Bisphenol and Phthalate Exposures in Triple Negative Breast Cancer

NCT04268693 | Withdrawn

• 1 other identifier: NCR191600
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Triple Negative Breast Cancer

Keywords

bisphenol; phthalate; doxorubicin

Outcome Measures

Primary Outcomes (3)

• 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)

Study Arms (1)

Study cohort

urinary bisphenol and phthalate levels

Other: urine collection

Interventions

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.

Study cohort

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• George Washington University: lead

Study Sites (1)

Milken Institute School of Public Health, George Washington University

Washington D.C., District of Columbia, 20052, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

urine samples

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

Urine Specimen Collection

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Kim Robien, PhD, RD

  Milken Institute School of Public Health, George Washington University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 11, 2020
• First Posted: February 13, 2020
• Study Start: September 1, 2022
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: November 17, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)