Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT07471776

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

Led by Fudan University · Updated on 2026-03-13

45

Participants Needed

2

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with advanced or metastatic HER2-negative breast cancer with confirmed metastatic disease
  • Planned to receive anti-TROP2 antibody-drug conjugate therapy as part of routine care
  • Will undergo protocol-defined ^68Ga-TROP2 PET/CT and ^18F-FDG PET/CT imaging during the study
  • Adults aged 18 years or older able to provide informed consent and comply with study procedures
Not Eligible

You will not qualify if you...

  • Incomplete medical records or inability to complete required imaging assessments
  • Prior exposure to any anti-TROP2 antibody-drug conjugate
  • Known contraindications or allergies to PET/CT, ^18F-FDG, or ^68Ga-TROP2 tracer
  • Pregnant or breastfeeding
  • Diagnosis of other active secondary primary tumors as determined by the investigator

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China, 200032

Actively Recruiting

2

Fudan University Shanghai Cancer Center

Shanghai, China, 200032

Not Yet Recruiting

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Research Team

B

Biyun Wang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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