Blood and Imaging Based Biomarkers in Patients with Estrogen Receptor Positive Stage 0-III Breast Cancer

This pilot research trial studies the blood and imaging based biomarkers in patients with estrogen receptor positive stage 0-III breast cancer. Studying blood and imaging based biomarkers may help doctors to find potential indicators of those who are at risk of developing aromatase inhibitor-induced musculoskeletal syndrome.

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
Post-menopausal women with 1st event of estrogen receptor positive (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 nonsteroidal anti-inflammatory drug (NSAID) use (except for daily aspirin use)
Current daily use of corticosteroids or immunosuppressive therapies

Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03665077.

PRIMARY OBJECTIVE:

I. To compare baseline oxylipin levels in women that do versus (vs.) those that do not develop aromatase inhibitor-induced musculoskeletal syndrome (AIMSS).

SECONDARY OBJECTIVE:

I. To correlate changes in levels of oxylipins with changes in pain scores through 6-month aromatase inhibitor (AI) treatment.

OUTLINE:

Patients undergo collection of blood for biomarker analysis.

Trial PhaseNo phase specified

Trial Typetreatment

Lead OrganizationBanner University Medical Center - Tucson

Principal InvestigatorPavani Chalasani

Primary ID1712078374
Secondary IDsNCI-2018-00099
ClinicalTrials.gov IDNCT03665077

Blood and Imaging Based Biomarkers in Patients with Estrogen Receptor Positive Stage 0-III Breast Cancer

Inclusion Criteria

Exclusion Criteria

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Blood and Imaging Based Biomarkers in Patients with Estrogen Receptor Positive Stage 0-III Breast Cancer

Description

Eligibility Criteria

Locations & Contacts

Trial Objectives and Outline

Trial Phase & Type

Lead Organization

Trial IDs

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