National Cancer Institute National Cancer Institute
U.S. National Institutes of Health National Cancer Institute
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
Last Modified: 3/17/2009     First Published: 12/21/2006  

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

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IINatural history/Epidemiology, Supportive care, TreatmentActive18 and overNCI, Pharmaceutical / IndustryUWCC-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

100

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

Outcomes

Primary Outcome(s)

Rate of vitamin D deficiency

Secondary Outcome(s)

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

Trial Sites

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 1
Date Submitted to PDQ 2006-10-27
Information Last Verified 2009-07-16

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.



Table of Links

1http://clinicaltrials.gov/ct/show/NCT00416715