Breast Cancer Metastases, HER2 Positive Breast
Conditions
Keywords
89Zr-trastuzumab, PET/CT, 14-156, 89Zr-pertuzumab, HER2-targeted
Brief summary
Some breast cancer cells make a protein called Human Epidermal Growth factor receptor 2 (HER2). Patients with HER2 positive (HER2+) breast cancer receive medicine that attacks HER2, which helps these patients live longer. Some HER2 negative (HER2-) breast cancer patients also benefit from medicines that attack HER2, but we do not know why or which patients will benefit. This study uses a new imaging method, HER2-targeted PET/CT, to identify patients that may benefit from medicines that attack HER2. This is experimental.
Interventions
Sponsors
United States Department of Defense
Genentech, Inc.
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women age \> 18 * Biopsy proven HER2 negative primary breast cancer and biopsy proven metastatic disease. * 5 or more foci of demonstrable metastases on recent imaging modalities (CT, MR, FDG PET/CT) * ECOG performance score of 0-2
Exclusion criteria
* Life expectancy \< 3months * Pregnancy or lactation * Patients who cannot undergo PET/CT scanning because of weight limits * CNS only disease on recent imaging
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With HER2- Primary Breast Cancer Who Develop Imagable HER2+ Metastases | 3 years | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 49 |
| Total | 49 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Not Treated | 4 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | HER2-targeted PET/CT |
|---|---|
| Age, Continuous | 51 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 44 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 36 Participants |
| Region of Enrollment United States | 49 Participants |
| Sex: Female, Male Female | 49 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 37 / 49 |
| other Total, other adverse events | 0 / 49 |
| serious Total, serious adverse events | 6 / 49 |
Outcome results
Primary
Percentage of Patients With HER2- Primary Breast Cancer Who Develop Imagable HER2+ Metastases
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.
Time frame: 3 years
Population: Thirteen percent of women with HER2-negative primary malignancy has HER2-positive metastatic disease detected by HER2-targeted imaging.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HER2-targeted PET/CT | Percentage of Patients With HER2- Primary Breast Cancer Who Develop Imagable HER2+ Metastases | 13 % of participants |