NCT07679360招募中3 期
A Phase III, Multicenter, Randomized, Open-Label Parallel-Controlled Study of Trastuzumab Rezetecan (SHR-A1811) in Combination With Adebrelimab (SHR-1316) Versus Investigator's Choice of Therapy in Subjects With Primary Triple Negative Breast Cancer Who Have Residual Invasive Disease Following Neoadjuvant Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Invasive disease-free survival (iDFS)
研究概览
简要总结
It is a randomized, open label, positive drug controlled, multicenter design Phase III clinical trial, aims to compare the efficacy and safety of SHR-A1811 combined with Adebrelimab and the treatment selected by the researchers in the adjuvant treatment of triple negative breast cancer with invasive residual cancer after neoadjuvant treatment, and to explore the PK characteristics and immunogenicity of SHR-A1811 and Adebrelimab.
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
- •Pathologically confirmed invasive triple negative breast cancer.
- •Pathologic evidence of residual invasive carcinoma in the breast or axillary lymph nodes following completion of preoperative therapy.
- •Previous neoadjuvant therapy must meet the requirements of the protocol.
- •Has received radical surgery for breast cancer.
- •ECOG PS 0~
- •Adequate organ functions.
- •Women of childbearing potential must be willing to use highly effective form of contraception.
排除标准
- •Stage IV metastatic breast cancer.
- •Previous invasive breast cancer or ductal carcinoma in situ.
- •Bilateral breast cancer.
- •Any clinical evidence indicating the exist of recurrent diseases after surgery.
- •History of other malignancy within the last 5 years, excluding cured skin basal cell carcinoma and cervical carcinoma in situ.
- •Previously received antibody coupled drug (ADC) therapy with topoisomerase inhibitors as effective payloads.
- •Previously received HER2 targeted therapy.
- •Active or previously recorded autoimmune or inflammatory diseases.
- •History of immunodeficiency.
- •Participants with known or suspected interstitial pneumonia.
- •Presence of active Hepatitis B.
- •Known to have active tuberculosis infection.
- •Uncontrolled infections requiring intravenous injection of antibiotics, antiviral drugs, or antifungal drugs for treatment.
- •Within the 6 months prior to randomization, there was a history of myocardial infarction, severe/unstable angina, symptomatic congestive heart failure, ≥ Grade 2 supraventricular or ventricular arrhythmias, and any grade of ventricular fibrillation.
- •Known allergy to any investigational drug or its excipients.
- •Other medical conditions that would interfere with study participation or follow-up.
研究组 & 干预措施
Trastuzumab Rezetecan combined with Adebrelimab Group
Experimental
Trastuzumab Rezetecan combined with Adebrelimab.
干预措施: Adebrelimab Injection (Drug)
Capecitabine and Pembrolizumab
Active Comparator
Capecitabine or Pembrolizumab or Capecitabine combined with Pembrolizumab.
干预措施: Pembrolizumab injection (Drug)
Trastuzumab Rezetecan combined with Adebrelimab Group
Experimental
Trastuzumab Rezetecan combined with Adebrelimab.
干预措施: Trastuzumab Rezetecan for Injection (Drug)
Capecitabine and Pembrolizumab
Active Comparator
Capecitabine or Pembrolizumab or Capecitabine combined with Pembrolizumab.
干预措施: Capecitabine tablets (Drug)
结局指标
主要结局
Invasive disease-free survival (iDFS)
时间窗: Until study completion, assessed up to approximately 5 years.
次要结局
- Disease-free survival (DFS)(Until study completion, assessed up to approximately 5 years.)
- Overall survival (OS)(Until study completion, assessed up to approximately 5 years.)
- DRFI (Distant recurrence-free interval)(Until study completion, assessed up to approximately 5 years.)
- Adverse events (AEs)(Until study completion, assessed up to approximately 2 years.)
- Serious adverse events (SAEs)(Until study completion, assessed up to approximately 3 years.)
研究者
研究点 (2)
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