Triple Negative Breast CancerEDC-TNBCNCT04268693
Bisphenol and Phthalate Exposures in Triple Negative Breast Cancer
An observational study of Triple Negative Breast Cancer, run by George Washington University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Triple Negative Breast Cancer
- What is being tested?
- urine collection
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2022to Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Milken Institute School of Public Health, George Washington University
Washington D.C., District of Columbia, 20052
About this study
Official title: 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.
Read the 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.
- Conditions
- Triple Negative Breast Cancer
- Being tested
- urine collection
- Keywords
- bisphenol, phthalate, doxorubicin
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
urine collectionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Study cohort | urinary bisphenol and phthalate levels Receives: Other: urine collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
urinary bisphenol and phthalate metabolite levels
quantification of bisphenol and phthalate metabolites by liquid chromotography-tandem mass spectrometry
Measured: baseline
urinary bisphenol and phthalate metabolite levels
quantification of bisphenol and phthalate metabolites by liquid chromotography-tandem mass spectrometry
Measured: post-neoadjuvant chemotherapy (either 16 or 20 weeks)
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
Measured: baseline and post-neoadjuvant chemotherapy (16 or 20 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2020
- Study startSep 2022 (estimated)
- Primary completionAug 2023 (estimated)
- Study completionAug 2023 (estimated)
Why it stopped: Study never initiated due to COVID pandemic, staffing changes
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple Negative Breast CancerStudies of the same condition, open and under way.
- More trials run by George Washington UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kimberly Robien, George Washington University
- Investigators
- Kim Robien, PhD, RD, Principal investigator, Milken Institute School of Public Health, George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04268693
- Sponsor's protocol ID
- NCR191600
- Acronym
- EDC-TNBC
- Status last verified
- Nov 2022
- First submitted
- 11 Feb 2020
- Last updated
- 17 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Will not share data until study is complete and all data deidentified
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bisphenol and Phthalate Exposures in Women With Triple Negative Breast Cancer Receiving Doxorubicin Chemotherapy - a Pilot Study
- ClinicalTrials.gov ID
- NCT04268693
- Acronym / sponsor ID
- EDC-TNBC / NCR191600
- Conditions
- Triple Negative Breast Cancer
- Keywords
- bisphenol, phthalate, doxorubicin
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study never initiated due to COVID pandemic, staffing changes
- Enrolment
- 0 participants (actual)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Study start
- Sep 2022 (estimated)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 13 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study cohort | – | Other: urine collectionurinary bisphenol and phthalate levels |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| urine collectionCollect 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. | Other | Study cohort |
Primary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2022.
- Individual participant dataSharing planned: No. Will not share data until study is complete and all data deidentified
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kim Robien, PhD, RD principal investigator
Milken Institute School of Public Health, George Washington University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Triple Negative Breast Cancer, run by George Washington University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
urinary bisphenol and phthalate metabolite levels (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2022.