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Celecoxib in Treating Postmenopausal Women Who Are Undergoing Surgery for Invasive Breast Cancer

This study is ongoing, but not recruiting participants.
Study NCT00070057.   Last updated on July 23, 2008.   Information provided by National Cancer Institute (NCI)

This Tabular View shows the required WHO registration data elements as marked by †

Descriptive Information Fields
Brief Title † Celecoxib in Treating Postmenopausal Women Who Are Undergoing Surgery for Invasive Breast Cancer
Official Title † A Study of COX-2 Inhibition and Aromatase Activity in Breast Cancer
Brief Summary

RATIONALE: Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.

PURPOSE: This randomized phase I trial is studying the side effects of celecoxib in treating postmenopausal women with invasive breast cancer who are scheduled to undergo surgery at Memorial Sloan-Kettering Cancer Center.
Detailed Description

OBJECTIVES:

Primary

  • Determine whether celecoxib suppresses aromatase activity in postmenopausal women with invasive breast cancer planning to undergo surgery.

Secondary

  • Correlate celecoxib-mediated inhibition of aromatase activity with levels of cyclooxygenase (COX)-2 and HER-2/neu and estrogen receptor status in these patients.
  • Determine the effect of this drug on histology, Ki67, RNA expression profile by microarray analysis, PI3-K, AKT and ERK1/2 MAP kinase activities, and PGE_2 levels in these patients.
  • Determine whether any observed biological effect of this drug is dose-dependent in these patients.
  • Identify collateral targets (COX-2-independent) of this drug in these patients.

OUTLINE: This is a randomized study. Patients are randomized to 1 of 3 treatment arms.

  • Arm I: Patients receive oral celecoxib twice daily for 1-3 weeks (according to the duration between biopsy and surgery) in the absence of unacceptable toxicity.
  • Arm II: Patients receive a higher dose of oral celecoxib as in arm I.
  • Arm III: Patients do not receive treatment. All patients undergo definitive surgery.

PROJECTED ACCRUAL: A total of 75 patients (25 per treatment arm) will be accrued for this study within 2-3 years.
Study Phase Phase I
Study Type † Interventional
Study Design † Treatment, Randomized, Active Control
Primary Outcome Measure †
Secondary Outcome Measure †
Condition † Breast Cancer
Intervention † Drug: celecoxib
Procedure: conventional surgery
Procedure: neoadjuvant therapy
MEDLINE PMIDs
Links Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status † Active, not recruiting
Enrollment †
Start Date † April 2003
Completion Date
Eligibility Criteria †

DISEASE CHARACTERISTICS:

  • Histologically confirmed invasive breast carcinoma

    • Tumor at least 1 cm by radiologic estimate or physical exam
    • No disease limited to ductal carcinoma in situ only
  • Planning to undergo surgery at Memorial Sloan-Kettering Cancer Center

  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age

  • Over 18

Sex

  • Female

Menopausal status

  • Postmenopausal as defined by at least 1 of the following:

    • No menstrual period within the past 12 months
    • Prior bilateral oophorectomy

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • No known liver disease

Renal

  • No renal insufficiency

Cardiovascular

  • No congestive heart failure
  • No coronary artery disease

Gastrointestinal

  • No history of documented peptic ulcer disease
  • No gastritis

Other

  • No medical condition that would preclude definitive surgery
  • No allergy to NSAIDs or sulfa-containing drugs

  • No connective tissue diseases, including any of the following:

    • Systemic lupus erythematosus
    • Reynaud's disease
    • Scleroderma

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • More than 3 months since prior chemotherapy

Endocrine therapy

  • More than 2 weeks since prior hormone replacement therapy
  • More than 2 weeks since prior tamoxifen
  • More than 2 weeks since prior aromatase inhibitors
  • More than 2 weeks since prior raloxifene
  • More than 2 weeks since prior steroids

Radiotherapy

  • Not specified

Surgery

  • See Disease Characteristics

Other

  • More than 1 week since prior nonsteroidal anti-inflammatory drugs (NSAIDs)
  • More than 1 week since prior cyclooxygenase (COX)-2 inhibitors
  • No concurrent warfarin
  • No concurrent thiazide or loop diuretics
  • No concurrent COX-2 inhibitors
  • No concurrent NSAIDs
Gender Female
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries † United States
Administrative Information Fields
NCT ID † NCT00070057
Organization ID CDR0000329919
Secondary IDs †† MSKCC-03027
Study Sponsor † Memorial Sloan-Kettering Cancer Center
Collaborators †† National Cancer Institute (NCI)
Investigators †
Principal Investigator:     Elisa Rush Port, MD     Memorial Sloan-Kettering Cancer Center    
Principal Investigator:     Clifford A. Hudis, MD     Memorial Sloan-Kettering Cancer Center    
Information Provided By National Cancer Institute (NCI)
Verification Date April 2005
First Received Date † October 3, 2003
Last Updated Date July 23, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.

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