Positron Emission Tomography in Women With Advanced HER2-Positive Breast Cancer
NCT ID: NCT01093612
Last Updated: 2025-11-14
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
NA
18 participants
INTERVENTIONAL
2011-03-16
2026-09-08
Brief Summary
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PURPOSE: This pilot trial is studying copper Cu 64-tetra-azacyclododecanetetra-acetic acid (DOTA)-trastuzumab-labeled positron emission tomography (PET) in women with human epidermal growth factor receptor 2 (HER2)-positive breast cancer.
Detailed Description
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I. Determine the dose of pre-administered cold antibody that optimizes image quality of 64Cu-DOTA-trastuzumab PET without increasing the radiation dose to the heart in women with metastatic HER2 positive breast cancer.
II. Determine whether tumor uptake on 64Cu-DOTA-trastuzumab PET correlates with tumor expression of HER2 in women with metastatic disease.
III. Perform an exploratory analysis of the relationship between uptake on 64Cu-DOTA-trastuzumab PET, HER2 overexpression, and inactivation of the PI3K/Akt pathway.
OUTLINE:
This is a part one dose-determining study followed by a part two study. PART ONE: Patients are randomized to 1 of 3 dose levels. Patients undergo a PET scan 24-48 hours after injection of 64 Cu-DOTA-trastuzumab. PART TWO: Patients undergo a PET scan 24-48 hours after injection of 64 Cu-DOTA-trastuzumab at the optimal dose as determined in part one of the study.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Arm I
PART ONE: Patients are randomized to 1 of 3 dose levels. Patients undergo a PET scan 24-48 hours after injection of copper Cu 64-DOTA-trastuzumab. PART TWO: Patients undergo a PET scan 24-48 hours after injection of copper Cu 64-DOTA-trastuzumab.
positron emission tomography
PET images performed on a GE Discovery 16 Ste PET-CT scanner
copper Cu 64-DOTA-trastuzumab
15 mCi of Cu 64-DOTA-trastuzumab, total trastuzumab dose less than 5 mg.
Biopsy
Correlative Studies
Immunohistochemistry staining method
Correlative studies
laboratory biomarker analysis
Correlative studies
mutation analysis
Correlative studies
Interventions
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positron emission tomography
PET images performed on a GE Discovery 16 Ste PET-CT scanner
copper Cu 64-DOTA-trastuzumab
15 mCi of Cu 64-DOTA-trastuzumab, total trastuzumab dose less than 5 mg.
Biopsy
Correlative Studies
Immunohistochemistry staining method
Correlative studies
laboratory biomarker analysis
Correlative studies
mutation analysis
Correlative studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants must have normal cardiac ejection fraction.
Ineligibility
* Participants who have received trastuzumab within the prior 2 months
* Participants who are not considered candidates for trastuzumab
* Metastatic disease in a single site
* No metastatic site greater than or equal to 2 cm
* Concurrent malignancy other than skin cancer
* Inability to provide informed consent
* Participants who are pregnant
18 Years
FEMALE
No
Sponsors
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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
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-2010-00322
Identifier Type: REGISTRY
Identifier Source: secondary_id
BC095002
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
09101
Identifier Type: -
Identifier Source: org_study_id