Clinical trial · Observational
Bisphenol and Phthalate Exposures in Triple Negative Breast Cancer
Bisphenol and Phthalate Exposures in Women With Triple Negative Breast Cancer Receiving Doxorubicin Chemotherapy - a Pilot Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study never initiated due to COVID pandemic, staffing changes
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Triple Negative Breast Cancer | Triple-Negative Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| urine collection | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Study cohort
- description
- urinary bisphenol and phthalate levels
- interventionNames
- Other: urine collection
Primary outcomes (3)
- measure
- urinary bisphenol and phthalate metabolite levels
- timeFrame
- baseline
- description
- quantification of bisphenol and phthalate metabolites by liquid chromotography-tandem mass spectrometry
- measure
- urinary bisphenol and phthalate metabolite levels
- timeFrame
- post-neoadjuvant chemotherapy (either 16 or 20 weeks)
- description
- quantification of bisphenol and phthalate metabolites by liquid chromotography-tandem mass spectrometry
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available