Bisphenol and Phthalate Exposures in Triple Negative Breast Cancer

Triple Negative Breast Cancer Clinical Trial

— EDC-TNBC  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04268693
• Other study ID #: NCR191600
• Status: Withdrawn
• Start date: September 2022
• Est. completion date: August 2023

Study information

• Verified date: November 2022
• Source: George Washington University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	Milken Institute School of Public Health, George Washington University	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
George Washington University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	urinary bisphenol and phthalate metabolite levels	quantification of bisphenol and phthalate metabolites by liquid chromotography-tandem mass spectrometry	baseline
Primary	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)
Primary	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)