Trial Information

Summary: A Study of Herceptin (Trastuzumab) Monotherapy in Women With Metastatic Breast Cancer

Status: Completed

Protocol Number: WO16229

Sponsor: Hoffmann-La Roche AG

Company Division: Pharmaceutical

Official Scientific Title: An open-label study of the effect of Herceptin monotherapy on tumor response in women with metastatic breast cancer with HER2 overexpression/amplification

Brief Summary: This study will assess the efficacy of treatment with intravenous Herceptin in patients with metastatic breast cancer who demonstrate overexpression of HER2. The anticipated time on study treatment is until disease progression and the target sample size is <100 individuals. Target sample size is 80.

Study Phase: II

Study Design / Study Details:

• Purpose: Treatment
• Allocation: Non-Randomized
• Masking: Open Label
• Control: Uncontrolled
• Assignment: Single Group
• Endpoints: Safety/Efficacy

Study Type:

Condition: Breast Cancer

Intervention Type: Drug

Intervention Name: trastuzumab[Herceptin]

Primary Outcome: 1. Efficacy: Tumor response rate and progression

Key Secondary Outcomes: 1. Efficacy: Time to progression, clinical benefit rate. Safety: Adverse events, LVEF measurement, hematologic and biochemical parameters

Inclusion Criteria:

Exclusion Criteria:

Gender: Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Trial Registration Date: 06/24/2005

Date Last Updated: 04/16/2008

Link To Trial Results

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Trial listings updated: May 13, 2008 at 1:50:00 PM