Status:
ACTIVE_NOT_RECRUITING
Testing a New Imaging Agent to Identify Cancer
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
HER-2 Positive Malignant Carcinoma of Breast
HER-2 Protein Overexpression
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to see whether 89Zr-ss-pertuzumab is safe in people with HER2+ cancer.
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
November 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04692831
Start Date
November 30 2020
End Date
November 30 2026
Last Update
April 20 2025
Active Locations (8)
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1
PATTY AND GEORGE HOAG CANCER CENTER (Data or Specimen Analysis Only)
Newport Beach, California, United States, 92663
2
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
3
Memorial Sloan Kettering Monmouth (Limited protocol activities)
Middletown, New Jersey, United States, 07748
4
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645