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NCT Number: NCT07471776

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.

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Key information

Conditions

Metastatic Breast Cancer ( HER2 Negative) Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

  1. 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).

  2. Correlation Between 68Ga-TROP2 PET Uptake and Tissue TROP2 Status

    Time frame: At baseline

  3. Comparative Performance: 68Ga-TROP2 PET/CT vs 18F-FDG PET/CT

    Time frame: At baseline

Other outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Biyun Wang

CONTACT

[email protected]

021-64175590

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Mar 13, 2026
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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