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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 20 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Evaluate clinical safety of 89Zr-ss-pertuzumab

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
1,936 Previous Clinical Trials
588,838 Total Patients Enrolled
203 Trials studying Breast Cancer
81,103 Patients Enrolled for Breast Cancer
National Institutes of Health (NIH)NIH
2,701 Previous Clinical Trials
7,506,790 Total Patients Enrolled
50 Trials studying Breast Cancer
110,785 Patients Enrolled for Breast Cancer
Randy Yeh, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
54 Total Patients Enrolled
1 Trials studying Breast Cancer
54 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent is the population involved in this research endeavor?

"Affirmative, according to clinicaltrials.gov the trial is actively recruiting participants who were initially posted on November 30th 2020 and last edited September 13th 2022. At this time, 20 individuals are being recruited from two distinct sites."

Answered by AI

Has the FDA given authorization for 89Zr-ss-pertuzumab PET/CT imaging?

"Taking into account the limited amount of safety and efficacy data, our team at Power have assigned 89Zr-ss-pertuzumab PET/CT a score of 1 on their scale from 1 to 3."

Answered by AI

Has recruitment for this medical trial commenced?

"According to the records found on clinicaltrials.gov, enrollment for this medical research is ongoing. It was initially posted in November of 2020 and its details were most recently edited in September 2022."

Answered by AI

Is this a pioneering endeavor in its field?

"According to current information, there are 90 active studies involving 89Zr-ss-pertuzumab PET/CT across 1397 cities and 62 countries. This medical technology was first tested in 2008 when Hoffmann La Roche sponsored a Phase 2 trial that included 720 patients. Over the last 12 years, 69 different trials utilizing this method have been concluded."

Answered by AI

What previous experiments have included 89Zr-ss-pertuzumab PET/CT as one of their tools?

"The first study of 89Zr-ss-pertuzumab PET/CT occured in 2008 at SCRI Tennessee Oncology Chattanooga. Over the last 12 years, 69 trials have been concluded with 90 still underway; particularly, many are located around Newport Beach, California."

Answered by AI

To what maladies is 89Zr-ss-pertuzumab PET/CT commonly prescribed?

"89Zr-ss-pertuzumab PET/CT is usually employed to treat the therapeutic procedure in question, but can also provide relief from brca1 gene, inflammatory breast cancer (ibc), and malignant neoplasms."

Answered by AI
~9 spots leftby Nov 2024