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

Alternate Title

Phase II Pilot Study of Vitamin D Deficiency and Myalgias and/or Arthralgias in Postmenopausal Women Receiving Adjuvant Letrozole for Stage I-III Breast Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Natural history/Epidemiology, Supportive care, Treatment	Active	18 and over	NCI, Pharmaceutical / Industry	UWCC-6346 6346, NOVARTIS-UWCC-6346, UWCC-06-2386-H/A, FHCRC-6346, NCT00416715

Trial Description

Purpose:

A study that evaluates vitamin D deficiency and muscle pain and/or joint pain in patients receiving letrozole for breast cancer may help doctors plan the best treatment for muscle pain and/or joint pain.

This phase II trial is studying vitamin D deficiency and muscle pain and/or joint pain in postmenopausal women receiving letrozole for stage I, stage II, or stage III breast cancer.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• Planning to receive letrozole
• No current muscle pain and/or joint pain
• 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 letrozole by mouth once a day. Treatment may continue for up to 28 weeks.

Patients will be evaluated for muscle pain and/or joint pain once a week for 6 months after beginning letrozole. Patients who develop significant muscle pain and/or joint pain and a vitamin D deficiency will receive calcium and vitamin D by mouth once a day.

Patients will undergo blood collection before beginning treatment, at week 4, at the start of calcium and vitamin D, and at 4 weeks after starting calcium and vitamin D 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

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Hannah Linden, MD, Principal investigator		Ph: 206-288-6710

U.S.A.
Washington
	Seattle
	Seattle Cancer Care Alliance
		Clinical Trials Office - Seattle Cancer Care Alliance	Ph:  800-804-8824

Registry Information
Official Title		Pilot Study of Vitamin D Deficiency and Myalgias/Arthralgias Associated with Letrozole (Femara®)
Trial Start Date		2006-10-11
Trial Completion Date		2009-12-31 (estimated)
Registered in ClinicalTrials.gov		NCT00416715
Date Submitted to PDQ		2006-10-27
Information Last Verified		2009-07-16

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