Trial Information

Summary: A Study to Evaluate the Efficacy and Safety of Herceptin (Trastuzumab) in Combination With an Aromatase Inhibitor in Patients With Metastatic Breast Cancer

Status: Completed

Protocol Number: BO16216

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: A randomized, open-label study of the effect of Herceptin plus Arimidex compared with Arimidex alone on progression-free survival in patients with HER2-positive and hormone-receptor positive metastatic breast cancer

Brief Summary: This 2 arm study will assess the safety and efficacy of adding intravenous Herceptin to daily oral anastrozole (Arimidex) tablets as first- and second-line treatment in postmenopausal patients with HER2 overexpressing metastatic breast cancer (ER+ve and/or PR+ve). Patients will be randomized to receive either anastrazole 1mg po daily,or anastrazole 1mg po daily + a loading dose of Herceptin 4mg/kg iv followed by weekly doses of Herceptin 2mg/kg iv. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals. Target sample size is 202.

Study Phase: III

Study Design / Study Details:

• Purpose: Treatment
• Allocation: Randomized
• Masking: Open Label
• Control: Active
• Assignment: Parallel
• Endpoints: Safety/Efficacy

Study Type:

Condition: Breast Cancer

Intervention Type: Drug

Intervention Name: trastuzumab [Herceptin]

Primary Outcome: 1. Tumor measurements Time frame: Event driven

Key Secondary Outcomes: 1. Hematology, serum chemistry, clinical safety assessments, cardiac monitoring. Time frame: Throughout study

Inclusion Criteria:

Exclusion Criteria:

Gender: Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Trial Registration Date: 06/24/2005

Date Last Updated: 10/17/2008

Link To Trial Results

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Trial listings updated: November 17, 2008 at 2:31:33 PM