Bisphenol and Phthalate Exposures in Triple Negative Brea... | NCT04268693

Studies
Bisphenol and Phthalate Exposures in Triple Negative Breast Cancer

NCT04268693

Sponsor

George Washington University

Status

Withdrawn

Last Update Posted

Nov 17, 2022Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Triple Negative Breast Cancer

Interventions

urine collection

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2022

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study never initiated due to COVID pandemic, staffing changes

Expanded Access Info

Start Date

Sep 2022Estimated

Primary Completion Date

Aug 2023Estimated

Completion Date

Aug 2023Estimated

First Submitted Date

Feb 11, 2020

First Submission Date that Met QC Criteria

Feb 12, 2020

First Posted Date

Feb 13, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 14, 2022

Last Update Posted Date

Nov 17, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Kimberly Robien, Associate Professor, George Washington UniversityPrincipal Investigator

Lead Sponsor

George Washington UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study cohort		urinary bisphenol and phthalate levels	Other: urine collection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
urine collection	Other	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
urinary bisphenol and phthalate metabolite levels	quantification of bisphenol and phthalate metabolites by liquid chromotography-tandem mass spectrometry	baseline
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)
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)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kim Robien, PhD, RD	Milken Institute School of Public Health, George Washington University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Milken Institute School of Public Health, George Washington University		Washington D.C.	District of Columbia	20052	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Will not share data until study is complete and all data deidentified

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D064726	Triple Negative Breast Neoplasms

Ancestor Terms

ID	Term
D001943	Breast Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D059349	Urine Specimen Collection

Ancestor Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided