NCT07471776招募中2 期
Study on Using TROP2-PET and 18F-FDG PET to Predict the Efficacy of Anti TROP2 ADC Treatment in Advanced Breast Cancer
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Area Under the Curve (AUC) of the Imaging-Based Prediction Model
研究概览
简要总结
This study aims to evaluate whether ^68Ga-TROP2 PET/CT, combined with ^18F-FDG PET/CT, can predict the efficacy of anti-TROP2 antibody-drug conjugates in patients with advanced HER2-negative breast cancer. Baseline and dynamic imaging parameters will be used to develop prediction models (primary endpoint: AUC), and their associations with clinical outcomes and tumor TROP2 status will be explored.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with advanced/metastatic HER2-negative breast cancer with confirmed metastatic disease, regardless of being de novo diagnosed or progressed from a non-metastatic stage.
- •Patients who are planned to receive anti-TROP2 antibody-drug conjugate (ADC) therapy (e.g., sacituzumab govitecan or datopotamab deruxtecan) as part of routine clinical care.
- •Patients who will undergo protocol-defined ^68Ga-TROP2 PET/CT and ^18F-FDG PET/CT during the study (baseline imaging, with repeat imaging per protocol if applicable).
- •Adult patients (≥18 years) who are able to provide informed consent and comply with study procedures.
排除标准
- •Patients with incomplete medical records or inability to complete the required imaging assessments.
- •Patients with prior exposure to an anti-TROP2 ADC.
- •Patients with known contraindications to PET/CT or known allergy to ^18F-FDG or the ^68Ga-TROP2 tracer (or their components).
- •Patients who are pregnant or breastfeeding.
- •Patients diagnosed with secondary primary tumors (other active malignancies), as determined by the investigator.
研究组 & 干预措施
TROP2 ADC
Other
干预措施: 68Ga-TROP2 PET/CT Imaging (Diagnostic Test)
TROP2 ADC
Other
干预措施: 18F-FDG PET Imaging (Diagnostic Test)
TROP2 ADC
Other
干预措施: Sacituzumab Govitecan、Datopotamab deruxtecan、Sacituzumab tirumotecan (Drug)
结局指标
主要结局
Area Under the Curve (AUC) of the Imaging-Based Prediction Model
时间窗: Baseline to first response assessment (after 2 cycles of therapy)
次要结局
- Correlation Between 68Ga-TROP2 PET Uptake and Tissue TROP2 Status(At baseline)
- Comparative Performance: 68Ga-TROP2 PET/CT vs 18F-FDG PET/CT(At baseline)
- Predictive Value of Baseline 68Ga-TROP2 PET/CT (± 18F-FDG PET/CT) Parameters(Baseline to first response assessment (after 2 cycles of therapy).)
研究者
研究点 (2)
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