Study on Using TROP2-PET and 18F-FDG PET to Predict the Efficacy of Anti TROP2 ADC Treatment in Advanced Breast Cancer
Fudan University
45 participants
Mar 11, 2026
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria4
- 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.
Exclusion Criteria5
- 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.
Interventions
TROP2-targeted antibody-drug conjugate administered according to standard clinical dosing schedule until disease progression or unacceptable toxicity.
Whole-body PET imaging using 68Ga-labeled TROP2-targeting tracer to assess in vivo TROP2 expression prior to TROP2 ADC treatment initiation.
Standard 18F-FDG PET imaging performed prior to TROP2 ADC treatment to assess tumor metabolic activity.
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT07471776