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)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by King Faisal Specialist Hospital & Research Center.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
King Faisal Specialist Hospital & Research Center
ClinicalTrials.gov Identifier:
NCT00544505
First received: October 15, 2007
Last updated: December 11, 2011
Last verified: December 2011

October 15, 2007
December 11, 2011
September 2007
September 2012   (final data collection date for primary outcome measure)
Efficacy [ Time Frame: overall ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00544505 on ClinicalTrials.gov Archive Site
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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 Provided

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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Interventional
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Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
Drug: Fluorouracil/Epirubicin/Cyclophosphamide
Phase III Comparison of Preoperative vs Postoperative FEC (Fluorouracil/Epirubicin/Cyclophosphamide) in Women with Operable Breast Cancer
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
10
September 2013
September 2012   (final data collection date for primary outcome measure)

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
Female
up to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
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NCT00544505
RAC#931-006
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King Faisal Specialist Hospital & Research Center
King Faisal Specialist Hospital & Research Center
Not Provided
Principal Investigator: Adnan Ezzat, MD King Faisal Specialist Hospital & Research Center, Riyadh, Saudi Arabia
King Faisal Specialist Hospital & Research Center
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP