RecruitingPhase 2NCT07471776

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


Sponsor

Fudan University

Enrollment

45 participants

Start Date

Mar 11, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether two types of PET scan imaging — one using a tracer that targets a protein called TROP2, and one using a standard glucose tracer (FDG) — can predict how well a TROP2-targeted antibody-drug conjugate (ADC) treatment will work in patients with advanced HER2-negative breast cancer. **You may be eligible if...** - You have been diagnosed with advanced or metastatic HER2-negative breast cancer - Your doctor has already planned to treat you with an anti-TROP2 ADC drug (such as sacituzumab govitecan or datopotamab deruxtecan) as part of your standard care - You are willing and able to undergo the required PET/CT scans during the study - You are 18 years of age or older **You may NOT be eligible if...** - Your medical records are incomplete or you cannot complete the required scans - You have previously been treated with an anti-TROP2 ADC - You have a known allergy to PET scan tracers or contraindications to PET/CT imaging - You are pregnant or breastfeeding - You have another active cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSacituzumab Govitecan、Datopotamab deruxtecan、Sacituzumab tirumotecan

TROP2-targeted antibody-drug conjugate administered according to standard clinical dosing schedule until disease progression or unacceptable toxicity.

DIAGNOSTIC_TEST68Ga-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_TEST18F-FDG PET Imaging

Standard 18F-FDG PET imaging performed prior to TROP2 ADC treatment to assess tumor metabolic activity.


Locations(2)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Fudan University Shanghai Cancer Center

Shanghai, China

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NCT07471776


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