Trial Information

Summary: A Study of Herceptin (Trastuzumab) in Women With HER2-Positive Advanced and/or Metastatic Breast Cancer

Status: Completed

Protocol Number: MO16419

Sponsor: Hoffmann-La Roche AG

Company Division: Pharmaceutical

Official Scientific Title: A randomized, open-label study of the effect of the combination of Herceptin and Taxotere, with and without Xeloda, on survival in patients with advanced and/or metastatic breast cancer with overexpressed HER2

Brief Summary: This study will assess the efficacy and safety of intravenous (IV) Herceptin in combination with intravenous (iv) docetaxel and oral capecitabine compared with that of Herceptin plus docetaxel in women with previously untreated HER2-positive advanced and/or metastatic breast cancer. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals. Target sample size is 220.

Study Phase: II

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: Overall response rate (complete and partial response)

Key Secondary Outcomes: 1. Efficacy: progression-free survival, overall survival. duration of response.Safety: Adverse events, hematologic and biochemical parameters and LVEF

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 1:44:57 PM