Phase 2
Completed N=95
A Study of Perjeta (Pertuzumab) in Combination With Herceptin (Trastuzumab) in Participants With Metastatic Breast Cancer
Source: ClinicalTrials.gov NCT01674062 ↗Enrolled (actual)
95
Serious AEs
13.7%
Results posted
Sep 2015
Primary outcomePrimary: Cohorts 1 and 2: Percentage of Participants With a Confirmed Best Overall Response of Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 During Dual-Agent Treatment — 24.2 percentage of participants
Summary
This study will evaluate the efficacy and safety of Perjeta (pertuzumab) in combination with Herceptin (trastuzumab) in participants with metastatic breast cancer who have progressed on trastuzumab-based therapy (Cohorts 1 and 2), and will make a preliminary assessment of the efficacy and safety of single-agent pertuzumab (Cohort 3). Objective response rate and clinical benefit will be assessed. Pertuzumab will be administered at an initial dose of 840 milligrams (mg) intravenously (IV) on Day 1, followed by 420 mg IV every 3 weeks. Trastuzumab will be administered at the same schedule the participant was following before entry into the study. An additional cohort of participants at certain centers will receive pertuzumab monotherapy at an initial dose of 840 mg IV on Day 1, followed by 420 mg IV every 3 weeks. These participants may have trastuzumab added to the regimen in the event of progression during single-agent pertuzumab treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cohorts 1 and 2: Percentage of Participants With a Confirmed Best Overall Response of Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 During Dual-Agent Treatment |
24.2 | — |
| PRIMARY Cohorts 1 and 2: Percentage of Participants With a Confirmed Best Overall Response of CR, PR, or Stable Disease (SD) According to RECIST Version 1.0 During Dual-Agent Treatment |
50.0 | — |
| SECONDARY Cohort 3: Percentage of Participants With a Confirmed Best Overall Response of CR or PR According to RECIST Version 1.0 During Single-Agent Treatment With Pertuzumab |
3.4 | — |
| SECONDARY Cohort 3: Percentage of Participants With a Confirmed Best Overall Response of CR, PR, or SD According to RECIST Version 1.0 During Single-Agent Treatment With Pertuzumab |
10.3 | — |
| SECONDARY Cohorts 1 and 2: Duration of Response According to RECIST Version 1.0 |
40.1; 50.14 | — |
| SECONDARY Cohorts 1 and 2: Time to Objective Response According to RECIST Version 1.0 |
11.14 | — |
| SECONDARY Cohorts 1 and 2: Percentage of Participants With Disease Progression According to RECIST Version 1.0 |
93.9 | — |
| SECONDARY Cohorts 1 and 2: Time to Progression (TTP) According to RECIST Version 1.0 |
23.2 | — |
| SECONDARY Cohorts 1 and 2: Progression-Free Survival (PFS) According to RECIST Version 1.0 |
24.0 | — |
| SECONDARY Cohorts 1 and 2: Percentage of Participants Who Died |
30.3 | — |
| SECONDARY Cohorts 1 and 2: Overall Survival (OS) |
38.5 | — |
Eligibility Criteria
Inclusion Criteria
- Females greater than or equal to (≥) 18 years of age, with histologically-confirmed HER2-positive breast cancer
- Metastatic breast cancer, with progression on trastuzumab-based therapy as last treatment for metastatic disease
- Less than or equal to (≤) 3 chemotherapy regimens prior to study entry
- Last trastuzumab dose ≤9 weeks before study entry for participants receiving pertuzumab + trastuzumab, and ≥4 weeks for participants receiving pertuzumab monotherapy
- Left ventricular ejection fraction ≥55% at study entry
Exclusion Criteria
- Previous treatment with an anti-cancer vaccine or any targeted therapy other than trastuzumab
- Brain metastases
- History of any cardiac adverse event related to trastuzumab therapy
- Any other malignancy in the last 5 years, except for basal cell cancer or cancer in situ of the cervix
Data sourced from ClinicalTrials.gov (NCT01674062). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.