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)
NCT ID: NCT00544505
Last Updated: 2011-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
10 participants
INTERVENTIONAL
2007-09-30
2013-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Fluorouracil/Epirubicin/Cyclophosphamide
Phase III Comparison of Preoperative vs Postoperative FEC (Fluorouracil/Epirubicin/Cyclophosphamide) in Women with Operable Breast Cancer
Eligibility Criteria
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Inclusion Criteria
* 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
70 Years
FEMALE
No
Sponsors
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King Faisal Specialist Hospital & Research Center
OTHER
Responsible Party
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Principal Investigators
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Adnan Ezzat, MD
Role: PRINCIPAL_INVESTIGATOR
King Faisal Specialist Hospital & Research Center, Riyadh, Saudi Arabia
Other Identifiers
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RAC#931-006
Identifier Type: -
Identifier Source: org_study_id