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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

NCT03786107 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 1583

Last updated 2021-05-19

No results posted yet for this study

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.

Conditions

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

Interventions

DIAGNOSTIC_TEST

Almac HER-Seq Assay

whole blood sample analysis

Sponsors & Collaborators

  • Puma Biotechnology, Inc.

    lead INDUSTRY

Principal Investigators

  • Senior Vice President Clinical Science and Pharmacology · Puma Biotechnology, Inc.

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-14
Primary Completion
2021-01-21
Completion
2021-01-21
FDA Device
Yes

Countries

  • United States
  • France
  • Ireland
  • Israel
  • Italy
  • Serbia
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03786107 on ClinicalTrials.gov