Can HER2 Targeted PET/CT Imaging Identify Unsuspected HER2 Positive Breast Cancer Metastases, Which Are Amenable to HER2 Targeted Therapy?

Study Overview
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Brief Summary
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Some breast cancer cells make a protein called Human Epidermal Growth factor receptor 2 (HER2). Patients with HER2 positive (HER2+) breast cancer receive medicine that attacks HER2, which helps these patients live longer. Some HER2 negative (HER2-) breast cancer patients also benefit from medicines that attack HER2, but we do not know why or which patients will benefit. This study uses a new imaging method, HER2-targeted PET/CT, to identify patients that may benefit from medicines that attack HER2. This is experimental.

Official Title
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Can HER2 Targeted PET/CT Imaging Identify Unsuspected HER2 Positive Breast Cancer Metastases, Which Are Amenable to HER2 Targeted Therapy?

Conditions
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Breast Cancer Metastases, HER2 Positive Breast

Intervention / Treatment
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* Radiation: 89Zr-trastuzumab
* Device: PET/CT scan
* Radiation: 89Zr-pertuzumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women age > 18 Biopsy proven HER2 negative primary breast cancer and biopsy proven metastatic disease. 5 or more foci of demonstrable metastases on recent imaging modalities (CT, MR, FDG PET/CT) ECOG performance score of 0-2 Exclusion Criteria: Life expectancy < 3months Pregnancy or lactation Patients who cannot undergo PET/CT scanning because of weight limits CNS only disease on recent imaging

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HER2-targeted PET/CT<br>Pts with confirmed HER2- breast cancer will then undergo HER2-targeted PET/CT. 89Zr-trastuzumab is a novel radiotracer which allows excellent visualization of HER2+ lesions. 89Zr-pertuzumab is a novel radiotracer which may allow for specific visualization of HER2+ lesions. PET/CT imaging with these novel radiotracers will allow evaluation of all identifiable malignant lesions, rather than evaluation of only single lesions by biopsy. Avid lesions will be considered suspicious for HER2+ malignancy. Pts with at least one 89Zr-trastuzumab or 89Zr-pertuzumab avid lesion will be biopsied to confirm HER2+ pathology. From these 50 pts, we will determine the proportion of HER2- primary breast cancer pts that express HER2+ malignancy imagable by HER2-targeted PET/CT. Pts recruited to the protocol, but then drop out prior to HER2-targeted PET/CT due HER2+ disease being identified on retesting of the patient's archived tissue samples, will be replaced with newly recruited pts. | Radiation: 89Zr-trastuzumab<br> <br> Device: PET/CT scan<br> <br> Radiation: 89Zr-pertuzumab<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients With HER2- Primary Breast Cancer Who Develop Imagable HER2+ Metastases | Both SUVmax and SUVpeak will be recorded for lesions, and SUVmax and SUVaverage will be recorded for background measurements. Only those foci qualitatively scored conspicuously positive by both readers (scores of 4 or 5) will be considered as positive. | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PET/CT, 89Zr-trastuzumab, 14-156, 89Zr-pertuzumab, HER2-targeted