Trial Outcomes & Findings for Can HER2 Targeted PET/CT Imaging Identify Unsuspected HER2 Positive Breast Cancer Metastases, Which Are Amenable to HER2 Targeted Therapy? (NCT NCT02286843)
NCT ID: NCT02286843
Last Updated: 2021-06-18
Results Overview
Both SUVmax and SUVpeak will be recorded for lesions, and SUVmax and SUVaverage will be recorded for background measurements. Only those foci qualitatively scored conspicuously positive by both readers (scores of 4 or 5) will be considered as "positive".
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
49 participants
Primary outcome timeframe
3 years
Results posted on
2021-06-18
Participant Flow
Participant milestones
| Measure |
HER2-targeted PET/CT
Pts with confirmed HER2- breast cancer will undergo HER2-targeted PET/CT. 89Zr-trastuzumab is a novel radiotracer which allows excellent visualization of HER2+ lesions. 89Zr-pertuzumab is a novel radiotracer which may allow for specific visualization of HER2+ lesions. PET/CT imaging with these novel radiotracers will allow evaluation of all identifiable malignant lesions, rather than evaluation of only single lesions by biopsy.
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|---|---|
|
Overall Study
STARTED
|
49
|
|
Overall Study
COMPLETED
|
43
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
HER2-targeted PET/CT
Pts with confirmed HER2- breast cancer will undergo HER2-targeted PET/CT. 89Zr-trastuzumab is a novel radiotracer which allows excellent visualization of HER2+ lesions. 89Zr-pertuzumab is a novel radiotracer which may allow for specific visualization of HER2+ lesions. PET/CT imaging with these novel radiotracers will allow evaluation of all identifiable malignant lesions, rather than evaluation of only single lesions by biopsy.
|
|---|---|
|
Overall Study
Not Treated
|
4
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Can HER2 Targeted PET/CT Imaging Identify Unsuspected HER2 Positive Breast Cancer Metastases, Which Are Amenable to HER2 Targeted Therapy?
Baseline characteristics by cohort
| Measure |
HER2-targeted PET/CT
n=49 Participants
Pts with confirmed HER2- breast cancer will undergo HER2-targeted PET/CT. 89Zr-trastuzumab is a novel radiotracer which allows excellent visualization of HER2+ lesions. 89Zr-pertuzumab is a novel radiotracer which may allow for specific visualization of HER2+ lesions. PET/CT imaging with these novel radiotracers will allow evaluation of all identifiable malignant lesions, rather than evaluation of only single lesions by biopsy.
|
|---|---|
|
Age, Continuous
|
51 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
44 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
49 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 3 yearsPopulation: Thirteen percent of women with HER2-negative primary malignancy has HER2-positive metastatic disease detected by HER2-targeted imaging.
Both SUVmax and SUVpeak will be recorded for lesions, and SUVmax and SUVaverage will be recorded for background measurements. Only those foci qualitatively scored conspicuously positive by both readers (scores of 4 or 5) will be considered as "positive".
Outcome measures
| Measure |
HER2-targeted PET/CT
n=49 Participants
Pts with confirmed HER2- breast cancer will undergo HER2-targeted PET/CT. 89Zr-trastuzumab is a novel radiotracer which allows excellent visualization of HER2+ lesions. 89Zr-pertuzumab is a novel radiotracer which may allow for specific visualization of HER2+ lesions. PET/CT imaging with these novel radiotracers will allow evaluation of all identifiable malignant lesions, rather than evaluation of only single lesions by biopsy.
|
|---|---|
|
Percentage of Patients With HER2- Primary Breast Cancer Who Develop Imagable HER2+ Metastases
|
13 % of participants
|
Adverse Events
HER2-targeted PET/CT
Serious events: 6 serious events
Other events: 0 other events
Deaths: 37 deaths
Serious adverse events
| Measure |
HER2-targeted PET/CT
n=49 participants at risk
Pts with confirmed HER2- breast cancer will undergo HER2-targeted PET/CT. 89Zr-trastuzumab is a novel radiotracer which allows excellent visualization of HER2+ lesions. 89Zr-pertuzumab is a novel radiotracer which may allow for specific visualization of HER2+ lesions. PET/CT imaging with these novel radiotracers will allow evaluation of all identifiable malignant lesions, rather than evaluation of only single lesions by biopsy.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
2.0%
1/49 • 1 year
|
|
Blood and lymphatic system disorders
Anemia
|
2.0%
1/49 • 1 year
|
|
Cardiac disorders
Cardiac arrest
|
2.0%
1/49 • 1 year
|
|
General disorders
Death NOS
|
2.0%
1/49 • 1 year
|
|
Gastrointestinal disorders
Duodenal ulcer
|
6.1%
3/49 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.0%
1/49 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.0%
1/49 • 1 year
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Gary Ulaner, MD, PhD
Memorial Sloan Kettering Cancer Center
Phone: 212-639-7373
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place