Bisphenol and Phthalate Exposures in Triple Negative Breast Cancer

NCT ID: NCT04268693

Last Updated: 2022-11-17

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-09-30
• Study Completion Date: 2023-08-31

Brief Summary

In this observational pilot study urine samples will be collected from women receiving neoadjuvant chemotherapy with doxorubicin for triple negative breast cancer to determine whether: 1) exposures bisphenol and phthalate levels change over the course of neoadjuvant chemotherapy, and 2) levels differ between black women and those of other racial groups.

The hypothesis is that bisphenol and phthalate levels will be similar to those of the general US female population at the time of diagnosis, however levels will increase during treatment due to exposure to plastics in the medical setting. The investigators also hypothesize that because of differences in personal care product use, black women may have higher urinary levels of bisphenols and phthalates prior to starting chemotherapy.

Detailed Description

Triple-negative breast cancer (TNBC) is an aggressive breast cancer subtype that does not express estrogen, progesterone, or the human epidermal growth factor (HER2/neu) receptors, and has a low overall survival rate compared to other types of breast cancer.

Unlike hormone and HER2/neu positive breast cancers, targeted therapies are not available for TNBC. Thus, the systemic chemotherapeutic agent doxorubicin is widely used for the treatment of TNBC. However, doxorubicin resistance is common, and leads to poorer treatment outcomes.

Understanding factors that contribute to doxorubicin resistance is critical to improving cancer treatment outcomes among women with TNBC. Pre-clinical in vitro studies indicate that exposure to endocrine disrupting chemicals, such as bisphenols and phthalates, contribute to doxorubicin resistance, but these findings have not been evaluated in humans.

Conditions

Triple Negative Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Study cohort

urinary bisphenol and phthalate levels

urine collection

Intervention Type: OTHER

Collect three urine samples either in the clinic or at home. This will occur prior to starting neoadjuvant chemotherapy, and again at the end of the scheduled course of neoadjuvant chemotherapy.

Interventions

urine collection

Collect three urine samples either in the clinic or at home. This will occur prior to starting neoadjuvant chemotherapy, and again at the end of the scheduled course of neoadjuvant chemotherapy.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• diagnosis of stage I - III triple negative breast cancer
• scheduled to receive a neoadjuvant chemotherapy regimen including doxorubicin
• receiving treatment at the George Washington University Cancer Center

Exclusion Criteria

• diagnosis of other types of breast cancer
• not scheduled to receive doxorubicin as part of the neoadjuvant chemotherapy regimen
• not planning to receive neoadjuvant chemotherapy at the George Washington University Cancer Center

• Minimum Eligible Age: 21 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

George Washington University

OTHER

Sponsor Role: lead

Responsible Party

Kimberly Robien

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kim Robien, PhD, RD

Role: PRINCIPAL_INVESTIGATOR

Milken Institute School of Public Health, George Washington University

Locations

Milken Institute School of Public Health, George Washington University

Washington D.C., District of Columbia, United States

Countries

United States

Other Identifiers

NCR191600

Identifier Type: -

Identifier Source: org_study_id