Testing a New Imaging Agent to Identify Cancer

Imaging of HER2-expressing Cancer With Site-Specifically Labeled 89Zr-ss-Pertuzumab

The purpose of this study is to see whether 89Zr-ss-pertuzumab is safe in people with HER2+ cancer.

Study Overview

• Status: Recruiting
• Conditions: HER2-positive Metastatic Breast Cancer; HER-2 Protein Overexpression; HER-2 Positive Malignant Carcinoma of Breast
• Intervention / Treatment: Combination product: 89Zr-ss-pertuzumab PET/CT

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Randy Yeh, MD; Phone Number: 212-639-3776; Email: yehr@mskcc.org
• Study Contact Backup: Name: Jason Lewis, PhD; Phone Number: 646-888-3038; Email: lewisj2@mskcc.org

Study Locations

• United States
  • California
    • Newport Beach, California, United States, 92663
      • Not yet recruiting
      • PATTY AND GEORGE HOAG CANCER CENTER (Data or Specimen Analysis Only)
      • Contact: Gary Ulaner, MD, PhD; Phone Number: 949-722-6237
  • New Jersey
    • Basking Ridge, New Jersey, United States, 07920
      • Recruiting
      • Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
      • Contact: Randy Yeh, MD; Phone Number: 212-639-3776
    • Middletown, New Jersey, United States, 07748
      • Recruiting
      • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
      • Contact: Randy Yeh, MD; Phone Number: 212-639-3776
    • Montvale, New Jersey, United States, 07645
      • Recruiting
      • Memorial Sloan Kettering Bergen (Limited Protocol Activities)
      • Contact: Randy Yeh, MD; Phone Number: 212-639-3776
  • New York
    • Commack, New York, United States, 11725
      • Recruiting
      • Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)
      • Contact: Randy Yeh, MD; Phone Number: 212-639-3776
    • Harrison, New York, United States, 10604
      • Recruiting
      • Memorial Sloan Kettering Westchester (Limited Protocol Activities)
      • Contact: Randy Yeh, MD; Phone Number: 212-639-3776
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering Cancer Center (All Protocol Activities)
      • Contact: Randy Yeh, MD; Phone Number: 212-639-3776
    • Rockville Centre, New York, United States, 11553
      • Recruiting
      • Memorial Sloan Kettering Nassau (Limited Protocol Activites)
      • Contact: Randy Yeh, MD; Phone Number: 212-639-3776

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Biopsy proven HER2-positive or HER2-low primary malignancy or metastatic disease

Note: HER2 positivity is defined according to American Society of Clinical Oncology guidelines or ERBB2 amplification on next generation sequencing Note: HER2-low is defined as low HER2 expression, with immunohistochemistry (IHC) 1+ or IHC 2+ and in situ hybridization [ISH]-negative, including FISH.

• Biopsy proven primary malignancy or metastatic disease
• At least one malignant lesion on CT, MR, or FDG PET/CT within 60 days of protocol enrollment
• Age 18 years or greater
• ECOG performance of 0-2

Exclusion Criteria:

• Creatinine > 2 times normal limit (obtained with 8 weeks of enrollment)
• AST/ALT > 2 times normal limit (obtained with 8 weeks of enrollment)
• Life expectancy < 3 months
• Pregnancy or lactation
• Patients who cannot undergo PET/CT due to weight limits (over 450 pounds)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HER2-positive malignancy; Participants will have a diagnosis of HER2-positive malignancy	Combination product: 89Zr-ss-pertuzumab PET/CT; Patients will receive 89Zr-ss-pertuzumab. 89Zr-ss-pertuzumab PET/CT images will be reconstructed using iterative reconstruction and displayed in multiplanar reconstruction. In the event that 89Zr-ss-pertuzumab is unavailable, randomly labelled 89Zr-pertuzumab PET will be allowed to make HER2 PET imaging available for our patients. Once 89Zr-ss-pertuzumab is available, then patients will be imaged with 89Zr-ss-pertuzumab and randomly labelled 89Zr-pertuzumab will no longer be used.
Experimental: HER2-low malignancy; Participants will have a diagnosis of HER2-low malignancy	Combination product: 89Zr-ss-pertuzumab PET/CT; Patients will receive 89Zr-ss-pertuzumab. 89Zr-ss-pertuzumab PET/CT images will be reconstructed using iterative reconstruction and displayed in multiplanar reconstruction. In the event that 89Zr-ss-pertuzumab is unavailable, randomly labelled 89Zr-pertuzumab PET will be allowed to make HER2 PET imaging available for our patients. Once 89Zr-ss-pertuzumab is available, then patients will be imaged with 89Zr-ss-pertuzumab and randomly labelled 89Zr-pertuzumab will no longer be used.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate clinical safety of 89Zr-ss-pertuzumab	CTCAE Version 5 will be utilized for toxicity evaluation	Up to 20 months

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Randy Yeh, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2020
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): November 30, 2024

Study Registration Dates

• First Submitted: December 30, 2020
• First Submitted That Met QC Criteria: December 30, 2020
• First Posted (Actual): January 5, 2021

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Memorial Sloan Kettering Cancer Center; HER2-positive Metastatic Breast Cancer; HER-2 Protein Overexpression; HER-2 Positive Malignant Carcinoma of Breast; 3+ HER2 IHC; 2+ HER2 IHC; 20-275; HER2-positive primary malignancy; Zr-ss-Pertuzumab
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Antineoplastic Agents; Antineoplastic Agents, Immunological; Pertuzumab
• Other Study ID Numbers: 20-275

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No