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

Triple Negative Breast Cancer Clinical Trial

Official title:

Epigenetics of Triple-Negative Breast Cancer in Overweight and Obese Hispanic and Non-Hispanic White Women

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04291950
• Other study ID #: 2001272738
• Secondary ID: 32097
• Status: Withdrawn
• Start date: August 30, 2022
• Est. completion date: August 30, 2025

Study information

• Verified date: December 2022
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 30, 2025
• Est. primary completion date: August 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Overweight
• Triple Negative Breast Cancer
• Triple Negative Breast Neoplasms

Intervention

Procedure:
• Needle core biopsy
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. The patient will be under light anesthesia for the port placement. Per standard care, we will also use local anesthetic for the needle core biopsy. Port placement requires ultrasound (US). We will take advantage of the US already available in the OR to guide the core needle biopsy. Within 30 minutes of procurement, the tissue from the biopsies will be flash frozen in liquid nitrogen by staff and taken to the lab.

Locations

Country	Name	City	State
United States	University of Arizona Cancer Center	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
University of Arizona

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine if BMI/ obesity differentially influence expression and epigenetic signatures in TNBC from Hispanic compared to NHW women.	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.	Two years