Combination Chemotherapy in Treating Women With Breast Cancer

• Status: Completed
• Trial end date: 2012-03-01
• 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 which combination chemotherapy regimen is more effective in treating breast cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of two different combination chemotherapy regimens in treating women who have primary breast cancer.

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

Details

• Lead Sponsor: Ludwig-Maximilians - University of Munich
• Treatments: Cyclophosphamide; Docetaxel; Epirubicin; Fluorouracil; Goserelin; Tamoxifen

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of primary epithelial invasive carcinoma of the breast

• T1-4, N1-2, M0

• Must have 4 metastatic axillary lymph nodes

• Complete resection of the primary tumor within the past 5 weeks

• Free of invasive carcinoma with at least 10 lymph nodes removed

• No inflammatory breast cancer

• No distant metastases by chest x-ray, liver ultrasound, and whole body bone scan

• Hormone receptor status:

• Estrogen and/or progesterone receptor status known

PATIENT CHARACTERISTICS:

Age

• 18 to 70

Sex

• Female

Menopausal status

• Not specified

Performance status

• ECOG 0-1

Life expectancy

• At least 32 weeks

Hematopoietic

• WBC at least 3,000/mm3

• Platelet count at least 100,000

Hepatic

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)

• SGOT/SGPT no greater than 1.5 times ULN

• Alkaline phosphatase no greater than 1.5 times ULN

• Albumin no greater than 1.5 times ULN

Renal

• Creatinine no greater than 1.5 times ULN

Cardiovascular

• No cardiomyopathy with impaired ventricular function

• No New York Heart Association class III or IV heart disease

• No cardiac arrhythmias influencing LVEF and requiring medication

• No myocardial infarction within the past 6 months

• No angina pectoris within the past 6 months

• No uncontrolled arterial hypertension

Other

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

• No known hypersensitivity to docetaxel, epirubicin, fluorouracil, cyclophosphamide, or other study medication

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• No prior cytotoxic or other antineoplastic therapy

• No other concurrent cytotoxic or other antineoplastic therapy

Endocrine therapy

• Not specified

Radiotherapy

• No prior radiotherapy

Surgery

• See Disease Characteristics

Other

• At least 3 weeks since prior investigational agents