Pre-operative Chemotherapy in Operable Breast Cancer, Phase III Study Comparing a Short Intensive Pre-operative Chemotherapy With the Same Therapy Initiated Shortly After Surgery(Peri-operatively)(POCOB)EORTC 10902)

Inclusion Criteria

• •Disease Characteristics:
• •Palpable, operable breast cancer that has been diagnosed by core needle biopsy (mandatory for T1c tumors) or fine needle aspiration within 21 days prior to entry
• •Stage T1c-4b, N0-1, M0
• •Hormone receptor status:
• •Not specified
• •No bilateral breast cancer
• •Prior/Concurrent Therapy:
• •No previous treatment for breast cancer
• •Biologic therapy:
• •Not specified
• •Chemotherapy:
• •No previous chemotherapy
• •Endocrine therapy:
• •Not specified
• •Radiotherapy:
• •Not specified
• •Surgery:
• •Core needle biopsy or fine needle aspiration within 21 days prior to entry
• •Repeated core needle biopsy permitted
• •Patient Characteristics:
• •Age:
• •16 to 70
• •Sex:
• •Women only
• •Menopausal status:
• •Not specified
• •Performance status:
• •WHO 0-2
• •Hematopoietic:
• •WBC at least 4,000
• •Platelets at least 100,000
• •Hepatic:
• •Bilirubin no greater than 2.8 mg/dL (50 micromoles/L)
• •Renal:
• •Creatinine no greater than 1.3 mg/dL (120 micromoles/L)
• •Cardiovascular:
• •No congestive heart failure
• •No significant arrhythmia
• •No bilateral bundle branch block
• •No recent myocardial infarction
• •No uncontrolled hypertension (diastolic pressure greater than 110 mm Hg)
• •Other:
• •No male breast cancer
• •No pregnant or nursing women
• •No second malignancy except adequately treated:
• •* Nonmelanomatous skin cancer
• •* Cervical cancer