Oral Aromatase Inhibitors Modify the Gut Microbiome Effecting Estrogen Bioavailability
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Change in Gut Microbial Levels - Fecal Swab
研究概览
简要总结
The purpose of this research is to study the bacteria in participants' gut before receiving a medicine called an aromatase inhibitor for breast cancer and after participants receive medicine for breast cancer.
详细描述
Primary Objective: To describe the microbiome shift of gut microbiome from baseline after 4-weeks and 12-weeks of oral aromatase inhibitor treatment.
Secondary Objective
- To correlate gut microbiome populations with circulating sex hormone metabolite concentrations at baseline and 12 weeks.
- To describe the correlation of change in the microbiome populations with change in circulating sex hormone metabolite concentrations from baseline to 12 weeks.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pathologic diagnosis in situ or invasive breast cancer for which initiating aromatase inhibitors therapy is recommended or initiating aromatase inhibitors for risk reduction.
- •ECOG performance status 0,1, 2,
- •Age ≥ 18 years
- •HER2+ breast cancer is allowed if patients are on a monoclonal antibody therapy for which a change is not anticipated while on study (12 weeks) and they have been on the monoclonal antibody therapy for at least 4 weeks.
- •Ability to read, understand and evaluate study materials and willingness to sign a written informed consent document.
排除标准
- •Have been on antibiotics within 4 weeks of enrollment.
- •Administered chemotherapy less than 4 weeks prior to enrollment.
- •Hormone replacement (defined as only estrogen and/or progesterone replacement) or anti-estrogen therapy within 4 weeks of starting aromatase inhibitors
- •Use of antibody drug conjugate (HER2+ breast cancer)
- •Male breast cancer
- •Any serious and/or unstable pre-existing medical, psychiatric, or other existing condition that would prevent compliance with the trial or consent process
研究组 & 干预措施
Aromatase inhibitor for breast cancer treatment
Participants will receive their standard of care for breast cancer treatment which includes an aromatase inhibitor. Pre-study assessments will be done at baseline as well as stool and blood samples at baseline, then again at 4 weeks and at 12 weeks during the course of the trial.
干预措施: Fecal swab collection (Biological)
Aromatase inhibitor for breast cancer treatment
Participants will receive their standard of care for breast cancer treatment which includes an aromatase inhibitor. Pre-study assessments will be done at baseline as well as stool and blood samples at baseline, then again at 4 weeks and at 12 weeks during the course of the trial.
干预措施: Blood samples (Biological)
结局指标
主要结局
Change in Gut Microbial Levels - Fecal Swab
时间窗: At baseline, 4 weeks and 12 weeks
To describe the microbiome shift of gut microbiome from baseline after 4-weeks and 12-weeks of oral aromatase inhibitor treatment Investigators will calculate the change in gut microbial levels using paired t-tests.
次要结局
- Change in Sex Hormone Concentrations - Blood Samples(At baseline and at 12 weeks)
- Change in Gut Microbial Levels - Blood Samples(At baseline and at 12 weeks)