A Multicenter Phase III Randomized Trial Comparing Docetaxel in Combination With Doxorubicin and Cyclophosphamide (TAC) Versus 5-Fluorouracil in Combination With Doxorubicin and Cyclophosphamide (FAC) as Adjuvant Treatment of High Risk Operable Breast Cancer Patients With Negative Axillary Lymph Nodes
Primary objective:
- To compare disease-free survival (DFS) after treatment with docetaxel in combination
with doxorubicin and cyclophosphamide (TAC) to 5-Fluorouracil in combination with
doxorubicin and cyclophosphamide (FAC) as adjuvant treatment of high risk operable
breast cancer patients with negative axillary lymph nodes.
Secondary objectives:
- To compare overall survival (OS) between the 2 above mentioned arms.
- To compare toxicity and quality of life between the 2 above mentioned arms.
- To evaluate pathologic markers for predicting efficacy (hormonal receptors and
c-erB-2).
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
10 year Disease-free survival (DFS)
Miguel MartÃn, MD, PhD
Study Chair
Spanish Breast Cancer Research Group
Spain: Spanish Agency of Medicines
GEICAM 9805
NCT00121992
June 1999
June 2005
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