HER-2 Positive Malignant Carcinoma of Breast, HER2-positive Metastatic Breast Cancer, HER-2 Protein Overexpression
Conditions
Keywords
HER-2 Positive Malignant Carcinoma of Breast, HER-2 Protein Overexpression, HER2-positive Metastatic Breast Cancer, 3+ HER2 IHC, 2+ HER2 IHC, 20-275, Memorial Sloan Kettering Cancer Center, HER2-positive primary malignancy, Zr-ss-Pertuzumab
Brief summary
The purpose of this study is to see whether 89Zr-ss-pertuzumab is safe in people with HER2+ cancer.
Interventions
COMBINATION_PRODUCT89Zr-ss-pertuzumab PET/CT
Patients will receive 89Zr-ss-pertuzumab. 89Zr-ss-pertuzumab PET/CT images will be reconstructed using iterative reconstruction and displayed in multiplanar reconstruction. In the event that 89Zr-ss-pertuzumab is unavailable, randomly labelled 89Zr-pertuzumab PET will be allowed to make HER2 PET imaging available for our patients. Once 89Zr-ss-pertuzumab is available, then patients will be imaged with 89Zr-ss-pertuzumab and randomly labelled 89Zr-pertuzumab will no longer be used.
Sponsors
Memorial Sloan Kettering Cancer Center
National Institutes of Health (NIH)
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
This protocol will perform a first-in-human imaging trial of 89Zr-ss-pertuzumab.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate clinical safety of 89Zr-ss-pertuzumab | Up to 20 months | CTCAE Version 5 will be utilized for toxicity evaluation |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSomali Gavane, MD
Memorial Sloan Kettering Cancer Center
Outcome results
None listed