Study on Using TROP2-PET and 18F-FDG PET to Predict the Efficacy of Anti TROP2 ADC Treatment in Advanced Breast Cancer

ConditionMetastatic Breast Cancer ( HER2 Negative)

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorFudan University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

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.
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.

Treatment groups

45 Participants

are divided into 1 treatment group

Group A: TROP2 ADCOther 3 interventions

Trial 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

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

Other outcomes

Immune Markers in Tissue/Blood and Associations With Imaging and Efficacy

Time frame

Baseline through first response assessment (after 2 cycles of therapy) and at disease progression.

Sponsors and contacts

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Fudan University

Lead sponsor

Source ClinicalTrials.gov

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