Bisphenol and Phthalate Exposures in Triple Negative Breast Cancer
关键词
抽象
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.
日期
| 最后验证: | 06/30/2020 |
| 首次提交: | 02/10/2020 |
| 提交的预估入学人数: | 02/11/2020 |
| 首次发布: | 02/12/2020 |
| 上次提交的更新: | 07/20/2020 |
| 最近更新发布: | 07/22/2020 |
| 实际学习开始日期: | 08/31/2020 |
| 预计主要完成日期: | 07/31/2021 |
| 预计完成日期: | 07/31/2021 |
状况或疾病
干预/治疗
Other: Study cohort
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Study cohort urinary bisphenol and phthalate levels | Other: Study cohort 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. |
资格标准
| 有资格学习的年龄 | 21 Years 至 21 Years |
| 有资格学习的性别 | Female |
| 取样方式 | Non-Probability Sample |
| 接受健康志愿者 | 是 |
| 标准 | 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 |
结果
主要结果指标
1. urinary bisphenol and phthalate metabolite levels [baseline]
2. urinary bisphenol and phthalate metabolite levels [post-neoadjuvant chemotherapy (either 16 or 20 weeks)]
3. change from baseline urinary bisphenol and phthalate levels at end of neoadjuvant chemotherapy [baseline and post-neoadjuvant chemotherapy (16 or 20 weeks)]
