Real-world Study of Pyrotinib-containing Regimens of Advanced HER2-positive Breast Cancer
2026年7月10日 更新者：Shu Wang、Peking University People's Hospital
Real-world Study of Pyrotinib-containing Regimens in First-line or Second-line Treatment of Advanced HER2-positive Breast Cancer
Given that pyrotinib has been proven to exert significant efficacy against HER2-positive advanced breast cancer in multiple Phase III studies, and the novel ADC drug disitamab vedotin has demonstrated potent anti-tumor activity, there remains insufficient real-world data on their sequential administration.
This multicenter, prospective real-world study plans to enroll 500 patients with HER2-positive advanced breast cancer receiving first-line or second-line treatment.
It aims to evaluate the efficacy and safety of sequential disitamab vedotin treatment after disease progression or intolerance to pyrotinib-based regimens (first-line: pyrotinib plus trastuzumab combined with chemotherapy; second-line: pyrotinib plus capecitabine).
The primary endpoint is real-world second progression-free survival (rwPFS2), while secondary endpoints cover real-world progression-free survival (rwPFS), tumor response, overall survival (OS), time to treatment failure, safety profiles and patient-reported outcomes.
It is currently expected to further validate the efficacy and safety of pyrotinib in patients with advanced HER2-positive breast cancer in the real-world setting, and to evaluate the efficacy and safety of recindopril trastuzumab following pyrotinib-containing regimens.
研究概览
研究类型
介入性
注册 (估计的)
500
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：peng yuan
- 电话号码：86+13671287670
- 邮箱：13671287670@163.com
学习地点
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Beijing Municipality
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Beijing、Beijing Municipality、中国、100044
- 招聘中
- Peking University People's Hospital
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接触：
- yuan peng
- 电话号码：86+13671287670
- 邮箱：13671287670@163.com
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Aged ≥ 18 years old;
- Histopathologically confirmed HER2-positive inoperable locally advanced or metastatic breast cancer;
Patients with first-line or second-line advanced disease:
First-line advanced disease: no prior systemic therapy for locally advanced or metastatic disease. For patients who received neoadjuvant or adjuvant therapy, the disease-free interval (DFI) after the completion of the last chemotherapy or HER2-targeted therapy was more than 12 months; Second-line advanced disease: prior treatment with taxane combined with trastuzumab, with or without pertuzumab, in the advanced setting; or recurrence occurring during neoadjuvant/adjuvant therapy, or a disease-free interval (DFI) of ≤ 12 months after completion of the last neoadjuvant/adjuvant chemotherapy and HER2-targeted therapy;
- Planned to receive pyrotinib-containing regimen, and judged by investigators based on clinical practice to have potential subsequent treatment with Ruikang trastuzumab after failure of pyrotinib-containing therapy;
- Traceable medical records available throughout the treatment period.
Exclusion Criteria:
- Failure to sign the informed consent form;
- Pregnant or lactating females;
- Patients participating in any interventional clinical trial involving investigational drugs or marketed drugs at enrollment;
- Other conditions deemed ineligible for enrollment by the investigator's judgment.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Cohort A
This cohort consists of patients with first-line advanced disease.
First-line advanced disease is defined as no prior systemic therapy administered for locally advanced or metastatic disease.
For patients who have received neoadjuvant or adjuvant therapy, the disease-free interval (DFI) after the completion of the last chemotherapy or HER2-targeted therapy must be longer than 12 months.
First-line patients receive treatment with pyrotinib plus trastuzumab combined with chemotherapy.
Upon disease progression or intolerance to pyrotinib-containing regimens, subsequent treatment with Trastuzumab Rezetecan will be administered.
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Pyrotinib: administered orally once daily at a dose of 400 mg, 320 mg or 240 mg within 30 minutes after breakfast.
A continuous administration of 21 days is defined as one treatment cycle.
The dosage of pyrotinib will be adjusted by physicians according to the individual clinical conditions.
Concomitant chemotherapeutic agents and other supportive care treatments are determined at the investigators' discretion in accordance with clinical practice guidelines and drug instructions.
Trastuzumab Rezetecan: administered intravenously at a dose of 4.8 mg/kg on Day 1 of each cycle, with a 21-day treatment cycle.
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实验性的：Cohort B
This cohort includes patients with second-line advanced breast cancer.
Second-line advanced disease is defined as prior receipt of taxane combined with trastuzumab, with or without pertuzumab, in the advanced setting; or disease recurrence during neoadjuvant/adjuvant therapy, or a disease-free interval (DFI) of ≤ 12 months after completion of the last cycle of neoadjuvant/adjuvant chemotherapy and HER2-targeted therapy.
Patients in the second-line setting are treated with pyrotinib plus capecitabine.
Following disease progression or intolerance to pyrotinib-containing regimens, subsequent treatment with Trastuzumab Rezetecan is administered.
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Pyrotinib: administered orally once daily at a dose of 400 mg, 320 mg or 240 mg within 30 minutes after breakfast.
A continuous administration of 21 days is defined as one treatment cycle.
The dosage of pyrotinib will be adjusted by physicians according to the individual clinical conditions.
Concomitant chemotherapeutic agents and other supportive care treatments are determined at the investigators' discretion in accordance with clinical practice guidelines and drug instructions.
Trastuzumab Rezetecan: administered intravenously at a dose of 4.8 mg/kg on Day 1 of each cycle, with a 21-day treatment cycle.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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rwPFS2
大体时间：From the start of first administration of pyrotinib-containing regimen (first-line or second-line) until disease progression or death occurring after the initiation of subsequent trastuzumab Rezetecan therapy，assessed up to 60 months.
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Second assessment of real-world progression-free survival (rwPFS2): defined as the time (in months) from the initial administration of pyrotinib-containing regimens (first-line pyrotinib combined with trastuzumab plus chemotherapy, or second-line pyrotinib combined with capecitabine) to disease progression or death after the initiation of subsequent Trastuzumab Rezetecan therapy.
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From the start of first administration of pyrotinib-containing regimen (first-line or second-line) until disease progression or death occurring after the initiation of subsequent trastuzumab Rezetecan therapy，assessed up to 60 months.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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rwPFS
大体时间：From the start of initial pyrotinib treatment until the occurrence of disease progression, death, or switch to trastuzumab rezetecan due to intolerable toxicity，assessed up to 60 months.
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Real-world progression-free survival (rwPFS): defined as the time from the initial initiation of pyrotinib treatment to disease progression, death, or switch to Trastuzumab Rezetecan due to intolerable toxicity.
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From the start of initial pyrotinib treatment until the occurrence of disease progression, death, or switch to trastuzumab rezetecan due to intolerable toxicity，assessed up to 60 months.
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OS
大体时间：From the initiation of the study treatment regimen to death from any cause，assessed up to 60 months.
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Overall Survival (OS): defined as the time from the initiation of the study treatment regimen to death from any cause.
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From the initiation of the study treatment regimen to death from any cause，assessed up to 60 months.
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rwORR
大体时间：From the initiation of the study treatment regimen until disease progression or study withdrawal，assessed up to 60 months.
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Real-world Objective Response Rate (rwORR): refers to the percentage of subjects with a best overall response of CR or PR from the initiation of the study treatment regimen until disease progression and study withdrawal, among the total number of subjects in the analysis set.
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From the initiation of the study treatment regimen until disease progression or study withdrawal，assessed up to 60 months.
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rwTTF
大体时间：From the initiation of the study treatment regimen until disease progression or study withdrawal，assessed up to 60 months.
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Real-world Time to Treatment Failure (rwTTF): defined as the time from the date of treatment initiation to treatment discontinuation for any reason, including but not limited to disease progression, death, adverse drug reactions/toxicity, patient preference, and initiation of subsequent-line therapy.
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From the initiation of the study treatment regimen until disease progression or study withdrawal，assessed up to 60 months.
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅：wang shu、Peking University People's Hospital
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年7月6日
初级完成 (估计的)
2031年12月30日
研究完成 (估计的)
2031年12月30日
研究注册日期
首次提交
2026年5月7日
首先提交符合 QC 标准的
2026年5月14日
首次发布 (实际的)
2026年5月20日
研究记录更新
最后更新发布 (实际的)
2026年7月13日
上次提交的符合 QC 标准的更新
2026年7月10日
最后验证
2026年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.