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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.
First Received: October 3, 2003   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00070057
  Purpose

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.


Condition Intervention Phase
Breast Cancer
 Drug: celecoxib
Procedure: conventional surgery
Procedure: neoadjuvant therapy
 Phase I

Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
Official Title: A Study of COX-2 Inhibition and Aromatase Activity in Breast Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer Surgery
Drug Information available for: Celecoxib
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: April 2003
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00070057

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
New York Weill Cornell Cancer Center at Cornell University
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
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
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers: CDR0000329919, MSKCC-03027
Study First Received: October 3, 2003
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00070057     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer

Study placed in the following topic categories:
Anti-Inflammatory Agents
Celecoxib
Skin Diseases
Analgesics, Non-Narcotic
Cyclooxygenase Inhibitors
Breast Neoplasms
 Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Breast Diseases

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Celecoxib
Skin Diseases
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Breast Neoplasms
Enzyme Inhibitors
Pharmacologic Actions
Neoplasms
 Neoplasms by Site
Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Central Nervous System Agents
Breast Diseases

ClinicalTrials.gov processed this record on July 02, 2009



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