The Efficacy and Safety of Pyrotinib, Trastuzumab Combined With Taxanes in the Treatment of Early Trastuzumab-treated HER2+ Advanced Breast Cancer (ABC).
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
This is a multi-center real-world study, in which patients who meet the inclusion criteria will receive treatment with Pyrotinib + Trastuzumab + Taxanes. Taxanes will be used for 6-8 cycles or discontinued due to intolerable Adverse Events (AEs), after which Capecitabine will be used for rhythmic chemotherapy combined with Pyrotinib + Trastuzumab. The aim is to explore the efficacy and safety of Pyrotinib, Trastuzumab, and Taxanes in treating Trastuzumab-treated HER2+ Advanced Breast Cancer (ABC).
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
- •Age: 18-70 years old, female;
- •Pathological examination confirmed HER-2 positive invasive breast cancer; (HER2 positivity is defined as an immunohistochemical (IHC) score of 3+ or in-situ hybridization (ISH) result for HER2 gene amplification in >10% of immunoreactive cells.
- •HER2 positivity needs to be verified by the pathology department of the research center involved in this study)
- •Imaging confirmed recurrent/metastatic breast cancer;
- •Patients who relapsed and metastasized three months after discontinuation of Trastuzumab treatment;
- •Have at least one measurable lesion (according to RECIST 1.1 criteria);
- •ECOG score of 0-2;
- •Expected life span ≥3 months;
- •Normal major organ function;
- •The researcher believes that the participant may benefit;
- •Volunteer to participate in this study, sign informed consent.
排除标准
- •Patients who meet any of the following criteria are not eligible for participation:
- •Have any confirmed history of drug allergies, or severe allergic reactions to any component of the investigational drug (NCI-CTCAE 5.0 grade > 3);
- •Patients in advanced stages who have undergone systemic treatment;
- •A history of serious heart diseases such as congestive heart failure, unstable angina, arrhythmia or myocardial infarction;
- •Suffer from serious pulmonary diseases, such as interstitial lung disease or pneumonia, pulmonary fibrosis, acute pulmonary diseases, etc.;
- •Currently suffering from severe liver-related diseases, such as acute hepatitis, explosive hepatitis, coagulation factor synthesis disorder, etc.; Those who are positive for HBV surface antigen or HBV core antibody must have a peripheral blood Hepatitis B virus DNA titer test < 1×10 ^3 IU/ml in order to participate;
- •Comorbidity or condition that may interfere with their participation in the study, or any serious medical impediment that might affect participant's safety (such as, active or uncontrolled infection, active liver/gallbladder disease requiring antiviral treatment);
- •Other invasive tumors (including second primary breast cancer) that may affect the evaluation of results and adherence to the protocol;
- •Having undergone major surgical procedure or are yet to recover from major internal diseases within the 4 weeks prior to the study;
- •Any circumstance that the researcher considers the participant unfit to participate in the study.
研究组 & 干预措施
Experimental arm
Pyrotinib, Trastuzumab Combined With Taxanes
*When taxane drugs are discontinued (after completing 6-8 cycles of treatment or due to intolerance), the therapy can be continued with the combination of metronomic capecitabine and trastuzumab, along with pyrotinib.
干预措施: Pyrotinib (Drug)
Experimental arm
Pyrotinib, Trastuzumab Combined With Taxanes
*When taxane drugs are discontinued (after completing 6-8 cycles of treatment or due to intolerance), the therapy can be continued with the combination of metronomic capecitabine and trastuzumab, along with pyrotinib.
干预措施: Trastuzumab (Drug)
Experimental arm
Pyrotinib, Trastuzumab Combined With Taxanes
*When taxane drugs are discontinued (after completing 6-8 cycles of treatment or due to intolerance), the therapy can be continued with the combination of metronomic capecitabine and trastuzumab, along with pyrotinib.
干预措施: Taxanes (Drug)
Experimental arm
Pyrotinib, Trastuzumab Combined With Taxanes
*When taxane drugs are discontinued (after completing 6-8 cycles of treatment or due to intolerance), the therapy can be continued with the combination of metronomic capecitabine and trastuzumab, along with pyrotinib.
干预措施: Capecitabine (Drug)
结局指标
主要结局
PFS
时间窗: 24months
the period of time from the start of treatment for cancer patients to the observation of disease progression, or death due to any reason
次要结局
- DCR(24months)
- CNS-PFS(24months)
- ORR(24months)
- OS(24months)
- Overall Number of Participants Who Experienced at Least One Adverse Event, Including Serious and Non-Serious Adverse Events(24months)