NCT05346861招募中3 期
Pyrotinib Rechallenge in Her2-positive Metastatic Breast Cancer Pretreated With Pyrotinib and Trastuzumab
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. This study is a randomized, open-label, multi-center, parallel design study of the combination of pyrotinib, trastuzumab and chemotherapy versus trastuzumab and chemotherapy in HER2+ MBC patients, who have prior received trastuzumab and pyrotinib. Patients will be randomized in a 2:1 ratio to one of the following treatment arms. Arm A: pyrotinib + trastuzumab + chemotherapy, Arm B: trastuzumab + chemotherapy. Patients will receive either arm of therapy until disease progression, unacceptable toxicity, or withdrawal of consent.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥18 and ≤75 years;
- •Pathologically confirmed HER2 positive patients with recurrence/ metastatic breast cancer: HER2 IHC 3+, or HER2 IHC 2+ and FISH detection gene amplification;
- •History of trastuzumab-containing chemotherapy in neoadjuvant, adjuvant or recurrence/ metastatic setting;
- •History of pyrotinib-containing chemotherapy in neoadjuvant or recurrence/ metastatic setting;
- •Previously reveived ≤2 systemic treatment in recurrence/ metastasis setting; (anti-HER2 ADCs such as T-DM1 is included in chemotherapy regimens, endocrine therapy alone is not included);
- •ECOG performance status of 0 to 1;
- •According to RECIST 1.1, at least one extracranial measurable lesion exists；
- •Signed informed consent.
排除标准
- •Patients with leptomeningeal metastasis or unstable brain metastasis;
- •History of neurological or psychiatric disorders;
- •Second malignancies within 5 years, except for cured skin basal cell carcinoma, carcinoma in-situ of uterine cervix and squamous-cell carcinoma;
- •Undergone major surgical procedures or significant trauma within 4 weeks prior to randomization, or expected to undergo major surgery.
- •Factors influencing the usage of oral administration (e.g. unable to swallow, chronic diarrhea and intestinal obstruction, etc.);
- •History of allergies to the drug components of this regimen;
- •History of Immunodeficiency, acquired or congenital immunodeficiency (HIV positive), history of organ transplantation;
- •Any other situations judged by investigator as not suitable for participating in this study.
研究组 & 干预措施
Trastuzumab plus chemotherapy
Active Comparator
干预措施: Trastuzumab plus chemotherapy (Drug)
Pyrotinib in combination with Trastuzumab plus chemotherapy
Experimental
干预措施: Trastuzumab in combination with pyrotinib plus chemotherapy (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: approximately 8 months
次要结局
- Objective Response Rate (ORR)(approximately 8 months)
- Adverse Events (AEs)(From the first drug administration to within 28 days for the last treatment)
研究者
研究点 (1)
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