Conditions: Breast Cancer
Keywords: adjuvant treatment
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1491
Healthy volunteers: no

Brief summary:
The purpose of this study was to compare disease-free survival after treatment with docetaxel in combination with doxorubicin and cyclophosphamide to 5-fluorouracil in combination with doxorubicin and cyclophosphamide in operable breast cancer patients with positive axillary lymph nodes.

Detailed description:
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.

Arms:
arm 1: docetaxel (75 mg/m\^2) in combination with doxorubicin (50 mg/m\^2) and cyclophosphamide (500 mg/m\^2) on day 1 every 3 weeks for 6 cycles of treatment arm 2: 5-fluorouracil (500 mg/m\^2) in combination with doxorubicin (50 mg/m\^2) and cyclophosphamide (500 mg/m\^2) on day 1 every 3 weeks for 6 cycles of treatment

Interventions: intervention 1: Docetaxel intervention 2: 5-fluorouracil intervention 3: Doxorubicin intervention 4: Cyclophosphamide
Intervention descriptions: intervention 1: intravenous intervention 2: intravenous intervention 3: intravenous intervention 4: intravenous

Protocol document: