NCT06318507招募中不适用
The Intestinal Microbiome in Triple Negative Breast Cancer Treated with Immunotherapy
适应症
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
- Pathologic Complete Response (pCR)
研究概览
简要总结
This study will determine how the intestinal microbiome differs between patients with obesity and early triple-negative breast cancer who achieve a pathologic complete response from preoperative anti-PD-1 immunotherapy (pembrolizumab) versus patients who do not.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Age ≥18 years
- •Female biological sex
- •Newly diagnosed, previously untreated, histologically confirmed early triple-negative breast cancer
- •Plan to initiate preoperative anti-PD-1 immunotherapy using pembrolizumab
- •Overweight or obesity, defined as a body mass index >=25 kg/m2
- •Ability to provide written informed consent
- •Allow the collection and storage of biospecimens and data for future use
排除标准
- •Active autoimmune disease
- •Concomitant conditions that require the use of antibiotics (e.g., chronic sinusitis)
- •Digestive disease disorders (e.g., irritable bowel syndrome, Crohn's disease)
- •Currently pregnant, breastfeeding, or planning to become pregnant within the next 24 weeks
- •Recent (within 90 days) use of glucocorticoids for more than 10 consecutive days
- •Any other cardiovascular, pulmonary, orthopedic, neurologic, psychiatric, or other condition that, in the investigator's opinion, would preclude participation or successful compliance with the protocol
- •Any other situation that, in the opinion of the investigator, would negatively impact subject safety or successful compliance with the protocol
结局指标
主要结局
Pathologic Complete Response (pCR)
时间窗: Week 24
Defined as ypT0/Tis ypN0, ypT0 ypN0, and ypT0/Tis
次要结局
未报告次要终点
研究者
Justin Brown
Associate Professor
Pennington Biomedical Research Center
研究点 (1)
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