PET Imaging with 89Zr-Trastuzumab for Prediction of HER2 Targeted Therapy Effectiveness

Who is this study for? Patients with HER2 positive breast cancer
What treatments are being studied? [89Zr]-Df-Trastuzumab+PET/MRI Imaging
Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test, Drug
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY

Our goal is to investigate the use of 89Zr-trastuzumab as a HER2 imaging agent to determine which patients are likely to respond to targeted HER2 agents as single agent therapy. We are proposing to perform a pilot study with goals of demonstrating the feasibility of imaging breast cancer patients with 89Zr-trastuzumab-PET/MRI, evaluating the relationship between tumor 89Zr-trastuzumab uptake and in vitro positivity of HER2, assessing the relationship between 89Zr-trastuzumab uptake and response to HER2 therapy.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• Be at least 18 years of age.

• Diagnosis of HER2 positive breast cancer as defined by to American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) 2018 guidelines: Immunohistochemistry (IHC) 3+ OR Single prove In situ hybridization (ISH) with average HER2 copy number \>= 6 OR dual probe ISH with both average HER2 copy number \>= 4 AND HER2 to CEP17 ratio \>=2

• Patients eligible for radiation therapy or systemic therapy using a regimen containing at least one anti-HER2 agent

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 and 1

• Ejection fraction greater than 50% by echocardiogram or multiple-gated acquisition (MUGA) scans

Locations
United States
Alabama
The Kirklin Clinic
RECRUITING
Birmingham
Contact Information
Primary
Denise Jeffers, PharmD
charlottejeffers@uabmc.edu
205-975-6469
Backup
Sebastian Eady, BS
smeady@uabmc.edu
2059962636
Time Frame
Start Date: 2017-11-21
Estimated Completion Date: 2027-10
Participants
Target number of participants: 10
Treatments
Experimental: [89Zr]-Df-Trastuzumab
\[89Zr\]-Df-Trastuzumab \[89Zr\]-Df-Trastuzumab will be administered intravenously. The administered dose will be 2 millicurie (mCi) at the time of injection. The amount of injected drug is 5 mg of Trastuzumab. 5-6 days post injection the patients will undergo PET/MRI imaging.
Related Therapeutic Areas
Sponsors
Leads: University of Alabama at Birmingham

This content was sourced from clinicaltrials.gov