Combination Chemotherapy in Treating Women With Stage III Breast Cancer

• Status: Suspended
• 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 may kill more tumor cells.

PURPOSE: Randomized phase III trial to compare cyclophosphamide, doxorubicin, and fluorouracil with cyclophosphamide, methotrexate, and fluorouracil in treating women with stage III breast cancer.

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

Details

• Lead Sponsor: Grupo Oncologico Cooperativo del Sur
• Treatments: Cyclophosphamide; Doxorubicin; Fluorouracil; Liposomal doxorubicin; Methotrexate

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed stage III breast cancer

• Measurable disease

• No inflammatory breast cancer

• No synchronous bilateral breast cancer

• Hormone receptor status:

• Not specified

PATIENT CHARACTERISTICS:

Age:

• 21 to 75

Sex:

• Female

Menopausal status:

• Not specified

Performance status:

• ECOG 0-1 OR

• Zubrod 0-1

Life expectancy:

• More than 12 weeks

Hematopoietic:

• WBC greater than 4,000/mm^3

• Platelet count greater than 100,000/mm^3

Hepatic:

• Bilirubin less than 1.25 times upper limit of normal (ULN)

• AST less than 1.25 times ULN

Renal:

• Creatinine clearance greater than 70 mL/min

Cardiovascular:

• No angina pectoris

• No significant arrhythmia requiring therapy

• No bilateral bundle branch block

• No congestive heart failure

• No myocardial infarction

Other:

• No medical or psychiatric disease that would preclude study therapy

• No other malignancy except adequately treated nonmelanomatous skin cancer or carcinoma in situ of the cervix

• Not pregnant

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• Not specified

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior radiotherapy

Surgery:

• No prior surgery except incisional biopsy or fine-needle aspiration

Other:

• No prior systemic therapy

• No concurrent caffeine or alcohol