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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Metastatic Cervical Cancer, Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer

Intervention / Treatment
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* Diagnostic Test: Almac HER-Seq Assay


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Almac HER-Seq Assay|whole blood sample analysis|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Eligible for Neratinib Treatment | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HER2, Circulating Tumor DNA, Genomic Screening, Metastatic, Breast, Cervical, ERBB2, Mutation, CDK4/6, HR Positive