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