Observational Study to Evaluate Mechanisms of Aromatase Inhibitor Associated Musculoskeletal Symptoms

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02118636

Enrollment

Registered

2014-04-21

Start date

2009-10-31

Completion date

2015-09-30

Last updated

2016-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthralgia, Breast Cancer

Keywords

Joint pain, Hormone receptor positive breast cancer, Estrogen, Androgen

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

21 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change in estradiol and development of musculoskeletal symptoms between baseline and 3 months	12 months	To identify associations between estradiol serum concentrations at baseline and after 3 months of aromatase inhibitor therapy and the development of aromatase inhibitor-associated musculoskeletal symptoms by 12 months

Secondary

Measure	Time frame	Description
Change in sex hormones and development of musculoskeletal symptoms between baseline and 3 months	12 months	To identify associations between change in estrogens and androgens at baseline and 3 months of aromatase inhibitor therapy and development of aromatase inhibitor-associated musculoskeletal symptoms by 12 months

Countries

United States

Outcome results