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

• Status: Completed
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Birmingham
• Treatments: Cyclophosphamide; Epirubicin; Fluorouracil; Methotrexate

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