Breast Cancer Clinical Trial
Official title:
An Exploratory Single-arm Study to Evaluate the Effect of Pertuzumab in Combination With Herceptin on Response Rate in Patients With HER2-positive Metastatic Breast Cancer
This study will evaluate the efficacy and safety of Perjeta (pertuzumab) in combination with Herceptin in patients with metastatic breast cancer who have progressed on Herceptin-based therapy, and will make a preliminary assessment of the efficacy and safety of single agent pertuzumab. Objective response rate and clinical benefit will be assessed. Pertuzumab will be administered at an initial dose of 840mg intravenously (iv) on day 1, followed by 420mg iv every 3 weeks. Herceptin will be administered at the same schedule the patient was following before entry into the study. An additional cohort of patients, at certain centers, will receive pertuzumab monotherapy, at an initial dose of 840mg iv on day 1, followed by 420mg iv every 3 weeks. The anticipated time on study treatment is until disease progression.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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