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Active (not recruiting) Phase 1 NCT04692831

Testing a New Imaging Agent to Identify Cancer

Phase 1 – testing safety in a small group of people
Conditions: HER-2 Positive Malignant Carcinoma of Breast HER-2 Protein Overexpression HER2-positive Metastatic Breast Cancer

Sponsor: Memorial Sloan Kettering Cancer Center

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Overview
The purpose of this study is to see whether 89Zr-ss-pertuzumab is safe in people with HER2+ cancer.
Who can participate
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)
Interventions
89Zr-ss-pertuzumab PET/CT
COMBINATION_PRODUCT
Locations 8
United States (8)
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge , New Jersey
Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)
Commack , New York
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison , New York
Memorial Sloan Kettering Monmouth (Limited protocol activities)
Middletown , New Jersey
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale , New Jersey
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York , New York
PATTY AND GEORGE HOAG CANCER CENTER (Data or Specimen Analysis Only)
Newport Beach , California
Memorial Sloan Kettering Nassau (Limited Protocol Activites)
Rockville Centre , New York
Technical details
Status
Active (not recruiting)
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
30.11.2020
Completion date
30.11.2026
Registry ID
NCT04692831
Source
clinicaltrials.gov
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