An observational study in Advanced Breast Cancer and Metastatic Breast Cancer, sponsored by Pfizer. Completed at 305 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-20.
Sponsored by Pfizer · Observational
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Among 182 studies in Breast Neoplasms by Pfizer — 6 open to participants now, 26 under way, 7 of them phase 3. Breast Neoplasms · Pfizer.
Among the 182 studies in Breast Neoplasms by Pfizer, this one is the 10th largest by enrollment of the 56 observational ones that give a count, is one of 7 that started in 2017, is one of 56 observational ones, and was the 97th registered.
14,832 studies on the registry are indexed under Breast Neoplasms; 3,320 are open to participants now.
Browse Breast Neoplasms studies →6 of the 182 studies in Breast Neoplasms by Pfizer are open now, in 12 countries. Recruiting first, the newest first:
Pfizer · Sites in United States, France, Spain
Ages 18+
Pfizer · Sites in United States, Argentina, Australia and 28 more countries
Ages 18+
Pfizer · Sites in United States, Argentina, China and 5 more countries
Ages 18+
Pfizer
Ages 18+
Pfizer
Ages 18+
By country, each count listing its studies:
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.
182 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 50 · Phase 2 56 · Phase 3 25 · Phase 4 3
First in 1998; this study’s year is marked. 7 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 1,285 is above the median of 184 across 3,235 observational studies indexed under Breast Neoplasms.
Median enrollment 75 across the 121 interventional studies, 399 across the 56 observational. Of the 145 that completed or were terminated, 94 (65%) have results posted.
This tab as a report to print or save as PDF → With an account.
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.
8 of the studies in Breast Neoplasms by Pfizer that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05909397Phase 3PfizerVepdegestrant (ARV-471/PF-07850327) + Palbociclib vs Letrozole + Palbociclib in ER(+)/HER2(-) Advanced Breast Cancer | 2026-12-30 |
| NCT07062965Phase 3PfizerA Study to Learn About the Study Medicine Called PF-07248144 in Combination With Fulvestrant in People With HR-positive, HER2-negative Advanced or Metastatic Breast Cancer Who Progressed After a Prior Line of Treatment. | 2027-07-22 |
| NCT06495164PfizerA Real-life Study to Understand the Use and Effects of Palbociclib in US Patients With Breast Cancer | 2026-12-30 |
| NCT04553133PfizerPF-07104091 as a Single Agent and in Combination Therapy | 2026-12-31 |
| NCT05382364PfizerSafety and Pharmacokinetics of Tucatinib (MK-7119) in Chinese Participants With Cancer (MK-7119-002) | 2026-12-31 |
Add all 8 to your calendar (.ics) → With an account.
Among the 182 studies in Breast Neoplasms by Pfizer, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This Non-Interventional Study will describe and analyze the clinical use of palbociclib in routine clinical practice in the treatment of advanced breast cancer.
HR+/HER2- ABC patients whose treatment decision with palbociclib has been made by their treating physician and who meet the eligibility criteria will be invited to participate in the study.
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:
Patients who are unable to understand the nature of the study and are unwilling to sign an .
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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.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
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.
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.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
This prospective, observational study will be conducted according to each site's routine clinical practice.
Other: non-interventional
This study also gives Palbociclib. No intervention listed here names it: that was found by reading the record.
Number of Participants According to Real-World Tumor Response
Real world tumor response included complete response (CR), Partial response (PR), Stable disease (SD), Progressive Disease (PD), and was determined by physician based on imaging, biopsies, biomarkers, and/or clinical judgment. Response as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) criteria may not be available for all participants. rwTR was derived as the best tumor response recorded from the palbociclib combination treatment start date until the first documentation of progressive disease. Only response assessments recorded on or before the start date of next subsequent line of treatment will be considered.
Time frame: From start of palbociclib combination treatment until first documentation of progression (up to approximately 3 years)
Real-World Tumor Response Rate
Real world tumor response rate was defined as the percentage of participants with a best tumor response of complete response or partial response. Tumor response was determined by physician based on imaging, biopsies, biomarkers, and/or clinical judgment. RECIST criteria may not be available for all participants.
Time frame: From start of palbociclib combination treatment until first documentation of progression (up to approximately 3 years)
Real World Progression Free Survival
Real world progression free survival was defined as time (months) from initiation of the palbociclib combination treatment to the earliest of clinician-documented progression or death due to any cause, whichever occurred first. Participants without documented disease progression or death were censored at the last date of response assessment.
Time frame: From initiation of the palbociclib combination treatment to the earliest of clinician-documented progression or death due to any cause, whichever occurs first. (up to approximately 3 years)
Overall Survival
Overall survival was defined as time from initiation of the palbociclib combination treatment to date of death due to any cause. Participants without a documented death were censored at last available visit date known to be alive.
Time frame: From initiation of the palbociclib combination treatment to death due to any cause or censored, (up to approximately 3 years)
Absolute Eastern Co-Operative Oncology Group (ECOG) Performance Status Scores at Baseline: Participants More Than or Equal to 70 Years Only
ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).
Time frame: Baseline (last observed measurement prior to treatment start date)
ECOG Performance Status Scores at Month 1: Participants More Than or Equal to 70 Years Only
ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).
Time frame: Month 1
ECOG Performance Status Scores at Month 2: Participants More Than or Equal to 70 Years Only
ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).
Time frame: Month 2
ECOG Performance Status Scores at Month 3: Participants More Than or Equal to 70 Years Only
ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).
Time frame: Month 3
ECOG Performance Status Scores at Month 6: Participants More Than or Equal to 70 Years Only
ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).
Time frame: Month 6
ECOG Performance Status Scores at Month 9: Participants More Than or Equal to 70 Years Only
ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).
Time frame: Month 9
ECOG Performance Status Scores at Month 12: Participants More Than or Equal to 70 Years Only
ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).
Time frame: Month 12
ECOG Performance Status Scores at Month 15: Participants More Than or Equal to 70 Years Only
ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).
Time frame: Month 15
ECOG Performance Status Scores at Month 18: Participants More Than or Equal to 70 Years Only
ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).
Time frame: Month 18
ECOG Performance Status Scores at Month 21: Participants More Than or Equal to 70 Years Only
ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).
Time frame: Month 21
ECOG Performance Status Scores at Month 24: Participants More Than or Equal to 70 Years Only
ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).
Time frame: Month 24
ECOG Performance Status Scores in Month 27: Participants More Than or Equal to 70 Years Only
ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).
Time frame: Month 27
ECOG Performance Status Scores at Month 30: Participants More Than or Equal to 70 Years Only
ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).
Time frame: Month 30
ECOG Performance Status Scores at Month 33: Participants More Than or Equal to 70 Years Only
ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).
Time frame: Month 33
ECOG Performance Status Scores in Month 36: Participants More Than or Equal to 70 Years Only
ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).
Time frame: Month 36
ECOG Performance Status Scores at Month 39: Participants More Than or Equal to 70 Years Only
ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).
Time frame: Month 39
ECOG Performance Status Scores at Month 42: Participants More Than or Equal to 70 Years Only
ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).
Time frame: Month 42
Geriatric 8 Screening Tool Scores at Baseline: Participants More Than or Equal to 70 Years Only
The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.
Time frame: Baseline (last observed measurement prior to treatment start date)
Geriatric 8 Screening Tool Scores at Month 1: Participants More Than or Equal to 70 Years Only
The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.
Time frame: Month 1
Geriatric 8 Screening Tool Scores at Month 2: Participants More Than or Equal to 70 Years Only
The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.
Time frame: Month 2
Geriatric 8 Screening Tool Scores at Month 3: Participants More Than or Equal to 70 Years Only
The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.
Time frame: Month 3
Geriatric 8 Screening Tool Scores at Month 6: Participants More Than or Equal to 70 Years Only
The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.
Time frame: Month 6
Geriatric 8 Screening Tool Scores at Month 9: Participants More Than or Equal to 70 Years Only
The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.
Time frame: Month 9
Geriatric 8 Screening Tool Scores at Month 12: Participants More Than or Equal to 70 Years Only
The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.
Time frame: Month 12
Geriatric 8 Screening Tool Scores at Month 15: Participants More Than or Equal to 70 Years Only
The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.
Time frame: Month 15
Geriatric 8 Screening Tool Scores at Month 18: Participants More Than or Equal to 70 Years Only
The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.
Time frame: Month 18
Geriatric 8 Screening Tool Scores at Month 21: Participants More Than or Equal to 70 Years Only
The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.
Time frame: Month 21
Geriatric 8 Screening Tool Scores at Month 24: Participants More Than or Equal to 70 Years Only
The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.
Time frame: Month 24
Geriatric 8 Screening Tool Scores at Month 27: Participants More Than or Equal to 70 Years Only
The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.
Time frame: Month 27
Geriatric 8 Screening Tool Scores at Month 30: Participants More Than or Equal to 70 Years Only
The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.
Time frame: Month 30
Geriatric 8 Screening Tool Scores at Month 33: Participants More Than or Equal to 70 Years Only
The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.
Time frame: Month 33
Geriatric 8 Screening Tool Scores at Month 36: Participants More Than or Equal to 70 Years Only
The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.
Time frame: Month 36
Geriatric 8 Screening Tool Scores at Month 39: Participants More Than 70 or Equal to Years Only
The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.
Time frame: Month 39
Geriatric 8 Screening Tool Scores at Month 42: Participants More Than or Equal to 70 Years Only
The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.
Time frame: Month 42
Change From Baseline to Month 6 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire 30: 30 item questionnaires composed of 5 functional subscales (physical, role, cognitive, emotional, and social); a global health/global quality of life scale; 3 symptom subscales (fatigue, pain and nausea/vomiting); and 6 single items that assessed additional symptoms (dyspnea, appetite loss, insomnia, constipation, diarrhea and financial difficulties). All scales and single item measures ranged in score from 0 to 100. Higher scores on functional and global quality of life scales represent better level of functioning. Higher scores on the symptom oriented scales represent more severe symptoms.
Time frame: Baseline (last observed measurement prior to treatment start date) and Month 6
Change From Baseline to Month 12 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline
EORTC QLQ-C30: 30 item questionnaire composed of 5 functional subscales (physical, role, cognitive, emotional, and social); a global health/global quality of life scale; 3 symptom subscales (fatigue, pain and nausea/vomiting); and 6 single items that assessed additional symptoms (dyspnea, appetite loss, insomnia, constipation, diarrhea and financial difficulties). All scales and single item measures ranged in score from 0 to 100. Higher scores on functional and global quality of life scales represent better level of functioning. Higher scores on the symptom oriented scales represent more severe symptoms.
Time frame: Baseline (last observed measurement prior to treatment start date) and Month 12
Change From Baseline to Month 18 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline
EORTC QLQ-C30: 30 item questionnaire composed of 5 functional subscales (physical, role, cognitive, emotional, and social); a global health/global quality of life scale; 3 symptom subscales (fatigue, pain and nausea/vomiting); and 6 single items that assessed additional symptoms (dyspnea, appetite loss, insomnia, constipation, diarrhea and financial difficulties). All scales and single item measures ranged in score from 0 to 100. Higher scores on functional and global quality of life scales represent better level of functioning. Higher scores on the symptom oriented scales represent more severe symptoms.
Time frame: Baseline (last observed measurement prior to treatment start date) and Month 18
Activities of Daily Living Scores at Baseline: Participants More Than or Equal to 70 Years Only
Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participant.
Time frame: Baseline (last observed measurement prior to treatment start date)
Activities of Daily Living Scores at Month 1: Participants More Than or Equal to 70 Years Only
Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.
Time frame: Month 1
Activities of Daily Living Scores at Month 2: Participants More Than or Equal to 70 Years Only
Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.
Time frame: Month 2
Activities of Daily Living Scores at Month 3: Participants More Than or Equal to 70 Years Only
Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.
Time frame: Month 3
Activities of Daily Living Scores Month 6: Participants More Than or Equal to 70 Years Only
Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.
Time frame: Month 6
Activities of Daily Living Scores at Month 9: Participants More Than or Equal to 70 Years Only
Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.
Time frame: Month 9
Activities of Daily Living Scores at Month 12: Participants More Than or Equal to 70 Years Only
Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.
Time frame: Month 12
Activities of Daily Living Scores at Month 15: Participants More Than or Equal to 70 Years Only
Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.
Time frame: Month 15
Activities of Daily Living Scores at Month 18: Participants More Than or Equal to 70 Years Only
Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participant.
Time frame: Month 18
Activities of Daily Living Scores at Month 21: Participants More Than or Equal to 70 Years Only
Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.
Time frame: Month 21
Activities of Daily Living Scores at Month 24: Participants More Than or Equal to 70 Years Only
Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.
Time frame: Month 24
Activities of Daily Living Scores at Month 27: Participants More Than or Equal to 70 Years Only
Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.
Time frame: Month 27
Activities of Daily Living Scores at Month 30: Participants More Than or Equal to 70 Years Only
Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.
Time frame: Month 30
Activities of Daily Living Scores at Month 33: Participants More Than or Equal to 70 Years Only
Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.
Time frame: Month 33
Activities of Daily Living Scores at Month 36: Participants More Than or Equal to 70 Years Only
Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.
Time frame: Month 36
Activities of Daily Living Scores at Month 39: Participants More Than or Equal to 70 Years Only
Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.
Time frame: Month 39
Activities of Daily Living Scores at Month 42: Participants More Than or Equal to 70 Years Only
Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.
Time frame: Month 42
Number of Participants With Adverse Events
An adverse event is any untoward medical occurrence in administered medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage.
Time frame: From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years)
Number of Participants With Serious Adverse Events
A serious adverse event was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) at any dose that: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect.
Time frame: From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years).
Number of Participants With Any Clinical Laboratory Abnormalities
Following lab parameters were assessed Anemia, Hemoglobin increased, Lymphocyte count decreased, Lymphocyte count increased, Neutrophil count decreased, Platelet count decreased, Leukocyte count decreased, Leukocyte count increased, Number of participants with any lab abnormality was reported.
Time frame: From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years).
Participants with hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer (ABC) who were prescribed palbociclib in routine clinical practice across the United States and Canada were enrolled in this prospective observational study. Participants were followed up for approximately 3 years post end of treatment or until withdrawal from the study or death.
| Milestone | Palbociclib + Endocrine Therapy |
|---|---|
| Started | 1250 |
| Completed | 54 |
| Not completed | 1196 |
| Withdrew: Death | 505 |
| Withdrew: Study terminated by sponsor | 383 |
| Withdrew: Other | 148 |
| Withdrew: No longer willing to participate in study | 101 |
| Withdrew: Lost to follow up | 39 |
| Withdrew: Adverse event | 20 |
Real world tumor response included complete response (CR), Partial response (PR), Stable disease (SD), Progressive Disease (PD), and was determined by physician based on imaging, biopsies, biomarkers, and/or clinical judgment. Response as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) criteria may not be available for all participants. rwTR was derived as the best tumor response recorded from the palbociclib combination treatment start date until the first documentation of progressive disease. Only response assessments recorded on or before the start date of next subsequent line of treatment will be considered.
| Participants | Palbociclib + Endocrine Therapy |
|---|---|
| Overall — Complete response | 72 |
| Overall — Partial Response | 310 |
| Overall — Stable disease | 499 |
| Overall — Progressive disease | 223 |
| Overall — Indeterminate | 146 |
| 1 Line of treatment — Complete response | 58 |
| 1 Line of treatment — Partial Response | 248 |
| 1 Line of treatment — Stable disease | 352 |
| 1 Line of treatment — Progressive disease | 144 |
| 1 Line of treatment — Indeterminate | 106 |
| 2 or more lines of treatment — Complete response | 14 |
| 2 or more lines of treatment — Partial Response | 62 |
| 2 or more lines of treatment — Stable disease | 147 |
| 2 or more lines of treatment — Progressive disease | 79 |
| 2 or more lines of treatment — Indeterminate | 40 |
Real world tumor response rate was defined as the percentage of participants with a best tumor response of complete response or partial response. Tumor response was determined by physician based on imaging, biopsies, biomarkers, and/or clinical judgment. RECIST criteria may not be available for all participants.
| Percentage of participants | Palbociclib + Endocrine Therapy |
|---|---|
| Overall | 30.6 (28.0 to 33.2) |
| 1 Line of treatment | 33.7 (30.6 to 36.9) |
| 2 or more lines of treatment | 22.2 (17.9 to 27.0) |
Real world progression free survival was defined as time (months) from initiation of the palbociclib combination treatment to the earliest of clinician-documented progression or death due to any cause, whichever occurred first. Participants without documented disease progression or death were censored at the last date of response assessment.
| Months | Palbociclib + Endocrine Therapy |
|---|---|
| Overall | 18.8 (17.2 to 20.5) |
| 1 line of treatment | 21.0 (18.8 to 24.7) |
| 2 or more lines of treatment | 13.2 (10.4 to 16.8) |
Overall survival was defined as time from initiation of the palbociclib combination treatment to date of death due to any cause. Participants without a documented death were censored at last available visit date known to be alive.
| Months | Palbociclib + Endocrine Therapy |
|---|---|
| Overall | 42.3 (39.3 to 47.1) |
| 1 line of treatment | 48.5 (42.0 to NA) |
| 2 or more lines of treatment | 37.2 (31.2 to 40.8) |
ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).
| Units on a scale | Palbociclib + Endocrine Therapy |
|---|---|
| Absolute Eastern Co-Operative Oncology Group (ECOG) Performance Status Scores at Baseline: Participants More Than or Equal to 70 Years Only | 0.7 ± 0.74 |
ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).
| Units on a scale | Palbociclib + Endocrine Therapy |
|---|---|
| ECOG Performance Status Scores at Month 1: Participants More Than or Equal to 70 Years Only | 0.7 ± 0.73 |
ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).
| Units on a scale | Palbociclib + Endocrine Therapy |
|---|---|
| ECOG Performance Status Scores at Month 2: Participants More Than or Equal to 70 Years Only | 0.7 ± 0.70 |
ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).
| Units on a scale | Palbociclib + Endocrine Therapy |
|---|---|
| ECOG Performance Status Scores at Month 3: Participants More Than or Equal to 70 Years Only | 0.7 ± 0.71 |
ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).
| Units on a scale | Palbociclib + Endocrine Therapy |
|---|---|
| ECOG Performance Status Scores at Month 6: Participants More Than or Equal to 70 Years Only | 0.8 ± 0.73 |
ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).
| Units on a scale | Palbociclib + Endocrine Therapy |
|---|---|
| ECOG Performance Status Scores at Month 9: Participants More Than or Equal to 70 Years Only | 0.8 ± 0.71 |
ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).
| Units on a scale | Palbociclib + Endocrine Therapy |
|---|---|
| ECOG Performance Status Scores at Month 12: Participants More Than or Equal to 70 Years Only | 0.8 ± 0.75 |
ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).
| Units on a scale | Palbociclib + Endocrine Therapy |
|---|---|
| ECOG Performance Status Scores at Month 15: Participants More Than or Equal to 70 Years Only | 0.8 ± 0.75 |
ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).
| Units on a scale | Palbociclib + Endocrine Therapy |
|---|---|
| ECOG Performance Status Scores at Month 18: Participants More Than or Equal to 70 Years Only | 0.7 ± 0.74 |
ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).
| Units on a scale | Palbociclib + Endocrine Therapy |
|---|---|
| ECOG Performance Status Scores at Month 21: Participants More Than or Equal to 70 Years Only | 0.8 ± 0.82 |
ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).
| Units on a scale | Palbociclib + Endocrine Therapy |
|---|---|
| ECOG Performance Status Scores at Month 24: Participants More Than or Equal to 70 Years Only | 0.7 ± 0.81 |
ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).
| Units on a scale | Palbociclib + Endocrine Therapy |
|---|---|
| ECOG Performance Status Scores in Month 27: Participants More Than or Equal to 70 Years Only | 0.9 ± 0.88 |
ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).
| Units on a scale | Palbociclib + Endocrine Therapy |
|---|---|
| ECOG Performance Status Scores at Month 30: Participants More Than or Equal to 70 Years Only | 0.9 ± 0.86 |
ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).
| Units on a scale | Palbociclib + Endocrine Therapy |
|---|---|
| ECOG Performance Status Scores at Month 33: Participants More Than or Equal to 70 Years Only | 0.9 ± 0.70 |
ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).
| Units on a scale | Palbociclib + Endocrine Therapy |
|---|---|
| ECOG Performance Status Scores in Month 36: Participants More Than or Equal to 70 Years Only | 0.6 ± 0.53 |
ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).
| Units on a scale | Palbociclib + Endocrine Therapy |
|---|---|
| ECOG Performance Status Scores at Month 39: Participants More Than or Equal to 70 Years Only | 0.4 ± 0.55 |
ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).
| Units on a scale | Palbociclib + Endocrine Therapy |
|---|---|
| ECOG Performance Status Scores at Month 42: Participants More Than or Equal to 70 Years Only | 0.5 ± 0.71 |
The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.
| Units on a scale | Palbociclib + Endocrine Therapy |
|---|---|
| Geriatric 8 Screening Tool Scores at Baseline: Participants More Than or Equal to 70 Years Only | 13.4 ± 2.24 |
The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.
| Units on a scale | Palbociclib + Endocrine Therapy |
|---|---|
| Geriatric 8 Screening Tool Scores at Month 1: Participants More Than or Equal to 70 Years Only | 13.3 ± 2.23 |
The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.
| Units on a scale | Palbociclib + Endocrine Therapy |
|---|---|
| Geriatric 8 Screening Tool Scores at Month 2: Participants More Than or Equal to 70 Years Only | 13.4 ± 2.36 |
The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.
| Units on a scale | Palbociclib + Endocrine Therapy |
|---|---|
| Geriatric 8 Screening Tool Scores at Month 3: Participants More Than or Equal to 70 Years Only | 13.4 ± 2.20 |
The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.
| Units on a scale | Palbociclib + Endocrine Therapy |
|---|---|
| Geriatric 8 Screening Tool Scores at Month 6: Participants More Than or Equal to 70 Years Only | 13.5 ± 2.05 |
The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.
| Units on a scale | Palbociclib + Endocrine Therapy |
|---|---|
| Geriatric 8 Screening Tool Scores at Month 9: Participants More Than or Equal to 70 Years Only | 13.7 ± 1.90 |
The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.
| Units on a scale | Palbociclib + Endocrine Therapy |
|---|---|
| Geriatric 8 Screening Tool Scores at Month 12: Participants More Than or Equal to 70 Years Only | 13.7 ± 1.97 |
The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.
| Units on a scale | Palbociclib + Endocrine Therapy |
|---|---|
| Geriatric 8 Screening Tool Scores at Month 15: Participants More Than or Equal to 70 Years Only | 13.6 ± 2.06 |
The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.
| Units on a scale | Palbociclib+ Endocrine Therapy |
|---|---|
| Geriatric 8 Screening Tool Scores at Month 18: Participants More Than or Equal to 70 Years Only | 13.4 ± 2.26 |
The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.
| Units on a scale | Palbociclib + Endocrine Therapy |
|---|---|
| Geriatric 8 Screening Tool Scores at Month 21: Participants More Than or Equal to 70 Years Only | 13.4 ± 1.70 |
The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.
| Units on a scale | Palbociclib + Endocrine Therapy |
|---|---|
| Geriatric 8 Screening Tool Scores at Month 24: Participants More Than or Equal to 70 Years Only | 13.5 ± 2.33 |
The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.
| Units on a scale | Palbociclib + Endocrine Therapy |
|---|---|
| Geriatric 8 Screening Tool Scores at Month 27: Participants More Than or Equal to 70 Years Only | 13.3 ± 2.17 |
The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.
| Units on a scale | Palbociclib + Endocrine Therapy |
|---|---|
| Geriatric 8 Screening Tool Scores at Month 30: Participants More Than or Equal to 70 Years Only | 13.1 ± 1.98 |
The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.
| Units on a scale | Palbociclib + Endocrine Therapy |
|---|---|
| Geriatric 8 Screening Tool Scores at Month 33: Participants More Than or Equal to 70 Years Only | 13.3 ± 1.89 |
The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.
| Units on a scale | Palbociclib + Endocrine Therapy |
|---|---|
| Geriatric 8 Screening Tool Scores at Month 36: Participants More Than or Equal to 70 Years Only | 14.1 ± 1.44 |
The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.
| Units on a scale | Palbociclib + Endocrine Therapy |
|---|---|
| Geriatric 8 Screening Tool Scores at Month 39: Participants More Than 70 or Equal to Years Only | 13.5 ± 2.65 |
The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.
| Units on a scale | Palbociclib + Endocrine Therapy |
|---|---|
| Geriatric 8 Screening Tool Scores at Month 42: Participants More Than or Equal to 70 Years Only | 13.0 ± 1.41 |
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire 30: 30 item questionnaires composed of 5 functional subscales (physical, role, cognitive, emotional, and social); a global health/global quality of life scale; 3 symptom subscales (fatigue, pain and nausea/vomiting); and 6 single items that assessed additional symptoms (dyspnea, appetite loss, insomnia, constipation, diarrhea and financial difficulties). All scales and single item measures ranged in score from 0 to 100. Higher scores on functional and global quality of life scales represent better level of functioning. Higher scores on the symptom oriented scales represent more severe symptoms.
| Units on a scale | Palbociclib + Endocrine Therapy |
|---|---|
| Global health status/QoL | 3.5 ± 22.5 |
| Dyspnoea | -1.9 ± 27.7 |
| Insomnia | -0.9 ± 32.8 |
| Appetite loss | -4.5 ± 31.3 |
| Constipation | -1.7 ± 29.1 |
| Diarrhoea | 0.5 ± 24.8 |
| Financial difficulties | -0.7 ± 30.4 |
| Physical functioning | 1.9 ± 19.3 |
| Role functioning | 4.2 ± 31.5 |
| Emotional functioning | 4.9 ± 20.3 |
| Cognitive functioning | 0.6 ± 20.9 |
| Social functioning | 3.9 ± 27.2 |
| Fatigue | -0.7 ± 25.0 |
| Nausea and vomiting | -1.7 ± 20.9 |
| Pain | -6.9 ± 29.8 |
EORTC QLQ-C30: 30 item questionnaire composed of 5 functional subscales (physical, role, cognitive, emotional, and social); a global health/global quality of life scale; 3 symptom subscales (fatigue, pain and nausea/vomiting); and 6 single items that assessed additional symptoms (dyspnea, appetite loss, insomnia, constipation, diarrhea and financial difficulties). All scales and single item measures ranged in score from 0 to 100. Higher scores on functional and global quality of life scales represent better level of functioning. Higher scores on the symptom oriented scales represent more severe symptoms.
| Units on a scale | Palbociclib + Endocrine Therapy |
|---|---|
| Global health status/QoL | 2.5 ± 23.1 |
| Dyspnoea | -1.8 ± 29.3 |
| Insomnia | -3.1 ± 32.9 |
| Appetite loss | -5.1 ± 32.1 |
| Constipation | -1.9 ± 26.3 |
| Diarrhoea | 0.1 ± 23.5 |
| Financial difficulties | -3.1 ± 28.9 |
| Physical functioning | 1.2 ± 20.0 |
| Role functioning | 4.5 ± 32.3 |
| Emotional functioning | 4.7 ± 20.4 |
| Cognitive functioning | 0.1 ± 21.5 |
| Social functioning | 3.4 ± 29.0 |
| Fatigue | -0.4 ± 25.9 |
| Nausea and vomiting | -1.3 ± 21.2 |
| Pain | -5.7 ± 30.2 |
EORTC QLQ-C30: 30 item questionnaire composed of 5 functional subscales (physical, role, cognitive, emotional, and social); a global health/global quality of life scale; 3 symptom subscales (fatigue, pain and nausea/vomiting); and 6 single items that assessed additional symptoms (dyspnea, appetite loss, insomnia, constipation, diarrhea and financial difficulties). All scales and single item measures ranged in score from 0 to 100. Higher scores on functional and global quality of life scales represent better level of functioning. Higher scores on the symptom oriented scales represent more severe symptoms.
| Units on a scale | Palbociclib + Endocrine Therapy |
|---|---|
| Global health status/QoL | 2.5 ± 24.5 |
| Dyspnoea | 0.4 ± 28.3 |
| Insomnia | -3.5 ± 32.8 |
| Appetite loss | -4.7 ± 31.7 |
| Constipation | -1.4 ± 30.3 |
| Diarrhoea | 0.8 ± 26.9 |
| Financial difficulties | -2.5 ± 30.9 |
| Physical functioning | 1.6 ± 21.6 |
| Role functioning | 6.0 ± 33.7 |
| Emotional functioning | 5.9 ± 19.4 |
| Cognitive functioning | -0.9 ± 22.2 |
| Social functioning | 4.8 ± 28.9 |
| Fatigue | -1.8 ± 26.0 |
| Nausea and vomiting | -2.2 ± 22.1 |
| Pain | -7.6 ± 31.8 |
Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participant.
| Units on a scale | Palbociclib + Endocrine Therapy |
|---|---|
| Activities of Daily Living Scores at Baseline: Participants More Than or Equal to 70 Years Only | 17.6 ± 1.14 |
Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.
| Units on a scale | Palbociclib + Endocrine Therapy |
|---|---|
| Activities of Daily Living Scores at Month 1: Participants More Than or Equal to 70 Years Only | 17.6 ± 1.23 |
Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.
| Units on a scale | Palbociclib + Endocrine Therapy |
|---|---|
| Activities of Daily Living Scores at Month 2: Participants More Than or Equal to 70 Years Only | 17.7 ± 1.08 |
Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.
| Units on a scale | Palbociclib + Endocrine Therapy |
|---|---|
| Activities of Daily Living Scores at Month 3: Participants More Than or Equal to 70 Years Only | 17.6 ± 1.00 |
Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.
| Units on a scale | Palbociclib + Endocrine Therapy |
|---|---|
| Activities of Daily Living Scores Month 6: Participants More Than or Equal to 70 Years Only | 17.6 ± 1.19 |
Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.
| Units on a scale | Palbociclib + Endocrine Therapy |
|---|---|
| Activities of Daily Living Scores at Month 9: Participants More Than or Equal to 70 Years Only | 17.6 ± 1.47 |
Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.
| Units on a scale | Palbociclib + Endocrine Therapy |
|---|---|
| Activities of Daily Living Scores at Month 12: Participants More Than or Equal to 70 Years Only | 17.4 ± 1.55 |
Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.
| Units on a scale | Palbociclib + Endocrine Therapy |
|---|---|
| Activities of Daily Living Scores at Month 15: Participants More Than or Equal to 70 Years Only | 17.5 ± 1.52 |
Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participant.
| Units on a scale | Palbociclib + Endocrine Therapy |
|---|---|
| Activities of Daily Living Scores at Month 18: Participants More Than or Equal to 70 Years Only | 17.6 ± 1.13 |
Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.
| Units on a scale | Palbociclib + Endocrine Therapy |
|---|---|
| Activities of Daily Living Scores at Month 21: Participants More Than or Equal to 70 Years Only | 17.7 ± 0.91 |
Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.
| Units on a scale | Palbociclib + Endocrine Therapy |
|---|---|
| Activities of Daily Living Scores at Month 24: Participants More Than or Equal to 70 Years Only | 17.6 ± 0.93 |
Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.
| Units on a scale | Palbociclib + Endocrine Therapy |
|---|---|
| Activities of Daily Living Scores at Month 27: Participants More Than or Equal to 70 Years Only | 17.5 ± 1.01 |
Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.
| Units on a scale | Palbociclib + Endocrine Therapy |
|---|---|
| Activities of Daily Living Scores at Month 30: Participants More Than or Equal to 70 Years Only | 17.3 ± 2.05 |
Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.
| Units on a scale | Palbociclib + Endocrine Therapy |
|---|---|
| Activities of Daily Living Scores at Month 33: Participants More Than or Equal to 70 Years Only | 17.5 ± 1.66 |
Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.
| Units on a scale | Palbociclib + Endocrine Therapy |
|---|---|
| Activities of Daily Living Scores at Month 36: Participants More Than or Equal to 70 Years Only | 17.3 ± 1.50 |
Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.
| Units on a scale | Palbociclib + Endocrine Therapy |
|---|---|
| Activities of Daily Living Scores at Month 39: Participants More Than or Equal to 70 Years Only | 17.3 ± 1.50 |
Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.
| Units on a scale | Palbociclib + Endocrine Therapy |
|---|---|
| Activities of Daily Living Scores at Month 42: Participants More Than or Equal to 70 Years Only | 16.5 ± 2.12 |
An adverse event is any untoward medical occurrence in administered medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage.
| Participants | Palbociclib+ Endocrine Therapy |
|---|---|
| Number of Participants With Adverse Events | 1123 |
A serious adverse event was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) at any dose that: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect.
| Participants | Palbociclib+ Endocrine Therapy |
|---|---|
| Number of Participants With Serious Adverse Events | 403 |
Following lab parameters were assessed Anemia, Hemoglobin increased, Lymphocyte count decreased, Lymphocyte count increased, Neutrophil count decreased, Platelet count decreased, Leukocyte count decreased, Leukocyte count increased, Number of participants with any lab abnormality was reported.
| Participants | Palbociclib + Endocrine Therapy |
|---|---|
| Number of Participants With Any Clinical Laboratory Abnormalities | 1170 |
Collected over From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Palbociclib + Endocrine Therapy | 505/1,250 (40.4%) | 403/1,250 (32.2%) | 1,035/1,250 (82.8%) |
| Event | Palbociclib + Endocrine Therapy |
|---|---|
| Aspartate aminotransferase increasedInvestigations | 66/1250 |
| Disease progressionGeneral disorders | 36/1250 |
| VomitingGastrointestinal disorders | 24/1250 |
| Breast cancer metastaticNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 23/1250 |
| SepsisInfections and infestations | 22/1250 |
| PneumoniaInfections and infestations | 20/1250 |
| NauseaGastrointestinal disorders | 20/1250 |
| AnaemiaBlood and lymphatic system disorders | 18/1250 |
| Acute kidney injuryRenal and urinary disorders | 16/1250 |
| Urinary tract infectionInfections and infestations | 15/1250 |
| Event | Palbociclib + Endocrine Therapy |
|---|---|
| FatigueGeneral disorders | 444/1250 |
| NeutropeniaBlood and lymphatic system disorders | 415/1250 |
| AnaemiaBlood and lymphatic system disorders | 310/1250 |
| NauseaGastrointestinal disorders | 308/1250 |
| Neutrophil count decreasedInvestigations | 284/1250 |
| White blood cell count decreasedInvestigations | 272/1250 |
| DiarrhoeaGastrointestinal disorders | 233/1250 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 202/1250 |
| Platelet count decreasedInvestigations | 161/1250 |
| Back painMusculoskeletal and connective tissue disorders | 150/1250 |
Safety analysis set included all eligible participants enrolled in the study and received at least one dose of study medication.
| Age, Continuous(Years) | Palbociclib + Endocrine Therapy |
|---|---|
| Mean | 63.0 ± 12.6 |
| Sex: Female, Male(Participants) | Palbociclib + Endocrine Therapy |
|---|---|
| Female | 1235 |
| Male | 15 |
| Ethnicity (NIH/OMB)(Participants) | Palbociclib + Endocrine Therapy |
|---|---|
| Hispanic or Latino | 106 |
| Not Hispanic or Latino | 1106 |
| Unknown or Not Reported | 38 |
| Race (NIH/OMB)(Participants) | Palbociclib + Endocrine Therapy |
|---|---|
| American Indian or Alaska Native | 8 |
| Asian | 23 |
| Native Hawaiian or Other Pacific Islander | 5 |
| Black or African American | 139 |
| White | 1022 |
| More than one race | 0 |
| Unknown or Not Reported | 53 |
Showing the first 100 of 305 sites across 2 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — 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.
Ran from Jan 2017 to primary completion in Oct 2022, 68 months.
Results were first posted in Sep 2024, 1 year 11 months after primary completion.
Of 189 industry-sponsored observational studies under Breast Neoplasms, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 70. This study's 68 months is above that.
Counting every sponsor, half of 1,381 studies reached it within 55 months; a quarter within 25 and three quarters within 125.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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