NCT05580887招募中不适用
Intestinal Microbiota Impact for Prognosis and Treatment Outcomes in Early Luminal Breast Cancer and Pancreatic Cancer Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Intestinal bacterial structure in BC and PnC (separately) patients with disease progression
研究概览
简要总结
The gut microbiota (GM) can influence as effectiveness of immunotherapy as prognosis factor in cancer patients. The goal of the study to identify GM pattern is associated with poor and favourable treatment outcomes in breast cancer and pancreatic cancer patients for further treatment strategy proper planning.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •untreated early HR+ HER2- BC:
- •planned neoadjuvant chemotherapy: dose dense doxorubicin and cyclophosphamide (AC) x 4 every 2 weeks followed by 12 weekly PAClitaxel + CARBOplatin every 21 days for 4 cycles
- •TanyN1-3M0 Ki67>40% G3
- •untreated early HR+ HER2- BC:
- •TanyN0M0 Ki67<20% G1
- •planned induction endocrine therapy (letrozole/anastrazole/tamoxifen)
- •untreated locally-advanced and/or borderline resectable pancreas cancer:
- •planned (neo)adjuvant chemotherapy: mFOLFIRINOX
- •previous surgery ( only R0 resection) is allowed
- •histology diagnosis verification
- •Informed consent
- •Eligible blood&fecal samples and tumor tissue for different time points
排除标准
- •autoimmune disease
- •active steroid therapy
- •ECOG > 2
- •any previous therapy for breast cancer
- •metastatic cancer
- •antibiotic use less than 28 days
- •other tumor
研究组 & 干预措施
Patients with high risk luminal B breast cancer
干预措施: Doxorubicin (Drug)
Patients with high risk luminal B breast cancer
干预措施: Cyclophosphamid (Drug)
Patients with high risk luminal B breast cancer
干预措施: Paclitaxel (Drug)
Patients with high risk luminal B breast cancer
干预措施: Carboplatin (Drug)
Patients with high pancreatic cancer
干预措施: mFOLFIRINOX (Drug)
结局指标
主要结局
Intestinal bacterial structure in BC and PnC (separately) patients with disease progression
时间窗: 24 months
Intestinal bacterial structure will performed by 16S RNA gene sequencing
次要结局
- Change from baseline of ctDNA level in the each type of breast cancer patients from diagnosis till 24 months after completion neoadjuvant chemotherapy followed by surgery(30 months (6 months treatment period+24 months follow up))
- Change from baseline in intestinal bacterial structure in patients with early high risk luminal breast cancer of recurrence and increasing ctDNA level who are receiving neo/adjuvant chemotherapy regimens(30 months)
- Change from baseline in intestinal bacterial structure in PnC patients 12 months after after the completion of combined treatment(18 months (6 months treatment period+ 12 months follow up))
- Change from baseline in intestinal bacterial structure in PnC patients with disease relapse on or after combined treatment completion (follow up 12 months)(18 months (6 months treatment period+ 12 months follow up))
研究者
研究点 (1)
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