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

Alternate Title

Phase II Randomized Study of Celecoxib in Women With Metastatic or Recurrent Breast Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	NCI	CALGB-40105 NCT00045591

Trial Description

Purpose:

Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for their growth and by stopping blood flow to the tumor. It is not yet known which regimen of celecoxib is more effective in treating breast cancer.

Randomized phase II trial to compare the effectiveness of two regimens of celecoxib in treating women who have metastatic or recurrent breast cancer

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• At least four previous courses of chemotherapy
• Measurable or evaluable disease
• At least 6 weeks since chemotherapy
• At least 4 weeks since radiation therapy
• 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 be randomly assigned to one of two groups. Patients in group one will receive high- dose celecoxib by mouth twice a day. Patients in group two will receive low-dose celecoxib by mouth twice a day. Treatment may continue for as long as benefit is shown. If the cancer progresses, patients may continue treatment in the same group or opposite group for up to 1 year. Patients will be evaluated every 3 months for 1 year and every 6 months for up to 4 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

Cancer and Leukemia Group B

Charles Shapiro, MD, Protocol chair		Ph: 614-293-6401 Email: charles.shapiro@osumc.edu

Registry Information
Official Title		Evaluation Of Novel Therapeutic Agents (Celecoxib: NSC # 719627) Against Breast Cancer: An Innovative Randomized Phase II Trial Design
Trial Start Date		2003-02-15
Registered in ClinicalTrials.gov		NCT00045591
Date Submitted to PDQ		2002-07-09
Information Last Verified		2004-07-22
NCI Grant/Contract Number		U10-CA31946

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