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Active, Not Recruiting

NCT Number: NCT04692831

Testing a New Imaging Agent to Identify Cancer

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

HER-2 Positive Malignant Carcinoma of Breast HER-2 Protein Overexpression HER2-Positive Metastatic Breast Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

89Zr-ss-pertuzumab PET/CT

Combination Product

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.

Primary outcomes

  1. Evaluate clinical safety of 89Zr-ss-pertuzumab

    Time frame: Up to 20 months

    CTCAE Version 5 will be utilized for toxicity evaluation

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Jan 5, 2021
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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