NCT07129187尚未招募2 期
An Open-label, Single-arm, Multicenter Study of SHR-A1811 as Neoadjuvant Therapy in HER2-positive Breast Cancer Patients With Suboptimal Neoadjuvant Response
Chuan Wang0 个研究点目标入组 30 人开始时间: 2025年10月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- tpCR
研究概览
简要总结
This is an open-label, single-arm, multicenter clinical study to evaluate the efficacy and safety of SHR-A1811 in early or locally advanced HER2-positive breast cancer patients with suboptimal response to neoadjuvant regimen. Patients who were determined by the researchers to have poor therapeutic effect will switch to SHR-A1811.
详细描述
Patients will receive SHR-A1811, until completion or treatment discontinuation due to progression, toxicity, or withdrawal. The primary endpoint is tpCR (ypT0/is ypN0). Secondary endpoints include bpCR, RCB, EFS, and safety. The study will recruit 30 eligible patients from multiple centers in China.
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
- •1.Female patients with newly diagnosed breast cancer aged 18 to 70 years old;
- •2.Early or locally advanced HER2-positive invasive breast cancer;
- •3.Known hormone receptor status;
- •4.ECOG score of 0-1;
- •5.Patients who were determined by the researchers to have poor therapeutic effect after 4 cycles of neoadjuvant therapy;
- •6.Organ function levels must meet the following requirements:
- •7.Women of childbearing age must undergo a serum pregnancy test within 7 days before enrollment, with a negative result, and be willing to use a medically approved highly effective contraceptive method during the study and within 3 months after the last administration of the study drug.
- •8.The subjects voluntarily participate in this study and sign the informed consent form.
排除标准
- •1. Patients with metastatic or bilateral breast cancer, or inflammatory breast cancer
- •2. Patients with grade 3 or higher thrombocytopenia during previous treatment, or grade 3 or higher nausea and vomiting despite primary prevention
- •3. History of other malignant tumors (except cured carcinoma in situ of the cervix, basal cell carcinoma, etc.) and related treatment history
- •4. Patients who received major non-breast cancer surgery within 4 weeks before enrollment and have not recovered (except biopsy and PICC)
- •5. Autoimmune diseases (except special cases such as hypothyroidism and stable type 1 diabetes)
- •6. Interstitial lung disease, non-infectious pneumonia, uncontrolled systemic diseases
- •7. History of or planned administration of live attenuated vaccines within 28 days
- •8. HIV infection, active hepatitis (hepatitis B, hepatitis C, etc.), autoimmune hepatitis
- •9. Severe infection within 4 weeks, CTCAE grade ≥ 2 active infection within 2 weeks (except neoplastic fever), or evidence of active tuberculosis within 1 year
- •10. History of allogeneic bone marrow or solid organ transplantation
- •11. Peripheral neuropathy of grade ≥ 2
- •12. Severe heart diseases
- •13. Receipt of systemic immunostimulant therapy within 4 weeks
- •14. Receipt of systemic immunosuppressant therapy within 2 weeks (except local or physiological dose of hormones)
- •15. Allergy to study drugs/excipients, or history of severe allergic reaction to other monoclonal antibodies
- •16. Pregnant or lactating women; fertile women with positive pregnancy test or unwilling to take effective contraception throughout the trial
- •17. History of neurological/psychiatric disorders , or history of substance abuse, alcoholism, or drug addiction
- •18. Other circumstances deemed unsuitable for enrollment by the researcher
研究组 & 干预措施
SHR-A1811
Experimental
干预措施: SHR-A1811 (Drug)
结局指标
主要结局
tpCR
时间窗: immediately after surgery
It is defined as the absence of residual invasive carcinoma in the resected breast cancer specimens stained with hematoxylin and eosin, and no cancer metastasis in all ipsilateral lymph node samples, after completion of neoadjuvant therapy and surgery.
次要结局
- Breast Pathological Complete Response(immediately after surgery)
- event free survival(until the end of the study)
- residual cancer burden(immediately after surgery)
研究者
Chuan Wang
MD
Fujian Medical University Union Hospital
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