NCT00003577

Combination Chemotherapy With or Without Epirubicin in Treating Women With Stage I or Stage II Breast Cancer

National Breast Cancer Study of Epirubicin + CMF v Classical CMF Adjuvant Therapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,000 (estimated)
• Sponsor: University Hospital Birmingham · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether combination chemotherapy plus epirubicin is more effective than combination chemotherapy alone for stage I or stage II breast cancer. PURPOSE: This randomized phase III trial is studying combination chemotherapy alone to see how well it works compared to combination chemotherapy and epirubicin in treating women with stage I or stage II breast cancer who have undergone surgery to remove the tumor.

Detailed description

OBJECTIVES: * Compare disease-free and overall survival of women with early stage breast cancer treated with adjuvant cyclophosphamide, methotrexate, and fluorouracil with or without epirubicin. * Compare the quality of life in a subgroup of these patients treated with these regimens. OUTLINE: This is a randomized study. Patients are stratified according to radiotherapy timing (concurrent versus sequential), nodal status (negative versus 1-3 versus at least 4), age (50 and under versus over 50), grade, and tumor size. Patients are randomized to one of two treatment arms. * Arm I: Patients receive oral cyclophosphamide on days 1-14 and methotrexate IV and fluorouracil IV on days 1 and 8. Treatment repeats every 4 weeks for 6 courses. * Arm II: Patients receive epirubicin IV on day 1 every 3 weeks for 4 courses followed by cyclophosphamide, methotrexate, and fluorouracil, as in arm I, for 4 courses. Some patients may receive radiotherapy during or after chemotherapy. Treatment continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed in a subset of patients (N=500) before chemotherapy starts, at 3 months of treatment, at the end of chemotherapy, and at 6, 12, and 18 months after treatment. Patients are followed annually for 10 years. Peer Reviewed and Funded or Endorsed by Cancer Research UK PROJECTED ACCRUAL: Approximately 2,000 patients will be accrued for this study within 4 years.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	CMF regimen
DRUG	cyclophosphamide
DRUG	epirubicin hydrochloride
DRUG	fluorouracil
DRUG	methotrexate
PROCEDURE	adjuvant therapy
RADIATION	radiation therapy

Timeline

• Start date: 1996-03-01
• Completion: 2008-09-01
• First posted: 2003-01-27
• Last updated: 2013-12-19

Locations

1 site across 1 country: United Kingdom