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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)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2011 by King Faisal Specialist Hospital & Research Center.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00544505
First Posted: October 16, 2007
Last Update Posted: December 13, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
King Faisal Specialist Hospital & Research Center
October 15, 2007
October 16, 2007
December 13, 2011
September 2007
September 2012   (Final data collection date for primary outcome measure)
Efficacy [ Time Frame: overall ]
Not Provided
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)
Not Provided
Interventional
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Intervention Model: Single Group Assignment
Masking: None (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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
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
Sexes Eligible for Study: Female
up to 70 Years   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00544505
RAC#931-006
Not Provided
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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