Trial Information

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

Status: Recruiting

Protocol Number: WO17299

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: An open-label study of the effect of first-line Herceptin alone or in combination with a taxane on tumor response and disease progression in patients with metastatic breast cancer who relapsed after receiving adjuvant Herceptin for HER2-positive early breast cancer

Brief Summary: This 2 arm study will assess the efficacy and safety of intravenous Herceptin with or without a taxane for the first line treatment of metastatic breast cancer in women who have relapsed at least 12 months after a minimum of 10 months of (neo)adjuvant treatment with Herceptin for HER2-positive early breast cancer.Patients will receive either Herceptin monotherapy (loading dose of 4mg/kg iv, followed by weekly doses of 2mg/kg iv, or 8mg/kg loading dose followed by 3-weekly doses of 6mg/kg)or Herceptin + a taxane (docetaxel 100mg/m2 iv every 3 weeks, or paclitaxel 175mg/m2 iv every 3 weeks or 75mg/m2 every week). The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals. Target sample size is 40.

Study Phase: II

Study Design / Study Details:

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

Study Type:

Condition: Breast Cancer

Intervention Type: Drug

Intervention Name: trastuzumab [Herceptin]

Primary Outcome: 1. Tumor response rate and progression Time frame: Event driven

Key Secondary Outcomes: 1. Duration of response, PFS, time to treatment failure, clinical benefit rate, survival. Time frame: Event driven 2. AEs, hematologic and biochemical parameters, LVEF. Time frame: Throughout study

Inclusion Criteria:

Exclusion Criteria:

Gender: Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: February, 2005

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