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Sponsors and Collaborators: |
Southwest Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00088972 |
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of celecoxib may be effective in preventing breast cancer.
PURPOSE: This randomized phase II trial is studying how well celecoxib works in preventing breast cancer in premenopausal women who are at risk for developing the disease.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: celecoxib Drug: placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control |
Official Title: | Randomized Placebo-Controlled Biomarker Modulation Trial Using Celecoxib in Premenopausal Women at High Risk for Breast Cancer |
Estimated Enrollment: | 100 |
Study Start Date: | October 2004 |
Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I: Experimental
Patients receive oral celecoxib twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.
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Drug: celecoxib
Given orally
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Arm II: Placebo Comparator
Patients receive oral placebo twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.
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Drug: placebo
Given orally
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OBJECTIVES:
OUTLINE: This is a randomized, placebo-controlled, double-blind, multicenter study. Patients are stratified according to risk category (lobular carcinoma in situ or ductal carcinoma in situ vs BRCA1/2 mutation AND any Gail risk vs Gail risk ≥1.7% but < 5% vs Gail risk ≥ 5%) and prior tamoxifen use (yes vs no). Patients are randomized to 1 of 2 treatment arms.
Patients are followed at 1 month.
PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
At elevated risk of developing breast cancer, as defined by 1 of the following:
Has undergone a baseline mammogram with a standard density wedge within 7-14 days after completion of the last menstrual period AND within 7 days before study entry
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Premenopausal, defined by 1 of the following criteria:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
More than 1 month since prior chronic daily aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) of more than 7 days duration
United States, California | |
Glendale Memorial Hospital Comprehensive Cancer Center | |
Glendale, California, United States, 91204 | |
United States, New Mexico | |
University of New Mexico Cancer Center | |
Albuquerque, New Mexico, United States, 87131-5636 | |
United States, Texas | |
Baylor University Medical Center - Houston | |
Houston, Texas, United States, 77030 | |
Ben Taub General Hospital | |
Houston, Texas, United States, 77030 | |
Methodist Hospital | |
Houston, Texas, United States, 77030 | |
St. Luke's Texas Cancer Institute at St. Luke's Episcopal Hospital | |
Houston, Texas, United States, 77030 | |
Veterans Affairs Medical Center - Houston | |
Houston, Texas, United States, 77030 | |
United States, Washington | |
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | |
Seattle, Washington, United States, 98122-4307 | |
University Cancer Center at University of Washington Medical Center | |
Seattle, Washington, United States, 98195-6043 |
Study Chair: | Powel H. Brown, MD, PhD | Baylor College of Medicine |
Study ID Numbers: | CDR0000377698, SWOG-S0300 |
Study First Received: | August 4, 2004 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00088972 |
Health Authority: | United States: Federal Government |
breast cancer breast cancer in situ lobular breast carcinoma in situ ductal breast carcinoma |
Carcinoma, Lobular Celecoxib Skin Diseases Carcinoma in Situ |
Breast Neoplasms Carcinoma, Ductal, Breast Breast Diseases Carcinoma |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Cyclooxygenase Inhibitors Physiological Effects of Drugs Enzyme Inhibitors Pharmacologic Actions Neoplasms Neoplasms by Site |
Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |