Clinical trial · Interventional
Study on Using TROP2-PET and 18F-FDG PET to Predict the Efficacy of Anti TROP2 ADC Treatment in Advanced Breast Cancer
NCT07471776CI-TRIAL-00105530recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Breast Cancer ( HER2 Negative) | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-FDG PET Imaging | Diagnostic Test | — | UNRESOLVED |
| 68Ga-TROP2 PET/CT Imaging | Diagnostic Test | — | UNRESOLVED |
| Sacituzumab Govitecan、Datopotamab deruxtecan、Sacituzumab tirumotecan | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- TROP2 ADC
- interventionNames
- Drug: Sacituzumab Govitecan、Datopotamab deruxtecan、Sacituzumab tirumotecan
- Diagnostic Test: 68Ga-TROP2 PET/CT Imaging
- Diagnostic Test: 18F-FDG PET Imaging
Primary outcomes (1)
- measure
- Area Under the Curve (AUC) of the Imaging-Based Prediction Model
- timeFrame
- Baseline to first response assessment (after 2 cycles of therapy)
Secondary outcomes (3)
- measure
- Predictive Value of Baseline 68Ga-TROP2 PET/CT (± 18F-FDG PET/CT) Parameters
- timeFrame
- Baseline to first response assessment (after 2 cycles of therapy).
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.