Copper Cu 64-DOTA-Trastuzumab PET in Predicting Response to Treatment With Ado-Trastuzumab Emtansine in Patients With Metastatic HER2 Positive Breast Cancer
NCT ID: NCT02226276
Last Updated: 2025-02-18
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
NA
10 participants
INTERVENTIONAL
2015-01-07
2025-10-30
Brief Summary
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Detailed Description
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I. Correlate uptake of 64Cu-DOTA-trastuzumab (copper Cu 64-DOTA-trastuzumab) PET by individual tumors with subsequent tumor response to ado-trastuzumab emtansine as assessed by serial 18F-fludeoxyglucose (FDG) (fludeoxyglucose F 18)/PET-computed tomography (CT).
II. Compare tumor uptake of 64Cu-DOTA-trastuzumab PET between patients who do and patients who do not respond to ado-trastuzumab emtansine.
III. Obtain tumor tissue for subsequent assessment of the presence of putative molecular mechanisms of resistance (MMRs) to ado-trastuzumab emtansine. When funding becomes available, those samples will be used to explore the correlation between the presence of MMRs as assessed by histopathology and tumor response to ado-trastuzumab emtansine both in univariate analysis and in combination with tumor uptake of 64Cu-DOTA-trastuzumab as measured with PET/CT.
OUTLINE:
Patients undergo whole body fludeoxyglucose F 18 PET/CT. Patients then receive trastuzumab intravenously (IV) over 15 minutes immediately before receiving copper Cu 64-DOTA-trastuzumab IV and then undergo PET scans at 24 and 48 hours. Patients then receive ado-trastuzumab emtansine IV every 3 weeks until complete response or disease progression at the discretion of the treating oncologist. Patients undergo restaging by whole body fludeoxyglucose F 18 PET/CT every 6 weeks for 1 year after initiation of treatment until disease progression.
After completion of study treatment, patients are followed up for 1 year.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Diagnostic (copper Cu 64-DOTA-trastuzumab PET)
Patients undergo whole body fludeoxyglucose F 18 PET/CT. Patients then receive trastuzumab IV over 15 minutes immediately before receiving copper Cu 64-DOTA-trastuzumab IV and then undergo PET scans at 24 and 48 hours. Patients then receive ado-trastuzumab emtansine IV every 3 weeks until complete response or disease progression at the discretion of the treating oncologist. Patients undergo restaging by whole body fludeoxyglucose F 18 PET/CT every 6 weeks after initiation of treatment until disease progression.
fludeoxyglucose F 18
Undergo fludeoxyglucose F 18 PET/CT
positron emission tomography
Undergo fludeoxyglucose F 18 PET/CT
computed tomography
Undergo fludeoxyglucose F 18 PET/CT
trastuzumab
Given IV
copper Cu 64-DOTA-trastuzumab
Given IV
positron emission tomography
Undergo copper Cu-DOTA-trastuzumab PET
ado-trastuzumab emtansine
Given IV
laboratory biomarker analysis
Correlative studies
Interventions
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fludeoxyglucose F 18
Undergo fludeoxyglucose F 18 PET/CT
positron emission tomography
Undergo fludeoxyglucose F 18 PET/CT
computed tomography
Undergo fludeoxyglucose F 18 PET/CT
trastuzumab
Given IV
copper Cu 64-DOTA-trastuzumab
Given IV
positron emission tomography
Undergo copper Cu-DOTA-trastuzumab PET
ado-trastuzumab emtansine
Given IV
laboratory biomarker analysis
Correlative studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* At least 1 site of metastasis \>= 20 mm in mean diameter must be identified
* The cancer must over express HER2 as determined by immunohistochemistry (IHC) and/or fluorescence in situ hybridization (FISH)
* Patients may not have received trastuzumab within 6 weeks of projected 64Cu-DOTA-trastuzumab/PET-CT
* Participants must have normal cardiac ejection fraction
* Ability to provide informed consent
* Patients that may need dose reduction to commence cycle 1 treatment
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* Negative serum pregnancy test (female of childbearing potential only)
* Patients must have adequate cardiac function; left ventricular ejection fraction (LVEF) \>= 50% as determined by multi gated acquisition (MUGA) scan or echocardiogram
Exclusion Criteria
* Participants who are not considered candidates for ado-trastuzumab-emtansine
* No metastatic sites \>= 20 mm
* Concurrent malignancy other than skin cancer - Inability to provide informed consent
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
City of Hope Medical Center
OTHER
Responsible Party
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Principal Investigators
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Joanne Mortimer
Role: PRINCIPAL_INVESTIGATOR
City of Hope Medical Center
Locations
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City of Hope Medical Center
Duarte, California, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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NCI-2014-01812
Identifier Type: REGISTRY
Identifier Source: secondary_id
14099
Identifier Type: OTHER
Identifier Source: secondary_id
14099
Identifier Type: -
Identifier Source: org_study_id
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