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



Status:Recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/22/2019
Start Date:November 21, 2017
End Date:January 2022
Contact:Denise Jeffers, PharmD
Email:charlottejeffers@uabmc.edu
Phone:205-975-6469

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Trial Summary
Trial Overview
Inclusion Criteria
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.


Inclusion Criteria:

- Adult female patients (n=10) with biopsy-proven HER2-positive, with at least one FDG
positive lesion by PERCIST

- Be at least 18 years of age

- Patients eligible for neoadjuvant therapy using a regimen containing at least one
anti-HER2 agent (stage 2 and 3 HER2+ breast cancer)

- ECOG performance status of 0 and 1

- Ejection fraction greater than 50% by echocardiogram or MUGA scans

- Be enrolled in the I-SPY 2 trial

Exclusion Criteria:

- Pregnant women and patients with other invasive malignancies, with the exception of
non-melanoma skin cancer, who had (or have) any evidence of the other cancer present
within the last 5 years or unable to tolerate up to 60 min of PET imaging per imaging
session

- Inability to provide informed consent

- Weight over 350 lbs., due to the scanner bore size

- Contraindication for MRI study (non-removable metal implants or certain tattoos)
We found this trial at
1
site
Kirklin Clinic
Birmingham, Alabama 35233
?
mi
from
Birmingham, AL
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