A Randomized, Open-label, Multicenter Phase III Study of SHR-A1811 Compared to Docetaxel+Carboplatin+Trastuzumab+Pertuzumab as a Neoadjuvant Therapy for the Initial Treatment of Early-stage or Locally Advanced HER2-positive Breast Cancer
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 740
- 试验地点
- 3
- 主要终点
- Postoperative total pathologic complete response (tpCR) evaluated by Independent Review Committee (IRC) after finishing neoadjuvant treatments.
研究概览
简要总结
This study is a multicenter, randomized, open-label, parallel Phase III clinical trial. 650 early-stage or locally advanced breast cancer participants will be enrolled and randomly assigned to SHR-A1811 monotherapy group (trial group) or TCbHP treatment group (control group) at a 1:1 ratio. Participants will receive neoadjuvant treatments of SHR-A1811 or TCbHP, while those who have completed neoadjuvant therapy and are suitable for surgery must undergo surgical treatment. The participants will be evaluated on tumor efficacy through postoperative pathological assessment by IRC and pathologists from the research center. The primary endpoint will be tpCR evaluated by IRC. Participants who complete surgical treatment will be followed up for at least 3 years at study endpoints such as EFS, DFS, and DDFS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Females treated for the first time, 18-75 years old;
- •ECOG score 0-1;
- •Has pathological diagnosis that meets the criteria: confirmed HER2 positive;
- •Results of laboratory tests meet the enrollment requirements;
- •Pregnancy test result must be negative and must agree to contraception;
- •Has signed the informed consent form.
排除标准
- •Confirmed HER2 negative;
- •Has tumor-related medical history or treatment history;
- •Has severe combined disease/medical history and treatment history;
- •Has received treatment with systemic immunostimulants or immunosuppressants;
- •Be allergic to the test drug;
- •Participate in other clinical trials simultaneously;
- •Has received vaccine within 30 days before the first dose;
- •Has received allograft bone marrow transplantation;
- •Has given birth within one year or is breastfeeding;
- •Has history of psychological drug abuse, alcoholism or drug use.
研究组 & 干预措施
SHR-A1811 Group
干预措施: SHR-A1811 for Injection (Drug)
Docetaxel+Carboplatin+Trastuzumab+Pertuzumab Group
干预措施: Docetaxel injection (Drug)
Docetaxel+Carboplatin+Trastuzumab+Pertuzumab Group
干预措施: Carboplatin for Injection (Drug)
Docetaxel+Carboplatin+Trastuzumab+Pertuzumab Group
干预措施: Trastuzumab Injection (Drug)
Docetaxel+Carboplatin+Trastuzumab+Pertuzumab Group
干预措施: Pertuzumab Injection (Drug)
结局指标
主要结局
Postoperative total pathologic complete response (tpCR) evaluated by Independent Review Committee (IRC) after finishing neoadjuvant treatments.
时间窗: From the enrollment of the first subject to the end of the study, it lasted about 36 months.
次要结局
- Event-free survival (EFS).(Followed up for at least 3 years.)
- Disease-free survival (DFS).(Followed up for at least 3 years.)
- Distant disease-free survival (DDFS).(Followed up for at least 3 years.)
- Objective response rate (ORR) assessed according to the preoperative evaluation utilizing RECIST v1.1 after finishing neoadjuvant treatments.(Followed up for at least 3 years.)
- Postoperative total pathologic complete response (tpCR) evaluated pathologists at the research center after finishing neoadjuvant treatments.(From the enrollment of the first subject to the end of the study, it lasted about 36 months.)