Testing a New Imaging Agent to Identify Cancer

Phase 1

Active, not recruiting

• Conditions: HER-2 Protein Overexpression; HER2-positive Metastatic Breast Cancer; HER-2 Positive Malignant Carcinoma of Breast
• Interventions: Combination Product: 89Zr-ss-pertuzumab PET/CT

• Registration Number: NCT04692831
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-30
• Study First Submitted: 2020-12-30
• Study First Submitted QC: 2020-12-30
• Study First Posted: 2021-01-05
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-16
• Last Update Posted: 2025-04-20
• Primary Completion: 2026-11-30
• Study Completion: 2026-11-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HER2-low malignancy	89Zr-ss-pertuzumab PET/CT	Participants will have a diagnosis of HER2-low malignancy
HER2-positive malignancy	89Zr-ss-pertuzumab PET/CT	Participants will have a diagnosis of HER2-positive malignancy

Primary Outcome Measures

Name	Time	Method
Evaluate clinical safety of 89Zr-ss-pertuzumab	Up to 20 months	CTCAE Version 5 will be utilized for toxicity evaluation

Trial Locations

Locations (8)

PATTY AND GEORGE HOAG CANCER CENTER (Data or Specimen Analysis Only); 🇺🇸 Newport Beach, California, United States

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities); 🇺🇸 Basking Ridge, New Jersey, 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 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 Cancer Center (All Protocol Activities); 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activites); 🇺🇸 Rockville Centre, New York, United States