Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

This phase II trial is studying vitamin D deficiency, muscle pain, joint pain, and joint stiffness in postmenopausal women receiving letrozole for stage I-III breast cancer. Learning about vitamin D deficiency and muscle pain, joint pain, and joint stiffness in patients receiving letrozole for breast cancer may help doctors plan treatment and may help patients live more comfortably

Further Study Information

PRIMARY OBJECTIVES:

I. To assess the rate of vitamin D deficiency in breast cancer patients who experience myalgias, arthralgias and/or joint stiffness following initiation of adjuvant letrozole treatment.

SECONDARY OBJECTIVES:

I. To determine if there is a correlation between letrozole serum levels and the development of myalgias, arthralgias and/or joint stiffness.

II. To assess if vitamin D supplementation may alleviate myalgias, arthralgias and/or joint stiffness associated with letrozole in those subjects with vitamin D deficiency.

OUTLINE:

Patients receive letrozole orally (PO) once daily (QD). Patients, who experience muscle pain, joint pain, or joint stiffness that requires an intervention and who are found to be vitamin D deficient, also receive calcium PO and vitamin D3 PO. Treatment continues for up to 28 weeks in the absence of disease progression or unacceptable toxicity.

Eligibility Criteria

Inclusion Criteria:

• Patients must have a histologically confirmed diagnosis of Stage I, II or III breast carcinoma

• Patients must be prescribed letrozole for adjuvant breast cancer treatment

• Prior adjuvant tamoxifen is permitted

• Patients must be postmenopausal; for study purposes, postmenopausal is defined as: a prior documented bilateral oophorectomy, or a history of at least 12 months without spontaneous menstrual bleeding, or have a persistently postmenopausal estradiol in the past 6 months without menses, and clinically in menopause at the judgment of the treating physician, or age 60 or older with a prior hysterectomy without oophorectomy, or age less than 60 with a prior hysterectomy without oophorectomy (or in whom the status of the ovaries is unknown), with a documented FSH level demonstrating confirmatory elevation in the postmenopausal range for the lab

Exclusion Criteria:

• Diagnosis of Stage IV breast carcinoma

• Pre-existing myalgias, arthralgias and/or joint stiffness >= Grade 1, as defined using CTEP CTC identified during baseline physical exam

• Inability to understand or cooperate with study procedures

• Receipt of investigational drug within 30 days before study entry

• Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome

• Unwillingness to give informed consent

• Unwillingness to participate or inability to comply with the protocol for the duration of the study

• Patients with serum calcium >= 14 mg/dL

• Patients with renal dysfunction defined as glomerular filtration rate <10ml/min calculated using Cockroft-Gault equation

Trial Contact Information

Trial Lead Organizations/Sponsors

Fred Hutchinson Cancer Research Center

Hannah Linden

Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00416715
Information obtained from ClinicalTrials.gov on January 30, 2012

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