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Monoclonal Antibodies
Copper Cu 64-DOTA-Trastuzumab PET for HER2 Positive 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 up to 1 year
Awards & highlights
Study Summary
This trial will study how well copper Cu 64-DOTA-trastuzumab PET works in predicting response to ado-trastuzumab emtansine in patients with HER2 positive breast cancer.
Who is the study for?
This trial is for women with HER2 positive metastatic breast cancer that has spread to the lung, liver, soft-tissue or bone. Participants must be able to consent, have a performance status of 0-2, a recent biopsy confirming HER2 positivity without subsequent HER2 therapy, normal heart function and at least one large enough metastasis. Pregnant women and those who've had trastuzumab within 6 weeks are excluded.Check my eligibility
What is being tested?
The study tests if Copper Cu 64-DOTA-trastuzumab PET scans can predict the effectiveness of ado-trastuzumab emtansine treatment in patients. It involves attaching a radioactive substance to chemotherapy drug trastuzumab and using PET scans to track its movement in the body.See study design
What are the potential side effects?
Potential side effects include reactions related to radioactivity exposure from PET scans such as nausea or allergic reactions, as well as typical chemotherapy-related issues like fatigue, lowered blood cell counts leading to increased infection risk, heart problems and possible organ damage.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Relationship Between Average Tumor Uptake of Copper Cu 64-DOTA-trastuzumab as Measured by PET and Patient Best Response
Relationship Between Tumor Minimum Uptake of Copper Cu 64-DOTA-trastuzumab as Measured by PET and Patient Best Response
Trial Design
1Treatment groups
Experimental Treatment
Group I: Diagnostic (copper Cu 64-DOTA-trastuzumab PET)Experimental Treatment7 Interventions
Patients undergo whole body fludeoxyglucose F 18 PET/CT. Patients then receive trastuzumab IV over 15 minutes immediately before receiving copper Cu 64-DOTA-trastuzumab IV and then undergo PET scans at 24 and 48 hours. Patients then receive ado-trastuzumab emtansine IV every 3 weeks until complete response or disease progression at the discretion of the treating oncologist. Patients undergo restaging by whole body fludeoxyglucose F 18 PET/CT every 6 weeks after initiation of treatment until disease progression.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
positron emission tomography
2010
Completed Phase 2
~1370
ado-trastuzumab emtansine
2014
Completed Phase 1
~20
fludeoxyglucose F 18
2005
Completed Phase 3
~3970
computed tomography
2010
Completed Phase 2
~1200
trastuzumab
2002
Completed Phase 3
~1790
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
565 Previous Clinical Trials
1,921,450 Total Patients Enrolled
43 Trials studying Breast Cancer
6,649 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,143 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer
Joanne MortimerPrincipal InvestigatorCity of Hope Medical Center
6 Previous Clinical Trials
165 Total Patients Enrolled
1 Trials studying Breast Cancer
18 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am able to care for myself and perform daily activities.My heart pumps well, with an ejection fraction of 50% or higher.I haven't taken trastuzumab in the last 6 weeks.I have another type of cancer besides skin cancer.My cancer has spread to my lung, liver, soft tissue, or bone.My cancer has not spread to areas larger than 20 mm.My heart pumps blood normally.I have not taken trastuzumab in the last 36 days.I am not a candidate for ado-trastuzumab-emtansine treatment.I had a biopsy within the last 28 days or up to 6 months if HER2-positive and untreated.I may need a lower dose to start my treatment.I have a cancer spread that is at least 20 mm wide.My cancer is HER2 positive based on specific tests.I am a woman with breast cancer that has spread beyond the original area and underarm.Women who can have children need to have a negative pregnancy test.
Research Study Groups:
This trial has the following groups:- Group 1: Diagnostic (copper Cu 64-DOTA-trastuzumab PET)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there opportunities for participants in this clinical trial at present?
"As indicated on clinicaltrials.gov, the initial posting of this trial was on July 1st 2015 and it has since been updated for the last time on June 29th 2022. Sadly, patient recruitment is not currently taking place; however, 3084 other trials are still enlisting participants at present."
Answered by AI
What circumstances generally warrant a Diagnostic (copper Cu 64-DOTA-trastuzumab PET) scan?
"Diagnostic (copper Cu 64-DOTA-trastuzumab PET) is typically employed for the treatment of breast cancer. Yet, it can also be utilized in cases where a high risk of recurrence exists, as first line treatment or when operative surgery is needed."
Answered by AI
How many individuals are included in this experiment?
"This particular trial has ceased recruitment. It was first posted on July 1st 2015 and most recently updated June 29th 2022. For those looking to join other studies, 2876 clinical trials are actively seeking participants with HER2-positive breast cancer and 208 for Diagnostic (copper Cu 64-DOTA-trastuzumab PET)."
Answered by AI
Has there been any precedent set for Diagnostic (copper Cu 64-DOTA-trastuzumab PET) regarding its use in clinical trials?
"Currently, 208 trials are examining Diagnostic (copper Cu 64-DOTA-trastuzumab PET) with 53 in the final phase of testing. Atlanta, Georgia is home to several studies while 16589 other locations have a research presence for this diagnostic process."
Answered by AI
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