Breast Cancer
Conditions
Brief summary
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)
Interventions
Phase III Comparison of Preoperative vs Postoperative FEC (Fluorouracil/Epirubicin/Cyclophosphamide) in Women with Operable Breast Cancer
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy | overall |