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PET Scan with Copper Cu 64-DOTA-Trastuzumab for Breast Cancer

N/A
Waitlist Available
Led By Joanne Mortimer
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours after injection of 64 cu-dota-trastuzumab
Awards & highlights

Summary

This trial is looking at using copper Cu 64-DOTA-trastuzumab-labeled PET to help plan better treatment for women with HER2-positive breast cancer.

Who is the study for?
This trial is for women with advanced HER2-positive breast cancer that has spread beyond the original tumor and axilla. They must have a biopsy confirming metastasis, not received trastuzumab in the last 2 months, and have at least one non-liver metastatic site over 2 cm. Participants need normal heart function and can't be pregnant or unable to consent.
What is being tested?
The study tests a PET scan using copper Cu 64-DOTA-trastuzumab to see if it helps plan better treatments for breast cancer. It includes laboratory biomarker analysis, immunohistochemistry staining method, mutation analysis, and biopsies to assess the cancer's characteristics.
What are the potential side effects?
While specific side effects are not listed for this diagnostic trial, potential risks may include reactions to tracers used in PET scans such as discomfort or bruising from injections, allergic reactions or exposure to radiation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours after injection of 64 cu-dota-trastuzumab
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours after injection of 64 cu-dota-trastuzumab for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Tumor Uptake of 64Cu-DOTA-trastuzumab After 24 Hours
Tumor Uptake of 64Cu-DOTA-trastuzumab After 48 Hours

Trial Design

1Treatment groups
Experimental Treatment
Group I: Arm IExperimental Treatment6 Interventions
PART ONE: Patients are randomized to 1 of 3 dose levels. Patients undergo a PET scan 24-48 hours after injection of copper Cu 64-DOTA-trastuzumab. PART TWO: Patients undergo a PET scan 24-48 hours after injection of copper Cu 64-DOTA-trastuzumab.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
mutation analysis
2002
Completed Phase 2
~3190
Biopsy
2014
Completed Phase 4
~1090
positron emission tomography
2010
Completed Phase 2
~1370

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
596 Previous Clinical Trials
1,923,519 Total Patients Enrolled
42 Trials studying Breast Cancer
6,631 Patients Enrolled for Breast Cancer
Joanne MortimerPrincipal InvestigatorCity of Hope Medical Center
6 Previous Clinical Trials
157 Total Patients Enrolled

Media Library

Breast Cancer Clinical Trial 2023: laboratory biomarker analysis Highlights & Side Effects. Trial Name: NCT01093612 — N/A
~1 spots leftby Sep 2025
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