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Active Not Recruiting
NCT04692831
Testing a New Imaging Agent to Identify Cancer
Conditions: HER-2 Positive Malignant Carcinoma of Breast, HER-2 Protein Overexpression, HER2-positive Metastatic Breast Cancer
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 60
Sponsor: Memorial Sloan Kettering Cancer Center
Location: Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) Basking Ridge New Jersey
Summary
The purpose of this study is to see whether 89Zr-ss-pertuzumab is safe in people with HER2+ cancer.
Eligibility Criteria
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)
Source: ClinicalTrials.gov (NCT04692831). StuddyBuddy aggregates publicly available trial information.