This trial is active, not recruiting.

Condition breast cancer
Treatment fluorouracil/epirubicin/cyclophosphamide
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)

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

time frame: overall

Eligibility Criteria

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

Additional Information

Principal investigator Adnan Ezzat, MD
Trial information was received from ClinicalTrials.gov and was last updated in December 2011.
Information provided to ClinicalTrials.gov by King Faisal Specialist Hospital & Research Center.