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)

Not Applicable

• Conditions: Breast Cancer

• Registration Number: NCT00544505
• Lead Sponsor: King Faisal Specialist Hospital & Research Center

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-10-15
• Study First Submitted QC: 2007-10-15
• Study First Posted: 2007-10-16
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-11
• Last Update Posted: 2011-12-13
• Primary Completion: 2012-09
• Study Completion: 2013-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 10

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Efficacy	overall