Safety and Efficacy of SHR-A1811 Combine With Pyrotinib for the Treatment of HER2 Positive Locally Advanced or Metastatic Breast Cancer, a Phase II Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 84
- 主要终点
- ORR
研究概览
简要总结
The goal of this clinical trial is to learn if SHR-A1811 combine with Pyrotinib is safe and tolerable for patients with HER2 positive breast cancer. It will also learn about the anti-tumor efficacy of this combination therapy. Participants will take SHR-A1811 and pyrotinib every three weeks, until disease progression or intolerable toxicity.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: ≥18 years old and ≤70 years old;
- •Pathologically confirmed HER2-positive locally advanced or metastatic breast cancer;
- •Progression during or after prior HER2-targeted therapy and chemotherapy in the advanced/metastatic setting OR progression during/within 12 months after completion of trastuzumab and taxane-based chemotherapy in the neoadjuvant/adjuvant setting OR after 2 cycles of trastuzumab and taxane-based chemotherapy in the neoadjuvant setting with suboptimal response (assessed as non-response) for locally advanced disease;
- •At least one measurable lesion per RECIST v1.1 criteria.
- •ECOG performance status of 0 or
- •Adequate Organ Function
- •Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days before the first dose. Male subjects with partners of childbearing potential must be surgically sterile or agree to use effective contraception during the trial. Sperm donation is not permitted during the study period.
- •Subjects must voluntarily enroll in this study, sign the informed consent form, demonstrate good compliance, and be willing to cooperate with follow-up.
排除标准
- •Prior Pyrotinib in Advanced/Metastatic Setting;
- •Prior Tropoisomerase I Inhibitor ADC Therapy;
- •Active CNS Metastases;
- •Other Malignancy;
- •Recent Major Surgery/Trauma;
- •Interstitial Lung Disease (ILD)/Severe Pulmonary Conditions;
- •Significant Cardiac Disease;
- •Inability to swallow oral medication, chronic diarrhea, intestinal obstruction, or other factors significantly affecting drug ingestion or absorption;
- •Known hypersensitivity to any component of the investigational drugs in this study protocol;
- •Immunodeficiency/Organ Transplant;
- •Uncontrolled Third-Space Fluid Accumulation;
- •Pregnancy/Breastfeeding/Contraception;
- •Severe concomitant illness or comorbid conditions that may interfere with planned treatment or preclude study participation, as assessed by the investigator. This includes, but is not limited to, active hepatitis B or pulmonary infection requiring treatment.
研究组 & 干预措施
Arm 1：SHR-A1811 4.0mg/kg + Pyrotinib 240mg/Day
干预措施: SHR-A1811 4.0mg/kg (Drug)
Arm 1：SHR-A1811 4.0mg/kg + Pyrotinib 240mg/Day
干预措施: Pyrotinib 240mg (Drug)
Arm 2：SHR-A1811 4.0mg/kg + Pyrotinib 320mg/Day
干预措施: SHR-A1811 4.0mg/kg (Drug)
Arm 2：SHR-A1811 4.0mg/kg + Pyrotinib 320mg/Day
干预措施: Pyrotinib 320mg (Drug)
Arm 3: SHR-A1811 4.8mg/kg + Pyrotinib 240mg/Day
干预措施: Pyrotinib 240mg (Drug)
Arm 3: SHR-A1811 4.8mg/kg + Pyrotinib 240mg/Day
干预措施: SHR-A1811 4.8mg/kg (Drug)
Arm4: SHR-A1811 4.8mg/kg + Pyrotinib 320mg/Day
干预措施: SHR-A1811 4.8mg/kg (Drug)
Arm4: SHR-A1811 4.8mg/kg + Pyrotinib 320mg/Day
干预措施: Pyrotinib 320mg (Drug)
结局指标
主要结局
ORR
时间窗: from initiation of the study treatment until disease progression (or treatment discontinuation), the observation period is up to 36 months.
Objective Response Rate: The proportion of subjects achieving a best overall response(per RECIST v1.1) of complete response (CR) or partial response (PR) during the period from initiation of the study treatment until disease progression (or treatment discontinuation), relative to the total number of subjects in the analysis set.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
时间窗: From the date of signing ICF until the end of the safety follow-up period, defined as 40 days after the last administration of SHR-A1811 or Pyrotinib
the proportion of patients who experienced treatment-emergent adverse events during the study treatment among the total number of patients experienced study treatment.
次要结局
- OS(The time from the date of enrollment to the date of death due to any cause. The observation period is up to 60 months.)
- PFS(from the date of enrollment until the first documented radiological disease progression (PD) or death from any cause, the observation period is up to 36 months.)
- DoR(from the date of first documented response to the date of disease progression or death of any cause, the observation period is up to 36 months.)
研究者
Ma Fei，MD
Chief Physician
Cancer Institute and Hospital, Chinese Academy of Medical Sciences