Epigenetics of TNBC in Overweight and Obese Hispanic & Non-Hispanic White Women

Withdrawn

• Conditions: Triple Negative Breast Cancer
• Interventions: Procedure: Needle core biopsy

• Registration Number: NCT04291950
• Lead Sponsor: University of Arizona

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.

Study Timeline

• Study First Submitted: 2020-02-27
• Study First Submitted QC: 2020-02-27
• Study First Posted: 2020-03-02
• Study Start: 2022-08-30
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-15
• Last Update Posted: 2022-12-20
• Primary Completion: 2025-08-30
• Study Completion: 2025-08-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Newly diagnosed TNBC	Needle core biopsy	Hispanic and NHW with newly diagnosed TNBC. Patients with TNBC will be eligible regardless of whether their treatment plan is surgery first or chemotherapy first (neoadjuvant chemotherapy).
Control group	Needle core biopsy	Hispanic and NHW women undergoing either a benign breast surgery or prophylactic mastectomy.

Primary Outcome Measures

Name	Time	Method
To determine if BMI/ obesity differentially influence expression and epigenetic signatures in TNBC from Hispanic compared to NHW women.	Two years	DXA studies will be completed prior to surgery or port placement. Blood draws will be done in OR by research staff. Tissue will be obtained at the time of their definitive surgery or at the time of port placement. For women going to surgery first, four (4) 16-gauge core needle biopsies will be obtained by research staff after the tumor has been removed from the patient and the specimen is on the collection table in the OR.; For women who are getting neo-adjuvant therapy prior to surgery, the core needle biopsies will be collected at the time of port placement in the OR.

Trial Locations

Locations (1)

University of Arizona Cancer Center; 🇺🇸 Tucson, Arizona, United States