Bisphenol and Phthalate Exposures in Triple Negative Breast Cancer (EDC-TNBC)

Bisphenol and Phthalate Exposures in Women With Triple Negative Breast Cancer Receiving Doxorubicin Chemotherapy - a Pilot Study

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.

Study Overview

• Status: Withdrawn
• Conditions: Triple Negative Breast Cancer
• Intervention / Treatment: Other: urine collection

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 Type: Observational

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20052
      • Milken Institute School of Public Health, George Washington University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women being treated at the George Washington University for stage I - III triple negative breast cancer who are scheduled to receive a neoadjuvant chemotherapy regimen containing doxorubicin.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study cohort; urinary bisphenol and phthalate levels	Other: 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: George Washington University
• Investigators: Principal Investigator: Kim Robien, PhD, RD, Milken Institute School of Public Health, George Washington University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): August 1, 2023
• Study Completion (Anticipated): August 1, 2023

Study Registration Dates

• First Submitted: February 11, 2020
• First Submitted That Met QC Criteria: February 12, 2020
• First Posted (Actual): February 13, 2020

Study Record Updates

• Last Update Posted (Actual): November 17, 2022
• Last Update Submitted That Met QC Criteria: November 14, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: doxorubicin; bisphenol; phthalate
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Triple Negative Breast Neoplasms
• Other Study ID Numbers: NCR191600

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Will not share data until study is complete and all data deidentified

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No