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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 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. Identifier: NCT00544505
Recruitment Status : Unknown
Verified December 2011 by King Faisal Specialist Hospital & Research Center.
Recruitment status was:  Active, not recruiting
First Posted : October 16, 2007
Last Update Posted : December 13, 2011
Information provided by (Responsible Party):
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)

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Fluorouracil/Epirubicin/Cyclophosphamide Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : September 2007
Estimated Primary Completion Date : September 2012
Estimated Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Intervention Details:
  • Drug: Fluorouracil/Epirubicin/Cyclophosphamide
    Phase III Comparison of Preoperative vs Postoperative FEC (Fluorouracil/Epirubicin/Cyclophosphamide) in Women with Operable Breast Cancer

Primary Outcome Measures :
  1. Efficacy [ Time Frame: overall ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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


  • No previous chemotherapy

Endocrine therapy:

  • Not specified


  • Not specified


  • Core needle biopsy or fine needle aspiration within 21 days prior to entry
  • Repeated core needle biopsy permitted

Patient Characteristics:


  • 16 to 70


  • Women only

Menopausal status:

  • Not specified

Performance status:

  • WHO 0-2


  • WBC at least 4,000
  • Platelets at least 100,000


  • Bilirubin no greater than 2.8 mg/dL (50 micromoles/L)


  • Creatinine no greater than 1.3 mg/dL (120 micromoles/L)


  • 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)


  • No male breast cancer
  • No pregnant or nursing women
  • No second malignancy except adequately treated:

    • Nonmelanomatous skin cancer
    • Cervical cancer

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00544505

Sponsors and Collaborators
King Faisal Specialist Hospital & Research Center
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Principal Investigator: Adnan Ezzat, MD King Faisal Specialist Hospital & Research Center, Riyadh, Saudi Arabia
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Responsible Party: King Faisal Specialist Hospital & Research Center Identifier: NCT00544505    
Other Study ID Numbers: RAC#931-006
First Posted: October 16, 2007    Key Record Dates
Last Update Posted: December 13, 2011
Last Verified: December 2011
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antimetabolites, Antineoplastic
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors