Phase II Study of SHR-A1811 as Neoadjuvant Treatment for Patients With HR-Positive, Low HER2 Expression Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR) Tumours (RECIST) v1.1
研究概览
简要总结
HR-positive breast cancers accounts for about 50% to 60% of all breast cancer patients. Neoadjuvant Chemotherapy is the core treatment mode for this type of breast cancer, and endocrine therapy can be used in some low-risk patients. However, the pathological complete response (pCR) rate obtained is low. HER2 is an important prognostic indicator and therapeutic target for breast cancer. Nearly 60% of HR-positive breast cancers have low expression of HER2, and antibody-drug conjugates (ADC) targeting HER2 may achieve better efficacy in this subtype.
详细描述
This prospective, single-arm study is being conducted to evaluate the efficacy and safety of SHR-A1811 for early-stage or locally advanced breast cancer patients with HR-Positive, Low HER2 Expression. Subjects will receive the neoadjuvant therapy of SHR-A1811 for eight cycles, and then undergo surgery within 4 weeks after neoadjuvant therapy. The follow-up visit will last for at least 5 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 to 70 years old (inclusive);
- •Treatment-naive patients with clinically confirmed T2-T3, any nodal status and M0;
- •HR-positive, HER2 low expression, the expression of Ki-67 exceed 14% invasive breast cancer confirmed by histology or cytology;
- •ECOG performance status of 0-1;
- •Normal organ and bone marrow function;
- •Patients of childbearing age must consent to use highly effective contraception for 7 months from the start of study screening until the last study medication and agree not to breastfeeding;
- •Patients voluntarily joined the study and signed informed consent;
排除标准
- •Patients have evidence of metastatic breast cancer, or inflammatory breast cancer;
- •Patients previously received antineoplastic therapy or radiotherapy for any malignancy, excluding cured malignancies such as cervical carcinoma in situ, basal cell carcinoma, or squamous carcinoma;
- •Patients received any other anti-tumor therapy at the same time, including endocrine therapy, bisphosphonates or immunotherapy;
- •Patients have major surgical procedures unrelated to breast cancer within 4 weeks before the first medication, or not fully recovered from surgical procedures;
- •Clinically significant pulmonary or cardiovascular disease;
- •Failure to swallow, chronic diarrhea, intestinal obstruction, or presence of other factors affecting drug administration and absorption;
- •Known to be allergic to any study drug or any of its excipients;
- •History of immunodeficiency, including HIV-positive, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation;
- •Pregnant and lactating women;
- •Patients with serious concomitant diseases or other comorbidities that will interfere with the planned treatment, or any other condition that is not suitable for participation assessed by investigator.
研究组 & 干预措施
SHR-A1811
SHR-A1811 group
干预措施: SHR-A1811 for injection (Drug)
结局指标
主要结局
Objective Response Rate (ORR) Tumours (RECIST) v1.1
时间窗: During 24 weeks of the neoadjuvant treatment
Objective Response Rate (ORR) according to Response Evaluation Criteria in Solid
次要结局
- Pathological complete response(At the time of surgery)
- Incidence of Adverse Events(from consent to 28 days after last dose)
- Residual cancer burden (RCB)(At the time of surgery)
- Event-free survival (EFS)(5 years)
- Disease-free survival (DFS)(5 years)
研究者
Zhenzhen Liu
Professor
Henan Cancer Hospital