Trial Information

Summary: BETH Study: A Study of Avastin (Bevacizumab) in Combination With Chemotherapy + Herceptin (Trastuzumab) in Patients With HER2-Positive Early Breast Cancer.

Status: Recruiting

Protocol Number: BO20906

Sponsor: Hoffmann-La Roche; NSABP

Company Division: Pharmaceutical

Official Scientific Title: BETH: A randomized, open-label study of adjuvant therapy for patients with HER2-positive node-positive or high risk node-negative breast cancer, comparing the effect on disease-free survival of chemotherapy plus Herceptin, with chemotherapy plus Herceptin plus Avastin

Brief Summary: This study will assess the efficacy and safety of adding Avastin to regimens of chemotherapy plus Herceptin in patients with resected node-positive or high risk node-negative, HER2-positive breast cancer. Patients will be randomized to receive standard chemotherapy + Herceptin (8mg/kg iv on day 1 of cycle 1 followed by 6mg/kg iv every 3 weeks) or standard chemotherapy + Herceptin + Avastin (15mg/kg iv every 3 weeks). The anticipated time on study treatment is 1 year, and the target sample size is 500+ individuals.In the US this trial is sponsored/managed by NSABP. Target sample size is 3600.

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: bevacizumab [Avastin]

Primary Outcome: 1. Invasive disease-free survival Time frame: Event driven

Key Secondary Outcomes: 1. Overall survival, recurrence-free interval, distant recurrence-free interval. Time frame: Event driven 2. Cardiac and non-cardiac toxicity Time frame: Throughout study

Inclusion Criteria:

Exclusion Criteria:

Gender: Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: September, 2008

Trial Registration Date: 04/18/2008

Date Last Updated: 10/17/2008

Link To Trial Results

This site is run by CenterWatch, a publishing company that focuses on the clinical trials industry. The information provided in this service is designed to help patients find clinical trials that may be of interest to them, and to help patients contact the centers conducting the research. CenterWatch is neither promoting this research nor involved in conducting any of these trials.

Trial listings updated: November 17, 2008 at 2:53:43 PM