Combination Chemotherapy in Treating Women With Stage III Breast Cancer

Launched by GRUPO ONCOLOGICO COOPERATIVO DEL SUR · Jan 26, 2003

Keywords

ClinConnect Summary

OBJECTIVES:

* Compare the response in women with stage III breast cancer treated with neoadjuvant fluorouracil, doxorubicin, and cyclophosphamide (FAC) vs cyclophosphamide, methotrexate, and fluorouracil (CMF).
* Compare the rates of conservative surgical resectability and locoregional control in patients treated with these neoadjuvant therapy regimens.
* Compare the disease-free and overall survival of patients treated with these regimens.
* Compare the toxic effects of these regimens in these patients.
* Compare the compliance of patients treated with these regimens.
* Assess the cosmeti...

Gender

FEMALE

Eligibility 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

Trial Officials