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
  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: 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
  Eligibility

Ages Eligible for Study:   up to 70 Years
Genders 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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: King Faisal Specialist Hospital & Research Center
ClinicalTrials.gov 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:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Fluorouracil
Epirubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
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

ClinicalTrials.gov processed this record on September 18, 2014