PET Imaging With Cu-64 Labeled Trastuzumab in HER2+ Metastatic Breast Cancer

Study Overview
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Brief Summary
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The purpose of this study is to learn more about how a new study agent works inside the body. The study agent is a protein called 64Cu-trastuzumab. This is a radioactive tracer that was developed at MSKCC to target HER2 protein on cancer cells. A radioactive tracer is a small amount of radioactive dye that follows something else that is not radioactive In this study the study agent, 64Cu-trastuzumab, is the tracer and what's being followed is trastuzumab (Herceptin™). By giving you this tracer after you have treatment with trastuzumab (Herceptin™), we will be able to use PET scans to show us which parts of your body and tumor sites the Herceptin goes to. This will help us to understand better how Herceptin works in the body to fight cancer.

Official Title
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Pilot Trial of PET Imaging With Cu-64 Labeled Trastuzumab in HER2+ Metastatic Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Radiation: PET Imaging With Cu-64 Labeled Trastuzumab
* Radiation: PET Imaging With Cu-64 Labeled Trastuzumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Registered patient at MSKCC Age ≥18 years Patients with HER2+ metastatic breast cancer (either 3+ by immunohistochemistry or with evidence of gene amplification (>2.0) by fluorescence in situ hybridization (FISH)) Measurable or evaluable disease Currently taking or about to commence treatment with trastuzumab at a dosing schedule of 2 mg/kg weekly or 6 mg/kg every three weeks, as per standard of care Karnofsky Performance Score ≥ 60 Signed informed consent Exclusion Criteria: Previous Grade 3 or higher allergic reaction to trastuzumab that resulted in discontinuation of trastuzumab therapy Claustrophobia/pain leading to inability to lie still for the duration of the scanning procedure. Pregnancy Test to be performed on female patients of childbearing potential within 24hrs before administration of radioactive material. Inability to provide written informed consent. Patients with liver metastases as the only site of distant disease Patients with known sensitivity or contraindication to Herceptin.

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>breast cancer pt receiving trastuzumab therapy will undergo two complete PET studies. | Radiation: PET Imaging With Cu-64 Labeled Trastuzumab<br>* The first 8 patients enrolled will undergo two complete PET studies, up to 3-6 weeks apart, to assess for reproducibility of measures of tracer uptake into individual organs and known sites of metastatic disease.<br>|
| Experimental: 2<br>breast cancer pt receiving trastuzumab therapy will undergo one complete PET studies | Radiation: PET Imaging With Cu-64 Labeled Trastuzumab<br>* The remaining 20 patients will undergo one PET study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| test safety & feas of (PET) imaging w radiolabeled 64Cu-trastuzumab to determine dosimetry & biodistribution of trastuzumab, using a radiotracer dilution technique w copper-64 labeled trastuzumab |  | conclusion of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to determine reproducibility of the measurement of the Standardized Uptake Value (SUV) in normal organs and tumors in a sub-cohort of 8 patients who will undergo two injections of the tracer. |  | conclusion of study | 
| to determine the pharmacokinetic profile of the 64Cu-trastuzumab radiotracer. |  | conclusion of study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cu-64 LABELED TRASTUZUMAB