Efficacy and Safety of T-DXd in Patients With HER2-positive and HER2-low Metastatic Breast Cancer: a Real-world Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
Evaluate the efficacy and safety of T-DXd in patients with HER2-positive and HER2-low metastatic breast cancer
详细描述
The DESTINY-Breast trials established trastuzumab deruxtecan (T-DXd) as a treatment significantly improving outcomes in human epidermal growth factor receptor 2 (HER2)-positive and HER2-low metastatic breast cancer (MBC). However, real-world effectiveness is susceptible to confounding factors. This multicenter, real-world study aims to systematically evaluate the efficacy and safety of T-DXd in patients with HER2-positive and HER2-low MBC. Key clinicopathological parameters were to be integrated to develop an individualized prognostic prediction model, facilitating precision medicine implementation in clinical practice.
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 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •female patients aged ≥18 years;
- •histologically confirmed HER2-positive (IHC 3+ or IHC 2+/FISH+) or HER2-low (IHC 1+ or IHC 2+/FISH-) disease;
- •radiologically confirmed recurrent or metastatic disease;
- •completion of ≥2 cycles of T-DXd therapy;
- •comprehensive medical documentation;
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤3;
- •measurable target lesions according to RECIST 1.1
排除标准
- •history of interstitial lung disease
- •incomplete medical records
- •concurrent malignancies;
- •pregnancy or lactation
- •psychiatric disorders compromising treatment adherence
研究组 & 干预措施
Observational Group
Patients receive T-DXd
干预措施: T- Dxd (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: 2 years
Progression-free survival estimated using Kaplan-Meier methods is defined as the time from the date of informed consent to the earlier of death or disease progression. Patients alive without disease progression are censored at the date of last disease evaluation. Progressive disease (PD) based on RECIST 1.1 is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Equivocal progression of non-target lesions also qualifies as PD.
次要结局
- The Number of Participants Who Experienced Adverse Events (AE)(2 years)