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 Operable Breast Cancer Patients With Positive Axillary Lymph Nodes.
In addition to the 5-year analysis conducted in September 2003, two other analyses were
planned when 590 and 700 Disease Free Survival events occurred. However, due to the lower
than predicted DFS event rate, and in agreement with FDA and EMA, a time-based final
analysis at 10 years was considered more appropriate than an event-based (700 Disease Free
Survival events) analysis.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants With Disease-Free Survival Events
Disease-Free Survival (DFS)- are defined as local, regional or metastatic relapse or the date of second primary cancer or death from any cause whichever occurs first.
up to 10 year follow-up
Poland: Ministry of Health
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