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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase II Chemoprevention Study of Celecoxib in Premenopausal Women at High Risk For Estrogen Receptor-Negative Breast Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Prevention	Completed	18 to 55	NCI	KUMC-HSC-8919-02 NCT00056082

Trial Description

Purpose:

Chemoprevention therapy uses certain drugs to try to prevent the development or recurrence of cancer. Celecoxib may be effective in preventing breast cancer in at-risk women.

Phase II trial to study the effectiveness of celecoxib in preventing breast cancer in premenopausal women who are at risk of developing cancer.

Eligibility:

Eligibility criteria include the following:

• 18-55 years old
• No more than 3 months since fine-needle aspiration
• At least 6 months since chemotherapy or hormone therapy
• No change (start or stop) in hormone therapy within the past 6 months
• At least 3 weeks since aspirin, rofecoxib, celecoxib, other COX-2 inhibitors, or NSAIDS
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will receive celecoxib by mouth twice a day. Treatment may continue for up to 1 year. Patients will undergo mammography at the beginning of the study and at 12 months, will have blood drawn for testing, and will undergo either ductal lavage or fine-needle aspiration. Patients will be evaluated at 2 weeks and once a year for 5 years.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center

Carol Fabian, MD, Protocol chair		Ph: 913-588-7791

Registry Information
Official Title		A Study to Identify Biomarker Modulation by a Cyclooxygenase-2 (COX-2) Inhibitor in Breast Tissue of Premenopausal Women at High Risk for Estrogen Receptor Negative (ERN) Breast Cancer
Trial Start Date		2003-01-10
Registered in ClinicalTrials.gov		NCT00056082
Date Submitted to PDQ		2003-01-28
Information Last Verified		2005-02-22
NCI Grant/Contract Number		CN15135

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