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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
  Purpose
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: None (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 ]

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
  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00544505


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

Responsible Party: King Faisal Specialist Hospital & Research Center
ClinicalTrials.gov Identifier: NCT00544505     History of Changes
Other Study ID Numbers: RAC#931-006
First Submitted: October 15, 2007
First Posted: October 16, 2007
Last Update Posted: December 13, 2011
Last Verified: December 2011

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Fluorouracil
Epirubicin
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
Antimetabolites, Antineoplastic
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors