Overview
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)
Status:
Unknown status
Unknown status
Trial end date:
2013-09-01
2013-09-01
Target enrollment:
0
0
Participant gender:
Female
Female
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)Phase:
N/AAccepts Healthy Volunteers?
NoDetails
Lead Sponsor:
King Faisal Specialist Hospital & Research CenterTreatments:
Cyclophosphamide
Epirubicin
Fluorouracil
Criteria
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