At a glance
ClinicalIndex Comparison Record- ✓Operable breast cancer (T1-T3) with negative axillary lymph nodes (≥10 dissected) and high-risk criteria per St. Gallen consensus
- ✓Histologically proven breast cancer; surgery (mastectomy or breast-conserving surgery) completed with histologically clear margins of invasive cancer and DCIS
- ✓Interval from surgery to registration <60 days
- ✓No metastatic disease
- ✕Prior systemic anticancer therapy for breast cancer (chemotherapy, immunotherapy, or hormonotherapy)
- ✕Prior anthracycline therapy or taxoid therapy (paclitaxel, docetaxel) for any malignancy
- ✕Prior radiation therapy for breast cancer
- ✕Bilateral invasive breast cancer
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase III Randomized Comparing Docetaxel, Doxorubicin and Cyclophosphamide (TAC) vs 5-Fluorouracil, Doxorubicin and Cyclophosphamide (FAC) as Adjuvant Treatment of High Risk Operable Breast Cancer Patients With Negative Axillary Lymph Nodes
In Brief
A Phase 3 clinical trial evaluating Docetaxel, 5-fluorouracil, and 2 other interventions for Breast Neoplasms. Completed, enrolled 1,060 participants across 1 site.
Detailed Summary
This is a prospective, non-blinded randomized phase III trial. Patients will be post-surgically stratified at inclusion first according to the participating institution, then according to menopausal status and will be randomly assigned to receive either: * TAC: Docetaxel 75 mg/m2 as a 1 hour intravenous (i.v.) infusion on day 1 every 3 weeks (q3w) in combination with doxorubicin 50 mg/m2 as an i.v. bolus and cyclophosphamide 500 mg/m2 as an i.v. bolus on day 1 every 3 weeks. * FAC: 5-fluorouracil 500 mg/m2 as an i.v. bolus on day 1 every 3 weeks in combination with doxorubicin 50 mg/m2 as an i.v. bolus and cyclophosphamide 500 mg/m2 as an i.v. bolus on day 1 every 3 weeks.