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

University Hospitals Birmingham NHS Foundation Trust (UHB)

Status and phase: Completed; Phase 3

Conditions: Breast Cancer

Treatments: Drug: CMF regimen; Drug: methotrexate; Drug: epirubicin hydrochloride; Radiation: radiation therapy; Drug: fluorouracil; Drug: cyclophosphamide; Procedure: adjuvant therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00003577

CRC-TU-NEAT

CDR0000066644

EU-98041

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,000 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Histological confirmation of invasive, early stage breast cancer

• Prior complete excision of tumor required (wide local excision or mastectomy)

• Hormone receptor status:

  • Not specified

PATIENT CHARACTERISTICS:

Age:

• Not specified

Sex:

• Female

Menopausal status:

• Pre-, peri-, or post-menopausal

Performance status:

• Not specified

Hematopoietic:

• Adequate bone marrow function

Hepatic:

• Adequate hepatic function

Renal:

• Adequate renal function

Other:

• No prior cancer except for basal cell carcinoma or carcinoma in situ
• Not pregnant or nursing
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy

Endocrine therapy:

• Concurrent hormone therapy allowed

Radiotherapy:

• No prior radiotherapy
• Concurrent radiotherapy allowed

Surgery:

• See Disease Characteristics
• No more than 6 weeks since prior surgery to the breast