Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TROP2 ADC | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sacituzumab Govitecan、Datopotamab deruxtecan、Sacituzumab tirumotecan | Drug | TROP2-targeted antibody-drug conjugate administered according to standard clinical dosing schedule until disease progression or unacceptable toxicity. |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve (AUC) of the Imaging-Based Prediction Model | Baseline to first response assessment (after 2 cycles of therapy) |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Immune Markers in Tissue/Blood and Associations With Imaging and Efficacy | Baseline through first response assessment (after 2 cycles of therapy) and at disease progression. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Biyun Wang | Contact | 021-64175590 | wangbiyun0107@hotmail.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 68Ga-TROP2 PET/CT Imaging | Diagnostic Test | Whole-body PET imaging using 68Ga-labeled TROP2-targeting tracer to assess in vivo TROP2 expression prior to TROP2 ADC treatment initiation. |
|
| 18F-FDG PET Imaging | Diagnostic Test | Standard 18F-FDG PET imaging performed prior to TROP2 ADC treatment to assess tumor metabolic activity. |
|
| Comparative Performance: 68Ga-TROP2 PET/CT vs 18F-FDG PET/CT | At baseline |
| Fudan University Shanghai Cancer Center | Not yet recruiting | Shanghai | 200032 | China |
|
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided