Trial Information

Summary: A Study of Xeloda (Capecitabine) in Patients With Advanced Breast Cancer

Status: Completed

Protocol Number: ML16505

Sponsor: Roche S.p.A. Italy

Company Division: Pharmaceutical

Official Scientific Title: A randomized, open-label study of the addition of oral Xeloda to intravenous Taxotere and epirubicin on progression-free survival in patients with advanced breast cancer

Brief Summary: This study will evaluate the efficacy and safety of oral Xeloda plus intravenousTaxotere and epirubicin, compared with the combination therapy alone. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals. Target sample size is 340.

Study Phase: III

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: capecitabine[Xeloda]

Primary Outcome: 1. Progression-free survival and overall survival

Key Secondary Outcomes: 1. Efficacy:Complete remission, partial remission, stable disease, progressive disease and overall survival. Safety: Adverse events and laboratory parameters

Inclusion Criteria:

Exclusion Criteria:

Gender: Females

Age Limits: Min: 18 Years Max: 70 Years

Accepts Healthy Volunteers: No

Trial Registration Date: 10/27/2005

Date Last Updated: 07/15/2008

Link To Trial Results

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Trial listings updated: July 21, 2008 at 2:19:43 PM