NCT07560475尚未招募2 期
Exploratory Study of Efficacy and Safety of Different Administration Routes of SHR-A1811 in Patients With HER2-Positive Advanced Breast Cancer
Tianjin Medical University Cancer Institute and Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年6月10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
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
An Exploratory Study on the Efficacy and Safety of Different Administration Routes of SHR-A1811 in the Treatment of HER2-Positive Advanced Breast Cancer
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥ 18 years old.
- •Pathologically confirmed HER2-positive advanced breast cancer. HER2 positivity is defined as IHC 3+ in >10% immunoreactive cells or HER2 gene amplification confirmed by in situ hybridization (ISH), which shall be verified by the pathology department of the participating center.
- •Patients with advanced breast cancer who have received no more than 2 lines of prior systemic therapies.
- •Expected survival time ≥ 4 months.
- •Have at least one measurable lesion per RECIST 1.1 criteria (helical CT scan lesion diameter ≥ 10 mm with slice thickness ≤ 5 mm).
- •Adequate major organ function without blood transfusion.
- •Voluntarily participate in the study, sign informed consent form, with good compliance and willingness to complete follow-up visits.
排除标准
- •Prior treatment with anti-HER2 antibody-drug conjugates (ADC).
- •Known leptomeningeal metastasis or active brain metastasis.
- •A history of other malignancies within the past 5 years, except for cured cervical carcinoma in situ, cutaneous basal cell carcinoma and squamous cell carcinoma. Malignancies cured solely by surgery more than 5 years prior to enrollment are allowed.
- •Major surgery or severe trauma within 4 weeks before enrollment, or planned major surgery during the study period.
- •Participation in other investigational new drug clinical trials within 4 weeks prior to enrollment.
- •Presence of hereditary bleeding tendency or coagulation disorders.
- •Uncontrolled hypertension with systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg despite standard antihypertensive therapy.
- •A history of clinically significant pulmonary diseases, including but not limited to interstitial pneumonia, active pneumonia, pulmonary fibrosis and radiation pneumonitis (excluding asymptomatic post-radiation changes without treatment requirement).
- •A history of severe cardiac diseases or uncontrolled cardiac conditions, including NYHA class II or higher cardiac insufficiency, unstable angina, myocardial infarction within one year, and arrhythmias requiring clinical intervention.
- •Conditions affecting drug intake and absorption, such as dysphagia, chronic diarrhea and intestinal obstruction.
- •Known allergy to any component of the study drugs.
- •Uncontrolled pleural effusion or ascites that cannot be relieved by drainage or other clinical interventions.
- •Severe uncontrolled comorbidities, including immune deficiency disorders (e.g. HIV positivity, history of organ transplantation), active hepatitis B or hepatitis C, and severe ongoing infections requiring systemic anti-infective treatment.
- •Any other conditions considered inappropriate for study enrollment by the investigator.
研究组 & 干预措施
Arm 1: Weekly administration group
Experimental
干预措施: SHR-A1811 (Drug)
Arm 2: Every-two-weeks (Q2W) administration group
Experimental
干预措施: SHR-A1811 (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: From enrollment until disease progression or up to 2 years
Defined as the proportion of patients who achieve confirmed complete response (CR) or partial response (PR) to the study treatment, assessed per RECIST 1.1 criteria.
次要结局
- Progression-Free Survival (PFS)(From enrollment until disease progression or up to 2 years)
研究者
研究点 (1)
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