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

Breast Cancer Clinical Trial

— Cu-64 HER2+  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00605397
• Other study ID #: 06-134
• Status: Completed
• Phase: Phase 1
• First received: January 18, 2008
• Last updated: December 23, 2015
• Start date: January 2007
• Est. completion date: December 2013

Study information

• Verified date: December 2015
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.
• PET Imaging With Cu-64 Labeled Trastuzumab
The remaining 20 patients will undergo one PET study.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No
Secondary	to determine the pharmacokinetic profile of the 64Cu-trastuzumab radiotracer.		conclusion of study	No

External Links

•   Memorial Sloan-Kettering Cancer Center