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

University of Arizona

Status: Completed

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03665077

1712078374

NCI-2018-00099 (Registry Identifier)

Details and patient eligibility

About

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

Full 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

Enrollment: 28 patients

Sex: Female

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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28 participants in 1 patient group

Participants

Experimental group

Description:

Patients with breast cancer who have completed all their primary treatments (surgery±radiation therapy) and are scheduled to start their adjuvant hormonal therapy.

Treatment:

Diagnostic Test: Blood draw at six months

Diagnostic Test: Blood draw at three months

Diagnostic Test: Initial SWE ultrasound

Diagnostic Test: SWE ultrasound at six months

Diagnostic Test: Initial blood draw