Study on Using TROP2-PET and 18F-FDG PET to Predict the Efficacy of Anti TROP2 ADC Treatment in Advanced Breast Cancer
Recruiting · NCT07471776 · Interventional (participants receive a specific treatment) · Lead sponsor: Fudan University
View the official record on ClinicalTrials.gov →Interventions studied
18F-FDG PET Imaging68Ga-TROP2 PET/CT ImagingSacituzumab Govitecan、Datopotamab deruxtecan、Sacituzumab tirumotecan
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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.
Where it is running
2 locations listed.
- Fudan University Shanghai Cancer Center - Shanghai, China
- Fudan University Shanghai Cancer Center - Shanghai, Shanghai Municipality, China