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

May 17, 2021 updated by: Puma Biotechnology, Inc.
This is a multi-center, observational genomic screening protocol to identify participants whose tumors harbor somatic mutations in the ERBB2 (HER2) gene, as measured in circulating tumor DNA (ctDNA) . Participants with histologically confirmed, hormone receptor positive, HER-2 negative, metastatic breast cancer (MBC) or metastatic cervical cancer (MCC) are eligible for screening at 6 months intervals, or if disease progression is suspected/confirmed. Blood samples will be collected from eligible participants and ctDNA will be extracted and sequenced at a central laboratory, using a HER2-targeted next generation sequencing (NGS) test. A certified molecular test report will be issued from the central laboratory and provided to the investigators and the study sponsor. Participants who are identified with HER2 mutations by this screening protocol will subsequently have access to an appropriate neratinib treatment protocol, pending medical eligibility.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1583

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Saint-Cloud, France, 92210
        • Institut Curie
  • Ireland
      • Dublin, Ireland, D07 R2WY
        • Mater Misericordiae University Hospital, Institute for Cancer Research
      • Dublin, Ireland, D09 V2N0
        • Beaumont Hospital, Cancer Clinical Trials & Research Unit
      • Waterford, Ireland, X91 ER8E
        • University Hospital Waterford, Department of Medical Oncology
    • Cork
      • Wilton, Cork, Ireland, T12 DC4A
        • Cork University Hospital
    • Dublin
      • Elm Park, Dublin, Ireland, D04 T6F4
        • St. Vincent's University Hospital
  • Israel
      • Ramat Gan, Israel, 5262100
        • Sheba Medical Center
      • Tel Aviv, Israel, 64239
        • Sourasky Medical Center
    • Central
      • Petah tikva, Central, Israel, 49100
        • Rabin Medical Center, Davidoff Cancer Center
      • Reẖovot, Central, Israel, 76101
        • Kaplan Medical Center
  • Italy
      • Napoli, Italy, 52-80131
        • Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"
  • Serbia
      • Belgrade, Serbia, 11000
        • Institute for Oncology and Radiology of Serbia
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clínic de Barcelona
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • Barcelona, Spain, 08028
        • Instituto Oncológico Dr. Rosell, Hospital Universitario Quirón Dexeus
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Madrid, Spain, 28050
        • Hospital Universitario Madrid Sanchinarro
      • Madrid, Spain, 28040
        • START Madrid, Hospital Universitario Fundacion Jimenez Diaz
      • Valencia, Spain, 46009
        • Fundación Instituto Valenciano de Oncología
      • Valencia, Spain, 46010
        • Hospital Clínico Universitario de Valencia
    • Madrid
      • Pozuelo de Alarcón, Madrid, Spain, 28223
        • Hospital Universitario Quironsalud Madrid
  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Magee-Womens Hospital of UPMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants with histologically-confirmed metastatic breast or metastatic cervical cancer

Description

Inclusion Criteria:

  • Women and men who are ≥18 years old at signing of informed consent
  • 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 known HER2-positive or HER2-amplified tumors
  • Participants with breast cancer with HR-negative tumors
  • Participants who have received HER2-directed TKI
  • Participants with previously documented somatic KRAS activating mutation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Eligible for Neratinib Treatment
Time Frame: From enrollment date to identification of HER2 positive mutation, assessed up to five years
Identification of participants with somatic, activating HER2 mutations who might qualify for enrollment into neratinib treatment protocols
From enrollment date to identification of HER2 positive mutation, assessed up to five years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Puma Biotechnology, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 14, 2019

Primary Completion (Actual)

January 21, 2021

Study Completion (Actual)

January 21, 2021

Study Registration Dates

First Submitted

December 20, 2018

First Submitted That Met QC Criteria

December 20, 2018

First Posted (Actual)

December 24, 2018

Study Record Updates

Last Update Posted (Actual)

May 19, 2021

Last Update Submitted That Met QC Criteria

May 17, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PUMA-NER-9501

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Puma Biotechnology is committed to sharing clinical trial data and information to help physicians and patients make informed treatment decisions, and to help qualified researchers advance scientific knowledge.

In accordance with legal and regulatory requirements, Puma publishes study protocol information and clinical study results on clinical trial registries, including ClinicalTrials.gov and EU Clinical Trials Register. Puma also publishes information about clinical studies in peer-reviewed scientific journals and shares data in scientific meetings.

Puma commits to safeguarding confidentiality and patient privacy throughout the clinical trial data and information sharing process. Any patient-level data will be anonymized to protect personally identifiable information.

Qualified researchers and study participants may submit requests for other study documentation and clinical trial data to clinicaltrials@pumabiotechnology.com for consideration.

IPD Sharing Time Frame

Clinical study documents and clinical trial data may be requested by qualified researchers and study participants for studies that have been completed for at least 18 months, and for which the indication of the drug has been approved in the US and/or EU, as applicable. Requests will be accepted for up to 24 months after the criteria described in this section are met.

IPD Sharing Access Criteria

Requestors must provide organizational contact information; a detailed research plan, including outcomes; timeline for completion of the research; qualifications of the research team; funding source; and potential conflicts of interest.

Puma will not provide access to patient-level data if there is a reasonable likelihood that individual patients could be identified, or in cases where confidentiality or consent provisions prohibit transfer of data or information to third parties. Additionally, Puma will not disclose information that jeopardizes intellectual property rights or divulges confidential commercial information.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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