Docetaxel in Node Positive Adjuvant Breast Cancer
Docetaxel in Node Positive Adjuvant Breast Cancer
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.
Inclusion Criteria:

 -  Histologically proven breast cancer (invasive adenocarcinoma with at least one
 axillary lymph node showing evidence of tumor among a minimum of six resected lymph
 nodes).

 -  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.

 Exclusion criteria:

 -  Prior systemic anticancer therapy for breast cancer (immunotherapy, hormonotherapy,
 chemotherapy).

 -  Prior anthracycline therapy or taxoids (paclitaxel, docetaxel) for any malignancy.