NCT03786107

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 1,583 (actual)
• Sponsor: Puma Biotechnology, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DIAGNOSTIC_TEST	Almac HER-Seq Assay	whole blood sample analysis

Timeline

• Start date: 2019-03-14
• Primary completion: 2021-01-21
• Completion: 2021-01-21
• First posted: 2018-12-24
• Last updated: 2021-05-19

Locations

22 sites across 7 countries: United States, France, Ireland, Israel, Italy, Serbia, Spain

Regulatory

• FDA-regulated device study