A Phase II Study of SHR-A1811 Alone or in Combination With Adebrelimab as Neoadjuvant Treatment in HR Positive/HER2 Low Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- Total pathological complete response (tpCR: ypT0-is/ypN0)
研究概览
简要总结
This is an open-label, phase II study evaluating the efficacy and safety of SHR-A1811 alone or in combination with Adebrelimab in Stage II-III HR Positive/HER2 Low Breast Cancer. Subjects will receive the neoadjuvant therapy of SHR-A1811 alone or in combination with Adebrelimab for six cycles, and then undergo surgery within 4 weeks after neoadjuvant therapy. Efficacy will be assessed every 2 cycles.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Female patients aged ≥ 18 but ≤ 75 years
- •Histologically confirmed to be HR+/HER2-Low invasive breast cancer
- •Treatment-naive patients with stage II-III
- •Eastern Cooperative Oncology Group (ECOG) score is 0 or 1
- •Good level of organ function
- •Subjects must participate voluntarily, sign the informed consent form, have good compliance, and cooperate with follow-up visits
排除标准
- •Previously been treated with any anti-tumor therapy (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.)
- •Received any other anti-tumor therapy at the same time
- •Bilateral breast cancer, inflammatory breast cancer or occult breast cancer
- •Stage IV breast cancer
- •Not confirmed by histopathology
- •With a history of any malignancies in the past 5 years, excluding cured cervical carcinoma in situ and melanoma skin cancer
- •Participated in other drug clinical trials within 4 weeks before enrollment
- •Known allergic history of the drug components of this protocol
- •History of immunodeficiency
- •Clinically significant cardiovascular diseases
- •Known or suspected interstitial lung disease
- •Active hepatitis and liver cirrhosis
- •Known hereditary or acquired bleeding thrombotic tendency
- •History of neurological or psychiatric disorders
研究组 & 干预措施
Arm 1 (PD-L1 Positive) SHR-A1811 Injection + Adebrelimab Injection
SHR-A1811 Injection + Adebrelimab Injection Drug: SHR-A1811 Injection Drug: Adebrelimab Injection
干预措施: SHR-A1811 Injection + Adebrelimab Injection (Drug)
Arm 2 (PD-L1 Negative) SHR-A1811 Injection + Adebrelimab Injection
SHR-A1811 Injection + Adebrelimab Injection Drug: SHR-A1811 Injection Drug: Adebrelimab Injection
干预措施: SHR-A1811 Injection + Adebrelimab Injection (Drug)
Arm 3 SHR-A1811 Injection
SHR-A1811 Injection Drug: SHR-A1811 Injection
干预措施: SHR-A1811 Injection (Drug)
结局指标
主要结局
Total pathological complete response (tpCR: ypT0-is/ypN0)
时间窗: At the time of surgery
次要结局
- Best overall response rate (BORR)(During 18 weeks of the neoadjuvant treatment)
- Overall survival (OS)(5 years)
- Event-free survival (EFS)(5 years)
- Health-related quality of life (HRQOL) (EORTC QLQ-C30)(During 18 weeks of the neoadjuvant treatment)
- Breast pathological complete response (bpCR：ypT0-is)(At the time of surgery)
- Health-related quality of life (HRQOL)(During 18 weeks of the neoadjuvant treatment)
- Residual cancer burden (RCB)(At the time of surgery)
- Disease-free survival (DFS)(5 years)
研究者
Caigang Liu
Director of the Cancer Center
Shengjing Hospital