Trial Outcomes & Findings for Pilot Imaging Study With 89Zr-Trastuzumab in HER2-positive Metastatic Breast Cancer Patients (NCT NCT01420146)
NCT ID: NCT01420146
Last Updated: 2017-04-18
Results Overview
A visual 'patient-based' classification capturing the whole disease burden was developed by using a side-by-side display, comparing baseline FDG-PET/CT(showing all FDG-positive mets independent of their HER2-imaging status) \& day4 HER2-PET/CT. Pts were grouped into 4 HER2-PET/CT patterns according to the proportion of FDG avid tumour load showing relevant 89Zr-T uptake. Pattern A: entire tumor load showed pertinent tracer uptake; B: dominant part of tumour load showed tracer uptake; C: minor part of tumor load showed tracer uptake; D: entire tumor load lacked tracer uptake. Patterns A+B='HER2-positive' \& C+D='HER2-negative'. In the 20 pts: 4 pts were classified "A", 5"B", 1"C" \& 10"D". This classification indicates substantial heterogeneity of 89Zr-T uptake within this so called 'HER2-positive' pt population. After dichotomization, 11(55%) pts were considered as HER2-PET/CT negative. Furthermore, HER2-PET/CT revealed intrapatient heterogeneity of tumour uptake(pts classified B or C).
COMPLETED
PHASE1
20 participants
4 years
2017-04-18
Participant Flow
Participant milestones
| Measure |
Zr89-trastuzumab PET/CT
Zr89-trastuzumab (trastuzumab labelled with zirconium 89) for PET/CT single arm
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pilot Imaging Study With 89Zr-Trastuzumab in HER2-positive Metastatic Breast Cancer Patients
Baseline characteristics by cohort
| Measure |
Zr89-trastuzumab PET/CT
n=20 Participants
Zr89-trastuzumab (trastuzumab labelled with zirconium 89) for PET/CT single arm
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
Belgium
|
20 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 4 yearsA visual 'patient-based' classification capturing the whole disease burden was developed by using a side-by-side display, comparing baseline FDG-PET/CT(showing all FDG-positive mets independent of their HER2-imaging status) \& day4 HER2-PET/CT. Pts were grouped into 4 HER2-PET/CT patterns according to the proportion of FDG avid tumour load showing relevant 89Zr-T uptake. Pattern A: entire tumor load showed pertinent tracer uptake; B: dominant part of tumour load showed tracer uptake; C: minor part of tumor load showed tracer uptake; D: entire tumor load lacked tracer uptake. Patterns A+B='HER2-positive' \& C+D='HER2-negative'. In the 20 pts: 4 pts were classified "A", 5"B", 1"C" \& 10"D". This classification indicates substantial heterogeneity of 89Zr-T uptake within this so called 'HER2-positive' pt population. After dichotomization, 11(55%) pts were considered as HER2-PET/CT negative. Furthermore, HER2-PET/CT revealed intrapatient heterogeneity of tumour uptake(pts classified B or C).
Outcome measures
| Measure |
Zr89-trastuzumab PET/CT
n=20 Participants
Zr89-trastuzumab (trastuzumab labelled with zirconium 89) for PET/CT single arm
|
|---|---|
|
Test the Diagnostic Accuracy of the HER2 Imaging Using the Labelled Monoclonal Antibody Trastuzumab by Correlating the HER2 PET/CT Imaging With the FDG-PET/CT and Molecular Characterization of Tumor Samples With Discordant Image Findings
Pattern A
|
4 Participants
|
|
Test the Diagnostic Accuracy of the HER2 Imaging Using the Labelled Monoclonal Antibody Trastuzumab by Correlating the HER2 PET/CT Imaging With the FDG-PET/CT and Molecular Characterization of Tumor Samples With Discordant Image Findings
Pattern B
|
5 Participants
|
|
Test the Diagnostic Accuracy of the HER2 Imaging Using the Labelled Monoclonal Antibody Trastuzumab by Correlating the HER2 PET/CT Imaging With the FDG-PET/CT and Molecular Characterization of Tumor Samples With Discordant Image Findings
Pattern C
|
1 Participants
|
|
Test the Diagnostic Accuracy of the HER2 Imaging Using the Labelled Monoclonal Antibody Trastuzumab by Correlating the HER2 PET/CT Imaging With the FDG-PET/CT and Molecular Characterization of Tumor Samples With Discordant Image Findings
Pattern D
|
10 Participants
|
SECONDARY outcome
Timeframe: blood sample at 5, 15, 30, 60 minutes, 1 day, 2 days and 4 or 6 days after tracer injection. Images : Day 0, Day 2 and Day 4 or 6Time activity curve of normal organ and tumor lesions: pharmacokinetic
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: within 60 min before tracer injectionevaluate the concentration of circulating HER2 extracellular domain in the blood and study his possible role as on imaging quality
Outcome measures
Outcome data not reported
Adverse Events
Zr89-trastuzumab PET/CT
Serious adverse events
| Measure |
Zr89-trastuzumab PET/CT
n=20 participants at risk
Zr89-trastuzumab PET/CT single arm
Zr89-trastuzumab: trastuzumab labelled with zirconium 89 for PET/CT
|
|---|---|
|
General disorders
Nausea - Pyrexia - Myalgia
|
5.0%
1/20 • Number of events 3
|
Other adverse events
| Measure |
Zr89-trastuzumab PET/CT
n=20 participants at risk
Zr89-trastuzumab PET/CT single arm
Zr89-trastuzumab: trastuzumab labelled with zirconium 89 for PET/CT
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
2/20 • Number of events 3
|
|
General disorders
Chills
|
20.0%
4/20 • Number of events 4
|
|
General disorders
Hypersensitivity
|
5.0%
1/20 • Number of events 1
|
|
General disorders
Influenza like illness
|
5.0%
1/20 • Number of events 1
|
|
General disorders
Pyrexia
|
20.0%
4/20 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.0%
1/20 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.0%
1/20 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.0%
1/20 • Number of events 1
|
|
Nervous system disorders
Headache
|
10.0%
2/20 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.0%
1/20 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.0%
1/20 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place