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Prospective Study of Aromatase Inhibitor-Associated Musculoskeletal Symptoms in Non-Metastatic, Post Menopausal Breast Cancer Patients

This study is currently Recruiting

June 2011 By University of California, Los Angeles

First Recieved on January 15, 2010

Last Updated on June 17, 2011

Sponsor: University of California, Los Angeles
Collaborators:
Information provided by: University of California, Los Angeles
Identifier: NCT01051609

Purpose

The purpose of this study is to compare pre and post Aromatase Inhibitor (AI) treatment serological markers of inflammation and assess for correlation with AI-MS.

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment, Masking: Open Label

Eligibility

Ages Eligible for Study:18 Years
Genders Eligible for Study:Female
Accepts Healthy Volunteers:No
Criteria

Inclusion Criteria: - Women 18 years and older with non-metastatic hormone receptor (ER and/or PR) positive breast cancer who are eligible for and planning on starting treatment with an AI within one month of signing consent. - Postmenopausal, defined as at least one of the following: a) amenorrhea for at least 12 months b) prior bilateral oophorectomy at least 2 years prior to trial registration. Exclusion Criteria: - History of autoimmune connective tissue disease, such as rheumatoid arthritis, lupus, or other autoimmune conditions affecting joints. - Treatment with steroid (for any condition, except for chemotherapy premedication) within 30 days of trial registration. - Prior treatment with an AI (patients previously or currently on tamoxifen are eligible as long as patients are off tamoxifen for 2 weeks prior to baseline blood draw) - Active or ongoing infection - Known metastatic disease - Known history of HIV or hepatitis infections - Ongoing radiation therapy (radiation must have been completed 2 weeks prior to starting treatment with an AI) - Non-invasive (DCIS, LCIS) cancer only (no diagnosis of invasive cancer) - Pregnant or lactating - Unable to speak, read, and write in English

Investigators

  • Investigator: Sara Hurvitz, M D - Principal Investigator - University of California, Los Angeles

Locations

  • UCLA Jonsson Comprehensive Cancer Center

    Los Angeles, California 90095 United States

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