Clinical Trial: Observational Study to Evaluate Mechanisms of Aromatase Inhibitor Associated Musculoskeletal Symptoms

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Prospective Observational Study of Breast Cancer Patients Starting Therapy With an AI to Evaluate Mechanisms Underlying Development of Aromatase Inhibitor Associated Musculoskeletal Symptoms

Brief Summary: Early stage hormone receptor positive breast cancer is typically treated with adjuvant endocrine therapy in order to decrease risk of breast cancer recurrence and to improve overall survival from the disease. Typical agents used for treatment include tamoxifen and the aromatase inhibitors. In postmenopausal women, aromatase inhibitor therapy is increasingly common because it is associated with fewer long-term serious toxicities compared to tamoxifen. However, aromatase inhibitors cause arthralgias in 40-50% of patients, which can influence adherence to therapy and can lead to treatment discontinuation in a minority of cases. The mechanism underlying development of this toxicity remains unclear, and predictors of who will develop these symptoms remain undefined. This observational study is designed to collect patient-reported outcomes and serial serum samples in order to investigate potential etiologies of this bothersome toxicity.

Detailed Summary:
Sponsor: Lynn Henry

Current Primary Outcome: Change in estradiol and development of musculoskeletal symptoms between baseline and 3 months [ Time Frame: 12 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Change in sex hormones and development of musculoskeletal symptoms between baseline and 3 months [ Time Frame: 12 months ]

Original Secondary Outcome: Same as current

Information By: University of Michigan Cancer Center

Dates:
Date Received: January 15, 2014
Date Started: October 2009
Date Completion:
Last Updated: March 3, 2016
Last Verified: March 2016