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Trial record 52 of 55 for:    hki-272 OR neratinib

HER-Seq: A Blood-based Screening Study to Identify Patients With HER2 Mutations for Enrollment Into Clinical Research Studies of Neratinib

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03786107
Recruitment Status : Recruiting
First Posted : December 24, 2018
Last Update Posted : October 3, 2019
Information provided by (Responsible Party):
Puma Biotechnology, Inc.

Brief Summary:
This is a multi-center, observational genomic screening protocol to identify patients whose tumors harbor somatic mutations in the ERBB2 (HER2) gene, as measured in circulating tumor DNA (ctDNA) . Patients with histologically confirmed metastatic breast cancer (MBC) or metastatic cervical cancer (MCC) are eligible for screening at 3 to 6 months intervals, or if disease progression is suspected/confirmed. Blood samples will be collected from eligible patients and ctDNA will be extracted and sequenced at a central laboratory, using HER2-targeted next generation sequencing (NGS). A certified molecular test report will be issued from the central laboratory and provided to the investigators and the study sponsor. Patients who are identified with HER2 mutations by this screening protocol will subsequently have access to an appropriate neratinib treatment protocol, pending medical eligibility.

Condition or disease Intervention/treatment
Metastatic Breast Cancer Metastatic Cervical Cancer Diagnostic Test: Almac HER-Seq Assay Kit

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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: HER-Seq: A Blood-based Screening Study to Identify Patients With HER2 Mutations for Enrollment Into Clinical Research Studies of Neratinib
Actual Study Start Date : March 14, 2019
Estimated Primary Completion Date : January 15, 2024
Estimated Study Completion Date : January 15, 2024

Resource links provided by the National Library of Medicine

Intervention Details:
  • Diagnostic Test: Almac HER-Seq Assay Kit
    whole blood sample analysis

Primary Outcome Measures :
  1. Number of Patients Eligible for Neratinib Treatment [ Time Frame: From enrollment date to identification of HER2 positive mutation, assessed up to five years ]
    Identification of patients with somatic, activating HER2 mutations who might qualify for enrollment into neratinib treatment protocols

Biospecimen Retention:   Samples With DNA
Circulating tumor DNA from plasma will be collected from eligible patients. Exons 8 and 17-24 will be sequenced by next generation sequencing (NGS) at a central laboratory.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with histologically-confirmed metastatic breast or metastatic cervical cancer

Inclusion Criteria:

  1. Women and men who are ≥18 years old at signing of informed consent
  2. Histologically-confirmed metastatic breast or metastatic cervical cancer
  3. Eastern Cooperative Oncology Group (ECOG) status of 0 to 2
  4. Provide written informed consent to participate in the study and for circulating tumor DNA screening
  5. Must be able to provide blood sample(s) for HER2 mutation testing

Exclusion Criteria:

  1. Breast cancer patients with known HER2+ or HER2-amplified tumors
  2. Patients who have received neratinib

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 identifier (NCT number): NCT03786107

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Contact: Puma Biotechnology Clinical Operations Senior Director (424) 248-6500

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Cork University Hospital Recruiting
Wilton, Cork, Ireland, T12 DC4A
St. Vincent's University Hospital Recruiting
Elm Park, Dublin, Ireland, D04 T6F4
Mater Misericordiae University Hospital, Institute for Cancer Research Recruiting
Dublin, Ireland, D07 R2WY
Beaumont Hospital, Cancer Clinical Trials & Research Unit Recruiting
Dublin, Ireland, D09 V2N0
University Hospital Waterford, Department of Medical Oncology Recruiting
Waterford, Ireland, X91 ER8E
Institute for Oncology and Radiology of Serbia Recruiting
Belgrade, Serbia, 11000
Hospital Universitario Quirónsalud Madrid Recruiting
Pozuelo de Alarcón, Madrid, Spain, 28223
Instituto Oncológico Dr. Rosell, Hospital Universitario Quirón Dexeus Recruiting
Barcelona, Spain, 08028
Hospital Universitari Vall D'Hebron Recruiting
Barcelona, Spain, 08035
Hospital Clinic de Barcelona Recruiting
Barcelona, Spain, 08036
Hospital Clínico San Carlos Recruiting
Madrid, Spain, 28040
START Madrid, Hospital Universitario Fundacion Jimenez Diaz Recruiting
Madrid, Spain, 28040
Hospital Universitario Madrid Sanchinarro Recruiting
Madrid, Spain, 28050
Fundación Instituto Valenciano de Oncológia Recruiting
Valencia, Spain, 46009
Hospital Clínico Universitario de Valencia Recruiting
Valencia, Spain, 46010
Sponsors and Collaborators
Puma Biotechnology, Inc.
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Study Director: Clinical Development Chief Medical and Scientific Officer Puma Biotechnology, Inc.

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Responsible Party: Puma Biotechnology, Inc. Identifier: NCT03786107     History of Changes
Other Study ID Numbers: PUMA-NER-9501
First Posted: December 24, 2018    Key Record Dates
Last Update Posted: October 3, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Puma Biotechnology, Inc.:
Circulating Tumor DNA
Genomic Screening
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female