Testing a New Imaging Agent to Identify Cancer

Running, not enrolling · Phase 1

Conditions studied: HER-2 Positive Malignant Carcinoma of Breast, HER-2 Protein Overexpression, HER2-positive Metastatic Breast Cancer

In brief

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

Key facts

Study ID

NCT04692831

Run by

Memorial Sloan Kettering Cancer Center

People needed

60

Starts

2020-11-30

Expected to finish

2027-11-30

Last updated by the study team

2026-07-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) — Basking Ridge, New Jersey, United States
• Memorial Sloan Kettering Monmouth (Limited protocol activities) — Middletown, New Jersey, United States
• Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale, New Jersey, United States
• Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity) — Commack, New York, United States
• Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison, New York, United States
• Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York, New York, United States
• Memorial Sloan Kettering Nassau (Limited Protocol Activites) — Rockville Centre, New York, United States

Full record on ClinicalTrials.gov

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