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Recruiting NCT07471776

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

Phase II Interventional Metastatic Breast Cancer ( HER2 Negative)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sacituzumab Govitecan、Datopotamab deruxtecan、Sacituzumab tirumotecan, 68Ga-TROP2 PET/CT Imaging, 18F-FDG PET Imaging.
Who it may be relevant to
Registry conditions: Metastatic Breast Cancer ( HER2 Negative). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

  • 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 outcome measures

  • Area Under the Curve (AUC) of the Imaging-Based Prediction Model [Time frame: Baseline to first response assessment (after 2 cycles of therapy)]
Secondary outcome measures (3)
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

China · 2 centers
  • Fudan University Shanghai Cancer Center — Shanghai
  • Fudan University Shanghai Cancer Center — Shanghai

Identifiers

NCT: NCT07471776 · YOUNGBC-34

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗