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

March 10, 2026 updated by: Biyun Wang, MD, Fudan University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

45

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China, 200032
        • Not yet recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: TROP2 ADC
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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).
Baseline to first response assessment (after 2 cycles of therapy).
Correlation Between 68Ga-TROP2 PET Uptake and Tissue TROP2 Status
Time Frame: At baseline
At baseline
Comparative Performance: 68Ga-TROP2 PET/CT vs 18F-FDG PET/CT
Time Frame: At baseline
At baseline

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 11, 2026

Primary Completion (Estimated)

March 11, 2028

Study Completion (Estimated)

March 11, 2029

Study Registration Dates

First Submitted

March 10, 2026

First Submitted That Met QC Criteria

March 10, 2026

First Posted (Actual)

March 13, 2026

Study Record Updates

Last Update Posted (Actual)

March 13, 2026

Last Update Submitted That Met QC Criteria

March 10, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YOUNGBC-34

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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