PET Imaging With Cu-64 Labeled Trastuzumab in HER2+ Metastatic Breast Cancer
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | January 2007 |
| End Date: | December 2013 |
Pilot Trial of PET Imaging With Cu-64 Labeled Trastuzumab in HER2+ Metastatic Breast Cancer
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.
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.
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.
We found this trial at
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Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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