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Can HER2 Targeted PET/CT Imaging Identify Unsuspected HER2 Positive Breast Cancer Metastases, Which Are Amenable to HER2 Targeted Therapy?

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ClinicalTrials.gov Identifier: NCT02286843
Recruitment Status : Completed
First Posted : November 10, 2014
Results First Posted : June 18, 2021
Last Update Posted : June 18, 2021
Sponsor:
Collaborators:
United States Department of Defense
Genentech, Inc.
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Breast Cancer Metastases HER2 Positive Breast Radiation: 89Zr-trastuzumab Device: PET/CT scan Radiation: 89Zr-pertuzumab Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Can HER2 Targeted PET/CT Imaging Identify Unsuspected HER2 Positive Breast Cancer Metastases, Which Are Amenable to HER2 Targeted Therapy?
Actual Study Start Date : November 6, 2014
Actual Primary Completion Date : June 30, 2020
Actual Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: HER2-targeted PET/CT
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.
 Radiation: 89Zr-trastuzumab
Device: PET/CT scan
Radiation: 89Zr-pertuzumab


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Patients With HER2- Primary Breast Cancer Who Develop Imagable HER2+ Metastases [ Time Frame: 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".


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02286843


Locations
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United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
United States Department of Defense
Genentech, Inc.
Investigators
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Principal Investigator: Gary Ulaner, MD,PhD Memorial Sloan Kettering Cancer Center
  Study Documents (Full-Text)

Documents provided by Memorial Sloan Kettering Cancer Center:
Study Protocol and Statistical Analysis Plan  [PDF] August 21, 2018

More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02286843    
Other Study ID Numbers: 14-156
First Posted: November 10, 2014    Key Record Dates
Results First Posted: June 18, 2021
Last Update Posted: June 18, 2021
Last Verified: July 2020
Keywords provided by Memorial Sloan Kettering Cancer Center:
89Zr-trastuzumab
PET/CT
14-156
89Zr-pertuzumab
HER2-targeted
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasm Metastasis
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
 Neoplastic Processes
Pathologic Processes
Trastuzumab
Pertuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents