Title
Docetaxel in Node Positive Adjuvant Breast Cancer
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.
Phase
Phase 3Lead Sponsor
SanofiStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Breast CancerIntervention/Treatment
doxorubicin fluorouracil cyclophosphamide docetaxel ...Study Participants
1491The 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.
intravenous
intravenous
intravenous
intravenous
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
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
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.
| Event Type | Organ System | Event Term | TAC (Docetaxel) | FAC (5-fluorouracil) |
|---|
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.
Overall Survival - time from the date of randomization up to the date of death of any cause.
Toxicity (second primary malignancies)- defined as histopathologically proven cancer, excluding nonmelanomatous skin cancer, in situ carcinoma of the cervix, and in situ carcinoma of the breast.
