NCT00193011

Weekly Docetaxel and CMF in the Adjuvant Treatment of Elderly Women With High-Risk Breast Cancer

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: SCRI Development Innovations, LLC · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Upon determination of eligibility, patients will be randomly assigned to one of two treatment arms: * Docetaxel * 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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Docetaxel	Docetaxel
DRUG	Cyclophosphamide	Cyclophosphamide
DRUG	Methotrexate	Methotrexate
DRUG	5-Fluorouracil	5-Fluorouracil

Timeline

• Start date: 2002-03-01
• Primary completion: 2004-08-01
• Completion: 2004-08-01
• First posted: 2005-09-19
• Last updated: 2011-05-03