Study on the Value of Non-invasive Dual-Pet Information in Subtype of Metastatic Breast Cancer

Study Overview
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Brief Summary
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Study on the Value of Non-invasive Dual-Pet(18F-FES PET and 68Ga-HER2-Affibody PET) Information in Subtype of Metastatic Breast Cancer

Detailed Description
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A Phase II, Single-center STudy on the vAlue of Non-invasive Dual-Pet（18F-FES PET and 68Ga-HER2-Affibody PET）InformatiOn IN Subtype of Metastatic Breast Cancer(MBC)

Official Title
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A Phase II, Single-center STudy on the vAlue of Non-invasive Dual-Pet（18F-FES PET and 68Ga-HER2-Affibody PET）InformatiOn IN Subtype of Metastatic Breast Cancer(MBC)

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: biopsy or surgical pathology in metastases
* Drug: 68Ga-HER2 affibody,18F-FDG, 18F-FES


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects voluntarily joined the study, signed informed consent, and had good compliance. Female patients aged over 18 years (including cutoff value). an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. Recurrence or metastatic breast cancer confirmed by histopathology, or expect to be feasible metastasis puncture or surgery to confirm histopathological recurrence or metastatic breast cancer. Exclusion Criteria: Pregnancy or lactation. Alcohol allergy is not suitable for FES-PET/ C. There are contraindications for patients who are expected to have metastasis puncture or surgery. Mental disorders or other conditions affecting patient compliance.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Metastatic breast cancer patients<br>50 metastatic breast cancer patients | Procedure: biopsy or surgical pathology in metastases<br>* biopsy or surgical pathology in extrahepatic/liver/brain metastases<br>Drug: 68Ga-HER2 affibody,18F-FDG, 18F-FES<br>* 68Ga-NOTA-MAL-MZHER2 (68Ga-HER2) affibody is an investigational Positron Emission Tomography (PET)/ Computed Tomography (CT) radiopharmaceutical.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Verify the subtype value of dual-PET in extrahepatic metastases | Verify whether the subtype value of FES-PET and HER2-PET is consistent with biopsy or surgical pathology in extrahepatic metastases. | 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Verify the HER2-PET value in liver metastasis | Verify whether the HER2-PET value is consistent with biopsy or surgical pathology in liver metastasis. | 2 year | 
| Verify the HER2-PET value in brain metastasis | Verify whether the HER2-PET value is consistent with biopsy or surgical pathology in brian metastasis. | 2 year | 
| Heterogeneity in metastatic lesions | Observe the heterogeneity of ER and HER2 expression in metastatic lesions. | 2 year |