Breast Cancer
Conditions
Keywords
Trastuzumab
Brief summary
The main purpose of this study is to see if Positron Emission Tomography (PET-Imaging) with 89Zr labeled trastuzumab can detect trastuzumab (HER2) positive breast cancer.
Interventions
DRUG89Zr-Trastuzumab Human Dosimetry and Safety
PET Imaging following administration of 89Zr labeled Trastuzumab for calculation of human dosimetry and overall safety
DRUGHER2 Positive Lesion Detection and Safety
Detection of HER2 Positive Breast Cancer with 89Zr Labeled Trastuzumab and PET imaging
Sponsors
National Cancer Institute (NCI)
Washington University School of Medicine
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female patients 18 years of age or older * Cohort 1: Her2-positive (defined as 3+) or FISH HER2:CEP17 ratio \> 2 biopsy proven breast cancer * Cohort 2: Her2-positive (defined as 3+) or FISH HER2:CEP17 ratio \> 2 OR HER2negative (0 or 1+, 2+ and FISH negative) biopsy-proven breast cancer * Primary or recurrent/metastatic lesion size ≥ 1.5 cm as determined by imaging studies (ultrasonography, mammography, CT or MRI) or physical examination * Able to give informed consent * Not currently pregnant or nursing: Subject must be surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), postmenopausal (cessation of menses for more than 1 year), non-lactating, or of childbearing potential for whom a urine pregnancy test (with the test performed within the 24 hour period immediately prior to administration of 89Zr-trastuzumab) is negative * Patients currently receiving trastuzumab therapy with or without other types of systemic therapy can participate if their disease progresses (development of new lesion(s) or worsening of known lesion(s) based on imaging modalities or physical examination.
Exclusion criteria
* Patients with other invasive malignancies, with the exception of non- melanoma skin cancer, who had (or have) any evidence of the other cancer present within the last 5 years * Unable to tolerate 60 min of PET imaging per imaging session
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability After 89Zr-Trastuzumab Administration | 30 Days following 89Zr-Trastuzumab Administration | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 12 |
| 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 | 40 |
| Total | 52 |
Baseline characteristics
| Characteristic | Cohort 1 | Cohort 2: Lesion Detection and Safety | Total |
|---|---|---|---|
| Age, Customized | 56.9 years | 56 years | 56.5 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants | 39 Participants | 51 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 12 participants | 40 participants | 52 participants |
| Sex: Female, Male Female | 12 Participants | 40 Participants | 52 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 40 |
| other Total, other adverse events | 1 / 12 | 1 / 40 |
| serious Total, serious adverse events | 0 / 12 | 0 / 40 |
Outcome results
Primary
Number of Participants With Adverse Events as a Measure of Safety and Tolerability After 89Zr-Trastuzumab Administration
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.
Time frame: 30 Days following 89Zr-Trastuzumab Administration
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1 | Number of Participants With Adverse Events as a Measure of Safety and Tolerability After 89Zr-Trastuzumab Administration | 1 participants |
| Cohort 2: Lesion Detection and Safety | Number of Participants With Adverse Events as a Measure of Safety and Tolerability After 89Zr-Trastuzumab Administration | 1 participants |