Clinical Treatment of Refractory Breast Cancer Based on Organoid Drug Sensitivity Results
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Objective Response Rate
研究概览
简要总结
This study aims to enroll refractory breast cancer patients. Patient-derived organoid will be established, and drug sensitivity test will be conducted to intervene in the selection of clinical treatment plans. Efficacy evaluation and prognosis analysis will also be conducted. It is hoped that this study will provide a basis for the development of personalized treatment plans.
详细描述
Forty patients with refractory breast cancer who met the inclusion criteria were enrolled in the study after signing an informed consent form. Tumor samples were obtained through clinical puncture, and qualified samples were subjected to organoid modeling. Perform drug sensitivity test on the established breast cancer organoids. The drugs used are all that have been marketed and applied in clinical practice. According to the results of organoid drug sensitivity analysis, the patient received a treatment plan with relatively sensitive drugs. Follow up prognostic data and relevant clinical information of enrolled patients, conduct statistical analysis on the consistency between drug sensitivity test results and patient treatment response, and evaluate the clinical effectiveness of treatment plans guided by organoid drug sensitivity results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female, aged ≥ 18 years and ≤ 75 years old;
- •Breast cancer confirmed by histology or cytology;
- •One of the following two conditions shall be met: a) Operable breast cancer: Recurrent progression during adjuvant therapy; or the time from initial treatment to the onset of disease progression is less than or equal to 2 years; b) Non-operable breast cancer: patients who have changed two line treatment plans within 6 months;
- •Being able to obtain sufficient fresh tissue specimens for organoid establishment through puncture;
- •Expected survival time ≥ 3 months;
- •The patient voluntarily joined this study and signed an informed consent form (ICF), with good compliance and cooperation in follow-up.
排除标准
- •Pregnant and lactating women;
- •Patients who have clinically significant (i.e. active) heart disease (such as congestive heart failure, symptomatic coronary artery disease, arrhythmia, etc.) or myocardial infarction within the past 12 months;
- •Individuals with a history of abuse of psychotropic drugs who are unable to quit or have mental disorders;
- •The researchers believe that patients are not suitable for inclusion.
结局指标
主要结局
Objective Response Rate
时间窗: 1-2 years
Percentage of patient's measurable disease who have achieved either complete response (CR) or partial response (PR) according to RECIST 1.1.
次要结局
- Overall survival time(2 years)
- Progressive free survival(1-2 years)