Testing a New Imaging Agent to Identify Cancer

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Active, not recruiting; Phase 1

Conditions: HER2-positive Metastatic Breast Cancer; HER-2 Protein Overexpression; HER-2 Positive Malignant Carcinoma of Breast

Treatments: Combination Product: 89Zr-ss-pertuzumab PET/CT

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04692831

20-275

Details and patient eligibility

About

The purpose of this study is to see whether 89Zr-ss-pertuzumab is safe in people with HER2+ cancer.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

HER2-positive malignancy

Experimental group

Description:

Participants will have a diagnosis of HER2-positive malignancy

Treatment:

Combination Product: 89Zr-ss-pertuzumab PET/CT

HER2-low malignancy

Experimental group

Description:

Participants will have a diagnosis of HER2-low malignancy

Treatment:

Combination Product: 89Zr-ss-pertuzumab PET/CT