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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)

Sponsor
King Faisal Specialist Hospital & Research Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT00544505
Collaborator
(none)
10
Enrollment
72
Duration (Months)

Study Details

Study Description

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
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Study Start Date :
Sep 1, 2007
Anticipated Primary Completion Date :
Sep 1, 2012
Anticipated Study Completion Date :
Sep 1, 2013

Outcome Measures

Primary Outcome Measures

  1. Efficacy [overall]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 70 Years
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
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

Locations

No locations specified.

Sponsors and Collaborators

  • King Faisal Specialist Hospital & Research Center

Investigators

  • Principal Investigator: Adnan Ezzat, MD, King Faisal Specialist Hospital & Research Center, Riyadh, Saudi Arabia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
King Faisal Specialist Hospital & Research Center
ClinicalTrials.gov Identifier:
NCT00544505
Other Study ID Numbers:
  • RAC#931-006
First Posted:
Oct 16, 2007
Last Update Posted:
Dec 13, 2011
Last Verified:
Dec 1, 2011
Additional relevant MeSH terms:
Breast Neoplasms
Cyclophosphamide
Fluorouracil
Epirubicin

Study Results

No Results Posted as of Dec 13, 2011