At a glance
ClinicalIndex Comparison Record- ✓Female patients age ≥18 years
- ✓Life expectancy ≥10 years (excluding breast cancer diagnosis)
- ✓Invasive adenocarcinoma on histology (excluding pure tubular or mucinous subtypes)
- ✓Primary tumor T1-3 by clinical and pathologic evaluation
- ✕Male patients
- ✕Pure tubular or mucinous adenocarcinomas
- ✕Bilateral breast malignancy or suspicious contralateral breast mass without benign biopsy proof
- ✕Primary tumor T4
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Clinical Trial Of Adjuvant Therapy Comparing Six Cycles Of 5-Fluorouracil, Epirubicin And Cyclophosphamide (FEC) To Four Cycles Of Adriamycin And Cyclophosphamide (AC) In Patients With Node-Negative Breast Cancer
In Brief
A Phase 3 clinical trial evaluating cyclophosphamide, adriamycin, and 2 other interventions for Breast Cancer. Completed, enrolled 2,722 participants across 606 sites in 3 countries.
Detailed Summary
RATIONALE: Drugs used in chemotherapy, such as fluorouracil, epirubicin, cyclophosphamide, and doxorubicin, work in different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen is more effective in treating breast cancer. PURPOSE: This randomized phase III trial is studying two combination chemotherapy regimens to compare how well they work in treating women who have undergone surgery for breast cancer that has not spread to the lymph nodes.
Study Details
Timeline
Interventions
Arm 1: cyclophosphamide 600 mg/m2 IV every 21 days for 4 cycles; Arm 2: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles
adriamycin 60 mg/m2 IV every 21 days for 4 cycles
epirubicin 100 mg/m2 IV every 21 days for 6 cycles
fluorouracil 500 mg/m2 IV every 21 days for 6 cycles