TheranosticTrials.org

Clinical Trial · NCT02065609

89ZrTrastuzumab Breast Imaging With Positron Emission Tomography

Overview

The main purpose of this study is to see if Positron Emission Tomography (PET-Imaging) with 89Zr labeled trastuzumab can detect trastuzumab (HER2) positive breast cancer.

Sponsor

Washington University School of Medicine

Phase

Early Phase 1

Contacts

Farrokh Dehdashti, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT02065609

Drug / Compound

Trastuzumab

Isotope(s):
Target(s):
  • HER2
Ligand Class: Antibodies
Chelator: DFO

Eligibility

Inclusion

  • Primary or recurrent/metastatic lesion size ≥ 1.5 cm as determined by imaging studies (ultrasonography, mammography, CT or MRI) or physical examination
  • Patients currently receiving trastuzumab therapy with or without other types of systemic therapy can participate if their disease progresses (development of new lesion(s) or worsening of known lesion(s) based on imaging modalities or physical examination.
  • Cohort 2: Her2-positive (defined as 3+) or FISH HER2:CEP17 ratio \> 2 OR HER2negative (0 or 1+, 2+ and FISH negative) biopsy-proven breast cancer
  • Cohort 1: Her2-positive (defined as 3+) or FISH HER2:CEP17 ratio \> 2 biopsy proven breast cancer

Exclusion

Exclusion criteria not yet provided.