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89Zr-ss-pertuzumab Imaging for Breast Cancer

Phase 1
Recruiting
Led By Randy Yeh, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 years or greater
HER2 positivity defined according to American Society of Clinical Oncology guidelines or ERBB2 amplification on next generation sequencing
Must not have
Patients who cannot undergo PET/CT due to weight limits (over 450 pounds)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 20 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether a new cancer drug is safe for people with HER2+ cancer.

Who is the study for?
This trial is for adults over 18 with HER2+ breast cancer, as defined by specific medical guidelines or genetic testing. Participants must have at least one detectable cancer lesion and be in fair to good physical condition (ECOG 0-2). Pregnant or breastfeeding individuals, those with certain kidney or liver conditions, a life expectancy under three months, or who exceed the weight limit for PET/CT scans cannot join.
What is being tested?
The study is evaluating the safety of a new imaging agent called 89Zr-ss-pertuzumab used in PET/CT scans to identify cancer in patients with HER2+ breast cancer. It aims to determine if this agent can effectively highlight tumors during imaging.
What are the potential side effects?
While not explicitly listed here, potential side effects may include reactions at the injection site, allergic responses to the imaging agent, and discomfort from undergoing PET/CT scans.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My cancer is HER2 positive based on specific guidelines or tests.
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My cancer has low HER2 levels, confirmed by specific tests.
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My cancer is confirmed to be HER2-positive or HER2-low.
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I can take care of myself and perform daily activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I weigh over 450 pounds and cannot have a PET/CT scan.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 20 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 20 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Evaluate clinical safety of 89Zr-ss-pertuzumab

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: HER2-positive malignancyExperimental Treatment1 Intervention
Participants will have a diagnosis of HER2-positive malignancy
Group II: HER2-low malignancyExperimental Treatment1 Intervention
Participants will have a diagnosis of HER2-low malignancy

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,979 Previous Clinical Trials
600,018 Total Patients Enrolled
208 Trials studying Breast Cancer
82,963 Patients Enrolled for Breast Cancer
National Institutes of Health (NIH)NIH
2,842 Previous Clinical Trials
8,173,090 Total Patients Enrolled
47 Trials studying Breast Cancer
110,252 Patients Enrolled for Breast Cancer
Randy Yeh, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
2 Previous Clinical Trials
84 Total Patients Enrolled
2 Trials studying Breast Cancer
84 Patients Enrolled for Breast Cancer

Media Library

89Zr-ss-pertuzumab PET/CT Clinical Trial Eligibility Overview. Trial Name: NCT04692831 — Phase 1
Breast Cancer Research Study Groups: HER2-positive malignancy, HER2-low malignancy
Breast Cancer Clinical Trial 2023: 89Zr-ss-pertuzumab PET/CT Highlights & Side Effects. Trial Name: NCT04692831 — Phase 1
89Zr-ss-pertuzumab PET/CT 2023 Treatment Timeline for Medical Study. Trial Name: NCT04692831 — Phase 1
~12 spots leftby Dec 2025
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