Celecoxib in Treating Postmenopausal Women Who Are Undergoing Surgery for Invasive Breast Cancer - Full Text View

Sponsor:	Memorial Sloan-Kettering Cancer Center
Collaborator:	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:	Allocation: Randomized Primary Purpose: Treatment
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

Drug Information available for: Celecoxib

U.S. FDA Resources

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

Study Start Date:	April 2003
Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

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

ClinicalTrials.gov Identifier:	NCT00070057 History of Changes
Other Study ID Numbers:	CDR0000329919, MSKCC-03027
Study First Received:	October 3, 2003
Last Updated:	May 8, 2010
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

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Celecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Central Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on February 12, 2012