drugset / Trial / NCT00615901

Dose Dense Adjuvant CMF (Cyclophosphamide, Methotrexate, Fluorouracil) at 14 and 10-11 Day Intervals for Women With Early Stage Breast Cancer

NCT00615901

NaSingle-groupOpen-labelTreatment

Summary

CMF (cyclophosphamide, methotrexate, fluorouracil) is used to treat early stage breast cancer. The combination, of these three drugs, has been used for approximately 30 years in the treatment of breast cancer, and has been shown to be safe and effective. It is usually given every 3 weeks. Doctors believe, based on other breast cancer trials, that giving this type of chemotherapy in a shorter amount of time, every 2 weeks or sooner, instead of every 3 weeks, may be better. The purpose of this study is to test the safety of these drugs, given every 2 weeks or sooner, to treat breast cancer. Other breast cancer chemotherapy regimens have shown to be more beneficial when the drugs are given more frequently.

Timeline

Start
2008-01
Primary completion
2010-06
Completion
2010-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclophosphamide Other / unclassified 600 mg/m2
Subject Methotrexate Small molecule 40 mg/m2
Subject fluorouracil Small molecule 600 mg/m2
Background Pegfilgrastim Protein / enzyme biologic 6 mg

Indications