Metastatic Breast Cancer ( HER2 Negative)
Conditions
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.
Interventions
DRUGSacituzumab Govitecan、Datopotamab deruxtecan、Sacituzumab tirumotecan
TROP2-targeted antibody-drug conjugate administered according to standard clinical dosing schedule until disease progression or unacceptable toxicity.
DIAGNOSTIC_TEST68Ga-TROP2 PET/CT Imaging
Whole-body PET imaging using 68Ga-labeled TROP2-targeting tracer to assess in vivo TROP2 expression prior to TROP2 ADC treatment initiation.
DIAGNOSTIC_TEST18F-FDG PET Imaging
Standard 18F-FDG PET imaging performed prior to TROP2 ADC treatment to assess tumor metabolic activity.
Sponsors
Fudan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area Under the Curve (AUC) of the Imaging-Based Prediction Model | Baseline to first response assessment (after 2 cycles of therapy) |
Secondary
| Measure | Time frame |
|---|---|
| Predictive Value of Baseline 68Ga-TROP2 PET/CT (± 18F-FDG PET/CT) Parameters | Baseline to first response assessment (after 2 cycles of therapy). |
| 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 |
Countries
China
Contacts
CONTACTBiyun Wang
Outcome results
None listed