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 Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
45
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.
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITINGFudan University Shanghai Cancer Center
Shanghai, China
NOT_YET_RECRUITINGArea Under the Curve (AUC) of the Imaging-Based Prediction Model
Time frame: Baseline to first response assessment (after 2 cycles of therapy)
Predictive Value of Baseline 68Ga-TROP2 PET/CT (± 18F-FDG PET/CT) Parameters
Time frame: Baseline to first response assessment (after 2 cycles of therapy).
Correlation Between 68Ga-TROP2 PET Uptake and Tissue TROP2 Status
Time frame: At baseline
Comparative Performance: 68Ga-TROP2 PET/CT vs 18F-FDG PET/CT
Time frame: At baseline
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