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.
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.
- Histologically proven breast cancer (invasive adenocarcinoma with at least one
axillary lymph node showing evidence of tumor among a minimum of six resected lymph
- Definitive surgical treatment must be either mastectomy, or breast conserving surgery
with axillary lymph node dissection for operable breast cancer. Margins of resected
specimen from definitive surgery must be histologically free of invasive
adenocarcinoma and ductal carcinoma.
- Prior systemic anticancer therapy for breast cancer (immunotherapy, hormonotherapy,
- Prior anthracycline therapy or taxoids (paclitaxel, docetaxel) for any malignancy.