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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
300
Drug: Chemotherapy plus dual-target therapy. Procedure: 18F-FDG PET/MRI and HER2 PET/MRI will be performed at baseline and after cycle 2.
Drug: Treatment including HER2 ADC. Procedure: 18F-FDG PET/MRI and HER2 PET/MRI will be performed at baseline and after cycle 2.
Drug: Treatment including immunotherapy. Procedure: 18F-FDG PET/MRI and FAPI PET/MRI will be performed at baseline and after cycle 2.
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.
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.
Drug: Treatment including CDK4/6 inhibitor. Procedure: 18F-FDG PET/MRI and CDKi PET/MRI will be performed at baseline and after cycle 2.
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
The correlation between specific tracer PET/MRI-related indicators and the efficacy of systemic treatment
Change in PET/MRI-related indicators such as SUVmax from baseline to cycle 2 on in correlation with efficacy of systemic treatment.
Time frame: through study completion, an average of 24 weeks
Event-free suvival (EFS)
Defined as the time period from the start of enrollment until the first occurrence of the relevant events. The relevant events include disease progression, disease recurrence and metastasis, contralateral invasive breast cancer, second primary invasive cancer, and any cause of death.
Time frame: Three-year post-surgery follow-up
Progression-free survival (PFS)
Defined as the time period from the start of enrollment until any recorded disease progression or any cause of death.
Time frame: Three-year post-surgery follow-up
Overall survival (OS)
Defined as the time period from the start of enrollment until any cause of death.
Time frame: Three-year post-surgery follow-up
CTCAE scale (V6.0)
To evaluate the rate of adverse effects of patient by the standard CTCAE scale (V6.0)
Time frame: Up to one year during follow-up
Exploration of translational research markers
The collected subjects' tumor tissues, paracancerous tissues, blood, and fecal samples will be used for discovering exploratory biomarkers. The correlations between discovered biomarkers and subjects' disease status and treatment responses will also be investigated.
Time frame: Up to one year during follow-up
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