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

NCT ID: NCT00605397

Last Updated: 2015-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2013-12-31

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.

Detailed Description

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Conditions

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Breast Cancer

Keywords

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Cu-64 LABELED TRASTUZUMAB

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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1

breast cancer pt receiving trastuzumab therapy will undergo two complete PET studies.

Group Type EXPERIMENTAL

PET Imaging With Cu-64 Labeled Trastuzumab

Intervention Type RADIATION

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.

2

breast cancer pt receiving trastuzumab therapy will undergo one complete PET studies

Group Type EXPERIMENTAL

PET Imaging With Cu-64 Labeled Trastuzumab

Intervention Type RADIATION

The remaining 20 patients will undergo one PET study.

Interventions

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PET Imaging With Cu-64 Labeled Trastuzumab

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.

Intervention Type RADIATION

PET Imaging With Cu-64 Labeled Trastuzumab

The remaining 20 patients will undergo one PET study.

Intervention Type RADIATION

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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jorge Carrasquillo, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

Countries

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United States

Related Links

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http://www.mskcc.org

Memorial Sloan-Kettering Cancer Center

Other Identifiers

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06-134

Identifier Type: -

Identifier Source: org_study_id