NCT05635487招募中2 期
A Phase II Study of SHR-A1811 Monotherapy or Combined With Pyrotinib Maleate as Neoadjuvant Treatment in HER2-positive Breast Cancer Patients
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 65
- 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 a phase II trial evaluating the efficacy and safety of SHR-A1811 monotherapy or combined with pyrotinib maleate in Stage II-III HER2-positive breast cancer. Subjects will receive the neoadjuvant therapy of SHR-A1811 monotherapy or combined with pyrotinib 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 HER2-positive invasive breast cancer
- •Treatment-naive patients with stage II-III
- •Eastern Cooperative Oncology Group (ECOG) score 0-1
- •Good level of organ function
排除标准
- •Previously received 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
- •With a history of any malignancies in the past 5 years, excluding cured cervical carcinoma in situ and melanoma skin cancer
- •Inability to swallow, chronic diarrhea, intestinal obstruction, and a variety of factors affecting drug administration and absorption
- •Participated in other drug clinical trials within 4 weeks before enrollment
- •History of allergies to the drug components of this protocol
- •Clinically significant pulmonary diseases
- •Clinically significant cardiovascular diseases
- •History of immunodeficiency
- •Active hepatitis and liver cirrhosis
研究组 & 干预措施
SHR-A1811+Pyrotinib
Experimental
干预措施: SHR-A1811 (Drug)
SHR-A1811+Pyrotinib
Experimental
干预措施: Pyrotinib (Drug)
SHR-A1811
Experimental
干预措施: SHR-A1811 (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)
- Health-related quality of life (HRQOL) (EORTC QLQ-C30)(During 18 weeks of the neoadjuvant treatment)
- Event-free survival (EFS)(5 years)
- Health-related quality of life (HRQOL)(During 18 weeks of the neoadjuvant treatment)
- Breast pathological complete response (bpCR：ypT0-is)(At the time of surgery)
- Overall survival (OS)(5 years)
- Disease-free survival (DFS)(5 years)
- Residual cancer burden (RCB)(At the time of surgery)
研究者
Caigang Liu
Director of the Cancer Center
Shengjing Hospital
研究点 (1)
Loading locations...
相似试验
招募中
2 期
SHR-A1811 Alone or in Combination With Adebrelimab as Neoadjuvant Treatment in HR Positive/HER2 Low Breast CancerHR Positive/HER2 Low Breast CancerNCT06340230Shengjing Hospital93
尚未招募
2 期
SHR-A1921 Combined With Adebrelimab in the Treatment of Advanced NSCLC Who Failed the Previous Standard First-line TreatmentNSCLCNCT06480136Shanghai Pulmonary Hospital, Shanghai, China32
招募中
1 期
A Trial of SHR-A1811 Combined With Other Antitumor Therapies in Advanced Solid Tumors.HER2-expressing Advanced Solid TumorsNCT06015048Jiangsu HengRui Medicine Co., Ltd.364
已完成
1 期
Investigation of Drug-drug Interaction of Ritonavir and Itraconazole on the Pharmacokinetics of SHR-A1811 in Subjects With HER2-expressing Advanced Breast CancerAdvanced Breast CancerNCT06710990Jiangsu HengRui Medicine Co., Ltd.17
进行中（未招募）
2 期
Phase II Clinical Study of SHR-A1811 in Patients With HER2 Expression / Amplification of Locally Advanced Unresectable or Recurrent Metastatic Biliary Tract CancerHER2 Expression / Amplification in Patients With Biliary Tract CancerNCT06413745Jiangsu HengRui Medicine Co., Ltd.59