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)
This trial is active, not recruiting.
|Sponsor||King Faisal Specialist Hospital & Research Center|
|Start date||September 2007|
|End date||September 2012|
|Trial size||10 participants|
|Trial identifier||NCT00544505, RAC#931-006|
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)
|Intervention model||single group assignment|
time frame: overall
Female participants up to 70 years old.
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
|Principal investigator||Adnan Ezzat, MD|
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