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HER2-PET Imaging for Breast Cancer
Phase 1 & 2
Recruiting
Led By Éric E Turcotte, MD, FRCPC
Research Sponsored by Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
HER2-low metastatic breast cancer
At least 18 years old
Must not have
Hepatic disorders such as cirrhosis, hepatitis, or any other liver condition judged as significant by the treating physician and that could impair the biliary excretion of 89Zr-trastuzumab
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to use a new imaging method with a radioactive substance attached to an antibody to detect HER2-positive cancers, including those with low levels of HER2 expression. The goal is to improve the
Eligible Conditions
- Breast cancer
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My breast cancer is HER2-low and has spread.
Select...
I am 18 years old or older.
Select...
I can lie on my back for at least 30 minutes without discomfort.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have significant liver conditions that could affect drug processing.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Evaluate 89Zr-trastuzumab PET imaging in a HER2-low breast cancer patient cohort
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%
Alanine aminotransferase increased
13%
Neurotoxicity
13%
Cough
13%
Vomting
9%
Musculoskeletal pain
9%
Headache
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: 89Zr-trastuzumab PET/CT imaging of HER2-low patientsExperimental Treatment1 Intervention
Following their inform consent, HER2-low breast cancer patients will be invited to come to our research center twice. The first time patients will receive an intravenous dose of 10-50mg trastuzumab, followed by a 0.5 MBq/kg (max 60 MBq) dose of 89Zr-trastuzumab. Patients will come back for a second visit 3-6 days later to get their PET/CT imaging examination. Images will be evaluated by two PET-trained physicians, and analysed by an imaging scientist.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
89Zr-trastuzumab
2014
N/A
~50
Find a Location
Who is running the clinical trial?
Centre de recherche du Centre hospitalier universitaire de SherbrookeLead Sponsor
62 Previous Clinical Trials
33,514 Total Patients Enrolled
Université de SherbrookeOTHER
307 Previous Clinical Trials
77,584 Total Patients Enrolled
Éric E Turcotte, MD, FRCPCPrincipal InvestigatorUniversité de Sherbrooke