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

• Status: Terminated
• Trial end date: 1969-12-31
• 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, and giving them after surgery, may kill any remaining tumor cells following surgery. It is not yet known whether combination chemotherapy is more effective than observation in treating relapsed nonmetastatic breast cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with that of observation in treating women who have undergone surgery for relapsed nonmetastatic breast cancer.

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

Details

• Lead Sponsor: UNICANCER
• Treatments: Anastrozole; Cyclophosphamide; Docetaxel; Epirubicin; Fluorouracil; Goserelin; Tamoxifen

Criteria

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