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Investigational Scan for Breast Cancer
Phase 4
Recruiting
Led By Joanne E 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
Women with documented metastatic HER2 positive breast cancer (American Society of Clinical Oncology [ASCO] College of American Pathologist [CAP] guidelines) who have brain metastases
Planned therapy with fam-trastuzumab deruxtecan
Timeline
Screening 3 weeks
Treatment Varies
Follow Up until disease progression or death, up to 5 years.
Awards & highlights
Study Summary
This trial is testing a new scan to see if it can find breast cancer that has spread to the brain and if it can predict how well patients will respond to standard chemotherapy.
Who is the study for?
This trial is for adults over 18 with HER2+ breast cancer that has spread to the brain. They must have a certain level of hemoglobin, kidney function, heart function, and blood cell counts. Patients already planning treatment with fam-trastuzumab deruxtecan can join. Those with serious recent heart issues or lung disease needing steroids cannot participate.Check my eligibility
What is being tested?
The study is testing a new scan combining PET and MRI using a tracer called 64Cu-DOTA-Trastuzumab to see if it's better at detecting HER2+ breast cancer in the brain and predicting response to standard chemotherapy (trastuzumab deruxtecan).See study design
What are the potential side effects?
Potential side effects may include reactions related to the tracer used in imaging such as allergic reactions or discomfort at injection site. Standard chemotherapy side effects like fatigue, nausea, hair loss could occur from trastuzumab deruxtecan.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a woman with HER2 positive breast cancer that has spread to my brain.
Select...
I am scheduled to receive fam-trastuzumab deruxtecan treatment.
Select...
I have cancer that has spread to the lining of my brain and spinal cord.
Select...
My kidneys are functioning well enough to clear waste.
Select...
I am older than 18 years.
Select...
I can take care of myself and am up and about more than 50% of my waking hours.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ until disease progression or death, up to 5 years.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~until disease progression or death, up to 5 years.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Comparison of average min SUVmax values in responders versus non-responders.
Percent of patients with quantifiable 64Cu-DOTA-trastuzumab PET uptake
Secondary outcome measures
Progression-free Survival
Side effects data
From 2014 Phase 4 trial • 32 Patients • NCT0130172959%
Leukopenia
56%
Neutropenia
34%
Hypoaesthesia
31%
Agranulocytosis
22%
Alopecia
22%
Asthenia
19%
Pyrexia
16%
Nail disorder
16%
Oedema peripheral
16%
Diarrhoea
16%
Hypophagia
13%
Neurotoxicity
13%
Alanine aminotransferase increased
13%
Cough
13%
Vomting
9%
Headache
9%
Musculoskeletal pain
9%
Aspartate aminotransferase increased
9%
Chest discomfort
9%
Rash
9%
Pigmentation disorder
9%
Nausea
9%
Bone marrow failure
9%
Anaemia
6%
Transaminases increased
6%
Insomnia
6%
Constipation
6%
Mouth ulceration
6%
Nasopharyngitis
6%
Paronychia
6%
Flushing
6%
Face oedema
6%
Thrombocytopenia
3%
Infection
3%
Upper respiratory tract infection
3%
Completed suicide
3%
Cataract
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trastuzumab
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment ( 64Cu-DOTA-trastuzumab PET/MRI)Experimental Treatment5 Interventions
Patients receive trastuzumab IV over 15 minutes on day 0. Patients then receive 64Cu-DOTA-trastuzumab IV and then undergo PET/MRI scan on day 1. Patients undergo repeat brain MRI every 6 weeks for 24 weeks and then every 9 weeks until disease progression. Patients then receive trastuzumab deruxtecan IV every 21 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trastuzumab
2014
Completed Phase 4
~5190
Trastuzumab Deruxtecan
2021
Completed Phase 3
~510
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Positron Emission Tomography
2008
Completed Phase 2
~2240
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
13,662 Previous Clinical Trials
40,926,063 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer
Joanne E MortimerPrincipal InvestigatorCity of Hope Medical Center
2 Previous Clinical Trials
334 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am scheduled to receive fam-trastuzumab deruxtecan treatment.I have a lung condition treated with steroids but it's not caused by an infection.Your absolute neutrophil count is higher than 1.5 x 10^9 per liter.I am a woman with HER2 positive breast cancer that has spread to my brain.I have had treatment for brain disease, but still have a lesion larger than 1.5 cm.I have a serious eye condition affecting the cornea.I haven't had a heart attack or serious heart issues in the last 6 months.I need urgent treatment for cancer that has spread to my brain.Your hemoglobin levels are higher than 9 grams per deciliter.I have cancer that has spread to the lining of my brain and spinal cord.My kidneys are functioning well enough to clear waste.Your heart's pumping function is too strong.I am older than 18 years.Your platelet count is higher than 100 billion per liter.Your total bilirubin levels should be less than three times the upper limit of normal.I can take care of myself and am up and about more than 50% of my waking hours.Your AST and ALT levels in the blood should be less than 5 times the upper limit of normal.Your blood clotting time is faster than normal.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment ( 64Cu-DOTA-trastuzumab PET/MRI)
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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 still opportunities to participate in this clinical investigation?
"Affirmative. Evidentiary information on clinicaltrials.gov demonstrates that this medical research, which was initially posted on January 16th 2023, is actively searching for applicants. 10 qualified patients are needed from one location."
Answered by AI
Does Trastuzumab pose significant health risks to patients?
"The safety rating of trastuzumab is a 3 given the fact that this drug has already been approved and is currently in Phase 4 trials."
Answered by AI
How many participants have joined this clinical investigation?
"Affirmative. According to the information held on clinicaltrials.gov, this research study is actively recruiting participants after being first posted on January 16th 2023 and last updated November 22nd 2022. The trial is looking for 10 volunteers from a single medical centre."
Answered by AI
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