试验雷达 AI | ||
|---|---|---|
临床试验 NCT06769919 针对乳腺癌目前尚未招募。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
一个试验符合筛选条件
卡片视图
A Randomized Controlled Study on the Efficacy and Safety of Neoadjuvant Radiotherapy Combined with Systemic Therapy for Early-stage Breast Cancer II期, III期 340 随机化
临床试验详情主要以英语提供。然而，试验雷达 AI可以提供帮助！只需点击“试验详解”即可查看和讨论您选择的语言的试验信息。
临床试验NCT06769919旨在研究治疗，主要针对乳腺癌。这是一项II期 III期 干预性研究试验，当前状态为尚未招募。试验尚未开始，计划于2024年12月31日开始，预计招募340名患者。该研究由Xijing Hospital主导，计划于2031年12月31日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2025年1月10日。
简要概括
A total of 340 early-stage breast cancer patients with axillary lymph node biopsy-confirmed positivity were enrolled and divided into two groups. The control group received neoadjuvant systemic therapy followed by surgery and adjuvant radiotherapy. The experimental group received neoadjuvant systemic therapy and neoadjuvant radiotherapy followed by surgery. The treatment response of breast cancer, patient survival ti...显示更多
详细描述
This study is a randomized, controlled, open-label clinical trial, planned to enroll 340 early-stage breast cancer patients with axillary lymph node biopsy-confirmed positivity. Participants will be divided into two groups. The control group will receive neoadjuvant systemic therapy, followed by surgery and adjuvant radiotherapy. The experimental group will receive neoadjuvant systemic therapy combined with neoadjuva...显示更多
官方标题
A Randomized Controlled Study on the Efficacy and Safety of Neoadjuvant Radiotherapy Combined with Systemic Therapy for Early-stage Breast Cancer
疾病
乳腺癌其他研究标识符
- WZ-1
NCT编号
实际开始日期
2024-12-31
最近更新发布
2025-01-10
预计完成日期
2031-12-31
计划入组人数
340
研究类型
干预性研究
试验分期 (阶段)
II期
III期
III期
试验状态
尚未招募
关键词
radiotherapy
system therapy
system therapy
主要目的
治疗方法
分配方式
随机
干预模型
平行
盲法
无（开放性试验）
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
无干预Adjuvant radiotherapy receive neoadjuvant systemic therapy, followed by surgery and adjuvant radiotherapy | 不适用 |
实验性Neoadjuvant radiotherapy receive neoadjuvant systemic therapy combined with neoadjuvant radiotherapy before undergoing surgery | 新辅助放疗 The experimental group will receive neoadjuvant systemic therapy combined with neoadjuvant radiotherapy before undergoing surgery |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Residual Cancer Burden (RCB) 0/I | Residual Cancer Burden (RCB) is a standardized method used to quantify the amount of residual disease in breast cancer patients after neoadjuvant therapy (treatment given before surgery). It is calculated based on the size of the primary tumor, the cellularity of the tumor bed, and the extent of lymph node involvement. RCB is divided into four categories:
RCB-0: Pathologic complete response (pCR), meaning no residual invasive cancer is found in the breast or lymph nodes.
RCB-I: Minimal residual disease, indicating a very small amount of cancer remains after treatment.
RCB-II: Moderate residual disease. RCB-III: Extensive residual disease. RCB-0 and RCB-I are often associated with better prognoses and higher survival rates compared to RCB-II and RCB-III | From enrollment to the end of treatment at 8 weeks |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Event-Free Survival (EFS) | Event-Free Survival (EFS) is defined as the time from randomization to the occurrence of any event, including disease progression, discontinuation of treatment for any reason, or death. | From enrollment to 10 years later or death. |
Invasive Disease-Free Survival (iDFS) | From enrollment to 10 years later or death. | |
Overall Survival (OS) | From enrollment to 10 years later or death. | |
Quality of life scores | From enrollment to 3 years after treatment completion. | |
ECOG performance status scores | From enrollment to 3 years after treatment completion. | |
Surgical incision healing scores | From enrollment to 1 years after treatment completion. | |
Adverse Events (AEs) | From enrollment to 3 years after treatment completion. |
参与助手
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
女性
- Female patients aged ≥18 years and ≤65 years；
- newly diagnosed breast cancer;
- Axillary lymph node biopsy-positive;
- ECOG performance status score of 0-1;
- metastatic breast cancer or bilateral breast cancer;
- inflammatory breast cancer;
- Pregnancy and Lactation;
Xijing Hospital研究中心联系人
联系人: Ju liang Zhang, 029-84775271, [email protected]
联系人: Mei ling Huang, 029-84775271, [email protected]
1 位于 1 个国家/地区的研究中心
Shaanxi
Xijing hospital, Xi'an, Shaanxi, 710032, China
Ju liang Zhang, 联系人, 029-84775271, [email protected]