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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| N1 | Experimental | If patients are HER2+ breast cancer receiving neoadjuvant therapy |
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| N2 | Experimental | If patients are HER2+ breast cancer receiving neoadjuvant therapy |
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| N3 | Experimental | If patients are TNBC receiving neoadjuvant therapy |
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| N4 | Experimental | If patients are breast cancer receiving neoadjuvant therapy |
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| A1 | Experimental | If patients are HER2+ breast cancer receiving salvage therapy |
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| A2 | Experimental | If patients are HER2+ breast cancer receiving salvage therapy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chemotherapy plus dual-target therapy | Diagnostic Test | Drug: Chemotherapy plus dual-target therapy. Procedure: 18F-FDG PET/MRI and HER2 PET/MRI will be performed at baseline and after cycle 2. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | through study completion, an average of 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Three-year post-surgery follow-up |
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Inclusion Criteria:
Female patients aged 18 to 70 years.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Histologically confirmed invasive breast cancer.
Known ER, PR and HER2 status.
At least one measurable lesion according to RECIST 1.1.
Adequate organ function, meeting all of the following:
Left ventricular ejection fraction (LVEF)≥55% at baseline as measured by echocardiography or multi-gated acquisition (MUGA) scan.
Women of childbearing potential must have a negative serum pregnancy test. Such patients must use a medically acceptable method of contraception during study treatment and for at least 6 months after the last dose of the study drug(s).
The subject voluntarily agrees to participate, signs the informed consent form, has good compliance, and is willing to adhere to follow-up.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Shanghai | Shanghai Municipality | 200032 | China |
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| A3 | Experimental | If patients are TNBC receiving salvage therapy |
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| A4 | Experimental | If patients are breast cancer receiving salvage therapy |
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| A5 | Experimental | If patients are breast cancer receiving salvage therapy |
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| A6 | Experimental | If patients are HR+/HER2- breast cancer receiving salvage therapy |
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| Treatment including HER2 ADC | Diagnostic Test | Drug: Treatment including HER2 ADC. Procedure: 18F-FDG PET/MRI and HER2 PET/MRI will be performed at baseline and after cycle 2. |
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| Treatment including immunotherapy | Diagnostic Test | Drug: Treatment including immunotherapy. Procedure: 18F-FDG PET/MRI and FAPI PET/MRI will be performed at baseline and after cycle 2. |
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| Treatment including Nectin-4 ADC | Diagnostic Test | 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. |
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| Treatment including Trop-2 ADC | Diagnostic Test | 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. |
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| Treatment including CDK4/6 inhibitor | Diagnostic Test | Drug: Treatment including CDK4/6 inhibitor. Procedure: 18F-FDG PET/MRI and CDKi PET/MRI will be performed at baseline and after cycle 2. |
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| Progression-free survival (PFS) | Defined as the time period from the start of enrollment until any recorded disease progression or any cause of death. | Three-year post-surgery follow-up |
| Overall survival (OS) | Defined as the time period from the start of enrollment until any cause of death. | 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) | 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. | Up to one year during follow-up |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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