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

Metastatic Cervical Cancer Clinical Trial

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

Status Terminated

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

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

• NCT number: NCT03786107
• Study type: Observational
• Source: Puma Biotechnology, Inc.
• Status: Terminated
• Start date: March 14, 2019
• Completion date: January 21, 2021