HER-Seq: A Blood-based Screening Study to Identify Patients With HER2 Mutations for Enrollment Into Clinical Research Studies of Neratinib
NCT ID: NCT03786107
Last Updated: 2021-05-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
1583 participants
OBSERVATIONAL
2019-03-14
2021-01-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Almac HER-Seq Assay
whole blood sample analysis
Eligibility Criteria
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Inclusion Criteria
* Eastern Cooperative Oncology Group (ECOG) status of 0 to 2
* Provide written informed consent to participate in the study and for circulating tumor DNA screening
* Must be able to provide blood sample(s) for HER2 mutation testing
* Participants with imaging or histologically confirmed, HR-positive, HER2-negative MBC who are presently receiving or have received CDK4/6 inhibitor as a prior therapy in any setting, or participants with imaging or histologically confirmed metastatic cervical cancer
* At least one measurable lesion, as defined by RECIST v1.1
Exclusion Criteria
* Participants with breast cancer with HR-negative tumors
* Participants who have received HER2-directed TKI
* Participants with previously documented somatic KRAS activating mutation
18 Years
ALL
No
Sponsors
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Puma Biotechnology, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Senior Vice President Clinical Science and Pharmacology
Role: STUDY_DIRECTOR
Puma Biotechnology, Inc.
Locations
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Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States
Institut Curie
Saint-Cloud, , France
Cork University Hospital
Wilton, Cork, Ireland
St. Vincent's University Hospital
Elm Park, Dublin, Ireland
Mater Misericordiae University Hospital, Institute for Cancer Research
Dublin, , Ireland
Beaumont Hospital, Cancer Clinical Trials & Research Unit
Dublin, , Ireland
University Hospital Waterford, Department of Medical Oncology
Waterford, , Ireland
Rabin Medical Center, Davidoff Cancer Center
Petah Tikva, Central District, Israel
Kaplan Medical Center
Rehovot, Central District, Israel
Sheba Medical Center
Ramat Gan, , Israel
Sourasky Medical Center
Tel Aviv, , Israel
Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"
Napoli, , Italy
Institute for Oncology and Radiology of Serbia
Belgrade, , Serbia
Hospital Universitario Quirónsalud Madrid
Pozuelo de Alarcón, Madrid, Spain
Instituto Oncológico Dr. Rosell, Hospital Universitario Quirón Dexeus
Barcelona, , Spain
Hospital Universitari Vall D'Hebron
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital Clínico San Carlos
Madrid, , Spain
START Madrid, Hospital Universitario Fundacion Jimenez Diaz
Madrid, , Spain
Hospital Universitario Madrid Sanchinarro
Madrid, , Spain
Fundación Instituto Valenciano de Oncológia
Valencia, , Spain
Hospital Clínico Universitario de Valencia
Valencia, , Spain
Countries
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Other Identifiers
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PUMA-NER-9501
Identifier Type: -
Identifier Source: org_study_id
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