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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Radiation: PET Imaging With Cu-64 Labeled Trastuzumab; Radiation: PET Imaging With Cu-64 Labeled Trastuzumab

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 1; breast cancer pt receiving trastuzumab therapy will undergo two complete PET studies.	Radiation: 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.; Radiation: PET Imaging With Cu-64 Labeled Trastuzumab; The remaining 20 patients will undergo one PET study.
EXPERIMENTAL: 2; breast cancer pt receiving trastuzumab therapy will undergo one complete PET studies	Radiation: 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.; Radiation: PET Imaging With Cu-64 Labeled Trastuzumab; The remaining 20 patients will undergo one PET study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan-Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (ACTUAL): December 1, 2013
• Study Completion (ACTUAL): December 1, 2013

Study Registration Dates

• First Submitted: January 18, 2008
• First Submitted That Met QC Criteria: January 30, 2008
• First Posted (ESTIMATE): January 31, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): December 28, 2015
• Last Update Submitted That Met QC Criteria: December 23, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Cu-64 LABELED TRASTUZUMAB
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Antineoplastic Agents; Antineoplastic Agents, Immunological; Trastuzumab
• Other Study ID Numbers: 06-134