89ZrTrastuzumab Breast Imaging With Positron Emission Tomography

Study Overview
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Brief Summary
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The main purpose of this study is to see if Positron Emission Tomography (PET-Imaging) with 89Zr labeled trastuzumab can detect trastuzumab (HER2) positive breast cancer.

Official Title
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Assessment of HER2 Receptors in Breast Carcinoma by Positron Emission Tomography (PET) Using 89 Zr-Trastuzumab

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: 89Zr-Trastuzumab Human Dosimetry and Safety
* Drug: HER2 Positive Lesion Detection and Safety


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female patients 18 years of age or older Cohort 1: Her2-positive (defined as 3+) or FISH HER2:CEP17 ratio > 2 biopsy proven breast cancer Cohort 2: Her2-positive (defined as 3+) or FISH HER2:CEP17 ratio > 2 OR HER2negative (0 or 1+, 2+ and FISH negative) biopsy-proven breast cancer Primary or recurrent/metastatic lesion size ≥ 1.5 cm as determined by imaging studies (ultrasonography, mammography, CT or MRI) or physical examination Able to give informed consent Not currently pregnant or nursing: Subject must be surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), postmenopausal (cessation of menses for more than 1 year), non-lactating, or of childbearing potential for whom a urine pregnancy test (with the test performed within the 24 hour period immediately prior to administration of 89Zr-trastuzumab) is negative Patients currently receiving trastuzumab therapy with or without other types of systemic therapy can participate if their disease progresses (development of new lesion(s) or worsening of known lesion(s) based on imaging modalities or physical examination. Exclusion Criteria: Patients with other invasive malignancies, with the exception of non- melanoma skin cancer, who had (or have) any evidence of the other cancer present within the last 5 years Unable to tolerate 60 min of PET imaging per imaging session

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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>89Zr-Trastuzumab Human Dosimetry and Safety | Drug: 89Zr-Trastuzumab Human Dosimetry and Safety<br>* PET Imaging following administration of 89Zr labeled Trastuzumab for calculation of human dosimetry and overall safety<br>Drug: HER2 Positive Lesion Detection and Safety<br>* Detection of HER2 Positive Breast Cancer with 89Zr Labeled Trastuzumab and PET imaging<br>|
| Experimental: Cohort 2: Lesion Detection and Safety<br>HER2 Positive Lesion Detection and Safety | Drug: 89Zr-Trastuzumab Human Dosimetry and Safety<br>* PET Imaging following administration of 89Zr labeled Trastuzumab for calculation of human dosimetry and overall safety<br>Drug: HER2 Positive Lesion Detection and Safety<br>* Detection of HER2 Positive Breast Cancer with 89Zr Labeled Trastuzumab and PET imaging<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability After 89Zr-Trastuzumab Administration | Subjects medical record was followed for 30 days following 89Zr-Trastuzumab Administration for AE Assessment with AE being defined as Any unfavorable medical occurrence in a human subject who receives 89Zr-Trastuzumab and PET/CT imaging, including any abnormal sign, symptom, or disease. The event does not necessarily have to be causally related to injection of 89Zr-Trastuzumab or PET/CT imaging to qualify as an adverse event, just temporally related. | 30 Days following 89Zr-Trastuzumab Administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Trastuzumab