Status:
COMPLETED
A Study of Xeloda (Capecitabine) in Women With High-Risk Breast Cancer
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE3
Brief Summary
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 cyc...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
2611 Patients enrolled
Trial Details
Trial ID
NCT00089479
Start Date
August 1 2002
End Date
May 1 2012
Last Update
December 21 2012
Active Locations (1)
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1
Houston, Texas, United States, 77060