Trial Information

Summary: A Study to Assess Xeloda (Capecitabine) in Patients With Locally Advanced or Metastatic Breast Cancer

Status: Recruiting

Protocol Number: NO16853

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: A randomized, open-label study of the effect of different dosing regimens of Xeloda in combination with Taxotere on disease progression in patients with locally advanced and/or metastatic breast cancer

Brief Summary: This 2 arm study will compare the efficacy and safety of label dose Xeloda to that of a lower dose of Xeloda plus Taxotere in patients with locally advanced or metastatic breast cancer after failure of chemotherapy with an anthracycline.Patients will be randomized to receive either 1250mg/m2 or 825mg/m2 po bid on days 1-14 of each 3 week cycle, in combination with Taxotere 75mg/m2 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 100-500 individuals. Target sample size is 440.

Study Phase: II

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: capecitabine [Xeloda]

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

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

Inclusion Criteria:

Exclusion Criteria:

Gender: Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: July, 2003

Trial Registration Date: 06/24/2005

Date Last Updated: 09/19/2008

Link To Trial Results

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Trial listings updated: October 6, 2008 at 2:33:09 PM