Bisphenol and Phthalate Exposures in Triple Negative Breast Cancer

Overview

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.

Full Title of Study: “Bisphenol and Phthalate Exposures in Women With Triple Negative Breast Cancer Receiving Doxorubicin Chemotherapy – a Pilot Study”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: February 2021

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • Study cohort
    • urinary bisphenol and phthalate levels

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 21 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • George Washington University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Kimberly Robien, Associate Professor – George Washington University
  • Overall Official(s)
    • Kim Robien, PhD, RD, Principal Investigator, Milken Institute School of Public Health, George Washington University
  • Overall Contact(s)
    • Kim Robien, PhD, RD, 202-994-2574, krobien@gwu.edu

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.