Real-World Treatment of ADC-Resistant HER2-Low Advanced Breast Cancer
Optimal Treatment Strategies for ADC-Resistant HER2-Low Advanced Breast Cancer: A Multicenter, Retrospective Real-World Study
This is a multicenter, retrospective real-world study aiming to evaluate the efficacy and safety of post-antibody-drug conjugate (post-ADC) treatment strategies in patients with HER2-low advanced breast cancer who have developed resistance to prior ADC therapy.
The study plans to enroll approximately 220 eligible patients from three centers in China (Jiangsu Province Hospital, Nanjing Drum Tower Hospital, and Nanjing General Hospital of Nanjing Military Command) between January 2018 and December 2025.
Key efficacy outcomes include progression-free survival (PFS), overall survival (OS), objective response rate (ORR), and clinical benefit rate (CBR).
Safety outcomes include the incidence of grade 3/4 adverse events and serious adverse events.
Subgroup analyses will compare different post-ADC regimens (e.g., alternative ADC, chemotherapy, endocrine therapy, immunotherapy) and explore the impact of visceral metastasis and prior ADC treatment response on subsequent outcomes.
This study seeks to identify optimal post-ADC treatment strategies and preferred patient populations for clinical benefit.
研究概览
地位
完全的
条件
研究类型
观察性的
注册 (实际的)
220
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。
学习地点
-
-
Jiangsu
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Nanjing、Jiangsu、中国、210029
- The First Affiliated Hospital with Nanjing Medical University
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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
取样方法
概率样本
研究人群
Patients with histologically confirmed HER2-low advanced or metastatic breast cancer who received antibody-drug conjugate (ADC) therapy in the advanced setting and subsequently experienced disease progression.
描述
Inclusion Criteria:
- females aged ≥18 years.
- confirmed pathologic diagnosis of HER2-low MBC (defined as HER2 IHC 1+ or 2+ without gene amplification by FISH detection).
- patients had disease progression following ADC treatment in advanced setting and had undergone at least one available efficacy evaluation.
- patients received at least one subsequent anti-tumor treatment following ADC failure, with at least one available efficacy evaluation.
Exclusion Criteria:
- patients previously treated with ADC during neoadjuvant or adjuvant setting.
- patients who had not experienced disease progression on their first ADC (ADC1) regimen and remained on ADC1 treatment.
- patients with no documented subsequent anti-tumor therapy following ADC1 treatment.
- patients who lacked evaluable efficacy assessment data during ADC1 or post-ADC therapy.
- patients with incomplete clinicopathological information.
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
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 |
|---|---|---|
|
real-world (rwPFS) of post-ADC therapy
大体时间:up to 12 months.
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the duration from the post-ADC treatment initiation to either disease progression or death from any cause, whichever came first
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up to 12 months.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
objective response rate (ORR)
大体时间:at 12 weeks
|
ORR was defined as the percentage of patients achieving a best overall response of complete response (CR) or partial response (PR).
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at 12 weeks
|
|
Clinical benefit rate (CBR) of post-ADC therapy
大体时间:at 12 weeks
|
CBR was determined by the percentage of patients achieving disease control, defined as complete response (CR), partial response (PR), or stable disease (SD).
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at 12 weeks
|
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overall survival (OS) of post-ADC therapy
大体时间:up to 24 months
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Overall survival was defined as the duration from post-ADC treatment initiation to death from any cause.
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up to 24 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。
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)
2018年3月1日
初级完成 (实际的)
2025年12月31日
研究完成 (实际的)
2025年12月31日
研究注册日期
首次提交
2026年4月14日
首先提交符合 QC 标准的
2026年5月8日
首次发布 (实际的)
2026年5月14日
研究记录更新
最后更新发布 (实际的)
2026年5月14日
上次提交的符合 QC 标准的更新
2026年5月8日
最后验证
2026年4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.