Testing a New Imaging Agent to Identify Cancer

Last updated: May 12, 2026
Sponsor: Memorial Sloan Kettering Cancer Center
Overall Status: Active - Not Recruiting

Phase

1

Condition

Breast Cancer - Her2 Positive

Treatment

89Zr-ss-pertuzumab PET/CT

Clinical Study ID

NCT04692831
20-275
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 protocolenrollment

  • Age 18 years or greater

  • ECOG performance of 0-2

Exclusion

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 Design

Total Participants: 60
Treatment Group(s): 1
Primary Treatment: 89Zr-ss-pertuzumab PET/CT
Phase: 1
Study Start date:
November 30, 2020
Estimated Completion Date:
November 30, 2026

Connect with a study center

  • PATTY AND GEORGE HOAG CANCER CENTER (Data or Specimen Analysis Only)

    Newport Beach, California 92663
    United States

    Site Not Available

  • Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

    Basking Ridge, New Jersey 07920
    United States

    Site Not Available

  • Memorial Sloan Kettering Monmouth (Limited protocol activities)

    Middletown, New Jersey 07748
    United States

    Site Not Available

  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)

    Montvale, New Jersey 07645
    United States

    Site Not Available

  • Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)

    Commack, New York 11725
    United States

    Site Not Available

  • Memorial Sloan Kettering Westchester (Limited Protocol Activities)

    Harrison, New York 10604
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)

    New York, New York 10065
    United States

    Site Not Available

  • Memorial Sloan Kettering Nassau (Limited Protocol Activites)

    Rockville Centre, New York 11553
    United States

    Site Not Available

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