The Detection of Cell-in-cell Structure (CICs) in Patients With Breast Cancer Undergoing Neoadjuvant Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 175
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
Breast cancer is the most common malignant tumor in women worldwide and neoadjuvant therapy has been the standard care for local advanced breast cancer. Moreover, neoadjuvant therapy undoubtedly provides an ideal model to evaluate the response to therapy. Cell-in-cell structures (CICs) refer to the presence of one or more cells inside host cell, which generally leads to the death of inner cells. Notably, established evidences indicated that CICs were present in breast cancer and tend to impact patient survival. However, whether CICs profile could predict efficacy of therapy remains unclear. In this prospective cohort study, the CICs number and profile will be detected in tumor tissue before and after the neoadjuvant therapy. Then the association between CICs number including dynamic changing and response rate will be explored.
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 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 18-65, female;
- •Pathological biopsy confirmed invasive ductal carcinoma;
- •Karnofsky Performance Status (KPS)≥ 60, expected survival ≥4 months;
- •Locally advanced breast cancer (HER2-positive disease and TNBC, ≥cT1c or ≥cN0； HER2-negative，HR positive disease，≥cT2 or ≥cN1；Large primary tumor relative to breast size in a patient who desires breast conservation) ;
- •According to the RECIST1.1 standard, at least one measurable lesion exists;
排除标准
- •Pregnant or lactating women;
- •Left ventricular ejection fraction less than 50%;
- •History of malignant tumor and concurrent occurrence of other tumors;
- •Serious medical pathology, such as congestive heart failure; unstable angina; uncontrolled high risk arrhythmias, and other serious illness or medical condition that may interfere with the study;
- •Refuse to participate in the study.
研究组 & 干预措施
Single group assignment
Patients with invasive breast cancer who need neoadjuvant therapy.
干预措施: Neoadjuvant therapy (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: Up to 24 weeks.
Response Evaluation Criteria in Solid Tumors (RECIST)：Progressive Disease (PD); Partial Response (PR); Complete Response (CR); Stable Disease (SD) Objective response rate (ORR), defined as the proportion of patients with a complete response (CR) partial response (PR) to treatment.
pCR(complete pathological response)
时间窗: Up to 24 weeks.
no invasive malignant cells identifiable in sections from the site of the tumor（Miller-Payne grades 5） the Miller-Payne grades 4 and 5 patients are grouped as responders.
Quantification of CIC structure in tumor tissue
时间窗: Up to 24 weeks.
CICs number and subtypes in tumor tissue (Core needle biopsy specimens before and after neoadjuvant therapy and surgical specimens based on neoadjuvant therapy.)
次要结局
未报告次要终点