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