Trial Information

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

Status: Recruiting

Protocol Number: BO15943

Sponsor: Hoffman-La Roche Ltd Global Development

Company Division: Pharmaceutical

Official Scientific Title: A single arm, multi-centre, international, continuation trial of recombinant humanized antibody Herceptin® (trastuzumab) in patients with HER2 overexpressing tumors.

Brief Summary: This study will evaluate the long-term safety of treatment with Herceptin in patients with metastatic breast cancer with HER2 overexpression who have completed a prior study with Herceptin. The anticipated time on study treatment is until Herceptin becomes commercially available or until disease progression , and the target sample size is <100 individuals. Target sample size is 23.

Study Phase: IV

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. Clinical outcome

Key Secondary Outcomes: 1. Safety: Serious adverse events

Inclusion Criteria:

Exclusion Criteria:

Gender: Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: June, 1999

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 1:43:49 PM