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

NCT00605397 | Completed Phase 1

• 1 other identifier: 06-134
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

Cu-64 LABELED TRASTUZUMAB

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (2)

1

EXPERIMENTAL

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

Radiation: PET Imaging With Cu-64 Labeled Trastuzumab

2

EXPERIMENTAL

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

Radiation: PET Imaging With Cu-64 Labeled Trastuzumab

Interventions

PET Imaging With Cu-64 Labeled Trastuzumab 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.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan-Kettering Cancer Center

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Jorge Carrasquillo, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2008
• First Posted: January 31, 2008
• Study Start: January 1, 2007
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 28, 2015

Record last verified: 2015-12

Locations

US (1)