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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aromatase inhibitor therapy | Subjects who are starting treatment with any of the three aromatase inhibitor (AI) medications |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in estradiol and development of musculoskeletal symptoms between baseline and 3 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 | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in sex hormones and development of musculoskeletal symptoms between baseline and 3 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 | 12 months |
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Inclusion Criteria:
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Postmenopausal women with hormone receptor positive breast cancer who are initiating therapy with an aromatase inhibitor
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| Name | Affiliation | Role |
|---|---|---|
| Norah L Henry, MD, PhD | University of Michigan Rogel Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48109 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D018771 | Arthralgia |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Whole blood is being collected at baseline for DNA extraction. Serum is being collected at baseline and after 3, 6, and 12 months.
| D017437 |
| Skin and Connective Tissue Diseases |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |