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

• Status: Recruiting
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Alabama at Birmingham
• Treatments: Trastuzumab

Criteria

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)