Trial Outcomes & Findings for 89ZrTrastuzumab Breast Imaging With Positron Emission Tomography (NCT NCT02065609)
NCT ID: NCT02065609
Last Updated: 2022-10-13
Results Overview
Subjects medical record was followed for 30 days following 89Zr-Trastuzumab Administration for AE Assessment with AE being defined as Any unfavorable medical occurrence in a human subject who receives 89Zr-Trastuzumab and PET/CT imaging, including any abnormal sign, symptom, or disease. The event does not necessarily have to be causally related to injection of 89Zr-Trastuzumab or PET/CT imaging to qualify as an adverse event, just temporally related.
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
52 participants
Primary outcome timeframe
30 Days following 89Zr-Trastuzumab Administration
Results posted on
2022-10-13
Participant Flow
Study first enrollment occurred in February 2014 and closed to enrollment 31 December 2017. Subjects were recruited from those patients being seen by medical oncology at Siteman Cancer Center. Planned enrollment was 67 participants with a total of 52 subjects enrolled with evaluable data at the end of the grant period.
Participant milestones
| Measure |
Cohort 1
89Zr-Trastuzumab Human Dosimetry and Safety
89Zr-Trastuzumab Human Dosimetry and Safety: PET Imaging following administration of 89Zr labeled Trastuzumab for calculation of human dosimetry and overall safety
HER2 Positive Lesion Detection and Safety: Detection of HER2 Positive Breast Cancer with 89Zr Labeled Trastuzumab and PET imaging
|
Cohort 2: Lesion Detection and Safety
HER2 Positive Lesion Detection and Safety
89Zr-Trastuzumab Human Dosimetry and Safety: PET Imaging following administration of 89Zr labeled Trastuzumab for calculation of human dosimetry and overall safety
HER2 Positive Lesion Detection and Safety: Detection of HER2 Positive Breast Cancer with 89Zr Labeled Trastuzumab and PET imaging
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
40
|
|
Overall Study
COMPLETED
|
12
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
89ZrTrastuzumab Breast Imaging With Positron Emission Tomography
Baseline characteristics by cohort
| Measure |
Cohort 1
n=12 Participants
89Zr-Trastuzumab Human Dosimetry and Safety
89Zr-Trastuzumab Human Dosimetry and Safety: PET Imaging following administration of 89Zr labeled Trastuzumab for calculation of human dosimetry and overall safety
HER2 Positive Lesion Detection and Safety: Detection of HER2 Positive Breast Cancer with 89Zr Labeled Trastuzumab and PET imaging
|
Cohort 2: Lesion Detection and Safety
n=40 Participants
HER2 Positive Lesion Detection and Safety
89Zr-Trastuzumab Human Dosimetry and Safety: PET Imaging following administration of 89Zr labeled Trastuzumab for calculation of human dosimetry and overall safety
HER2 Positive Lesion Detection and Safety: Detection of HER2 Positive Breast Cancer with 89Zr Labeled Trastuzumab and PET imaging
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
56.9 years
n=5 Participants
|
56 years
n=7 Participants
|
56.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
40 participants
n=7 Participants
|
52 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 Days following 89Zr-Trastuzumab AdministrationSubjects medical record was followed for 30 days following 89Zr-Trastuzumab Administration for AE Assessment with AE being defined as Any unfavorable medical occurrence in a human subject who receives 89Zr-Trastuzumab and PET/CT imaging, including any abnormal sign, symptom, or disease. The event does not necessarily have to be causally related to injection of 89Zr-Trastuzumab or PET/CT imaging to qualify as an adverse event, just temporally related.
Outcome measures
| Measure |
Cohort 1
n=12 Participants
89Zr-Trastuzumab Human Dosimetry and Safety
89Zr-Trastuzumab Human Dosimetry and Safety: PET Imaging following administration of 89Zr labeled Trastuzumab for calculation of human dosimetry and overall safety
HER2 Positive Lesion Detection and Safety: Detection of HER2 Positive Breast Cancer with 89Zr Labeled Trastuzumab and PET imaging
|
Cohort 2: Lesion Detection and Safety
n=40 Participants
HER2 Positive Lesion Detection and Safety
89Zr-Trastuzumab Human Dosimetry and Safety: PET Imaging following administration of 89Zr labeled Trastuzumab for calculation of human dosimetry and overall safety
HER2 Positive Lesion Detection and Safety: Detection of HER2 Positive Breast Cancer with 89Zr Labeled Trastuzumab and PET imaging
|
|---|---|---|
|
Number of Participants With Adverse Events as a Measure of Safety and Tolerability After 89Zr-Trastuzumab Administration
|
1 participants
|
1 participants
|
Adverse Events
Cohort 1
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 2: Lesion Detection and Safety
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1
n=12 participants at risk
89Zr-Trastuzumab Human Dosimetry and Safety
89Zr-Trastuzumab Human Dosimetry and Safety: PET Imaging following administration of 89Zr labeled Trastuzumab for calculation of human dosimetry and overall safety
HER2 Positive Lesion Detection and Safety: Detection of HER2 Positive Breast Cancer with 89Zr Labeled Trastuzumab and PET imaging
|
Cohort 2: Lesion Detection and Safety
n=40 participants at risk
HER2 Positive Lesion Detection and Safety
89Zr-Trastuzumab Human Dosimetry and Safety: PET Imaging following administration of 89Zr labeled Trastuzumab for calculation of human dosimetry and overall safety
HER2 Positive Lesion Detection and Safety: Detection of HER2 Positive Breast Cancer with 89Zr Labeled Trastuzumab and PET imaging
|
|---|---|---|
|
General disorders
non-neutropenic fever
|
8.3%
1/12 • Number of events 2 • Subjects were monitored for adverse events for the 30 days following 89Zr-Trastuzumab administration
AE assessment was based on the following: Any unfavorable medical occurrence in a human subject who receives 89Zr-Trastuzumab and PET/CT imaging, including any abnormal sign, symptom, or disease. The event does not necessarily have to be causally related to injection of 89Zr-Trastuzumab or PET/CT imaging to qualify as an adverse event, just temporally related. The event of kidney injury and sepsis noted at 30 day follow up was directly related to SOC therapy and not considered study related AE
|
0.00%
0/40 • Subjects were monitored for adverse events for the 30 days following 89Zr-Trastuzumab administration
AE assessment was based on the following: Any unfavorable medical occurrence in a human subject who receives 89Zr-Trastuzumab and PET/CT imaging, including any abnormal sign, symptom, or disease. The event does not necessarily have to be causally related to injection of 89Zr-Trastuzumab or PET/CT imaging to qualify as an adverse event, just temporally related. The event of kidney injury and sepsis noted at 30 day follow up was directly related to SOC therapy and not considered study related AE
|
|
General disorders
Flu Like Symptoms
|
8.3%
1/12 • Number of events 2 • Subjects were monitored for adverse events for the 30 days following 89Zr-Trastuzumab administration
AE assessment was based on the following: Any unfavorable medical occurrence in a human subject who receives 89Zr-Trastuzumab and PET/CT imaging, including any abnormal sign, symptom, or disease. The event does not necessarily have to be causally related to injection of 89Zr-Trastuzumab or PET/CT imaging to qualify as an adverse event, just temporally related. The event of kidney injury and sepsis noted at 30 day follow up was directly related to SOC therapy and not considered study related AE
|
0.00%
0/40 • Subjects were monitored for adverse events for the 30 days following 89Zr-Trastuzumab administration
AE assessment was based on the following: Any unfavorable medical occurrence in a human subject who receives 89Zr-Trastuzumab and PET/CT imaging, including any abnormal sign, symptom, or disease. The event does not necessarily have to be causally related to injection of 89Zr-Trastuzumab or PET/CT imaging to qualify as an adverse event, just temporally related. The event of kidney injury and sepsis noted at 30 day follow up was directly related to SOC therapy and not considered study related AE
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/12 • Subjects were monitored for adverse events for the 30 days following 89Zr-Trastuzumab administration
AE assessment was based on the following: Any unfavorable medical occurrence in a human subject who receives 89Zr-Trastuzumab and PET/CT imaging, including any abnormal sign, symptom, or disease. The event does not necessarily have to be causally related to injection of 89Zr-Trastuzumab or PET/CT imaging to qualify as an adverse event, just temporally related. The event of kidney injury and sepsis noted at 30 day follow up was directly related to SOC therapy and not considered study related AE
|
2.5%
1/40 • Number of events 2 • Subjects were monitored for adverse events for the 30 days following 89Zr-Trastuzumab administration
AE assessment was based on the following: Any unfavorable medical occurrence in a human subject who receives 89Zr-Trastuzumab and PET/CT imaging, including any abnormal sign, symptom, or disease. The event does not necessarily have to be causally related to injection of 89Zr-Trastuzumab or PET/CT imaging to qualify as an adverse event, just temporally related. The event of kidney injury and sepsis noted at 30 day follow up was directly related to SOC therapy and not considered study related AE
|
|
Infections and infestations
Sepsis
|
0.00%
0/12 • Subjects were monitored for adverse events for the 30 days following 89Zr-Trastuzumab administration
AE assessment was based on the following: Any unfavorable medical occurrence in a human subject who receives 89Zr-Trastuzumab and PET/CT imaging, including any abnormal sign, symptom, or disease. The event does not necessarily have to be causally related to injection of 89Zr-Trastuzumab or PET/CT imaging to qualify as an adverse event, just temporally related. The event of kidney injury and sepsis noted at 30 day follow up was directly related to SOC therapy and not considered study related AE
|
2.5%
1/40 • Number of events 2 • Subjects were monitored for adverse events for the 30 days following 89Zr-Trastuzumab administration
AE assessment was based on the following: Any unfavorable medical occurrence in a human subject who receives 89Zr-Trastuzumab and PET/CT imaging, including any abnormal sign, symptom, or disease. The event does not necessarily have to be causally related to injection of 89Zr-Trastuzumab or PET/CT imaging to qualify as an adverse event, just temporally related. The event of kidney injury and sepsis noted at 30 day follow up was directly related to SOC therapy and not considered study related AE
|
Additional Information
Dr. Farrokh Dehdashti
Washington University School of Medicine in St. Louis
Phone: 314-362-1474
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place