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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00605397
First received: January 18, 2008
Last updated: December 18, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Breast Cancer
Radiation: PET Imaging With Cu-64 Labeled Trastuzumab

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Pilot Trial of PET Imaging With Cu-64 Labeled Trastuzumab in HER2+ Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • 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 [ Time Frame: conclusion of study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]
  • to determine the pharmacokinetic profile of the 64Cu-trastuzumab radiotracer. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]

Enrollment: 11
Study Start Date: January 2007
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Experimental: 2
breast cancer pt receiving trastuzumab therapy will undergo one complete PET studies
Radiation: PET Imaging With Cu-64 Labeled Trastuzumab
The remaining 20 patients will undergo one PET study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00605397

Locations
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Jorge Carrasquillo, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00605397     History of Changes
Other Study ID Numbers: 06-134
Study First Received: January 18, 2008
Last Updated: December 18, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Cu-64 LABELED TRASTUZUMAB

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Trastuzumab
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014