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Trial record 1 of 1 for:    PUMA-NER-9501
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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 : December 10, 2020
Information provided by (Responsible Party):
Puma Biotechnology, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment
Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer Metastatic Cervical Cancer Diagnostic Test: Almac HER-Seq Assay

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Study Type : Observational
Estimated Enrollment : 6000 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
    whole blood sample analysis

Primary Outcome Measures :
  1. 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

Biospecimen Retention:   Samples With DNA
Circulating tumor DNA from plasma will be collected from eligible participants. ERBB2 (HER2) gene exons 8 and 17-24 will be sequenced by next generation sequencing (NGS) at a central laboratory.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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
Participants with histologically-confirmed metastatic breast or metastatic cervical cancer

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

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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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    
Other Study ID Numbers: PUMA-NER-9501
First Posted: December 24, 2018    Key Record Dates
Last Update Posted: December 10, 2020
Last Verified: December 2020
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
HR Positive
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