Bisphenol and Phthalate Exposures in Triple Negative Breast Cancer

Withdrawn

• Conditions: Triple Negative Breast Cancer
• Interventions: Other: urine collection

• Registration Number: NCT04268693
• Lead Sponsor: George Washington University

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.

Study Timeline

• Study First Submitted: 2020-02-11
• Study First Submitted QC: 2020-02-12
• Study First Posted: 2020-02-13
• Study Start: 2022-09
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-14
• Last Update Posted: 2022-11-17
• Primary Completion: 2023-08
• Study Completion: 2023-08

Recruitment & Eligibility

• Status: WITHDRAWN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

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study cohort	urine collection	urinary bisphenol and phthalate levels

Primary Outcome Measures

Name	Time	Method
change from baseline urinary bisphenol and phthalate levels at end of neoadjuvant chemotherapy	baseline and post-neoadjuvant chemotherapy (16 or 20 weeks)	percent of change in urinary bisphenol and phthalate levels from pre- to post-neoadjuvant chemotherapy
urinary bisphenol and phthalate metabolite levels	post-neoadjuvant chemotherapy (either 16 or 20 weeks)	quantification of bisphenol and phthalate metabolites by liquid chromotography-tandem mass spectrometry

Trial Locations

Locations (1)

Milken Institute School of Public Health, George Washington University; 🇺🇸 Washington, District of Columbia, United States