Trial Information

Summary: A Study of Herceptin (Trastuzumab) in Combination Chemotherapy in Patients With Advanced Breast Cancer

Status: No longer recruiting

Protocol Number: WO16437

Sponsor: F Hoffman-La Roche Ltd; Genentech Inc.

Company Division: Pharmaceutical

Official Scientific Title: A randomized, open-label study of the effect of Taxotere and Herceptin, with and without cisplatin or carboplatin, as first-line therapy on time to progression in patients with advanced breast cancer with HER2 NEU alteration

Brief Summary: This study will assess the safety and efficacy of Herceptin and docetaxel, with or without carboplatin, in patients with advanced breast cancer and HER2 amplification. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals. Target sample size is 250.

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. Efficacy: Time to progression

Key Secondary Outcomes: 1. Efficacy: Response rate, duration of overall response, complete response, partial response, and survival

Inclusion Criteria:

Exclusion Criteria:

Gender: Females

Age Limits: Min: 18 Years Max: 75 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: December, 2001

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 1:42:08 PM