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
Conditions
Intervention / Treatment
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
Contacts and Locations
Study Locations
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District of Columbia
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Washington, District of Columbia, United States, 20052
- Milken Institute School of Public Health, George Washington University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Study cohort
urinary bisphenol and phthalate levels
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
urinary bisphenol and phthalate metabolite levels
Time Frame: baseline
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quantification of bisphenol and phthalate metabolites by liquid chromotography-tandem mass spectrometry
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baseline
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urinary bisphenol and phthalate metabolite levels
Time Frame: post-neoadjuvant chemotherapy (either 16 or 20 weeks)
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quantification of bisphenol and phthalate metabolites by liquid chromotography-tandem mass spectrometry
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post-neoadjuvant chemotherapy (either 16 or 20 weeks)
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change from baseline urinary bisphenol and phthalate levels at end of neoadjuvant chemotherapy
Time Frame: baseline and post-neoadjuvant chemotherapy (16 or 20 weeks)
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percent of change in urinary bisphenol and phthalate levels from pre- to post-neoadjuvant chemotherapy
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baseline and post-neoadjuvant chemotherapy (16 or 20 weeks)
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Collaborators and Investigators
Sponsor
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)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCR191600
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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