Combination Chemotherapy Compared With Observation After Surgery in Treating Women With Relapsed Nonmetastatic Breast Cancer

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the breast

• No contralateral breast cancer

• Local tumor recurrence more than 6 months after conservative surgery

• Complete or conservative resection of the recurrent tumor NOTE: Initial complete surgical resection not allowed

• No local inflammatory disease or disease that is not amenable to complete surgical resection

• No positive axillary lymph nodes

• No distant metastases, including subclavicular lymph nodes

• Hormone receptor status:

• Hormone receptor status known

PATIENT CHARACTERISTICS:

Age

• 18 to 65

Sex

• Female

Menopausal status

• Menopausal status known

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• Neutrophil count at least 2,000/mm^3

• Platelet count at least 100,000/mm^3

Hepatic

• Bilirubin no greater than upper limit of normal (ULN)

• Transaminases no greater than 1.5 times ULN

• Alkaline phosphatase no greater than 2.5 times ULN

• No chronic hepatitis B

• No active hepatitis C

Renal

• Not specified

Cardiovascular

• Cardiac function normal by echocardiogram or isotopes

Other

• No contraindications to anthracyclines such as any of the following:

• Prior doxorubicin over 300 mg/m^2

• Prior epirubicin over 600 mg/m^2

• Prior mitoxantrone over 90 mg/m^2

• No other invasive malignancy

• No chronic somatic or psychiatric condition that would preclude study participation

• No familial, social, geographic, or psychological reason that would preclude study participation

• Not pregnant

• Fertile patients must use effective contraception

• HIV negative

• CA 153 no greater than 2 times ULN

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• See Patient Characteristics-Other

• No prior neoadjuvant chemotherapy

Endocrine therapy

• No prior neoadjuvant hormonal therapy

Radiotherapy

• No prior neoadjuvant radiotherapy

Surgery

• See Disease Characteristics

• At least 41 days since prior surgery