Trial Information

Summary: A Study of Xeloda (Capecitabine) in Women With HER2-Negative Metastatic Breast Cancer

Status: No longer recruiting

Protocol Number: ML18527

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: An open-label study of Xeloda plus Avastin at time of disease progression in treatment-naïve women with HER2-negative metastatic breast cancer

Brief Summary: This single arm study will evaluate the efficacy and safety of oral Xeloda plus intravenous Avastin as first line treatment in women with metastatic breast cancer. Patients will receive Xeloda 1000mg/m2 po bid on days 1-15, and Avastin 15mg iv on day 1, of each 3 week cycle.The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals. Target sample size is 92.

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: capecitabine [Xeloda]

Primary Outcome: 1. Time to first disease progression or death Time frame: Event driven

Key Secondary Outcomes: 1. Overall response rate, time to response, response duration, time to treatment failure, duration of disease stabilization, overall survival. Time frame: Event driven 2. AEs, laboratory parameters, vital signs, premature withdrawals Time frame: Throughout study

Inclusion Criteria:

Exclusion Criteria:

Gender: Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: April, 2005

Trial Registration Date: 08/31/2005

Date Last Updated: 07/15/2008

Link To Trial Results

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Trial listings updated: July 21, 2008 at 2:24:42 PM