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

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.

ClinicalTrials.gov IDNCT07471776

PhasePHASE2

Enrollment45

SponsorFudan University

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Metastatic Breast Cancer ( HER2 Negative)

About this study

Interventions

Drug: Sacituzumab Govitecan、Datopotamab deruxtecan、Sacituzumab tirumotecan — TROP2-targeted antibody-drug conjugate administered according to standard clinical dosing schedule until disease progression or unacceptable toxicity.
Diagnostic Test: 68Ga-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 Test: 18F-FDG PET Imaging — Standard 18F-FDG PET imaging performed prior to TROP2 ADC treatment to assess tumor metabolic activity.

Primary outcomes

Area Under the Curve (AUC) of the Imaging-Based Prediction Model (Baseline to first response assessment (after 2 cycles of therapy))

Eligibility information

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.

Study locations

Fudan University Shanghai Cancer Center, Shanghai, Shanghai Municipality 200032 China
Fudan University Shanghai Cancer Center, Shanghai, 200032 China

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.