Optimal Treatment Strategies for ADC-Resistant HER2-Low Advanced Breast Cancer: A Multicenter, Retrospective Real-World Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- real-world (rwPFS) of post-ADC therapy
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
real-world (rwPFS) of post-ADC therapy
时间窗: up to 12 months.
the duration from the post-ADC treatment initiation to either disease progression or death from any cause, whichever came first
次要结局
- objective response rate (ORR)(at 12 weeks)
- Clinical benefit rate (CBR) of post-ADC therapy(at 12 weeks)
- overall survival (OS) of post-ADC therapy(up to 24 months)