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

Alternate Title

Phase I Study of White Button Mushroom Extract in Preventing the Recurrence of Breast Cancer in Postmenopausal Women Who Are Breast Cancer Survivors

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Biomarker/Laboratory analysis, Prevention	Active	21 and over	NCI	CHNMC-07213 07213, NCT00709020

Trial Description

Purpose:

White button mushroom extract may stop or delay the recurrence of breast cancer in postmenopausal breast cancer survivors.

This phase I trial is studying the side effects and best dose of white button mushroom extract in preventing the recurrence of breast cancer in postmenopausal women who are breast cancer survivors.

Eligibility:

Eligibility criteria include the following:

• At least 21 years old
• At least 6 months since finishing cancer treatment other than reconstructive surgery
• No allergy to mushrooms
• No osteoporosis
• More than 3 months since oral contraceptives, hormone replacement therapy, or other hormone therapy
• At least 1 month since mushroom extracts or DHEA dietary supplements
• 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 white button mushroom extract by mouth twice a day for up to 12 weeks.

Patients will undergo blood and urine sample collection at the beginning of the study and periodically during treatment for laboratory studies.

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

City of Hope Comprehensive Cancer Center

Melanie Palomares, MD, MS, Principal investigator		Ph: 626-256-8662; 800-826-4673

U.S.A.
California
	Duarte
	City of Hope Comprehensive Cancer Center
		Melanie Palomares, MD, MS	Ph:  800-826-4673
			Email: mpalomares@coh.org
	Pasadena
	City of Hope Medical Group
		Steven Kohler, MD	Ph:  626-396-2900

Registry Information
Official Title		A Translational Breast Cancer Prevention Trial of Mushroom Powder in Postmenopausal Breast Cancer Survivors
Trial Start Date		2008-06-16
Trial Completion Date		2011-06-16 (estimated)
Registered in ClinicalTrials.gov		NCT00709020
Date Submitted to PDQ		2008-06-20
Information Last Verified		2008-12-07
NCI Grant/Contract Number		CA33572