A Randomized Multicenter Trial Comparing Weekly Docetaxel and CMF in the Adjuvant Treatment of Women With High-Risk Breast Cancer Who Are > 65 Years Old or Are Not Candidates for Anthracycline-Based Adjuvant Therapy
Upon determination of eligibility, patients will be randomly assigned to one of two
- Cyclophosphamide + Methotrexate + 5-fluorouracil
This is not a blinded study so both the patient and the investigator will know which
treatment has been assigned.
Chemotherapy will be followed by breast and/or regional radiotherapy in appropriate
patients, and by hormone therapy with tamoxifen for 5 years in patients who are
estrogen-receptor positive. Patients who are considered poor candidates to receive
tamoxifen may receive hormonal therapy with anastrazole.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Denise Yardley, MD
Sarah Cannon Research Institute
United States: Food and Drug Administration
SCRI BRE 41