Clinical trial NCT04268693: Bisphenol and Phthalate Exposures in Triple Negative Breast Cancer
Official title: Bisphenol and Phthalate Exposures in Women With Triple Negative Breast Cancer Receiving Doxorubicin Chemotherapy - a Pilot Study
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Triple Negative Breast Cancer
Keywords: bisphenol
phthalate
doxorubicin
Lead sponsor: George Washington University
Sponsor class: OTHER
First posted: 2020-02-13
Enrollment: 0
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: urinary bisphenol and phthalate metabolite levels
timeFrame: baseline
measure: urinary bisphenol and phthalate metabolite levels
timeFrame: post-neoadjuvant chemotherapy (either 16 or 20 weeks)
measure: change from baseline urinary bisphenol and phthalate levels at end of neoadjuvant chemotherapy
timeFrame: baseline and post-neoadjuvant chemotherapy (16 or 20 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Milken Institute School of Public Health, George Washington University
state: District of Columbia
Study officials:
affiliation: Milken Institute School of Public Health, George Washington University
name: Kim Robien, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References: