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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
Summary
This trial uses a special scan to track a drug in patients with advanced HER2 positive breast cancer. The scan helps predict if the treatment will be effective by showing how much of the drug reaches the tumors. Patients are then treated with a specific cancer drug.
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.
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.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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
trastuzumab
2002
Completed Phase 3
~1790
positron emission tomography
2010
Completed Phase 2
~1370
fludeoxyglucose F 18
2005
Completed Phase 3
~3970
computed tomography
2010
Completed Phase 2
~1200
ado-trastuzumab emtansine
2014
Completed Phase 1
~20
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
HER2-targeted therapies, such as trastuzumab and ado-trastuzumab emtansine, are designed to treat HER2-positive breast cancer by targeting the HER2 protein on cancer cells. Trastuzumab is a monoclonal antibody that binds to the HER2 receptor, inhibiting cell proliferation and marking the cells for destruction by the immune system.
Ado-trastuzumab emtansine combines trastuzumab with a chemotherapy drug, delivering the cytotoxic agent directly to the cancer cells, thereby increasing the treatment's efficacy while minimizing systemic side effects. These targeted approaches are significant for patients as they offer more precise and effective treatment options, potentially leading to better outcomes and fewer side effects compared to traditional chemotherapy.
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Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
596 Previous Clinical Trials
1,923,527 Total Patients Enrolled
43 Trials studying Breast Cancer
6,649 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,990 Total Patients Enrolled
945 Trials studying Breast Cancer
1,543,964 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.
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