Overview

A Study of Perjeta (Pertuzumab) in Combination With Herceptin (Trastuzumab) in Participants With Metastatic Breast Cancer

Status:
Completed
Trial end date:
2015-09-01
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hoffmann-La Roche
Treatments:
Pertuzumab
Trastuzumab
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