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

2014-08-27 03:54:33 | BioPortfolio

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Breast Cancer

Intervention

capecitabine [Xeloda], capecitabine [Xeloda], Taxotere

Location

Birmingham
Alabama
United States
35233

Status

Active, not recruiting

Source

Hoffmann-La Roche

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:54:33-0400

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Medical and Biotech [MESH] Definitions

A deoxycytidine derivative and fluorouracil PRODRUG that is used as an ANTINEOPLASTIC ANTIMETABOLITE in the treatment of COLON CANCER; BREAST CANCER and GASTRIC CANCER.

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