Combination Chemotherapy in Treating Women With Resected Breast Cancer

• Status: Unknown status
• 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 tumor cells remaining after surgery. It is not yet known which combination chemotherapy regimen is more effective in treating resected stage I or stage II breast cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of different combination chemotherapy regimens in treating women who have resected stage I or stage II breast cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute of Cancer Research, United Kingdom
• Treatments: Cyclophosphamide; Docetaxel; Epirubicin; Fluorouracil; Methotrexate; Tamoxifen

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed completely resected, invasive breast cancer for which adjuvant chemotherapy is indicated

• No clinical or radiological evidence of locoregional or metastatic disease

• No locally advanced tumors at diagnosis, indicated by any of the following:

• Fixed tumors

• Peau d'orange skin changes

• Skin ulceration

• Inflammatory changes (T4 or T3b, N2 disease)

• No male breast cancer

• No prior invasive breast cancer or bilateral breast cancer

• Prior ductal carcinoma in situ or lobular carcinoma in situ is allowed

• Must begin study chemotherapy within 8 weeks after definitive surgery

• Hormone receptor status:

• Estrogen receptor and progesterone receptor status known

PATIENT CHARACTERISTICS:

Age:

• Over 18

Sex:

• Female

Menopausal status:

• Not specified

Performance status:

• WHO 0-1

Life expectancy:

• At least 2 years

Hematopoietic:

• WBC at least 3,000/mm^3

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

• Hemoglobin at least 9 g/dL

Hepatic:

• Bilirubin normal

• AST no greater than 1.5 times normal

• Alkaline phosphatase no greater than 1.5 times normal

Renal:

• Creatinine no greater than 1.5 times normal

Cardiovascular:

• No myocardial infarction within the past 6 months

• No congestive heart failure

Other:

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No other invasive malignancy within the past 10 years except surgically cured nonmelanoma skin cancer or carcinoma in situ of the cervix

• No other serious medical illness that would limit life expectancy

• No psychiatric condition that would preclude informed consent

• No active uncontrolled bacterial, viral, or fungal infection

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior biologic therapy

Chemotherapy:

• See Disease Characteristics

• No prior cytotoxic chemotherapy

Endocrine therapy:

• No concurrent hormonal therapy (e.g., tamoxifen) during study chemotherapy

• No concurrent hormone replacement therapy

Radiotherapy:

• No prior radiotherapy

Surgery:

• See Disease Characteristics

Other:

• At least 4 weeks since any prior unlicensed drugs

• No other concurrent experimental drugs