Adjuvant Chemotherapy Plus Radiation Therapy in Treating Women With Early-Stage Breast Cancer

• Status: Completed
• Trial end date: 2006-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumors cells. Combining chemotherapy with radiation therapy may kill more tumor cells. It is not yet known which regimen of chemotherapy plus radiation therapy is more effective for early-stage breast cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of adjuvant chemotherapy plus radiation therapy in treating women who have early-stage breast cancer.

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

Details

• Lead Sponsor: University Hospital Birmingham
• Treatments: Cyclophosphamide; Doxorubicin; Epirubicin; Fluorouracil; Liposomal doxorubicin; Methotrexate; Mitomycin; Mitomycins; Mitoxantrone

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed invasive breast cancer

• Early-stage disease

• No metastatic disease

• Complete surgical excision of tumor

• Planned use of adjuvant chemotherapy and radiotherapy

• If participating in the cosmetic outcome evaluation portion of the study, must have unilateral disease

• Hormone receptor status

• Not specified

PATIENT CHARACTERISTICS:

Age:

• Not specified

Sex:

• Female

Menopausal status:

• Not specified

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• Bone marrow function adequate

Hepatic:

• Hepatic function adequate

Renal:

• Renal function adequate

Cardiovascular:

• Cardiac function adequate

Other:

• No other prior malignancy except basal cell or squamous cell skin cancer or carcinoma in situ

• No other medical or social condition that would preclude study compliance

• Fit to receive both adjuvant chemotherapy and radiotherapy (administered either synchronously or sequentially)

• Not pregnant or nursing

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• See Disease Characteristics

• No prior chemotherapy

• No concurrent epirubicin and doxorubicin as a study combination chemotherapy regimen

Endocrine therapy:

• Prior or concurrent hormonal therapy allowed

• No concurrent tamoxifen if treated with methotrexate, mitomycin, and mitoxantrone as a study combination chemotherapy regimen

Radiotherapy:

• See Disease Characteristics

• No concurrent internal mammary chain irradiation

• No concurrent orthovoltage irradiation to the whole breast

Surgery:

• See Disease Characteristics

• Recovered from prior surgery

Other:

• Concurrent participation in another clinical trial allowed