A Phase 3 interventional study of Cyclophosphamide and Doxorubicin in Early Breast Cancer, sponsored by Hoffmann-La Roche. Completed at 107 sites in 19 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-26.
Sponsored by Hoffmann-La Roche · Phase 3, Interventional, and Treatment
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Among 103 studies testing pertuzumab in Breast Neoplasms — 25 open to participants now, 44 under way, 7 of them phase 3. pertuzumab · Breast Neoplasms.
Among the 103 studies testing pertuzumab in Breast Neoplasms, this one is the 14th largest by enrollment, is one of 6 that started in 2018, is one of 23 in phase 3, and was the 51st registered.
14,832 studies on the registry are indexed under Breast Neoplasms; 3,320 are open to participants now.
Browse Breast Neoplasms studies →25 of the 103 studies testing pertuzumab in Breast Neoplasms are open now, in 11 countries. Recruiting first, the newest first:
Wen-Ming Cao · Sites in China
Ages 60+ · Women only
Rutgers, The State University of New Jersey · Sites in United States
Ages 18–90
Shanghai Jiao Tong University School of Medicine · Sites in China
Ages 18–70 · Women only
M.D. Anderson Cancer Center · Sites in United States
Ages 18+
Alliance for Clinical Trials in Oncology · Sites in United States, Puerto Rico
Ages 18+
By country, each count listing its studies:
pertuzumab: first FDA approval 2012 (PERJETA), first EMA approval 2013. 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.
On this site’s reading of the record, pertuzumab is the treatment under test here. Read study by study →
103 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 12 · Phase 2 63 · Phase 3 23 · Phase 4 3
First in 2003; this study’s year is marked. 6 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 500 is above the median of 72 across 10,903 interventional studies indexed under Breast Neoplasms.
Median enrollment 100 across the 103 interventional studies. Of the 50 that completed or were terminated, 34 (68%) have results posted.
This tab as a report to print or save as PDF → With an account.
34 of 103 have an industry lead sponsor. The 10 most frequent:
Hoffmann-La Roche is the lead sponsor of 2,101 studies on the registry; 88 are open to participants now.
Of its 330 completed or terminated interventional studies of FDA-regulated products, 248 (75%) have results posted.
229 studies in Breast Neoplasms by Hoffmann-La Roche: 16 open now, 28 under way, 13 of them phase 3. Of 193 finished, 120 (62%) have results posted.
Among the 229 studies in Breast Neoplasms by Hoffmann-La Roche, this one is the 31st largest by enrollment of the 170 interventional ones that give a count, is one of 8 that started in 2018, is one of 61 in phase 3, and was the 184th registered.
Hoffmann-La Roche’s Breast Neoplasms studies by the year they started, since 1998.
10 of the studies testing pertuzumab in Breast Neoplasms that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04784715Phase 3AstraZenecaTrastuzumab Deruxtecan (T-DXd) With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer (DESTINY-Breast09) | 2027-05-03 |
| NCT05891561Shanghai Jiao Tong University School of MedicineShort-course Trastuzumab, Pertuzumab with Taxanes in the Adjuvant Treatment of Early HER2-positive Breast Cancer | 2026-12 |
| NCT07095023Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityNeoadjuvant Oral Paclitaxel Plus Subcutaneous Pertuzumab/Trastuzumab in Patients With HER2-positive Breast Cancer | 2026-12-30 |
| NCT07187752Shandong Cancer Hospital and InstituteIdentification of HER2-Positive Breast Cancer Molecular Characterization and Subtypes | 2026-12-31 |
| NCT04733118MedSIRChemotherapy-Free pCR-Guided Strategy With Trastuzumab-pertuzumab and T-DM1 in HER2-positive Early Breast Cancer | 2027-03 |
Add all 10 to your calendar (.ics) → With an account.
Among the 103 studies testing pertuzumab in Breast Neoplasms, from their registry updates:
Among Hoffmann-La Roche’s 229 in Breast Neoplasms:
This tab as a report to print or save as PDF → With an account.
This is a global Phase III, two-arm, open-label, multicenter, randomized study to investigate the pharmacokinetics, efficacy, and safety of the fixed-dose combination (FDC) of pertuzumab and trastuzumab for subcutaneous (SC) administration in combination with chemotherapy in patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer in the neoadjuvant/adjuvant setting.
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.
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.
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.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
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.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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.
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.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
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.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
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.
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.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
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.
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.
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.
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.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
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.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive 8 cycles of investigator's choice of neoadjuvant chemotherapy. This will include either: 1) 4 cycles of dose-dense doxorubicin plus cyclophosphamide (ddAC) once every 2 weeks (Q2W) (given with granulocyte colony-stimulating factor \[G-CSF\] support as needed according to local guidelines) followed by paclitaxel Q1W for 12 weeks; or 2) 4 cycles of doxorubicin plus cyclophosphamide (AC) once every 3 weeks (Q3W) followed by docetaxel Q3W for 4 cycles. Pertuzumab and trastuzumab will be given intravenously (IV) for 4 cycles Q3W concurrently with the taxane component of chemotherapy. After completing their neoadjuvant therapy, participants will undergo surgery. Thereafter, participants will receive an additional 14 cycles of pertuzumab IV and trastuzumab IV for a total of 18 cycles.
Drug: Cyclophosphamide · Drug: Doxorubicin · Drug: Docetaxel · Drug: Paclitaxel · Drug: Pertuzumab IV · Drug: Trastuzumab IV · Drug: Trastuzumab SC · Procedure: Surgery · Radiation: Post-operative Radiotherapy · Drug: Hormone Therapy
Participants will receive 8 cycles of investigator's choice of neoadjuvant chemotherapy. This will include either: 1) 4 cycles of ddAC Q2W (given with G-CSF support as needed according to local guidelines) followed by paclitaxel once every week (QW) for 12 weeks; or 2) 4 cycles of AC Q3W followed by docetaxel Q3W for 4 cycles. The fixed-dose combination (FDC) of pertuzumab and trastuzumab will be given subcutaneously (SC) for 4 cycles (Q3W) concurrently with the taxane component of chemotherapy. After completing their neoadjuvant therapy, participants will undergo surgery. Thereafter, participants will receive an additional 14 cycles of the FDC of pertuzumab and trastuzumab SC for a total of 18 cycles.
Drug: Cyclophosphamide · Drug: Doxorubicin · Drug: Docetaxel · Drug: Paclitaxel · Drug: FDC of Pertuzumab and Trastuzumab SC · Procedure: Surgery · Radiation: Post-operative Radiotherapy · Drug: Hormone Therapy
Cyclophosphamide 600 mg/m2 will be administered IV on Day 1 of each cycle of treatment (as part of ddAC Q2W or AC Q3W) for Cycles 1-4.
Doxorubicin 60 mg/m2 will be administered IV on Day 1 of each cycle of treatment (as part of either ddAC Q2W or AC Q3W) for Cycles 1-4.
As part of one of the two investigator's choices of chemotherapy (AC followed by docetaxel), docetaxel 75 mg/m2 will be administered IV on Day 1 of Cycle 5 and then 100 mg/m2 IV at the discretion of the investigator for Cycles 6-8 (Q3W), if no dose-limiting toxicity occurs.
As part of one of the two investigator's choices of chemotherapy (ddAC followed by paclitaxel), paclitaxel 80 mg/m2 will be administered IV QW for 12 weeks.
Pertuzumab will be administered as a fixed non-weight-based dose of 840-mg IV loading dose and then 420-mg IV maintenance dose Q3W.
Also known as: Perjeta, RO4368451
Drug page: Pertuzumab/Trastuzumab/Hyaluronidase-zzxf
The FDC of pertuzumab and trastuzumab will be administered SC at a fixed non-weight-based dose. A loading dose of 1200 mg SC pertuzumab and 600 mg SC trastuzumab is then followed by a maintenance dose of 600 mg SC pertuzumab and 600 mg SC trastuzumab Q3W.
Also known as: Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf, RO7198574, RG6264
Trastuzumab will be administered as an 8-mg/kg IV loading dose and then 6 mg/kg IV maintenance dose Q3W.
Also known as: Herceptin, RO0452317
After surgery (from Cycle 9 onwards), participants in Arm A will be allowed to switch from trastuzumab IV to trastuzumab SC, at the discretion of the investigator, in the countries where trastuzumab SC is routinely used. For participants who switch, a fixed dose of 600 mg trastuzumab SC (irrespective of the patient's weight) will be administered in the adjuvant phase.
Also known as: Herceptin, RO0452317
Participants in both cohorts are scheduled to undergo surgery after 8 cycles of neoadjuvant therapy. Participants may undergo breast-conserving surgery or mastectomy according to routine clinical practice.
If indicated, radiotherapy is given after chemotherapy and surgery, during adjuvant HER2-targeted therapy and hormone therapy (for hormone-receptor positive disease).
For hormone receptor positive breast cancer, tamoxifen or aromatase inhibitors will be allowed as adjuvant hormone therapy for postmenopausal participants and with ovarian suppression or ablation for premenopausal participants in countries where it has been registered for this indication. Its use must be consistent with the registered label. Hormone therapy is given after chemotherapy and surgery during adjuvant HER2-targeted therapy.
Trough Serum Concentration (Ctrough) of Pertuzumab During Cycle 7 (Pre-Dose Cycle 8)
The observed pertuzumab trough serum concentration (Ctrough) at Cycle 7 was assessed following 3 cycles of pertuzumab IV and trastuzumab IV or the fixed-dose combination (FDC) of pertuzumab and trastuzumab SC. The Per Protocol Pharmacokinetics (PK) analysis population includes all enrolled participants who adhered to the protocol. Exclusions from the Per Protocol PK analysis population were made for the following reasons: participants were missing the Ctrough pre-dose Cycle 8 PK sample, participants with a Ctrough sample collected with at least 2 days deviation from the planned date on Day 21 (i.e., before Day 19 or after Day 23), participants given a dose amount that deviated from the planned dose by \>20% within 3 cycles (from Cycle 5), participants with a dose delay of more than 7 days, a subcutaneous injection site other than thigh was used, if the Cycle 8 pre-dose and post-dose samples were switched, and an assay error impacting Ctrough measurement.
Time frame: Pre-dose on Cycle 8, Day 1 (up to 21 weeks)
Ctrough of Trastuzumab During Cycle 7 (Pre-Dose Cycle 8)
The observed trastuzumab trough serum concentration (Ctrough) at Cycle 7 was assessed following 3 cycles of pertuzumab IV and trastuzumab IV or the fixed-dose combination (FDC) of pertuzumab and trastuzumab SC. The Per Protocol Pharmacokinetics (PK) analysis population includes all enrolled participants who adhered to the protocol. Exclusions from the Per Protocol PK analysis population were made for the following reasons: participants were missing the Ctrough pre-dose Cycle 8 PK sample, participants with a Ctrough sample collected with at least 2 days deviation from the planned date on Day 21 (i.e., before Day 19 or after Day 23), participants given a dose amount that deviated from the planned dose by \>20% within 3 cycles (from Cycle 5), participants with a dose delay of more than 7 days, a subcutaneous injection site other than thigh was used, if the Cycle 8 pre-dose and post-dose samples were switched, and an assay error impacting Ctrough measurement.
Time frame: Pre-dose on Cycle 8, Day 1 (up to 21 weeks)
Percentage of Participants With Total Pathological Complete Response (tpCR), According to Local Pathologist Assessment
Total pCR (tpCR) was defined as eradication of invasive disease in the breast and axilla; that is, ypT0/is ypN0, according to the local pathologists' assessment. Pathologic response to therapy was determined at the time of surgery. The tpCR rate is the percentage of participants in the ITT population who achieved a tpCR. Participants with missing data for tpCR (i.e., do not undergo surgery or have an invalid pCR assessment) were included in the analysis and classified as non-responders. Rates of tpCR were calculated in each treatment arm and were assessed using the difference between the Arm B: Pertuzumab and Trastuzumab FDC SC and the Arm A: Pertuzumab IV and Trastuzumab IV tpCR rates and corresponding 95% Clopper-Pearson confidence intervals (CIs). The difference between the tpCR rates along with corresponding 95% Hauck-Anderson CIs were calculated. The lower bound of the CI will reliably reflect the largest tpCR difference that can be considered unlikely.
Time frame: Following completion of surgery (up to 33 weeks)
Kaplan-Meier Estimate of the Percentage of Participants Who Are Event-Free According to Invasive Disease-Free Survival (iDFS; Excluding Second Primary Non-Breast Cancer [SPNBC]) Criteria
iDFS (excluding SPNBC) is defined as the time from the first date of no disease (i.e., the date of primary surgery) to the first occurrence of one of the following events: ipsilateral invasive breast tumor recurrence; ipsilateral local-regional invasive breast cancer reccurrence; distant recurrence; contralateral invasive breast cancer; or death attributable to any cause. Ipsilateral or contralateral in situ disease and SPNBC (including in situ carcinomas and non-melanoma skin cancers) will not be counted as progressive disease or relapse.
Time frame: At 1, 2, 3, and 4 years
Kaplan-Meier Estimate of the Percentage of Participants Who Are Event-Free According to iDFS (Including SPNBC) Criteria
Invasive disease-free survival (iDFS) including second primary non-breast cancer (SPNBC) is defined as the time from the first date of no disease (i.e., the date of primary surgery) to the first occurrence of one of the following events: ipsilateral invasive breast tumor recurrence; ipsilateral local-regional invasive breast cancer reccurrence; distant recurrence; contralateral invasive breast cancer; or death attributable to any cause. It also includes SPNBC as an event (with the exception of non-melanoma skin cancers and in situ carcinoma of any site).
Time frame: At 1, 2, 3, and 4 years
Kaplan-Meier Estimate of the Percentage of Participants Who Are Event-Free According to Event-Free Survival (EFS; Excluding SPNBC) Criteria
Event-free survival (EFS) excluding second primary non-breast cancer (SPNBC) is defined as the time from enrollment to the first occurrence of one of the following events: breast cancer progression; breast cancer recurrence; or death from any cause. Ipsilateral or contralateral in situ disease and SPNBC (including in situ carcinomas and non-melanoma skin cancers) will not be counted as progressive disease or relapse.
Time frame: At 1, 2, 3, and 4 years
Kaplan-Meier Estimate of the Percentage of Participants Who Are Event-Free According to EFS (Including SPNBC) Criteria
Event-free survival (EFS) including second primary non-breast cancer (SPNBC) is defined as the time from enrollment to the first occurrence of one of the following events: breast cancer progression; breast cancer recurrence; or death from any cause. It also includes SPNBC as an event (with the exception of non-melanoma skin cancers and in situ carcinoma of any site).
Time frame: At 1, 2, 3, and 4 years
Kaplan-Meier Estimate of the Percentage of Participants Who Are Event-Free According to Distant Recurrence-Free Interval (DRFI) Criteria
The distant recurrence-free interval (DRFI) is defined as the time between randomization and the date of distant breast cancer recurrence.
Time frame: At 1, 2, 3, and 4 years
Kaplan-Meier Estimate of the Percentage of Participants in Overall Survival
Overall survival is defined as the time from randomization to death from any cause.
Time frame: At 1, 2, 3, and 4 years
Summary of the Number of Participants With at Least One Adverse Event, Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0), Over the Course of the Entire Study
The adverse event (AE) severity grading scale for the NCI CTCAE v4.0 was used for assessing AE severity. Any AEs that were not specifically listed in the NCI CTCAE, v4.0 were graded per the following 5 grades: Grade 1 = mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; or intervention not indicated. Grade 2 = moderate; minimal, local, or non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living. Grade 3 = severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living. Grade 4 = life-threatening consequences or urgent intervention indicated. Grade 5 = death related to AE. The terms "severe" and "serious" are not synonymous and are independently assessed for each AE. Multiple occurrences of AEs were counted only once per participant at the highest (worst) grade.
Time frame: From first dose of study treatment until 28 days after last dose of study treatment (up to 1 year, 6 months)
Number of Participants With a Primary Cardiac Event During the Neoadjuvant Phase
A primary cardiac event is defined as the occurrence of either of the following events: - Incidence of a symptomatic ejection fraction decrease (heart failure) of New York Heart Association (NYHA) Class III or IV and a drop in left ventricular ejection fraction (LVEF) of at least 10-percentage points from baseline and to below 50%; or - Cardiac death, defined as: Definite cardiac death (due to heart failure, myocardial infarction, or documented primary arrhythmia); or, Probable cardiac death (sudden unexpected death within 24 hours of a definite or probable cardiac event \[e.g., syncope, cardiac arrest, chest pain, infarction, arrhythmia\] without documented etiology).
Time frame: From first dose of study treatment until the completion of neoadjuvant therapy (24 weeks)
Number of Participants With a Secondary Cardiac Event During the Neoadjuvant Phase
A secondary cardiac event is defined as asymptomatic or mildly symptomatic Left Ventricular Systolic Dysfunction (LVSD) of NYHA Class II, defined as a left ventricular ejection fraction (LVEF) decrease of at least 10-percentage points below the baseline measurement to an absolute LVEF value of \<50% confirmed by a second assessment within approximately 3 weeks.
Time frame: From first dose of study treatment until the completion of neoadjuvant therapy (24 weeks)
Number of Participants With a Primary Cardiac Event During the Adjuvant Phase
A primary cardiac event is defined as the occurrence of either of the following events: - Incidence of a symptomatic ejection fraction decrease (heart failure) of New York Heart Association (NYHA) Class III or IV and a drop in left ventricular ejection fraction (LVEF) of at least 10-percentage points from baseline and to below 50%; or - Cardiac death, defined as: Definite cardiac death (due to heart failure, myocardial infarction, or documented primary arrhythmia); or, Probable cardiac death (sudden unexpected death within 24 hours of a definite or probable cardiac event \[e.g., syncope, cardiac arrest, chest pain, infarction, arrhythmia\] without documented etiology).
Time frame: From surgery until 28 days after the last dose of adjuvant treatment (42 weeks)
Number of Participants With a Secondary Cardiac Event During the Adjuvant Phase
A secondary cardiac event is defined as asymptomatic or mildly symptomatic Left Ventricular Systolic Dysfunction (LVSD) of NYHA Class II, defined as a left ventricular ejection fraction (LVEF) decrease of at least 10-percentage points below the baseline measurement to an absolute LVEF value of \<50% confirmed by a second assessment within approximately 3 weeks.
Time frame: From surgery until 28 days after the last dose of adjuvant treatment (42 weeks)
Number of Participants With Laboratory Test Abnormalities at the Highest NCI CTCAE v4 Grade Post-Baseline Over the Course of the Entire Study
Clinical laboratory tests were performed at local laboratories; any abnormal values (High or Low) were based on local laboratory normal ranges. Laboratory abnormalities are presented by the highest (worst) severity grade (according to NCI-CTCAE v4.0) post-baseline. Not every abnormal laboratory value qualified as an adverse event, only if it met any of the following criteria: clinically significant (per investigator); accompanied by clinical symptoms; resulted in a change in study treatment; or required a medical intervention or a change in concomitant therapy. For a participant with multiple post-baseline abnormalities, only the highest (worst) grade for a given laboratory test is reported. 'Any Grade' indicates the total number of participants with a post-baseline abnormality of any grade for the specified test.
Time frame: From first dose of study treatment until 28 days after last dose of study treatment (up to 1 year, 6 months)
| Milestone | Arm A: Pertuzumab IV + Trastuzumab IV + Chemotherapy | Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy |
|---|---|---|
| Started | 252 | 248 |
| Received at least one dose of study drug | 252 | 248 |
| Completed | 242 | 234 |
| Not completed | 10 | 14 |
| Withdrew: Adverse event | 3 | 5 |
| Withdrew: Death | 1 | 1 |
| Withdrew: Protocol violation | 0 | 1 |
| Withdrew: Withdrawal by subject | 1 | 2 |
| Withdrew: Progressive disease | 3 | 3 |
| Withdrew: Other | 1 | 2 |
| Withdrew: Other | 1 | 0 |
| Milestone | Arm A: Pertuzumab IV + Trastuzumab IV + Chemotherapy | Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy |
|---|---|---|
| Started | 242 | 234 |
| Completed surgery | 239 | 234 |
| Completed | 209 | 217 |
| Not completed | 33 | 17 |
| Withdrew: Adverse event | 12 | 7 |
| Withdrew: Lack of efficacy | 0 | 2 |
| Withdrew: Progressive disease | 4 | 0 |
| Withdrew: Withdrawal by subject | 2 | 2 |
| Withdrew: Other | 7 | 2 |
| Withdrew: Death | 1 | 1 |
| Withdrew: Physician decision | 3 | 2 |
| Withdrew: Disease relapse | 4 | 1 |
| Milestone | Arm A: Pertuzumab IV + Trastuzumab IV + Chemotherapy | Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy |
|---|---|---|
| Started | 247 | 241 |
| Completed | 223 | 219 |
| Not completed | 24 | 22 |
| Withdrew: Death | 10 | 11 |
| Withdrew: Withdrawal by subject | 10 | 10 |
| Withdrew: Lost to follow-up | 4 | 1 |
The observed pertuzumab trough serum concentration (Ctrough) at Cycle 7 was assessed following 3 cycles of pertuzumab IV and trastuzumab IV or the fixed-dose combination (FDC) of pertuzumab and trastuzumab SC. The Per Protocol Pharmacokinetics (PK) analysis population includes all enrolled participants who adhered to the protocol. Exclusions from the Per Protocol PK analysis population were made for the following reasons: participants were missing the Ctrough pre-dose Cycle 8 PK sample, participants with a Ctrough sample collected with at least 2 days deviation from the planned date on Day 21 (i.e., before Day 19 or after Day 23), participants given a dose amount that deviated from the planned dose by \>20% within 3 cycles (from Cycle 5), participants with a dose delay of more than 7 days, a subcutaneous injection site other than thigh was used, if the Cycle 8 pre-dose and post-dose samples were switched, and an assay error impacting Ctrough measurement.
| micrograms per millilitre (μg/mL) | Arm A: Pertuzumab IV + Trastuzumab IV + Chemotherapy | Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy |
|---|---|---|
| Trough Serum Concentration (Ctrough) of Pertuzumab During Cycle 7 (Pre-Dose Cycle 8) | 72.4 ± 34.1 | 88.7 ± 33.6 |
The observed trastuzumab trough serum concentration (Ctrough) at Cycle 7 was assessed following 3 cycles of pertuzumab IV and trastuzumab IV or the fixed-dose combination (FDC) of pertuzumab and trastuzumab SC. The Per Protocol Pharmacokinetics (PK) analysis population includes all enrolled participants who adhered to the protocol. Exclusions from the Per Protocol PK analysis population were made for the following reasons: participants were missing the Ctrough pre-dose Cycle 8 PK sample, participants with a Ctrough sample collected with at least 2 days deviation from the planned date on Day 21 (i.e., before Day 19 or after Day 23), participants given a dose amount that deviated from the planned dose by \>20% within 3 cycles (from Cycle 5), participants with a dose delay of more than 7 days, a subcutaneous injection site other than thigh was used, if the Cycle 8 pre-dose and post-dose samples were switched, and an assay error impacting Ctrough measurement.
| micrograms per milllilitre (μg/mL) | Arm A: Pertuzumab IV + Trastuzumab IV + Chemotherapy | Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy |
|---|---|---|
| Ctrough of Trastuzumab During Cycle 7 (Pre-Dose Cycle 8) | 43.2 ± 34.7 | 57.5 ± 37.0 |
Total pCR (tpCR) was defined as eradication of invasive disease in the breast and axilla; that is, ypT0/is ypN0, according to the local pathologists' assessment. Pathologic response to therapy was determined at the time of surgery. The tpCR rate is the percentage of participants in the ITT population who achieved a tpCR. Participants with missing data for tpCR (i.e., do not undergo surgery or have an invalid pCR assessment) were included in the analysis and classified as non-responders. Rates of tpCR were calculated in each treatment arm and were assessed using the difference between the Arm B: Pertuzumab and Trastuzumab FDC SC and the Arm A: Pertuzumab IV and Trastuzumab IV tpCR rates and corresponding 95% Clopper-Pearson confidence intervals (CIs). The difference between the tpCR rates along with corresponding 95% Hauck-Anderson CIs were calculated. The lower bound of the CI will reliably reflect the largest tpCR difference that can be considered unlikely.
| Percentage of participants | Arm A: Pertuzumab IV + Trastuzumab IV + Chemotherapy | Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy |
|---|---|---|
| Percentage of Participants With Total Pathological Complete Response (tpCR), According to Local Pathologist Assessment | 59.5 (53.2 to 65.6) | 59.7 (53.3 to 65.8) |
iDFS (excluding SPNBC) is defined as the time from the first date of no disease (i.e., the date of primary surgery) to the first occurrence of one of the following events: ipsilateral invasive breast tumor recurrence; ipsilateral local-regional invasive breast cancer reccurrence; distant recurrence; contralateral invasive breast cancer; or death attributable to any cause. Ipsilateral or contralateral in situ disease and SPNBC (including in situ carcinomas and non-melanoma skin cancers) will not be counted as progressive disease or relapse.
| Percentage of participants | Arm A: Pertuzumab IV + Trastuzumab IV + Chemotherapy | Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy |
|---|---|---|
| 1 Year | 96.07 (93.55 to 98.59) | 97.37 (95.30 to 99.45) |
| 2 Years | 92.98 (89.66 to 96.30) | 90.75 (86.98 to 94.52) |
| 3 Years | 90.71 (86.93 to 94.50) | 89.86 (85.93 to 93.79) |
| 4 Years | 89.60 (85.54 to 93.65) | 88.50 (84.34 to 92.66) |
Invasive disease-free survival (iDFS) including second primary non-breast cancer (SPNBC) is defined as the time from the first date of no disease (i.e., the date of primary surgery) to the first occurrence of one of the following events: ipsilateral invasive breast tumor recurrence; ipsilateral local-regional invasive breast cancer reccurrence; distant recurrence; contralateral invasive breast cancer; or death attributable to any cause. It also includes SPNBC as an event (with the exception of non-melanoma skin cancers and in situ carcinoma of any site).
| Percentage of participants | Arm A: Pertuzumab IV + Trastuzumab IV + Chemotherapy | Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy |
|---|---|---|
| 1 Year | 95.63 (92.99 to 98.28) | 96.94 (94.70 to 99.17) |
| 2 Years | 92.10 (88.60 to 95.60) | 89.44 (85.44 to 93.43) |
| 3 Years | 89.39 (85.37 to 93.40) | 88.54 (84.40 to 92.69) |
| 4 Years | 88.27 (84.01 to 92.53) | 87.64 (83.35 to 91.93) |
Event-free survival (EFS) excluding second primary non-breast cancer (SPNBC) is defined as the time from enrollment to the first occurrence of one of the following events: breast cancer progression; breast cancer recurrence; or death from any cause. Ipsilateral or contralateral in situ disease and SPNBC (including in situ carcinomas and non-melanoma skin cancers) will not be counted as progressive disease or relapse.
| Percentage of participants | Arm A: Pertuzumab IV + Trastuzumab IV + Chemotherapy | Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy |
|---|---|---|
| 1 Year | 96.79 (94.60 to 98.98) | 97.95 (96.18 to 99.73) |
| 2 Years | 92.29 (88.96 to 95.62) | 91.67 (88.17 to 95.16) |
| 3 Years | 89.77 (85.96 to 93.57) | 88.29 (84.21 to 92.37) |
| 4 Years | 88.47 (84.44 to 92.49) | 86.57 (82.24 to 90.90) |
Event-free survival (EFS) including second primary non-breast cancer (SPNBC) is defined as the time from enrollment to the first occurrence of one of the following events: breast cancer progression; breast cancer recurrence; or death from any cause. It also includes SPNBC as an event (with the exception of non-melanoma skin cancers and in situ carcinoma of any site).
| Percentage of participants | Arm A: Pertuzumab IV + Trastuzumab IV + Chemotherapy | Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy |
|---|---|---|
| 1 Year | 96.38 (94.06 to 98.70) | 97.54 (95.59 to 99.48) |
| 2 Years | 91.47 (87.98 to 94.96) | 90.41 (86.69 to 94.14) |
| 3 Years | 88.53 (84.52 to 92.53) | 87.04 (82.78 to 91.30) |
| 4 Years | 87.22 (83.02 to 91.43) | 85.75 (81.31 to 90.18) |
The distant recurrence-free interval (DRFI) is defined as the time between randomization and the date of distant breast cancer recurrence.
| Percentage of participants | Arm A: Pertuzumab IV + Trastuzumab IV + Chemotherapy | Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy |
|---|---|---|
| 1 Year | 99.59 (98.80 to 100.00) | 99.58 (98.77 to 100.00) |
| 2 Years | 95.88 (93.39 to 98.38) | 95.37 (92.70 to 98.04) |
| 3 Years | 93.77 (90.72 to 96.82) | 93.23 (90.02 to 96.43) |
| 4 Years | 92.49 (89.15 to 95.83) | 91.92 (88.44 to 95.41) |
Overall survival is defined as the time from randomization to death from any cause.
| Percentage of participants | Arm A: Pertuzumab IV + Trastuzumab IV + Chemotherapy | Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy |
|---|---|---|
| 1 Year | 99.60 (98.82 to 100.00) | 99.19 (98.06 to 100.00) |
| 2 Years | 98.38 (96.80 to 99.95) | 96.68 (94.42 to 98.94) |
| 3 Years | 96.73 (94.50 to 98.96) | 95.83 (93.30 to 98.36) |
| 4 Years | 95.47 (92.86 to 98.09) | 94.13 (91.14 to 97.11) |
The adverse event (AE) severity grading scale for the NCI CTCAE v4.0 was used for assessing AE severity. Any AEs that were not specifically listed in the NCI CTCAE, v4.0 were graded per the following 5 grades: Grade 1 = mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; or intervention not indicated. Grade 2 = moderate; minimal, local, or non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living. Grade 3 = severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living. Grade 4 = life-threatening consequences or urgent intervention indicated. Grade 5 = death related to AE. The terms "severe" and "serious" are not synonymous and are independently assessed for each AE. Multiple occurrences of AEs were counted only once per participant at the highest (worst) grade.
| Participants | Arm A: Pertuzumab IV + Trastuzumab IV + Chemotherapy | Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy |
|---|---|---|
| Any Adverse Event (AE): Any Grade | 251 | 248 |
| AE with Fatal Outcome (Grade 5) | 2 | 2 |
| Any AE: Grades 3 to 5 | 149 | 132 |
| Serious AE | 52 | 49 |
| Related Serious AE | 29 | 29 |
| Anaphylaxis and Hypersensitivity AEs, Any Grade | 3 | 3 |
| Anaphylaxis and Hypersensitivity AEs, Grade ≥3 | 1 | 0 |
| Infusion/Admin.-Related Reactions Within 24 hrs, Any Grade | 39 | 54 |
| Infusion/Admin.-Related Reactions Within 24 hrs, Grade ≥3 | 3 | 0 |
| Serious Rash/Skin Reactions, Any Grade | 0 | 1 |
| Serious Rash/Skin Reactions, Grade ≥3 | 0 | 0 |
| Diarrhoea, Any Grade | 149 | 153 |
| Diarrhoea, Grade ≥3 | 13 | 16 |
| Cardiac Dysfunction, Any Grade | 65 | 52 |
| Cardiac Dysfunction, Grade ≥3 | 12 | 3 |
| Interstitial Lung Disease, Any Grade | 3 | 5 |
| Interstitial Lung Disease, Grade ≥3 | 0 | 0 |
| Neutropenia/Febrile Neutropenia, Any Grade | 142 | 123 |
| Neutropenia/Febrile Neutropenia, Grade ≥3 | 92 | 82 |
| Serious Mucositis, Any Grade | 3 | 3 |
| Serious Mucositis, Grade ≥3 | 3 | 2 |
| Pregnancy- and Neonatal-Related AEs, Any Grade | 0 | 0 |
| AE Leading to Study Drug Discontinuation | 32 | 22 |
| AE Leading to HER2-Targeted Therapy Discontinuation | 15 | 12 |
| AE Leading to Any Chemotherapy Drug Discontinuation | 23 | 14 |
A primary cardiac event is defined as the occurrence of either of the following events: - Incidence of a symptomatic ejection fraction decrease (heart failure) of New York Heart Association (NYHA) Class III or IV and a drop in left ventricular ejection fraction (LVEF) of at least 10-percentage points from baseline and to below 50%; or - Cardiac death, defined as: Definite cardiac death (due to heart failure, myocardial infarction, or documented primary arrhythmia); or, Probable cardiac death (sudden unexpected death within 24 hours of a definite or probable cardiac event \[e.g., syncope, cardiac arrest, chest pain, infarction, arrhythmia\] without documented etiology).
| Participants | Arm A: Pertuzumab IV + Trastuzumab IV + Chemotherapy | Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy |
|---|---|---|
| Any Primary Cardiac Event | 0 | 2 |
| Heart Failure and Significant LVEF Decline | 0 | 1 |
| Cardiac Death (Definite or Probable) | 0 | 1 |
A secondary cardiac event is defined as asymptomatic or mildly symptomatic Left Ventricular Systolic Dysfunction (LVSD) of NYHA Class II, defined as a left ventricular ejection fraction (LVEF) decrease of at least 10-percentage points below the baseline measurement to an absolute LVEF value of \<50% confirmed by a second assessment within approximately 3 weeks.
| Participants | Arm A: Pertuzumab IV + Trastuzumab IV + Chemotherapy | Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy |
|---|---|---|
| Any Secondary Cardiac Event | 4 | 1 |
| Identified by Initial LVEF Assessment | 4 | 1 |
| Confirmed by Second LVEF Assessment | 1 | 1 |
A primary cardiac event is defined as the occurrence of either of the following events: - Incidence of a symptomatic ejection fraction decrease (heart failure) of New York Heart Association (NYHA) Class III or IV and a drop in left ventricular ejection fraction (LVEF) of at least 10-percentage points from baseline and to below 50%; or - Cardiac death, defined as: Definite cardiac death (due to heart failure, myocardial infarction, or documented primary arrhythmia); or, Probable cardiac death (sudden unexpected death within 24 hours of a definite or probable cardiac event \[e.g., syncope, cardiac arrest, chest pain, infarction, arrhythmia\] without documented etiology).
| Participants | Arm A: Pertuzumab IV + Trastuzumab IV + Chemotherapy | Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy |
|---|---|---|
| Any Primary Cardiac Event | 1 | 2 |
| Heart Failure and Significant LVEF Decline | 1 | 2 |
| Cardiac Death (Definite or Probable) | 1 | 0 |
A secondary cardiac event is defined as asymptomatic or mildly symptomatic Left Ventricular Systolic Dysfunction (LVSD) of NYHA Class II, defined as a left ventricular ejection fraction (LVEF) decrease of at least 10-percentage points below the baseline measurement to an absolute LVEF value of \<50% confirmed by a second assessment within approximately 3 weeks.
| Participants | Arm A: Pertuzumab IV + Trastuzumab IV + Chemotherapy | Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy |
|---|---|---|
| Any Secondary Cardiac Event | 15 | 8 |
| Identified by Initial LVEF Assessment | 15 | 8 |
| Confirmed by Second LVEF Assessment | 0 | 0 |
Clinical laboratory tests were performed at local laboratories; any abnormal values (High or Low) were based on local laboratory normal ranges. Laboratory abnormalities are presented by the highest (worst) severity grade (according to NCI-CTCAE v4.0) post-baseline. Not every abnormal laboratory value qualified as an adverse event, only if it met any of the following criteria: clinically significant (per investigator); accompanied by clinical symptoms; resulted in a change in study treatment; or required a medical intervention or a change in concomitant therapy. For a participant with multiple post-baseline abnormalities, only the highest (worst) grade for a given laboratory test is reported. 'Any Grade' indicates the total number of participants with a post-baseline abnormality of any grade for the specified test.
| Participants | Arm A: Pertuzumab IV + Trastuzumab IV + Chemotherapy | Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy |
|---|---|---|
| Albumin, Low - Any Grade | 50 | 39 |
| Albumin, Low - Grade 1 | 41 | 34 |
| Albumin, Low - Grade 2 | 8 | 5 |
| Albumin, Low - Grade 3 | 1 | 0 |
| Alkaline Phosphatase, High - Any Grade | 80 | 71 |
| Alkaline Phosphatase, High - Grade 1 | 78 | 70 |
| Alkaline Phosphatase, High - Grade 2 | 2 | 1 |
| SGPT/ALT, High - Any Grade | 172 | 149 |
| SGPT/ALT, High - Grade 1 | 145 | 132 |
| SGPT/ALT, High - Grade 2 | 18 | 13 |
| SGPT/ALT, High - Grade 3 | 9 | 4 |
| SGOT/AST, High - Any Grade | 149 | 130 |
| SGOT/AST, High - Grade 1 | 137 | 125 |
| SGOT/AST, High - Grade 2 | 7 | 3 |
| SGOT/AST, High - Grade 3 | 5 | 2 |
| Creatinine, High - Any Grade | 225 | 217 |
| Creatinine, High - Grade 1 | 214 | 204 |
| Creatinine, High - Grade 2 | 9 | 13 |
| Creatinine, High - Grade 3 | 2 | 0 |
| Glucose, Low - Any Grade | 23 | 22 |
| Glucose, Low - Grade 1 | 20 | 22 |
| Glucose, Low - Grade 2 | 3 | 0 |
| Glucose, High - Any Grade | 3 | 4 |
| Glucose, High - Grade 3 | 3 | 4 |
| Hemoglobin, Low - Any Grade | 233 | 223 |
| Hemoglobin, Low - Grade 1 | 129 | 139 |
| Hemoglobin, Low - Grade 2 | 93 | 77 |
| Hemoglobin, Low - Grade 3 | 11 | 7 |
| Hemoglobin, High - Any Grade | 12 | 6 |
| Hemoglobin, High - Grade 1 | 12 | 6 |
| Lymphocytes, Abs., Low - Any Grade | 144 | 150 |
| Lymphocytes, Abs., Low - Grade 1 | 23 | 22 |
| Lymphocytes, Abs., Low - Grade 2 | 59 | 68 |
| Lymphocytes, Abs., Low - Grade 3 | 55 | 56 |
| Lymphocytes, Abs., Low - Grade 4 | 7 | 4 |
| Lymphocytes, Abs., High - Any Grade | 4 | 3 |
| Lymphocytes, Abs., High - Grade 2 | 4 | 3 |
| Neutrophils, Total, Abs., Low - Any Grade | 110 | 114 |
| Neutrophils, Total, Abs., Low - Grade 1 | 27 | 42 |
| Neutrophils, Total, Abs., Low - Grade 2 | 30 | 23 |
| Neutrophils, Total, Abs., Low - Grade 3 | 17 | 24 |
| Neutrophils, Total, Abs., Low - Grade 4 | 36 | 25 |
| Platelets, Low - Any Grade | 72 | 67 |
| Platelets, Low - Grade 1 | 68 | 65 |
| Platelets, Low - Grade 2 | 3 | 2 |
| Platelets, Low - Grade 3 | 1 | 0 |
| Potassium, Low - Any Grade | 45 | 41 |
| Potassium, Low - Grade 2 | 38 | 28 |
| Potassium, Low - Grade 3 | 6 | 11 |
| Potassium, Low - Grade 4 | 1 | 2 |
| Potassium, High - Any Grade | 24 | 32 |
| Potassium, High - Grade 1 | 17 | 26 |
| Potassium, High - Grade 2 | 7 | 3 |
| Potassium, High - Grade 3 | 0 | 2 |
| Potassium, High - Grade 4 | 0 | 1 |
| Sodium, Low - Any Grade | 27 | 33 |
| Sodium, Low - Grade 1 | 22 | 32 |
| Sodium, Low - Grade 3 | 4 | 0 |
| Sodium, Low - Grade 4 | 1 | 1 |
| Sodium, High - Any Grade | 25 | 16 |
| Sodium, High - Grade 1 | 19 | 13 |
| Sodium, High - Grade 2 | 4 | 1 |
| Sodium, High - Grade 3 | 0 | 1 |
| Sodium, High - Grade 4 | 2 | 1 |
| Bilirubin, High - Any Grade | 24 | 22 |
| Bilirubin, High - Grade 1 | 16 | 17 |
| Bilirubin, High - Grade 2 | 7 | 5 |
| Bilirubin, High - Grade 3 | 1 | 0 |
| Total Leukocyte Count, Low - Any Grade | 199 | 203 |
| Total Leukocyte Count, Low - Grade 1 | 57 | 64 |
| Total Leukocyte Count, Low - Grade 2 | 81 | 78 |
| Total Leukocyte Count, Low - Grade 3 | 41 | 43 |
| Total Leukocyte Count, Low - Grade 4 | 20 | 18 |
| Total Leukocyte Count, High - Any Grade | 0 | 1 |
| Total Leukocyte Count, High - Grade 1 | 0 | 1 |
Collected over Adverse events (AEs): From first dose of study treatment until 28 days after last dose of study treatment (up to 1 year, 6 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 4 years, 11 months). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm A: Pertuzumab IV + Trastuzumab IV + Chemotherapy | 12/252 (4.8%) | 52/252 (20.6%) | 251/252 (99.6%) |
| Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy | 14/248 (5.6%) | 49/248 (19.8%) | 248/248 (100%) |
| Event | Arm A: Pertuzumab IV + Trastuzumab IV + Chemotherapy | Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy |
|---|---|---|
| Febrile neutropeniaBlood and lymphatic system disorders | 10/252 | 9/248 |
| Cardiac failureCardiac disorders | 6/252 | 4/248 |
| Neutropenic sepsisInfections and infestations | 1/252 | 3/248 |
| Neutrophil count decreasedInvestigations | 1/252 | 3/248 |
| NeutropeniaBlood and lymphatic system disorders | 3/252 | 1/248 |
| PyrexiaGeneral disorders | 3/252 | 2/248 |
| PneumoniaInfections and infestations | 3/252 | 0/248 |
| SepsisInfections and infestations | 2/252 | 2/248 |
| PneumonitisRespiratory, thoracic and mediastinal disorders | 1/252 | 2/248 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 1/252 | 2/248 |
| Event | Arm A: Pertuzumab IV + Trastuzumab IV + Chemotherapy | Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy |
|---|---|---|
| AlopeciaSkin and subcutaneous tissue disorders | 184/252 | 196/248 |
| NauseaGastrointestinal disorders | 157/252 | 151/248 |
| DiarrhoeaGastrointestinal disorders | 148/252 | 152/248 |
| AnaemiaBlood and lymphatic system disorders | 109/252 | 90/248 |
| AstheniaGeneral disorders | 84/252 | 79/248 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 82/252 | 71/248 |
| FatigueGeneral disorders | 62/252 | 71/248 |
| MyalgiaMusculoskeletal and connective tissue disorders | 52/252 | 67/248 |
| HeadacheNervous system disorders | 68/252 | 45/248 |
| StomatitisGastrointestinal disorders | 61/252 | 63/248 |
| Age, Continuous(Years) | Arm A: Pertuzumab IV + Trastuzumab IV + Chemotherapy | Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy | Total |
|---|---|---|---|
| Mean | 50.3 ± 10.8 | 51.7 ± 10.7 | 51.0 ± 10.8 |
| Sex: Female, Male(Participants) | Arm A: Pertuzumab IV + Trastuzumab IV + Chemotherapy | Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy | Total |
|---|---|---|---|
| Female | 250 | 248 | 498 |
| Male | 2 | 0 | 2 |
| Ethnicity (NIH/OMB)(Participants) | Arm A: Pertuzumab IV + Trastuzumab IV + Chemotherapy | Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy | Total |
|---|---|---|---|
| Hispanic or Latino | 32 | 42 | 74 |
| Not Hispanic or Latino | 200 | 189 | 389 |
| Unknown or Not Reported | 20 | 17 | 37 |
| Race (NIH/OMB)(Participants) | Arm A: Pertuzumab IV + Trastuzumab IV + Chemotherapy | Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy | Total |
|---|---|---|---|
| American Indian or Alaska Native | 10 | 10 | 20 |
| Asian | 54 | 51 | 105 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 3 | 6 |
| White | 164 | 165 | 329 |
| More than one race | 2 | 3 | 5 |
| Unknown or Not Reported | 19 | 16 | 35 |
| Randomization Stratification Factors: Hormone Receptor Status(Participants) | Arm A: Pertuzumab IV + Trastuzumab IV + Chemotherapy | Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy | Total |
|---|---|---|---|
| ER Negative and PgR Negative | 97 | 96 | 193 |
| ER Positive and PgR Positive | 155 | 151 | 306 |
| Unknown | 0 | 1 | 1 |
| Randomization Stratification Factors: Clinical Stage at Presentation(Participants) | Arm A: Pertuzumab IV + Trastuzumab IV + Chemotherapy | Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy | Total |
|---|---|---|---|
| Stage II-IIIA | 201 | 198 | 399 |
| Stage IIIB-IIIC | 51 | 50 | 101 |
| Randomization Stratification Factors: Neoadjuvant Chemotherapy Regimen(Participants) | Arm A: Pertuzumab IV + Trastuzumab IV + Chemotherapy | Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy | Total |
|---|---|---|---|
| ddAC Followed by Paclitaxel | 120 | 120 | 240 |
| AC Followed by Docetaxel | 132 | 128 | 260 |
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PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/innovation/process/clinical-trials/data-sharing/).
Ran from Jun 2018 to primary completion in Jul 2019, 12 months.
Results were first posted in Jun 2020, 11 months after primary completion.
Of 272 industry-sponsored phase 3 interventional studies under Breast Neoplasms, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 63. This study's 12 months is below that.
Counting every sponsor, half of 600 studies reached it within 59 months; a quarter within 36 and three quarters within 96.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Pertuzumab · Pertuzumab/Trastuzumab/Hyaluronidase-zzxf