89ZrTrastuzumab Breast Imaging With Positron Emission Tomography

Assessment of HER2 Receptors in Breast Carcinoma by Positron Emission Tomography (PET) Using 89 Zr-Trastuzumab

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: 89Zr-Trastuzumab Human Dosimetry and Safety; Drug: HER2 Positive Lesion Detection and Safety

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine @ Barnes-Jewish Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Female patients 18 years of age or older
• Cohort 1: Her2-positive (defined as 3+) or FISH HER2:CEP17 ratio > 2 biopsy proven breast cancer
• 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
• Primary or recurrent/metastatic lesion size ≥ 1.5 cm as determined by imaging studies (ultrasonography, mammography, CT or MRI) or physical examination
• Able to give informed consent
• Not currently pregnant or nursing: Subject must be surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), postmenopausal (cessation of menses for more than 1 year), non-lactating, or of childbearing potential for whom a urine pregnancy test (with the test performed within the 24 hour period immediately prior to administration of 89Zr-trastuzumab) is negative
• 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.

Exclusion Criteria:

• 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
• Unable to tolerate 60 min of PET imaging per imaging session

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1; 89Zr-Trastuzumab Human Dosimetry and Safety	Drug: 89Zr-Trastuzumab Human Dosimetry and Safety; PET Imaging following administration of 89Zr labeled Trastuzumab for calculation of human dosimetry and overall safety; Drug: HER2 Positive Lesion Detection and Safety; Detection of HER2 Positive Breast Cancer with 89Zr Labeled Trastuzumab and PET imaging
Experimental: Cohort 2: Lesion Detection and Safety; HER2 Positive Lesion Detection and Safety	Drug: 89Zr-Trastuzumab Human Dosimetry and Safety; PET Imaging following administration of 89Zr labeled Trastuzumab for calculation of human dosimetry and overall safety; Drug: HER2 Positive Lesion Detection and Safety; Detection of HER2 Positive Breast Cancer with 89Zr Labeled Trastuzumab and PET imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Events as a Measure of Safety and Tolerability After 89Zr-Trastuzumab Administration	Subjects medical record was followed for 30 days following 89Zr-Trastuzumab Administration for AE Assessment with AE being defined as Any unfavorable medical occurrence in a human subject who receives 89Zr-Trastuzumab and PET/CT imaging, including any abnormal sign, symptom, or disease. The event does not necessarily have to be causally related to injection of 89Zr-Trastuzumab or PET/CT imaging to qualify as an adverse event, just temporally related.	30 Days following 89Zr-Trastuzumab Administration

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Farrokh Dehdashti, MD, Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): February 13, 2018

Study Registration Dates

• First Submitted: February 5, 2014
• First Submitted That Met QC Criteria: February 14, 2014
• First Posted (Estimate): February 19, 2014

Study Record Updates

• Last Update Posted (Actual): October 13, 2022
• Last Update Submitted That Met QC Criteria: October 5, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Trastuzumab
• Additional Relevant MeSH Terms: Antineoplastic Agents; Antineoplastic Agents, Immunological; Trastuzumab
• Other Study ID Numbers: 201307037; R21CA182945 (U.S. NIH Grant/Contract)