HER2-positive Metastatic Breast Cancer Clinical Trial
Official title:
Imaging of HER2-expressing Cancer With Site-Specifically Labeled 89Zr-ss-Pertuzumab
The purpose of this study is to see whether 89Zr-ss-pertuzumab is safe in people with HER2+ cancer.
| Status | Recruiting |
| Enrollment | 60 |
| Est. completion date | November 30, 2024 |
| Est. primary completion date | November 30, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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) |
| Country | Name | City | State |
|---|---|---|---|
| United States | Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) | Basking Ridge | 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 Monmouth (Limited protocol activities) | Middletown | New Jersey |
| United States | Memorial Sloan Kettering Bergen (Limited Protocol Activities) | Montvale | New Jersey |
| United States | Memorial Sloan Kettering Cancer Center (All Protocol Activities) | New York | New York |
| United States | PATTY AND GEORGE HOAG CANCER CENTER (Data or Specimen Analysis Only) | Newport Beach | California |
| United States | Memorial Sloan Kettering Nassau (Limited Protocol Activites) | Rockville Centre | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Memorial Sloan Kettering Cancer Center | National Institutes of Health (NIH) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Evaluate clinical safety of 89Zr-ss-pertuzumab | CTCAE Version 5 will be utilized for toxicity evaluation | Up to 20 months |
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