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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2010-02-28

Brief Summary

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

Detailed Description

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PRIMARY OBJECTIVES:

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

SECONDARY OBJECTIVES:

I. Correlate celecoxib-mediated inhibition of aromatase activity with levels of cyclooxygenase (COX)-2 and HER-2/neu and estrogen receptor status in these patients.

II. 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.

III. Determine whether any observed biological effect of this drug is dose-dependent in these patients.

IV. 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.

Conditions

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Stage I Breast Cancer Stage II Breast Cancer Stage IIIA Breast Cancer Stage IIIB Breast Cancer Stage IIIC Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

celecoxib

Given orally

Intervention Type DRUG

therapeutic conventional surgery

Undergo surgery

Intervention Type PROCEDURE

pharmacological study

Correlative studies

Intervention Type OTHER

laboratory biomarker analysis

Correlative studies

Intervention Type OTHER

Other Intervention Names

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Celebrex SC-58635 pharmacological studies

Eligibility Criteria

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Inclusion Criteria

* 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
* Female
* Postmenopausal as defined by at least 1 of the following:

* No menstrual period within the past 12 months
* Prior bilateral oophorectomy
* No known liver disease
* No renal insufficiency
* No congestive heart failure
* No coronary artery disease
* No history of documented peptic ulcer disease
* No gastritis
* 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
* More than 3 months since prior chemotherapy
* 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
* 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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elisa Port

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Site Status

Countries

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United States