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

Обзор

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.

Вмешательства

• Препарат Sacituzumab Govitecan、Datopotamab deruxtecan、Sacituzumab tirumotecan
  TROP2-targeted antibody-drug conjugate administered according to standard clinical dosing schedule until disease progression or unacceptable toxicity.
• Диагностический тест 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.
• Диагностический тест 18F-FDG PET Imaging
  Standard 18F-FDG PET imaging performed prior to TROP2 ADC treatment to assess tumor metabolic activity.

Первичные конечные точки

• Area Under the Curve (AUC) of the Imaging-Based Prediction Model [Срок оценки: Baseline to first response assessment (after 2 cycles of therapy)]

Вторичные конечные точки (3)

• Predictive Value of Baseline 68Ga-TROP2 PET/CT (± 18F-FDG PET/CT) Parameters [Срок оценки: Baseline to first response assessment (after 2 cycles of therapy).]
• Correlation Between 68Ga-TROP2 PET Uptake and Tissue TROP2 Status [Срок оценки: At baseline]
• Comparative Performance: 68Ga-TROP2 PET/CT vs 18F-FDG PET/CT [Срок оценки: At baseline]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Китай · 2 центра

• Fudan University Shanghai Cancer Center — Шанхай
• Fudan University Shanghai Cancer Center — Шанхай

Идентификаторы

NCT: NCT07471776 · YOUNGBC-34

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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