Фаза 1 – тестване на безопасността при малка група хора
Заболявания:
HER-2 Positive Malignant Carcinoma of Breast
HER-2 Protein Overexpression
HER2-positive Metastatic Breast Cancer
Спонсор: Memorial Sloan Kettering Cancer Center
Налично на:
БГ
Обобщение
The purpose of this study is to see whether 89Zr-ss-pertuzumab is safe in people with HER2+ cancer.
Кой може да участва
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)
Интервенции
89Zr-ss-pertuzumab PET/CT
COMBINATION_PRODUCT
Места на провеждане
8
САЩ (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)