Study on Using TROP2-PET and 18F-FDG PET to Predict the Efficacy of Anti TROP2 ADC Treatment in Advanced Breast Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFudan University
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Sacituzumab Govitecan、Datopotamab deruxtecan、Sacituzumab tirumotecan
- 68Ga-TROP2 PET/CT Imaging
- 18F-FDG PET Imaging
Treatment groups
45 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov