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:
Participant gender:
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.