RECRUITING
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Testing a New Imaging Agent to Identify Cancer
The purpose of this study is to see whether 89Zr-ss-pertuzumab is safe in people with HER2+ cancer.
Conditions:
🦠 HER-2 Positive Malignant Carcinoma of Breast 🦠 HER-2 Protein Overexpression 🦠 HER2-positive Metastatic Breast Cancer
🗓️ Study Start (Actual) 30 November 2020
🗓️ Primary Completion (Estimated) 30 November 2024
✅ Study Completion (Estimated) 30 November 2024
👥 Enrollment (Estimated) 60
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE1
Locations:
📍 Newport Beach, California, United States
📍 Basking Ridge, New Jersey, United States
📍 Middletown, New Jersey, United States
📍 Montvale, New Jersey, United States
📍 Commack, New York, United States
📍 Harrison, New York, United States
📍 New York, New York, United States
📍 Rockville Centre, New York, United States
More locations available...

📋 Eligibility Criteria

Description

    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)
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 30 December 2020
  • First Submitted that Met QC Criteria 30 December 2020
  • First Posted 5 January 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 15 April 2024
  • Last Update Posted 16 April 2024
  • Last Verified April 2024
I'm interested ...!!