Evaluation of Blood/Imaging Based Biomarkers, Aromatase Inhibitor Induced Musculoskeletal Syndrome

This is a prospective single arm study enrolling patients (n = 25) with breast cancer
scheduled to start adjuvant hormonal therapy. Patients would have completed all their primary
treatments (surgery± radiation therapy) and are scheduled to start their adjuvant hormonal
therapy. They get baseline blood drawn for oxylipins and sheer wave elastrography (SWE)
ultrasound of their hands including wrists. They start adjuvant anastrozole and have blood
drawn at 3mths and 6mths for measurement of oxylipins. SWE ultrasound is repeated at 6mths.
This is a pilot trial to evaluate for blood and imaging biomarkers. Once pilot data is
analyzed, goal is to apply for funding for a larger trial to further evaluate and validate
these biomarkers

Inclusion Criteria:

1. Be capable of understanding the investigational nature of the study and all pertinent
aspects of the study

2. Be capable of signing and providing written consent in accordance with institutional
and federal guidelines

3. Have a histologically-confirmed diagnosis of breast cancer

4. Be willing and able to comply with scheduled visits, treatment plan, and SWE
ultrasound imaging

5. Age ≥ 21 years

6. Post-menopausal women with 1st event of ER+ early stage breast cancer (0-3)

7. Completed definitive therapy (surgery ± radiation)

8. Candidates for adjuvant AI therapy

Exclusion Criteria:

1. Have received adjuvant or neo-adjuvant chemotherapy

2. Prior endocrine therapy (AI or tamoxifen)

3. History of rheumatoid arthritis or other autoimmune arthritis

4. Daily non-steroidal anti-inflammatory drug (NSAID) use (except for daily aspirin use)

5. Current use of daily corticosteroids or immunosuppressive therapies