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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test, Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Fudan University Shanghai Cancer Center
NOT_YET_RECRUITING
Shanghai
Contact Information
Primary
Biyun Wang
wangbiyun0107@hotmail.com
021-64175590
Time Frame
Start Date: 2026-03-11
Estimated Completion Date: 2029-03-11
Participants
Target number of participants: 45
Treatments
Other: TROP2 ADC
Related Therapeutic Areas
Sponsors
Leads: Fudan University

This content was sourced from clinicaltrials.gov