Clinical trial NCT04291950: Epigenetics of TNBC in Overweight and Obese Hispanic & Non-Hispanic White Women
Official title: Epigenetics of Triple-Negative Breast Cancer in Overweight and Obese Hispanic and Non-Hispanic White Women
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Triple Negative Breast Cancer
Keywords: triple negative
breast cancer
TNBC
obesity
overweight
Hispanic
non-Hispanic white
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2020-03-02
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: he overall strategy for this pilot project is to collect breast tissue from 30 non-tumor (control) subjects and 30 TNBC patients. The women will be stratified by BMI (lean, overweight, obese) and ethnicity (Hispanic vs NHW). Race and ethnicity will be self-reported. Hispanic women can be of any race. Due to the Southwestern location of the University of Arizona (UA) and the regional demographics, we expect that approximately 90% of the Hispanic women recruited for this study will be White of Mexican/Mexican-American ancestry. However, eligible non-White, Hispanic or non-Hispanic, subjects will not be excluded.

Brief summary: A key tenet of this project is that of reaching translational human diagnosis and biomarker end points. To lay a foundation and make progress towards these translational goals, investigators will address the following specific aim:

To determine if BMI/ obesity differentially influence expression and epigenetic signatures in triple negative breast cancer (TNBC) from Hispanic compared to NHW women.

Detailed description: The intended goal of this Project is to develop epigenetic biomarkers to monitor the role of obesity and ethnicity on he development of triple negative breast cancer (TNBC). The proposed approach will seek to clarify for the first time if BMI is a biological factor that regulates aromatic hydrocarbon receptor (AhR) expression and epigenetic activity at breast cancer susceptibility and hormone receptor genes based on Hispanic or non-Hispanic white (NHW) ethnicity. If successful, the proposed experiments have the potential to highlight the role of overweight and obesity for dietary prevention of TNBC and to underscore the consideration of breast cancer screening among overweight/obese Hispanic women. Additionally, this study will provide the opportunity to begin testing the utility of AhR as a biomarker of TNBC development related to BMI and ethnicity.

Eligibility criteria: Inclusion Criteria:

* Hispanic or NHW women
* ≥ 18 years of age
* scheduled for a breast procedure as standard of care treatment - benign breast surgery or prophylactic mastectomy\\
* Newly diagnosed TNBC - Patients with TNBC will be eligible regardless of whether their treatment plan is surgery first or chemotherapy first (neoadjuvant chemotherapy)
* Eligible non-white women could be included

Exclusion Criteria:

* BRCA1/2 mutation carriers
* Family history of breast cancer in a first-degree relative and have NOT had genetic testing for BRCA1/2
* Patients who have already undergone radiation or chemotherapy
* Pregnant women
* Male
* Prisoners

Primary outcomes:
measure: To determine if BMI/ obesity differentially influence expression and epigenetic signatures in TNBC from Hispanic compared to NHW women.
timeFrame: Two years
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona Cancer Center
state: Arizona
Study officials:
affiliation: University of Arizona
name: Pavani Chalasani, MD
role: PRINCIPAL_INVESTIGATOR
References: