Expired Study
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Houston, Texas 77060


Purpose:

This 2 arm study will compare the efficacy and safety of Taxotere + Xeloda, versus Taxotere alone, following a regimen of Adriamycin plus Cytoxan in women with high-risk breast cancer. Following 4 cycles of Adriamycin and Cytoxan, patients will be randomized to receive either 1)Taxotere 75mg/m2 iv on day 1 and Xeloda 825mg/m2 po bid on days 1-14 of each 3 week cycle or 2) Taxotere 100mg/m2 iv alone on day 1 of each 3 week cycle. The anticipated time on study treatment is until disease progression, and the target sample size is 500+ individuals.


Criteria:

Inclusion Criteria: - female patients 18-70 years of age; - adenocarcinoma of the breast; - previous invasive breast cancer if diagnosed >5 years before entering study; - no evidence of metastatic disease. Exclusion Criteria: - history of severe hypersensitivity reaction to Taxotere; - previous treatment with anthracycline, anthracenedione (mitoxantrone), or taxane; - treatment with fluoropyrimidine (5-fluorouracil) within the last 5 years.


NCT ID:

NCT00089479


Primary Contact:

Study Director
Clinical Trials
Hoffmann-La Roche


Backup Contact:

N/A


Location Contact:

Houston, Texas 77060
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 16, 2017

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