Back to resultsCan HER2 Targeted PET/CT Imaging Identify Unsuspected HER2 Positive Breast Cancer Metastases, Which Are Amenable to HER2 Targeted Therapy?
Primary Purpose
Breast Cancer Metastases, HER2 Positive Breast
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
89Zr-trastuzumab
PET/CT scan
89Zr-pertuzumab
Sponsored by
About this trial
This is an interventional diagnostic trial for Breast Cancer Metastases focused on measuring 89Zr-trastuzumab, PET/CT, 14-156, 89Zr-pertuzumab, HER2-targeted
Eligibility Criteria
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
Sites / Locations
- Memorial Sloan Kettering Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HER2-targeted PET/CT
Arm Description
Pts with confirmed HER2- breast cancer will then 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. Avid lesions will be considered suspicious for HER2+ malignancy. Pts with at least one 89Zr-trastuzumab or 89Zr-pertuzumab avid lesion will be biopsied to confirm HER2+ pathology. From these 50 pts, we will determine the proportion of HER2- primary breast cancer pts that express HER2+ malignancy imagable by HER2-targeted PET/CT. Pts recruited to the protocol, but then drop out prior to HER2-targeted PET/CT due HER2+ disease being identified on retesting of the patient's archived tissue samples, will be replaced with newly recruited pts.
Outcomes
Primary Outcome Measures
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".
Secondary Outcome Measures
Full Information
NCT ID
NCT02286843
First Posted
November 6, 2014
Last Updated
May 25, 2021
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
United States Department of Defense, Genentech, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02286843
Brief Title
Can HER2 Targeted PET/CT Imaging Identify Unsuspected HER2 Positive Breast Cancer Metastases, Which Are Amenable to HER2 Targeted Therapy?
Official Title
Can HER2 Targeted PET/CT Imaging Identify Unsuspected HER2 Positive Breast Cancer Metastases, Which Are Amenable to HER2 Targeted Therapy?
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
November 6, 2014 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
United States Department of Defense, Genentech, Inc.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Metastases, HER2 Positive Breast
Keywords
89Zr-trastuzumab, PET/CT, 14-156, 89Zr-pertuzumab, HER2-targeted
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HER2-targeted PET/CT
Arm Type
Experimental
Arm Description
Pts with confirmed HER2- breast cancer will then 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. Avid lesions will be considered suspicious for HER2+ malignancy. Pts with at least one 89Zr-trastuzumab or 89Zr-pertuzumab avid lesion will be biopsied to confirm HER2+ pathology. From these 50 pts, we will determine the proportion of HER2- primary breast cancer pts that express HER2+ malignancy imagable by HER2-targeted PET/CT. Pts recruited to the protocol, but then drop out prior to HER2-targeted PET/CT due HER2+ disease being identified on retesting of the patient's archived tissue samples, will be replaced with newly recruited pts.
Intervention Type
Radiation
Intervention Name(s)
89Zr-trastuzumab
Intervention Type
Device
Intervention Name(s)
PET/CT scan
Intervention Type
Radiation
Intervention Name(s)
89Zr-pertuzumab
Primary Outcome Measure Information:
Title
Percentage of Patients With HER2- Primary Breast Cancer Who Develop Imagable HER2+ Metastases
Description
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary Ulaner, MD,PhD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
32515679
Citation
Ulaner GA, Carrasquillo JA, Riedl CC, Yeh R, Hatzoglou V, Ross DS, Jhaveri K, Chandarlapaty S, Hyman DM, Zeglis BM, Lyashchenko SK, Lewis JS. Identification of HER2-Positive Metastases in Patients with HER2-Negative Primary Breast Cancer by Using HER2-targeted 89Zr-Pertuzumab PET/CT. Radiology. 2020 Aug;296(2):370-378. doi: 10.1148/radiol.2020192828. Epub 2020 Jun 9.
Results Reference
derived
PubMed Identifier
28872549
Citation
Ulaner GA, Hyman DM, Lyashchenko SK, Lewis JS, Carrasquillo JA. 89Zr-Trastuzumab PET/CT for Detection of Human Epidermal Growth Factor Receptor 2-Positive Metastases in Patients With Human Epidermal Growth Factor Receptor 2-Negative Primary Breast Cancer. Clin Nucl Med. 2017 Dec;42(12):912-917. doi: 10.1097/RLU.0000000000001820.
Results Reference
derived
Links:
URL
http://www.mskcc.org/
Description
Memorial Sloan Kettering Cancer Center
Learn more about this trial
Can HER2 Targeted PET/CT Imaging Identify Unsuspected HER2 Positive Breast Cancer Metastases, Which Are Amenable to HER2 Targeted Therapy?
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