Weekly Docetaxel and CMF in the Adjuvant Treatment of Elderly Women With High-Risk Breast Cancer
This trial will evaluate the effectiveness of standard adjuvant treatment with CMF chemotherapy versus treatment with weekly docetaxel in patients with high-risk breast cancer who are 65 years of age and older or are poor candidates for anthracycline-containing regimens. This CMF regimen has decreased dose intensity and may be slightly less active in patients with metastatic breast cancer; however, the patient population in this trial has tolerated more intensive CMF regimens poorly in other trials.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- disease-free survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]
- overall survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]
- toxicity [ Time Frame: 18 months ] [ Designated as safety issue: No ]
|Study Start Date:||March 2002|
|Study Completion Date:||August 2004|
|Primary Completion Date:||August 2004 (Final data collection date for primary outcome measure)|
Other Name: Docetaxel
Cyclophosphamide + Methotrexate + 5-fluorouracil
Other Name: CyclophosphamideDrug: Methotrexate
Other Name: MethotrexateDrug: 5-Fluorouracil
Other Name: 5-Fluorouracil
Upon determination of eligibility, patients will be randomly assigned to one of two treatment arms:
- 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.