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
Information provided by (Responsible Party):
King Faisal Specialist Hospital & Research Center Identifier:
First received: October 15, 2007
Last updated: December 11, 2011
Last verified: December 2011
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 Intervention
Breast Cancer
Drug: Fluorouracil/Epirubicin/Cyclophosphamide

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by King Faisal Specialist Hospital & Research Center:

Primary Outcome Measures:
  • Efficacy [ Time Frame: overall ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: September 2007
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Fluorouracil/Epirubicin/Cyclophosphamide
    Phase III Comparison of Preoperative vs Postoperative FEC (Fluorouracil/Epirubicin/Cyclophosphamide) in Women with Operable Breast Cancer

Ages Eligible for Study:   up to 70 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00544505

Sponsors and Collaborators
King Faisal Specialist Hospital & Research Center
Principal Investigator: Adnan Ezzat, MD King Faisal Specialist Hospital & Research Center, Riyadh, Saudi Arabia
  More Information

Responsible Party: King Faisal Specialist Hospital & Research Center Identifier: NCT00544505     History of Changes
Other Study ID Numbers: RAC#931-006 
Study First Received: October 15, 2007
Last Updated: December 11, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Alkylating Agents
Antibiotics, Antineoplastic
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Physiological Effects of Drugs
Topoisomerase II Inhibitors
Topoisomerase Inhibitors processed this record on May 24, 2016