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Trial Information
Summary: HERA study - A Study of Intravenous Herceptin (Trastuzumab) in Women With HER2-Positive Primary Breast CancerStatus: No longer recruiting Protocol Number: BO16348 Sponsor: F Hoffman-La Roche Ltd Company Division: Pharmaceutical Official Scientific Title: A randomized, open-label study of the effect of Herceptin on disease-free and overall survival in women with HER2-positive primary breast cancer who have completed adjuvant chemotherapy Brief Summary: This study will compare the efficacy and safety of different treatment durations of intravenous Herceptin compared to observation (no treatment) in women with HER2-positive primary breast cancer who have completed adjuvant chemotherapy. The anticipated time on study treatment is 2+ years, and the target sample size is 500+ individuals. Target sample size is 4482. Study Phase: III Study Design / Study Details:
Study Type: Interventional
Condition: Breast Cancer Intervention Type: Drug Intervention Name: trastuzumab[Herceptin] Primary Outcome: 1. Disease-free survival Key Secondary Outcomes: 1. Efficacy: Overall survival, relapse-free survival, distant disease-free survival. Safety: Adverse events, with special emphasis on cardiac safety, laboratory parameters. Inclusion Criteria:
Exclusion Criteria:
Gender: Females Age Limits: Min: 18 Years Accepts Healthy Volunteers: No Anticipated Start Date: December, 2001 Trial Registration Date: 06/24/2005 Date Last Updated: 04/16/2008
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