Bisphenol and Phthalate Exposures in Women With Triple Negative Breast Cancer Receiving Doxorubicin Chemotherapy - a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- change from baseline urinary bisphenol and phthalate levels at end of neoadjuvant chemotherapy
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
change from baseline urinary bisphenol and phthalate levels at end of neoadjuvant chemotherapy
时间窗: baseline and post-neoadjuvant chemotherapy (16 or 20 weeks)
percent of change in urinary bisphenol and phthalate levels from pre- to post-neoadjuvant chemotherapy
urinary bisphenol and phthalate metabolite levels
时间窗: post-neoadjuvant chemotherapy (either 16 or 20 weeks)
quantification of bisphenol and phthalate metabolites by liquid chromotography-tandem mass spectrometry
次要结局
未报告次要终点
研究者
Kimberly Robien
Associate Professor
George Washington University