Observational Study to Evaluate Mechanisms of Aromatase Inhibitor Associated Musculoskeletal Symptoms

Lynn Henry

Status: Completed

Conditions: Breast Cancer; Arthralgia

Study type: Observational

Funder types: Other

Identifiers

NCT02118636

UMCC 2009.057

Details and patient eligibility

About

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.

Enrollment: 75 patients

Sex: Female

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Stage I-III breast cancer who are scheduled to receive endocrine therapy with an aromatase inhibitor
• All prior surgery, chemotherapy, and radiation therapy should be complete or should be completed by the time of AI treatment initiation (within 28 days of study enrollment)
• Age 21 and above and postmenopausal

Trial design

75 participants in 1 patient group

Aromatase inhibitor therapy

Description:

Subjects who are starting treatment with any of the three aromatase inhibitor (AI) medications