Back to resultsPre-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)
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Fluorouracil/Epirubicin/Cyclophosphamide
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer
Eligibility 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
Sites / Locations
Outcomes
Primary Outcome Measures
Efficacy
Secondary Outcome Measures
Full Information
NCT ID
NCT00544505
First Posted
October 15, 2007
Last Updated
December 11, 2011
Sponsor
King Faisal Specialist Hospital & Research Center
1. Study Identification
Unique Protocol Identification Number
NCT00544505
Brief Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Unknown status
Study Start Date
September 2007 (undefined)
Primary Completion Date
September 2012 (Anticipated)
Study Completion Date
September 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King Faisal Specialist Hospital & Research Center
4. Oversight
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Fluorouracil/Epirubicin/Cyclophosphamide
Intervention Description
Phase III Comparison of Preoperative vs Postoperative FEC (Fluorouracil/Epirubicin/Cyclophosphamide) in Women with Operable Breast Cancer
Primary Outcome Measure Information:
Title
Efficacy
Time Frame
overall
10. Eligibility
Sex
Female
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adnan Ezzat, MD
Organizational Affiliation
King Faisal Specialist Hospital & Research Center, Riyadh, Saudi Arabia
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
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)
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