Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

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

Objectives

Primary

1. Determine the rate of vitamin D deficiency in postmenopausal women with stage I-III breast cancer who develop myalgias and/or arthralgias after beginning adjuvant letrozole.

Secondary

1. Correlate letrozole serum levels with the development of myalgias and/or arthralgias in these patients.
2. Determine if vitamin D supplementation may alleviate myalgias and/or arthralgias associated with letrozole in these patients.

Entry Criteria

Disease Characteristics:

• Histologically confirmed breast cancer
  • Stage I-III disease



• Planning to receive letrozole as adjuvant treatment



• No pre-existing myalgias and/or arthralgias ≥ grade 1



• Hormone receptor status not specified

Prior/Concurrent Therapy:

• See Disease Characteristics
• Prior adjuvant tamoxifen allowed
• More than 30 days since prior investigational drugs

Patient Characteristics:

• Female
• Postmenopausal
• Must have physical integrity of the upper gastrointestinal tract
• No malabsorption syndrome
• Calcium < 14 mg/dL
• Glomerular filtration rate ≥ 10 mL/min

Expected Enrollment

A total of 100 patients will be accrued for this study.

Outcomes

Rate of vitamin D deficiency

Correlation of letrozole serum levels with the development of myalgias and/or arthralgias
Efficacy of vitamin D supplementation

Outline

This is an open-label, controlled, pilot, multicenter study.

Patients receive oral letrozole once daily for up to 28 weeks in the absence of disease progression or unacceptable toxicity.

Patients are monitored weekly for myalgias and/or arthralgias for 6 months after beginning letrozole. Patients who experience myalgias and/or arthralgias of at least grade 2 and are found to be vitamin D deficient receive oral calcium and vitamin D daily.

Blood is collected at baseline, week 4, at the start of calcium and vitamin D intervention, and at 4 weeks after beginning calcium and vitamin D. Blood is examined for estradiol, estrone, sex hormone-binding globulin, free testosterone, vitamin D, calcium, and letrozole levels.

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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