Overview

Combination Chemotherapy Following Surgery in Treating Women With Early Stage Breast Cancer

Status:
Completed
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. It is not yet known which combination chemotherapy regimen is more effective following surgery for breast cancer. PURPOSE: Randomized phase III trial to study the effectiveness of combination chemotherapy consisting of cyclophosphamide, methotrexate, and fluorouracil with or without epirubicin in treating women who have early stage breast cancer.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Scottish Cancer Therapy Network
Treatments:
Cyclophosphamide
Epirubicin
Fluorouracil
Methotrexate
Criteria
DISEASE CHARACTERISTICS: Histologically confirmed, early stage, unilateral invasive breast
cancer of TNM stages T0 - T3, N0-1, M0, i.e., Histologically proven axillary node
metastases OR Lymph node negative Not locally advanced If supraclavicular node is enlarged
or suspicious of metastasis, negative biopsy for supraclavicular node metastases required
No evidence of any other metastases clinically or on routine staging investigations No past
history of pure in situ carcinoma in either breast Primary tumor is completely excised

PATIENT CHARACTERISTICS: Age: Not specified Sex: Female Performance status: Not specified
Hematopoietic: Neutrophil count greater than 2,000/mm3 Platelet count greater than
100,000/mm3 No evidence of sepsis Hepatic: Adequate hepatic function Bilirubin normal
AST/ALT normal Renal: Adequate renal function Creatinine less than 1.2 mg/dL
Cardiovascular: No clinically significant cardiovascular disease Other: No prior or
concurrent other malignancy except adequately treated basal or squamous cell carcinoma of
the skin or in situ carcinoma of the cervix Not pregnant or nursing Fertile patients must
use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy Endocrine therapy: Prior tamoxifen allowed Radiotherapy: No prior radiotherapy
Surgery: See Disease Characteristics