Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Syndrome

Breast Neoplasms

All Drugs and Chemicals

Aromatase Inhibitors

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

At baseline, patients will undergo a blood draw.

Initial blood draw

At baseline, patients will undergo a sheer wave elastrography (SWE) ultrasound of their hands including wrists.

Initial SWE ultrasound

Blood drawn at three months to evaluate oxylipins.

Blood draw at three months

Blood drawn at six months to evaluate oxylipins.

Blood draw at six months

SWE ultrasound at six months to evaluate tendon stiffness.

SWE ultrasound at six months

Pavani Chalasani

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

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

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

Pilot Trial to Evaluate Blood and Imaging Based Biomarkers for Aromatase Inhibitor Induced Musculoskeletal Syndrome

Change Oxylipin levels at Baseline, Three and 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.

University of Arizona

This is a pilot trial to evaluate oxylipins as blood biomarkers of aromatase inhibitor induced musculoskeletal syndrome. Adverse events were monitored for blood draws and analysis of oxylipins only. Anastrozole treatment was done as standard of care, and thus, side effects from anastrozole were managed per patients' standard of care and were not recorded for the purposes of this study.

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

Initial blood draw: At baseline, patients will undergo a blood draw.

Initial SWE ultrasound: At baseline, patients will undergo a sheer wave elastrography (SWE) ultrasound of their hands including wrists.

Blood draw at three months: Blood drawn at three months to evaluate oxylipins.

Blood draw at six months: Blood drawn at six months to evaluate oxylipins.

SWE ultrasound at six months: SWE ultrasound at six months to evaluate tendon stiffness.

Participants

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Staging is based on the patients' surgical pathology report. American Joint Committee on Cancer (AJCC) 7th staging criteria for breast cancer was used for this study. Overall 7th Edition AJCC stage (IIV) is based on the TNM classification. The lower the number, the lower the cancer stage and the better the prognosis for the patient. The higher the stage, the worse the prognosis.

Spots Global Cancer Trial Database for initial blood draw