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
Trial end date:
2013-09-01
Target enrollment:
0
Participant gender:
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/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
King Faisal Specialist Hospital & Research Center
Treatments:
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