36.42 to 55.22) |
pCR was defined as the absence of residual invasive cancer in the breast and axillary lymph nodes on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy (ie, ypT0/Tis ypN0 in the current AJCC staging system). pCR rate by ICR was defined as the percentage of participants achieving pCR by ICR after talazoparib treatment for 24 weeks, followed by surgery, among all participants in the evaluable population (Evaluable Analysis Set as per ICR). The exact CI was calculated using the Blaker's method.
| Percentage of participants | Talazoparib 1 mg QD |
|---|---|
| Percentage of Participants Achieving pCR as Per ICR in Evaluable Analysis Set as Per ICR With 95% CI | 45.8 (31.98 to 60.62) |
pCR was defined as the absence of residual invasive cancer in the breast and axillary lymph nodes on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy (ie, ypT0/Tis ypN0 in the current AJCC staging system). pCR rate by ICR in ITT Analysis Set was defined as the percentage of participants achieving pCR by ICR after talazoparib treatment for 24 weeks, followed by surgery, among all participants in the ITT Analysis Set. The exact CI was calculated using the Blaker's method.
| Percentage of participants | Talazoparib 1 mg QD |
|---|---|
| Percentage of Participants Achieving pCR as Per ICR in Intention-to-Treat (ITT) Analysis Set With 80% CI | 49.2 (40.97 to 57.39) |
pCR was defined as the absence of residual invasive cancer in the breast and axillary lymph nodes on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy (ie, ypT0/Tis ypN0 in the current AJCC staging system). pCR rate by ICR in ITT Analysis Set was defined as the percentage of participants achieving pCR by ICR after talazoparib treatment for 24 weeks, followed by surgery, among all participants in the ITT Analysis Set. The exact CI was calculated using the Blaker's method.
| Percentage of participants | Talazoparib 1 mg QD |
|---|---|
| Percentage of Participants Achieving pCR as Per ICR in ITT Analysis Set With 95% CI | 49.2 (36.70 to 61.63) |
pCR was defined as the absence of residual invasive cancer in the breast and axillary lymph nodes on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy (ie, ypT0/Tis ypN0 in the current AJCC staging system). pCR rate by investigator was defined as the percentage of participants achieving pCR by investigator review after talazoparib treatment for 24 weeks, followed by surgery, among all participants in the evaluable population (Evaluable Analysis Set as per Investigator). The exact CI was calculated using the Blaker's method.
| Percentage of participants | Talazoparib 1 mg QD |
|---|---|
| Percentage of Participants Achieving pCR as Per Investigator in Evaluable Analysis Set as Per Investigator | 45.8 (31.98 to 60.62) |
pCR was defined as the absence of residual invasive cancer in the breast and axillary lymph nodes on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy (ie, ypT0/Tis ypN0 in the current AJCC staging system). pCR rate by investigator in ITT Analysis Set was defined as the percentage of participants achieving pCR by investigator review after talazoparib treatment for 24 weeks, followed by surgery, among all participants in the ITT Analysis Set. The exact CI was calculated using the Blaker's method.
| Percentage of participants | Talazoparib 1 mg QD |
|---|---|
| Percentage of Participants Achieving pCR as Per Investigator in ITT Analysis Set | 47.5 (35.03 to 60.09) |
pCR in breast was defined as the absence of residual invasive cancer in the breast and axillary lymph nodes on hematoxylin and eosin evaluation of the complete resected breast specimen following completion of neoadjuvant therapy with talazoparib. pCR rate in breast by investigator was defined as the percentage of participants achieving pCR in breast by investigator review after talazoparib treatment for 24 weeks, followed by surgery, among all participants in the evaluable population (Evaluable Analysis Set as per Investigator). The exact CI was calculated using the Blaker's method.
| Percentage of participants | Talazoparib 1 mg QD |
|---|---|
| Percentage of Participants Achieving pCR in Breast Only as Per Investigator in Evaluable Analysis Set as Per Investigator | 45.8 (31.98 to 60.62) |
pCR in breast was defined as the absence of residual invasive cancer in the breast and axillary lymph nodes on hematoxylin and eosin evaluation of the complete resected breast specimen following completion of neoadjuvant therapy with talazoparib. pCR rate in breast by investigator in ITT Analysis Set was defined as the percentage of participants achieving pCR in breast by investigator review after talazoparib treatment for 24 weeks, followed by surgery, among all participants in the ITT Analysis Set. The exact CI was calculated using the Blaker's method.
| Percentage of participants | Talazoparib 1 mg QD |
|---|---|
| Percentage of Participants Achieving pCR in Breast Only as Per Investigator in ITT Analysis Set | 47.5 (35.03 to 60.09) |
pCR in breast was defined as the absence of residual invasive cancer in the breast and axillary lymph nodes on hematoxylin and eosin evaluation of the complete resected breast specimen following completion of neoadjuvant therapy with talazoparib. pCR rate in breast by ICR was defined as the percentage of participants achieving pCR in breast by ICR after talazoparib treatment for 24 weeks, followed by surgery, among all participants in the evaluable population (Evaluable Analysis Set as per ICR). The exact CI was calculated using the Blaker's method.
| Percentage of participants | Talazoparib 1 mg QD |
|---|---|
| Percentage of Participants Achieving pCR in Breast Only as Per ICR in Evaluable Analysis Set as Per ICR | 47.9 (34.11 to 62.75) |
pCR in breast was defined as the absence of residual invasive cancer in the breast and axillary lymph nodes on hematoxylin and eosin evaluation of the complete resected breast specimen following completion of neoadjuvant therapy with talazoparib. pCR rate in breast by ICR in ITT Analysis Set was defined as the percentage of participants achieving pCR in breast by ICR after talazoparib treatment for 24 weeks, followed by surgery, among all participants in the ITT Analysis Set. The exact CI was calculated using the Blaker's method.
| Percentage of participants | Talazoparib 1 mg QD |
|---|---|
| Percentage of Participants Achieving pCR in Breast Only as Per ICR in ITT Analysis Set | 50.8 (38.37 to 63.30) |
The RCB is a continuous index derived from the following: primary tumor dimensions; cellularity of the tumor bed; axillary nodal burden. Residual cancer burden by ICR is reported as a categorical variable with four classes (categories): RCB 0 (pCR), I (minimal RCB), II (moderate RCB), III (extensive RCB). Participants who had progressive disease or was unable to be assessed for RCB due to missing required axillary specimen were counted in the "Missing" category. The simultaneous exact CI was calculated using Goodman's method.
| Percentage of participants | Talazoparib 1 mg QD |
|---|---|
| RCB - 0 | 45.8 (29.0 to 63.7) |
| RCB - I | 0.0 (0.0 to 12.1) |
| RCB - II | 31.3 (17.2 to 49.8) |
| RCB - III | 0.0 (0.0 to 12.1) |
| Missing (Participants who had progressive disease or with missing required axillary specimen) | 22.9 (11.2 to 41.2) |
The RCB is a continuous index derived from the following: primary tumor dimensions; cellularity of the tumor bed; axillary nodal burden. Residual cancer burden by ICR is reported as a categorical variable with four classes (categories): RCB 0 (pCR), I (minimal RCB), II (moderate RCB), III (extensive RCB). Participants who had progressive disease or was unable to be assessed for RCB due to missing required axillary specimen were counted in the "Missing" category. The simultaneous exact CI was calculated using Goodman's method.
| Percentage of participants | Talazoparib 1 mg QD |
|---|---|
| RCB - 0 | 49.2 (33.6 to 64.9) |
| RCB - I | 1.6 (0.2 to 12.6) |
| RCB - II | 27.9 (15.8 to 44.2) |
| RCB - III | 0.0 (0.0 to 9.8) |
| Missing (Participants who had progressive disease or with missing required axillary specimen) | 21.3 (11.0 to 37.3) |
Event-Free Survival (EFS) is defined as the time from surgery date to first documentation of local or distant recurrence or death or initiation of antineoplastic therapy before documentation of first relapse. Participants discontinuing study before documentation of first relapse or death, but after surgery were censored observations for EFS. EFS at 3 years is defined as the probability of being event free at 3 years after surgery using Kaplan Meier methods.
No measurements were reported for this outcome.
Overall Survival (OS) is defined as the time from first dose of talazoparib to death due to any cause. Participants not known to have died at the time of the analysis were right censored on the date they were last known to be alive before the analysis data cutoff date. OS at 3 years is defined as the probability of being alive at 3 years after first dose of talazoparib using Kaplan Meier methods.
No measurements were reported for this outcome.
OS is defined as the time from first dose of talazoparib to death due to any cause. Participants not known to have died at the time of the analysis were right censored on the date they were last known to be alive before the analysis data cutoff date. OS at 3 years is defined as the probability of being alive at 3 years after first dose of talazoparib using Kaplan Meier methods.
No measurements were reported for this outcome.
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with study treatment. TEAEs=AEs that occurred between first dose of study drug and up to 28 days after the last dose that were absent before treatment or worsened relative to pretreatment state. Grades of AEs were defined by National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 4.03. Grade 1=asymptomatic/mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2=minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activity of daily living (ADL); Grade 3=severe or medically significant but not immediately life-threatening, hospitalization of prolongation of hospitalization indicated; disabling limiting self-care ADL; Grade 4=events with life-threatening consequences, urgent intervention indicated; Grade 5= death related to AE.
| Participants | Talazoparib 1 mg QD |
|---|---|
| All-causality TEAEs | 60 |
| All-causality Grade 3 or 4 TEAEs | 29 |
| All-causality Grade 5 TEAEs | 0 |
| Treatment-related TEAEs | 58 |
| Treatment-related Grade 3 or 4 TEAEs | 27 |
| Treatment-related Grade 5 TEAEs | 0 |
An SAE was any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect. Treatment-related SAEs were determined by the investigator.
| Participants | Talazoparib 1 mg QD |
|---|---|
| All-causality SAEs | 11 |
| Treatment-related SAEs | 9 |
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with the study treatment. TEAEs were AEs that occurred between first dose of study drug and up to 28 days after the last dose that were absent before treatment or that worsened relative to pretreatment state.
| Participants | Talazoparib 1 mg QD |
|---|---|
| All-causality TEAEs | 3 |
| Treatment-related TEAEs | 3 |
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with the study treatment. TEAEs were AEs that occurred between first dose of study drug and up to 28 days after the last dose that were absent before treatment or that worsened relative to pretreatment state.
| Participants | Talazoparib 1 mg QD |
|---|---|
| All-causality TEAEs | 20 |
| Treatment-related TEAEs | 19 |
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with the study treatment. TEAEs were AEs that occurred between first dose of study drug and up to 28 days after the last dose that were absent before treatment or that worsened relative to pretreatment state.
| Participants | Talazoparib 1 mg QD |
|---|---|
| All-causality TEAEs | 24 |
| Treatment-related TEAEs | 24 |
Laboratory parameters included hematology, serum chemistry, urinalysis and coagulation. Grades of laboratory abnormalities were defined according to NCI CTCAE version 4.03. Participants with laboratory test abnormalities meeting specified criteria (\>upper limit of normal \[ULN\] or \<lower limit of normal \[LLN\]) (without regards to baseline abnormality) are reported.
| Participants | Talazoparib 1 mg QD |
|---|---|
| Erythrocyte Mean Corpuscular Volume <LLN | 1 |
| Erythrocyte Mean Corpuscular Volume >ULN | 33 |
| Erythrocytes <LLN | 38 |
| Hematocrit <LLN | 39 |
| Blood urea nitrogen >ULN | 3 |
| Lactate dehydrogenase >ULN | 8 |
| Protein <LLN | 5 |
| Protein >ULN | 2 |
| Prothrombin Time <LLN | 2 |
Hematology laboratory parameters included hematocrit, hemoglobin, mean corpuscular volume, red blood cells, platelets, white blood cells with differential (neutrophils, lymphocytes, monocytes, eosinophils, basophils). Grades of lab results were defined by NCI CTCAE version 4.03. Grade 1(mild)=asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2(moderate)=minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activity of daily living (ADL); Grade 3=severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated; disabling limiting self-care ADL; Grade 4=life-threatening consequences, urgent intervention indicated; Grade 5=death related to AE. This outcome measure was based only on laboratory data. As Grade 4 anemia cannot be assessed based only on laboratory data, it was not applicable for analysis in this outcome measure.
| Participants | Talazoparib 1 mg QD |
|---|---|
| Anemia Grade 0 to Grade 3 | 7 |
| Anemia Grade 1 to Grade 3 | 1 |
| Anemia Grade 2 to Grade 3 | 0 |
| Lymphocyte count decreased Grade 0 to Grade 3 | 1 |
| Lymphocyte count decreased Grade 1 to Grade 3 | 0 |
| Lymphocyte count decreased Grade 2 to Grade 3 | 0 |
| Lymphocyte count decreased Grade 0 to Grade 4 | 0 |
| Lymphocyte count decreased Grade 1 to Grade 4 | 0 |
| Lymphocyte count decreased Grade 2 to Grade 4 | 0 |
| Neutrophil count decreased Grade 0 to Grade 3 | 3 |
| Neutrophil count decreased Grade 0 to Grade 4 | 0 |
| Neutrophil count decreased Grade 1 to Grade 3 | 0 |
| Neutrophil count decreased Grade 1 to Grade 4 | 0 |
| Neutrophil count decreased Grade 2 to Grade 3 | 0 |
| Neutrophil count decreased Grade 2 to Grade 4 | 0 |
| White blood cell decreased Grade 0 to Grade 3 | 1 |
| White blood cell decreased Grade 0 to Grade 4 | 0 |
| White blood cell decreased Grade 1 to Grade 3 | 0 |
| White blood cell decreased Grade 1 to Grade 4 | 0 |
| White blood cell decreased Grade 2 to Grade 3 | 0 |
| White blood cell decreased Grade 2 to Grade 4 | 0 |
Chemistry laboratory parameters included albumin, total protein, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, total bilirubin, blood urea nitrogen, creatinine, non-fasting glucose, bicarbonate, calcium, chloride, magnesium, phosphate, potassium, sodium, and lactate dehydrogenase. Grades of laboratory results were defined by NCI CTCAE version 4.03. Grade 1 (Mild) = asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2 (Moderate ) = minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activity of daily living (ADL); Grade 3 = severe or medically significant but not immediately life-threatening, hospitalization of prolongation of hospitalization indicated; disabling limiting self-care ADL; Grade 4 = events with life-threatening consequences, urgent intervention indicated; Grade 5 = death related to AE.
| Participants | Talazoparib 1 mg QD |
|---|---|
| Hyperglycemia Baseline grade not reported to Grade 3 | 0 |
| Hyperglycemia Baseline grade not reported to Grade 4 | 0 |
| Hyperglycemia Grade 0 to Grade 3 | 1 |
| Hyperglycemia Grade 0 to Grade 4 | 0 |
| Hyperglycemia Grade 1 to Grade 3 | 0 |
| Hyperglycemia Grade 1 to Grade 4 | 0 |
| Hyperglycemia Grade 2 to Grade 3 | 0 |
| Hyperglycemia Grade 2 to Grade 4 | 0 |
| Hypophosphatemia Baseline grade not reported to Grade 3 | 0 |
| Hypophosphatemia Baseline grade not reported to Grade 4 | 0 |
| Hypophosphatemia Grade 0 to Grade 3 | 1 |
| Hypophosphatemia Grade 0 to Grade 4 | 0 |
| Hypophosphatemia Grade 1 to Grade 3 | 0 |
| Hypophosphatemia Grade 1 to Grade 4 | 0 |
| Hypophosphatemia Grade 2 to Grade 3 | 0 |
| Hypophosphatemia Grade 2 to Grade 4 | 0 |
| picograms per milliliter (pg/mL) | Talazoparib 1 mg QD |
|---|---|
| Cycle 2 | 4703 ± 71.5 |
| Cycle 3 | 4699 ± 119.9 |
| Cycle 4 | 4198 ± 139.8 |
Within-participant average Ctrough of talazoparib at steady state for each participant was defined as the average (mean) value of the steady state Ctrough values (Cycle 2 Day 1, Cycle 3 Day 1 and Cycle 4 Day 1 trough concentrations) for each individual participant.
| pg/mL | Talazoparib 1 mg QD |
|---|---|
| Within-Participant Average Ctrough of Talazoparib at Steady State in PK Analysis Set | 4525 ± 109.5 |
| pg/mL | Talazoparib 1 mg QD |
|---|---|
| Cycle 2 | 5241 ± 57.9 |
| Cycle 3 | 5208 ± 53.8 |
| Cycle 4 | 4537 ± 84.6 |
Within-participant average Ctrough of talazoparib at steady state for each participant was defined as the average (mean) value of the steady state Ctrough values (Cycle 2 Day 1, Cycle 3 Day 1 and Cycle 4 Day 1 trough concentrations) for each individual participant.
| pg/mL | Talazoparib 1 mg QD |
|---|---|
| Within-Participant Average Ctrough of Talazoparib at Steady State in Dose-Compliant PK Analysis Set | 5001 ± 65.2 |
EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes (PROs), consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the GHS/QoL scale, participants rated their overall health and quality of life within the past week. A 10 point change from baseline was used to indicate clinically meaningful change. Definitive deterioration was defined as ≥10 point decrease from baseline without any subsequent \<10 point decrease.
| Participants | Talazoparib 1 mg QD |
|---|---|
| Number of Participants Who Achieved Definitive Deterioration in Global Health Status (GHS)/Quality of Life (QoL) Per European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-30) | 19 |
EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the GHS/QoL scale, participants rated their overall health and quality of life within the past week. A 10 point change from baseline was used to indicate clinically meaningful change. Definitive deterioration was defined as ≥10 point decrease from baseline without any subsequent \<10 point decrease.
| Months | Talazoparib 1 mg QD |
|---|---|
| Kaplan-Meier Estimate of Time to Definitive Deterioration in GHS/QoL Per EORTC QLQ-30 | NA (4.6 to NA) |
EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all to 4=very much). For the GHS/QoL scale, participants rated their overall health and quality of life within the past week. A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best. A 10 point change from baseline was used to indicate clinically meaningful change. Definitive deterioration was defined as ≥10 point decrease from baseline without any subsequent \<10 point decrease. Probability of not achieving definitive deterioration (being event-free) at specified time points (3 and 6 months post-baseline) using the Kaplan Meier method were reported.
| Probability of being event-free | Talazoparib 1 mg QD |
|---|---|
| 3 months | 0.696 (0.547 to 0.805) |
| 6 months | 0.594 (0.435 to 0.721) |
EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the nausea and vomiting symptoms scale, participants self-rated how much they had felt nauseated and/or vomited during the past week. A 10 point change from baseline was used to indicate clinically meaningful change. Definitive deterioration was defined as ≥10 point increase from baseline without any subsequent \<10 point increase.
| Participants | Talazoparib 1 mg QD |
|---|---|
| Number of Participants Who Achieved Definitive Deterioration in Nausea and Vomiting Symptoms Per EORTC QLQ-C30 | 9 |
EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the nausea and vomiting symptoms scale, participants self-rated how much they had felt nauseated and/or vomited during the past week. A 10 point change from baseline was used to indicate clinically meaningful change. Definitive deterioration was defined as ≥10 point increase from baseline without any subsequent \<10 point increase.
| Months | Talazoparib 1 mg QD |
|---|---|
| Kaplan-Meier Estimate of Time to Definitive Deterioration in Nausea and Vomiting Symptoms Per EORTC QLQ-C30 | NA (NA to NA) |
EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, with 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores (1=very poor to 7=excellent); other items have 4 possible scores (1=not at all to 4=very much). For the nausea and vomiting symptoms scale, participants self-rated how much they had felt nauseated and/or vomited during the past week. A linear transformation was applied to raw scores so that transformed scores lie between 0 to 100, with 0 being the best and 100 being the worst for this symptom scale. A 10 point change from baseline was used to indicate clinically meaningful change. Definitive deterioration was defined as≥10 point increase from baseline without any subsequent \<10 point increase. Probability of not achieving definitive deterioration (being event-free) at specified time points (3 and 6 months post-baseline) using Kaplan Meier method were reported.
| Probability of being event-free | Talazoparib 1 mg QD |
|---|---|
| 3 months | 0.863 (0.734 to 0.932) |
| 6 months | 0.818 (0.678 to 0.901) |
EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the GHS/QoL scale, participants rated their overall health and quality of life within the past week. Negative change from baseline indicates deterioration in GHS/QoL and positive change indicates improvement.
| Units on a scale | Talazoparib 1 mg QD |
|---|---|
| Cycle 1 Day 15 | -6.0 (-10.43 to -1.59) |
| Cycle 2 Day 1 | -7.4 (-11.98 to -2.87) |
| Cycle 2 Day 15 | -5.3 (-9.36 to -1.25) |
| Cycle 3 Day 1 | -9.1 (-14.70 to -3.42) |
| Cycle 4 Day 1 | -10.3 (-15.14 to -5.40) |
| Cycle 5 Day 1 | -13.0 (-19.29 to -6.78) |
| Cycle 6 Day 1 | -11.3 (-17.17 to -5.41) |
| End of treatment | -7.9 (-13.00 to -2.71) |
| Post-surgical follow-up | -13.3 (-19.64 to -7.02) |
EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the physical functioning scale, participants self-rated levels of difficulty in doing strenuous activities, taking a walk, how much they needed to stay in bed or a chair, or needed help with eating, dressing, bathing, using the toilet. Negative change from baseline indicates deterioration in physical functioning and positive change indicates improvement.
| Units on a scale | Talazoparib 1 mg QD |
|---|---|
| Cycle 1 Day 15 | -3.6 (-5.73 to -1.40) |
| Cycle 2 Day 1 | -6.1 (-9.12 to -3.05) |
| Cycle 2 Day 15 | -6.1 (-8.95 to -3.17) |
| Cycle 3 Day 1 | -8.4 (-12.53 to -4.29) |
| Cycle 4 Day 1 | -9.3 (-12.66 to -5.95) |
| Cycle 5 Day 1 | -9.7 (-14.39 to -5.10) |
| Cycle 6 Day 1 | -9.0 (-13.82 to -4.24) |
| End of treatment | -5.1 (-8.83 to -1.45) |
| Post-surgical follow-up | -14.2 (-21.16 to -7.28) |
EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the role functioning scale, participants self-rated how much they were limited in doing work or daily activities, or in pursuing hobbies or other leisure time activities during the past week. Negative change from baseline values indicates deterioration in role functioning and positive change indicates improvement.
| Units on a scale | Talazoparib 1 mg QD |
|---|---|
| Cycle 1 Day 15 | -4.7 (-9.31 to 0.01) |
| Cycle 2 Day 1 | -9.4 (-14.71 to -4.14) |
| Cycle 2 Day 15 | -6.4 (-10.97 to -1.91) |
| Cycle 3 Day 1 | -10.9 (-18.04 to -3.70) |
| Cycle 4 Day 1 | -8.9 (-13.15 to -4.67) |
| Cycle 5 Day 1 | -9.4 (-15.94 to -2.87) |
| Cycle 6 Day 1 | -7.0 (-12.85 to -1.13) |
| End of treatment | -4.8 (-10.90 to 1.38) |
| Post-surgical follow-up | -21.7 (-31.49 to -11.84) |
EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the emotional functioning scale, participants self-rated how much they felt tense, worried, irritable or depressed during the past week. Negative change from baseline values indicates deterioration in emotional functioning and positive change indicates improvement.
| Units on a scale | Talazoparib 1 mg QD |
|---|---|
| Cycle 1 Day 15 | 2.9 (-2.10 to 7.91) |
| Cycle 2 Day 1 | 0.4 (-4.39 to 5.11) |
| Cycle 2 Day 15 | 1.3 (-3.74 to 6.39) |
| Cycle 3 Day 1 | -0.9 (-6.05 to 4.24) |
| Cycle 4 Day 1 | -4.8 (-9.47 to -0.22) |
| Cycle 5 Day 1 | -3.0 (-8.89 to 2.90) |
| Cycle 6 Day 1 | -7.8 (-14.54 to -1.06) |
| End of treatment | -4.0 (-9.87 to 1.78) |
| Post-surgical follow-up | -3.1 (-10.61 to 4.50) |
EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the cognitive functioning scale, participants self-rated the extent of difficulty in concentrating on things or remembering things during the past week. Negative change from baseline values indicates deterioration in cognitive functioning and positive change indicates improvement.
| Units on a scale | Talazoparib 1 mg QD |
|---|---|
| Cycle 1 Day 15 | -2.3 (-7.02 to 2.37) |
| Cycle 2 Day 1 | -5.4 (-9.62 to -1.25) |
| Cycle 2 Day 15 | -5.3 (-9.78 to -0.83) |
| Cycle 3 Day 1 | -6.9 (-12.93 to -0.84) |
| Cycle 4 Day 1 | -9.7 (-15.64 to -3.74) |
| Cycle 5 Day 1 | -7.7 (-13.49 to -1.90) |
| Cycle 6 Day 1 | -9.7 (-17.69 to -1.66) |
| End of treatment | -7.1 (-13.84 to -0.44) |
| Post-surgical follow-up | -7.8 (-16.98 to 1.43) |
EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the social functioning scale, participants self-rated how much their physical condition or medical treatment interfered with their family life and social activities during the past week. Negative change from baseline values indicates deterioration in social functioning and positive change indicates improvement.
| Units on a scale | Talazoparib 1 mg QD |
|---|---|
| Cycle 1 Day 15 | -2.3 (-8.62 to 3.96) |
| Cycle 2 Day 1 | -4.3 (-9.71 to 1.02) |
| Cycle 2 Day 15 | -1.9 (-7.16 to 3.37) |
| Cycle 3 Day 1 | -7.6 (-14.18 to -1.03) |
| Cycle 4 Day 1 | -5.4 (-10.00 to -0.85) |
| Cycle 5 Day 1 | -6.0 (-14.25 to 2.28) |
| Cycle 6 Day 1 | -8.1 (-15.45 to -0.68) |
| End of treatment | -8.1 (-14.21 to -1.98) |
| Post-surgical follow-up | -20.6 (-30.59 to -10.52) |
EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the fatigue symptoms scale, participants self-rated how much they had felt weak, tired or needed to rest during the past week. Negative change from baseline values indicates improvement of fatigue symptoms and positive change indicates deterioration.
| Units on a scale | Talazoparib 1 mg QD |
|---|---|
| Cycle 1 Day 15 | 16.3 (9.98 to 22.58) |
| Cycle 2 Day 1 | 18.4 (12.70 to 24.02) |
| Cycle 2 Day 15 | 17.4 (11.58 to 23.27) |
| Cycle 3 Day 1 | 21.0 (13.88 to 28.15) |
| Cycle 4 Day 1 | 22.2 (16.74 to 27.71) |
| Cycle 5 Day 1 | 21.7 (14.45 to 28.85) |
| Cycle 6 Day 1 | 20.4 (12.41 to 28.45) |
| End of treatment | 14.3 (7.32 to 21.25) |
| Post-surgical follow-up | 23.3 (16.33 to 30.34) |
EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the nausea and vomiting symptoms scale, participants self-rated how much they had felt nauseated and/or vomited during the past week. Negative change from baseline values indicates improvement of nausea and vomiting symptoms and positive change indicates deterioration.
| Units on a scale | Talazoparib 1 mg QD |
|---|---|
| Cycle 1 Day 15 | 11.2 (6.80 to 15.68) |
| Cycle 2 Day 1 | 8.0 (4.40 to 11.55) |
| Cycle 2 Day 15 | 7.2 (3.67 to 10.72) |
| Cycle 3 Day 1 | 5.4 (1.97 to 8.90) |
| Cycle 4 Day 1 | 3.9 (0.74 to 7.01) |
| Cycle 5 Day 1 | 4.3 (1.06 to 7.49) |
| Cycle 6 Day 1 | 7.5 (2.83 to 12.22) |
| End of treatment | 0.5 (-2.46 to 3.42) |
| Post-surgical follow-up | 1.1 (-2.13 to 4.35) |
EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the pain symptoms scale, participants self-rated the extent of pain and how much the pain interfered with daily activities during the past week. Negative change from baseline values indicates improvement of pain symptoms and positive change indicates deterioration.
| Units on a scale | Talazoparib 1 mg QD |
|---|---|
| Cycle 1 Day 15 | -1.9 (-6.01 to 2.13) |
| Cycle 2 Day 1 | -0.0 (-4.78 to 4.78) |
| Cycle 2 Day 15 | -1.5 (-6.50 to 3.47) |
| Cycle 3 Day 1 | 0.7 (-4.99 to 6.44) |
| Cycle 4 Day 1 | -2.7 (-7.83 to 2.41) |
| Cycle 5 Day 1 | 1.3 (-6.09 to 8.66) |
| Cycle 6 Day 1 | -1.1 (-7.76 to 5.61) |
| End of treatment | 1.4 (-4.36 to 7.22) |
| Post-surgical follow-up | 14.4 (6.65 to 22.24) |
EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the dyspnoea symptoms scale, participants self-rated the intensity of shortness of breath during the past week. Negative change from baseline values indicates improvement of dyspnoea symptoms and positive change indicates deterioration.
| Units on a scale | Talazoparib 1 mg QD |
|---|---|
| Cycle 1 Day 15 | -0.8 (-2.34 to 0.79) |
| Cycle 2 Day 1 | 5.1 (0.42 to 9.72) |
| Cycle 2 Day 15 | 5.3 (0.44 to 10.16) |
| Cycle 3 Day 1 | 8.0 (2.38 to 13.56) |
| Cycle 4 Day 1 | 16.3 (9.43 to 23.13) |
| Cycle 5 Day 1 | 8.5 (3.16 to 13.93) |
| Cycle 6 Day 1 | 8.6 (2.31 to 14.89) |
| End of treatment | 3.8 (-0.81 to 8.43) |
| Post-surgical follow-up | 4.4 (-2.67 to 11.56) |
EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the insomnia symptoms scale, participants self-rated the intensity of shortness of breath during the past week. Negative change from baseline values indicates improvement of insomnia symptoms and positive change indicates deterioration.
| Units on a scale | Talazoparib 1 mg QD |
|---|---|
| Cycle 1 Day 15 | -4.7 (-12.59 to 3.29) |
| Cycle 2 Day 1 | -4.3 (-13.10 to 4.41) |
| Cycle 2 Day 15 | -10.6 (-18.72 to -2.49) |
| Cycle 3 Day 1 | -6.5 (-14.50 to 1.46) |
| Cycle 4 Day 1 | -7.0 (-15.52 to 1.56) |
| Cycle 5 Day 1 | -2.6 (-12.90 to 7.77) |
| Cycle 6 Day 1 | -6.5 (-18.85 to 5.94) |
| End of treatment | -4.8 (-16.59 to 7.07) |
| Post-surgical follow-up | 1.1 (-13.68 to 15.90) |
EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the appetite loss symptoms scale, participants self-rated the extent of lack of appetite during the past week. Negative change from baseline values indicates improvement of appetite loss symptoms and positive change indicates deterioration.
| Units on a scale | Talazoparib 1 mg QD |
|---|---|
| Cycle 1 Day 15 | 10.1 (2.47 to 17.68) |
| Cycle 2 Day 1 | 3.6 (-3.37 to 10.62) |
| Cycle 2 Day 15 | 0.8 (-6.32 to 7.84) |
| Cycle 3 Day 1 | 5.8 (-2.63 to 14.22) |
| Cycle 4 Day 1 | 3.1 (-3.91 to 10.11) |
| Cycle 5 Day 1 | 4.3 (-3.64 to 12.18) |
| Cycle 6 Day 1 | 4.3 (-4.48 to 13.09) |
| End of treatment | 1.9 (-4.87 to 8.67) |
| Post-surgical follow-up | 2.2 (-5.74 to 10.18) |
EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the constipation symptoms scale, participants self-rated the intensity of constipation during the past week. Negative change from baseline values indicates improvement of constipation symptoms and positive change indicates deterioration.
| Units on a scale | Talazoparib 1 mg QD |
|---|---|
| Cycle 1 Day 15 | 12.4 (5.32 to 19.49) |
| Cycle 2 Day 1 | 9.4 (1.71 to 17.13) |
| Cycle 2 Day 15 | 12.1 (4.84 to 19.40) |
| Cycle 3 Day 1 | 8.0 (0.69 to 15.26) |
| Cycle 4 Day 1 | 6.2 (-0.23 to 12.63) |
| Cycle 5 Day 1 | 7.7 (0.48 to 14.90) |
| Cycle 6 Day 1 | 5.4 (-4.65 to 15.41) |
| End of treatment | 3.8 (-1.58 to 9.20) |
| Post-surgical follow-up | 3.3 (-4.90 to 11.57) |
EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the diarrhea symptoms scale, participants self-rated the intensity of diarrhea during the past week. Negative change from baseline values indicates improvement of diarrhea symptoms and positive change indicates deterioration.
| Units on a scale | Talazoparib 1 mg QD |
|---|---|
| Cycle 1 Day 15 | 1.6 (-2.30 to 5.40) |
| Cycle 2 Day 1 | 2.2 (-1.68 to 6.02) |
| Cycle 2 Day 15 | 1.5 (-2.24 to 5.27) |
| Cycle 3 Day 1 | 0.0 (-2.09 to 2.09) |
| Cycle 4 Day 1 | 2.3 (-1.14 to 5.79) |
| Cycle 5 Day 1 | 3.4 (-1.41 to 8.25) |
| Cycle 6 Day 1 | 0.0 (-4.46 to 4.46) |
| End of treatment | 1.9 (-0.79 to 4.60) |
| Post--surgical follow-up | 1.1 (-2.87 to 5.09) |
EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the symptom scale of financial difficulties, participants self-rated how much their physical condition or medical treatment caused financial difficulties. Negative change from baseline values indicates improvement of financial difficulties and positive change indicates deterioration.
| Units on a scale | Talazoparib 1 mg QD |
|---|---|
| Cycle 1 Day 15 | -3.9 (-8.47 to 0.72) |
| Cycle 2 Day 1 | -1.4 (-9.52 to 6.62) |
| Cycle 2 Day 15 | -3.0 (-11.15 to 5.09) |
| Cycle 3 Day 1 | -0.7 (-8.39 to 6.94) |
| Cycle 4 Day 1 | 1.6 (-6.81 to 9.91) |
| Cycle 5 Day 1 | 5.1 (-5.25 to 15.51) |
| Cycle 6 Day 1 | 3.2 (-8.31 to 14.76) |
| End of treatment | 10.5 (-0.20 to 21.15) |
| Post-surgical follow-up | 16.7 (4.55 to 28.79) |
EORTC-QLQ-BR23 is a 23-item breast cancer module developed as a supplement for the EORTC-QLQ-C30 to assess the quality of life of participants with breast cancer, consisting of 2 functional scales, 3 symptoms scales, and 3 single-item scales. Each scale has 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the functional scale of body image, participants self-rated how much they felt physically less attractive or less feminine, difficult to look at themselves naked, or dissatisfied with their body during the past week. Negative change from baseline indicates worsening of self-rated body image and positive change indicates improvement.
| Units on a scale | Talazoparib 1 mg QD |
|---|---|
| Cycle 1 Day 15 | 0.2 (-2.79 to 3.18) |
| Cycle 2 Day 1 | 1.7 (-1.37 to 4.78) |
| Cycle 2 Day 15 | -0.2 (-3.84 to 3.45) |
| Cycle 3 Day 1 | -0.4 (-3.53 to 2.79) |
| Cycle 4 Day 1 | -6.3 (-11.11 to -1.59) |
| Cycle 5 Day 1 | -9.4 (-15.17 to -3.69) |
| Cycle 6 Day 1 | -6.1 (-11.08 to -1.14) |
| End of treatment | -6.9 (-12.10 to -1.63) |
| Post-surgical follow-up | -13.8 (-20.64 to -6.95) |
EORTC-QLQ-BR23 is a 23-item breast cancer module developed as a supplement for the EORTC-QLQ-C30 to assess the quality of life of participants with breast cancer, consisting of 2 functional scales, 3 symptoms scales, and 3 single-item scales. Each scale has 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the sexual functioning scale, participants self-rated to what extent they were interested in sex and were sexually active (with or without intercourse) during the past 4 weeks. Negative change from baseline values indicates worsening of sexual functioning and positive change indicates improvement.
| Units on a scale | Talazoparib 1 mg QD |
|---|---|
| Cycle 1 Day 15 | -1.6 (-7.45 to 4.35) |
| Cycle 2 Day 1 | -3.0 (-9.33 to 3.27) |
| Cycle 2 Day 15 | -2.7 (-8.73 to 3.31) |
| Cycle 3 Day 1 | -0.4 (-7.33 to 6.59) |
| Cycle 4 Day 1 | -1.2 (-8.39 to 6.01) |
| Cycle 5 Day 1 | -3.5 (-11.17 to 4.15) |
| Cycle 6 Day 1 | -2.8 (-11.59 to 6.04) |
| End of treatment | -3.4 (-11.11 to 4.25) |
| Post-surgical follow-up | -10.9 (-20.55 to -1.29) |
EORTC-QLQ-BR23 is a 23-item breast cancer module developed as a supplement for the EORTC-QLQ-C30 to assess the quality of life of participants with breast cancer, consisting of 2 functional scales, 3 symptoms scales, and 3 single-item scales. Each scale has 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the functional scale of sexual enjoyment, participants self-rated to what extent sex was enjoyable for them during the past 4 weeks. Negative change from baseline values indicates worsening of sexual enjoyment and positive change indicates improvement.
| Units on a scale | Talazoparib 1 mg QD |
|---|---|
| Cycle 1 Day 15 | -3.3 (-11.95 to 5.29) |
| Cycle 2 Day 1 | 0.0 (-11.75 to 11.75) |
| Cycle 2 Day 15 | -3.7 (-16.28 to 8.87) |
| Cycle 3 Day 1 | -10.5 (-21.31 to 0.25) |
| Cycle 4 Day 1 | -12.3 (-23.27 to -1.29) |
| Cycle 5 Day 1 | -5.9 (-18.35 to 6.59) |
| Cycle 6 Day 1 | -12.8 (-28.29 to 2.65) |
| End of treatment | -13.3 (-30.14 to 3.47) |
| Post-surgical follow-up | -18.5 (-37.13 to 0.10) |
EORTC-QLQ-BR23 is a 23-item breast cancer module developed as a supplement for the EORTC-QLQ-C30 to assess the quality of life of participants with breast cancer, consisting of 2 functional scales, 3 symptoms scales, and 3 single-item scales. Each scale has 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the functional scale of future perspective, participants self-rated how much they were worried about their health in the future. Negative change from baseline values indicates worsening of future perspective and positive change indicates improvement.
| Units on a scale | Talazoparib 1 mg QD |
|---|---|
| Cycle 1 Day 15 | 3.1 (-3.91 to 10.11) |
| Cycle 2 Day 1 | 11.4 (3.50 to 19.23) |
| Cycle 2 Day 15 | 11.6 (3.91 to 19.34) |
| Cycle 3 Day 1 | 5.9 (-2.42 to 14.27) |
| Cycle 4 Day 1 | 5.6 (-2.36 to 13.48) |
| Cycle 5 Day 1 | 6.1 (-1.86 to 14.14) |
| Cycle 6 Day 1 | 6.7 (-3.87 to 17.21) |
| End of treatment | -2.0 (-12.26 to 8.34) |
| Post-surgical follow-up | 10.3 (-0.95 to 21.64) |
EORTC-QLQ-BR23 is a 23-item breast cancer module developed as a supplement for the EORTC-QLQ-C30 to assess the quality of life of participants with breast cancer, consisting of 2 functional scales, 3 symptoms scales, and 3 single-item scales. Each scale has 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the systemic therapy side effects scale, participants self-rated the intensity of symptoms of dry mouth, unusual taste, pain and irritation of eyes, hair loss, feeling ill or unwell, hot flushes and headaches during the past week. Negative change from baseline= improvement of these side effects, positive change = deterioration.
| Units on a scale | Talazoparib 1 mg QD |
|---|---|
| Cycle 1 Day 15 | 7.1 (3.74 to 10.43) |
| Cycle 2 Day 1 | 6.6 (3.70 to 9.50) |
| Cycle 2 Day 15 | 9.1 (5.90 to 12.26) |
| Cycle 3 Day 1 | 11.2 (7.57 to 14.87) |
| Cycle 4 Day 1 | 15.0 (10.93 to 19.00) |
| Cycle 5 Day 1 | 13.5 (9.10 to 17.97) |
| Cycle 6 Day 1 | 16.5 (11.57 to 21.44) |
| End of treatment | 6.9 (3.22 to 10.50) |
| Post-surgical follow-up | 3.3 (-0.28 to 6.84) |
EORTC-QLQ-BR23 is a 23-item breast cancer module developed as a supplement for the EORTC-QLQ-C30 to assess the quality of life of participants with breast cancer, consisting of 2 functional scales, 3 symptoms scales, and 3 single-item scales. Each scale has 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the breast symptoms scale, participants self-rated how much they had pain or skin problems (e.g. itchy, dry, flaky) on or in the area of affected breast, and how much this area was swollen or oversensitive during the past week. Negative change from baseline indicates improvement of breast symptoms and positive change indicates deterioration.
| Units on a scale | Talazoparib 1 mg QD |
|---|---|
| Cycle 1 Day 15 | -2.1 (-5.97 to 1.71) |
| Cycle 2 Day 1 | -4.9 (-9.02 to -0.82) |
| Cycle 2 Day 15 | -9.1 (-13.61 to -4.60) |
| Cycle 3 Day 1 | -8.0 (-12.20 to -3.73) |
| Cycle 4 Day 1 | -5.6 (-9.72 to -1.39) |
| Cycle 5 Day 1 | -7.7 (-12.75 to -2.61) |
| Cycle 6 Day 1 | -6.4 (-11.85 to -0.93) |
| End of treatment | 0.2 (-5.55 to 6.04) |
| Post-surgical follow-up | 8.6 (-0.16 to 17.40) |
EORTC-QLQ-BR23 is a 23-item breast cancer module developed as a supplement for the EORTC-QLQ-C30 to assess the quality of life of participants with breast cancer, consisting of 2 functional scales, 3 symptoms scales, and 3 single-item scales. Each scale has 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the arm symptoms scale, participants self-rated how much they had pain in the arm or shoulder, how much the arm or hand was swollen, and difficulty in raising the arm or moving it sideways. Negative change from baseline indicates improvement of arm symptoms and positive change indicates deterioration.
| Units on a scale | Talazoparib 1 mg QD |
|---|---|
| Cycle 1 Day 15 | -1.6 (-4.59 to 1.49) |
| Cycle 2 Day 1 | -0.8 (-4.05 to 2.53) |
| Cycle 2 Day 15 | -1.6 (-5.25 to 2.15) |
| Cycle 3 Day 1 | -0.7 (-4.40 to 2.92) |
| Cycle 4 Day 1 | -1.3 (-4.40 to 1.76) |
| Cycle 5 Day 1 | 0.3 (-3.73 to 4.32) |
| Cycle 6 Day 1 | -1.5 (-6.20 to 3.23) |
| End of treatment | -1.0 (-5.18 to 3.22) |
| Post-surgical follow-up | 13.0 (5.70 to 20.35) |
EORTC-QLQ-BR23 is a 23-item breast cancer module developed as a supplement for the EORTC-QLQ-C30 to assess the quality of life of participants with breast cancer, consisting of 2 functional scales, 3 symptoms scales, and 3 single-item scales. Each scale has 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the upset by hair loss scale, participants self-rated how upset they were due to loss of hair during the past week. Negative change from baseline values indicates improvement of upset by hair loss and positive change indicates deterioration.
| Units on a scale | Talazoparib 1 mg QD |
|---|---|
| Cycle 1 Day 15 | 0.0 (NA to NA) |
| Cycle 2 Day 1 | -33.3 (-456.87 to 390.21) |
| Cycle 2 Day 15 | -11.1 (-137.60 to 115.37) |
| Cycle 3 Day 1 | 33.33 (33.33 to 33.33) |
| Cycle 4 Day 1 | 11.1 (-161.26 to 183.48) |
| End of treatment | 33.33 (NA to NA) |
| Post-surgical follow-up | 33.3 (NA to NA) |
EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the nausea and vomiting symptoms scale, participants self-rated how much they had felt nauseated and/or vomited during the past week. A 10 point change from baseline was used to indicate clinically meaningful change. Deterioration in nausea and vomiting symptoms was defined as a 10 point or more increase from baseline for that specific time point.
| Participants | Talazoparib 1 mg QD |
|---|---|
| Cycle 1 Day 15 | 21 |
| Cycle 2 Day 1 | 20 |
| Cycle 2 Day 15 | 18 |
| Cycle 3 Day 1 | 14 |
| Cycle 4 Day 1 | 10 |
| Cycle 5 Day 1 | 11 |
| Cycle 6 Day 1 | 10 |
| End of treatment | 3 |
| Post-surgical follow-up | 5 |
EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the nausea and vomiting symptoms scale, participants self-rated how much they had felt nauseated and/or vomited during the past week. A 10 point change from baseline was used to indicate clinically meaningful change. Improvement in nausea and vomiting symptoms was defined as a 10 point or more decrease from baseline for that specific time point.
| Participants | Talazoparib 1 mg QD |
|---|---|
| Cycle 1 Day 15 | 1 |
| Cycle 2 Day 1 | 2 |
| Cycle 2 Day 15 | 2 |
| Cycle 3 Day 1 | 2 |
| Cycle 4 Day 1 | 2 |
| Cycle 5 Day 1 | 2 |
| Cycle 6 Day 1 | 0 |
| End of treatment | 3 |
| Post-surgical follow-up | 3 |
EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all to 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the nausea and vomiting symptoms scale, participants self-rated how much they had felt nauseated and/or vomited during the past week. A 10 point change from baseline was used to indicate clinically meaningful change. No change in nausea/vomiting symptoms=having neither deterioration (≥10 point increase from baseline) nor improvement (≥10 point decrease from baseline) for the time point.
| Participants | Talazoparib 1 mg QD |
|---|---|
| Cycle 1 Day 15 | 21 |
| Cycle 2 Day 1 | 24 |
| Cycle 2 Day 15 | 24 |
| Cycle 3 Day 1 | 30 |
| Cycle 4 Day 1 | 31 |
| Cycle 5 Day 1 | 26 |
| Cycle 6 Day 1 | 21 |
| End of treatment | 29 |
| Post-surgical follow-up | 22 |
Missed expected menstrual period was assessed electronically using the PRO CTCAE questionnaire, a PRO measure developed to evaluate symptomatic toxicity in patients on cancer clinical trials. This objective captures the concept of fertility preservation through PRO, since there is a possible fertility sparing effect of talazoparib versus chemotherapy.
| Participants | Talazoparib 1 mg QD |
|---|---|
| Baseline | 0 |
| Cycle 1 Day 15 | 1 |
| Cycle 2 Day 1 | 0 |
| Cycle 2 Day 15 | 2 |
| Cycle 3 Day 1 | 0 |
| Cycle 4 Day 1 | 3 |
| Cycle 5 Day 1 | 1 |
| Cycle 6 Day 1 | 1 |
| End of treatment | 0 |
| Post-surgical follow-up | 1 |
Collected over Adverse events were assessed from Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months). All-cause mortality was assessed from Baseline until participant died or withdrew consent for follow-up, or study termination (maximum of approximately 16 months).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Talazoparib 1 mg QD | 2/61 (3.3%) | 11/61 (18%) | 60/61 (98.4%) |
| Event | Talazoparib 1 mg QD |
|---|---|
| AnaemiaBlood and lymphatic system disorders | 9/61 |
| NeutropeniaBlood and lymphatic system disorders | 1/61 |
| Intestinal obstructionGastrointestinal disorders | 1/61 |
| Influenza like illnessGeneral disorders | 1/61 |
| Event | Talazoparib 1 mg QD |
|---|---|
| FatigueGeneral disorders | 48/61 |
| NauseaGastrointestinal disorders | 42/61 |
| AlopeciaSkin and subcutaneous tissue disorders | 35/61 |
| AnaemiaBlood and lymphatic system disorders | 30/61 |
| HeadacheNervous system disorders | 26/61 |
| DizzinessNervous system disorders | 20/61 |
| ConstipationGastrointestinal disorders | 19/61 |
| DiarrhoeaGastrointestinal disorders | 13/61 |
| Upper respiratory tract infectionInfections and infestations | 12/61 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 11/61 |
Baseline analysis population included all participants who received any amount of talazoparib.
| Age, Continuous(Years) | Talazoparib 1 mg QD |
|---|---|
| Mean | 44.6 ± 12.7 |
| Age, Customized(Participants) | Talazoparib 1 mg QD |
|---|---|
| 18-44 Years | 37 |
| 45-64 Years | 18 |
| >=65 Years | 6 |
| Sex: Female, Male(Participants) | Talazoparib 1 mg QD |
|---|---|
| Female | 61 |
| Male | 0 |
| Race/Ethnicity, Customized(Participants) | Talazoparib 1 mg QD |
|---|---|
| White | 47 |
| Black or African American | 7 |
| Asian | 3 |
| Not reported | 4 |
| Race/Ethnicity, Customized(Participants) | Talazoparib 1 mg QD |
|---|---|
| Chinese | 1 |
| African American | 7 |
| Ashkenazi Jew | 1 |
| Other | 49 |
| Not reported | 3 |
| Number of Participants with Triple Negative Breast Cancer (TNBC) at Baseline(Participants) | Talazoparib 1 mg QD |
|---|---|
| Count of participants | 61 |
| Duration of Breast Cancer at Baseline(Weeks) | Talazoparib 1 mg QD |
|---|---|
| Median | 3.57 (0.43 to 21.14) |
| Number of Participants with Breast Cancer Gene 1/2 (BRCA1/2) Mutations at Baseline(Participants) | Talazoparib 1 mg QD |
|---|---|
| BRCA1 | 48 |
| BRCA2 | 13 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Data sharing details ↗ · www.pfizer.com
Ran from Aug 2018 to primary completion in Sep 2020, 24 months.
Results were first posted in Nov 2021, 1 year 1 month after primary completion.
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Studies of the drug tested here: Talazoparib