EDC-TNBC: Bisphenol and Phthalate Exposures in Triple Negative Breast Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | 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.
|
Outcome Measures
Primary Outcome Measures
- urinary bisphenol and phthalate metabolite levels [baseline]
quantification of bisphenol and phthalate metabolites by liquid chromotography-tandem mass spectrometry
- 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
- 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
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Milken Institute School of Public Health, George Washington University | Washington | District of Columbia | United States | 20052 |
Sponsors and Collaborators
- George Washington University
Investigators
- Principal Investigator: Kim Robien, PhD, RD, Milken Institute School of Public Health, George Washington University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NCR191600