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A Platform Study Based on Specific Tracer for Evaluating the Therapeutic Efficacy of Systemic Treatment for Breast Cancer Using PET/MRI
Sponsor: Fudan University
Summary
This study is a prospective, open-label, phase II clinical trial, aiming to explore the predictive effect of different specific tracers on the effectiveness of various systemic treatments for breast cancer. The unique feature of this study is that it is a platform study. The research cohort can be updated accordingly as specific tracers for PET/MRI and systemic treatment regimens for breast cancer are updated. The study will be divided into two treatment cohorts: neoadjuvant therapy and salvage therapy. The research cohort will be further subdivided based on specific treatment regimens and specific tracers for PET/MRI. The subjects will undergo one 18F-FDG PET/MRI and specific tracer PET/MRI examination at baseline (before treatment) and after 2 treatment courses. This study is an exploratory phase II clinical trial, and its main purpose is to screen valuable cohorts for subsequent larger-sample randomized controlled III-phase clinical studies.
Official title: A Platform Study Based on Specific Tracer for Evaluating the Therapeutic Efficacy of Systemic Treatment for Breast Cancer Using PET/MRI (A Prospective, Open-label, Phase II Platform Trial)
Key Details
Gender
FEMALE
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2026-03-01
Completion Date
2032-01-01
Last Updated
2026-02-19
Healthy Volunteers
No
Conditions
Interventions
Chemotherapy plus dual-target therapy
Drug: Chemotherapy plus dual-target therapy. Procedure: 18F-FDG PET/MRI and HER2 PET/MRI will be performed at baseline and after cycle 2.
Treatment including HER2 ADC
Drug: Treatment including HER2 ADC. Procedure: 18F-FDG PET/MRI and HER2 PET/MRI will be performed at baseline and after cycle 2.
Treatment including immunotherapy
Drug: Treatment including immunotherapy. Procedure: 18F-FDG PET/MRI and FAPI PET/MRI will be performed at baseline and after cycle 2.
Treatment including Nectin-4 ADC
Drug: Treatment including Nectin-4 ADC. Procedure: 18F-FDG PET/MRI and Nectin-4 PET/MRI will be performed at baseline and after cycle 2.
Treatment including Trop-2 ADC
Drug: Treatment including Trop-2 ADC. Procedure: 18F-FDG PET/MRI and Trop-2 PET/MRI will be performed at baseline and after cycle 2.
Treatment including CDK4/6 inhibitor
Drug: Treatment including CDK4/6 inhibitor. Procedure: 18F-FDG PET/MRI and CDKi PET/MRI will be performed at baseline and after cycle 2.
Locations (1)
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China