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

Not Applicable

Completed

Conditions: Aromatase Inhibitor Induced Musculoskeletal Syndrome (AIMSS)
Breast Cancer

Interventions: Diagnostic Test: Initial blood draw
Diagnostic Test: Initial SWE ultrasound
Diagnostic Test: Blood draw at three months
Diagnostic Test: Blood draw at six months
Diagnostic Test: SWE ultrasound at six months

Brief Summary: This is a pilot trial to evaluate for blood and imaging biomarkers in patients with breast cancer scheduled to start adjuvant hormonal therapy.

Detailed Description: 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

Recruitment & Eligibility

Inclusion Criteria

Be capable of understanding the investigational nature of the study and all pertinent aspects of the study
Be capable of signing and providing written consent in accordance with institutional and federal guidelines
Have a histologically-confirmed diagnosis of breast cancer
Be willing and able to comply with scheduled visits, treatment plan, and SWE ultrasound imaging
Age ≥ 21 years
Post-menopausal women with 1st event of ER+ early stage breast cancer (0-3)
Completed definitive therapy (surgery ± radiation)
Candidates for adjuvant AI therapy

Exclusion Criteria

Have received adjuvant or neo-adjuvant chemotherapy
Prior endocrine therapy (AI or tamoxifen)
History of rheumatoid arthritis or other autoimmune arthritis
Daily non-steroidal anti-inflammatory drug (NSAID) use (except for daily aspirin use)
Current use of daily corticosteroids or immunosuppressive therapies

Arm && Interventions

Group	Intervention	Description
Participants	Initial blood draw	Patients with breast cancer who have completed all their primary treatments (surgery±radiation therapy) and are scheduled to start their adjuvant hormonal therapy.
Participants	Blood draw at six months	Patients with breast cancer who have completed all their primary treatments (surgery±radiation therapy) and are scheduled to start their adjuvant hormonal therapy.
Participants	SWE ultrasound at six months	Patients with breast cancer who have completed all their primary treatments (surgery±radiation therapy) and are scheduled to start their adjuvant hormonal therapy.
Participants	Initial SWE ultrasound	Patients with breast cancer who have completed all their primary treatments (surgery±radiation therapy) and are scheduled to start their adjuvant hormonal therapy.
Participants	Blood draw at three months	Patients with breast cancer who have completed all their primary treatments (surgery±radiation therapy) and are scheduled to start their adjuvant hormonal therapy.

Primary Outcome Measures

Name	Time	Method
Oxylipin Levels	Baseline, Three months, and Six months	Change Oxylipin levels at Baseline, Three and Six Months

Secondary Outcome Measures

Name	Time	Method
Tendon Stiffness	Baseline	Tendon stiffness at baseline
Pain Levels	Baseline, Six months	Pain levels at baseline and 6 months. Pain assessment was done using the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index; the WOMAC pain assessment consists of 5 items, and each item has a scale that ranges from 0-4 (higher scores indicate higher pain levels). The scores of the 5 items are summed up to obtain the WOMAC-total pain score, which ranges from 0-20.