NCT07471776
Recruiting
Phase 2
Study on Using TROP2-PET and 18F-FDG PET to Predict the Efficacy of Anti TROP2 ADC Treatment in Advanced Breast Cancer
Overview
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Fudan University
- Enrollment
- 45
- Locations
- 2
- Primary Endpoint
- Area Under the Curve (AUC) of the Imaging-Based Prediction Model
Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
TROP2 ADC
Other
Intervention: 68Ga-TROP2 PET/CT Imaging (Diagnostic Test)
TROP2 ADC
Other
Intervention: 18F-FDG PET Imaging (Diagnostic Test)
TROP2 ADC
Other
Intervention: Sacituzumab Govitecan、Datopotamab deruxtecan、Sacituzumab tirumotecan (Drug)
Outcomes
Primary Outcomes
Area Under the Curve (AUC) of the Imaging-Based Prediction Model
Time Frame: Baseline to first response assessment (after 2 cycles of therapy)
Secondary Outcomes
- 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).)
Investigators
Biyun Wang, MD
Professor
Fudan University
Study Sites (2)
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