Ignite Creation Date:
2024-05-06 @ 12:31 PM
Last Modification Date:
2024-10-26 @ 1:00 PM
Study NCT ID:
NCT03786107
Status:
TERMINATED
Last Update Posted:
2021-05-19
First Post:
2018-12-20
Brief Title:
HER-Seq A Blood-based Screening Study to Identify Patients With HER2 Mutations for Enrollment Into Clinical Research Studies of Neratinib
Sponsor:
Puma Biotechnology Inc
Organization:
Puma Biotechnology Inc
Study Overview
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
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was stopped early due to increased global access to genomic screening It is no longer economical to continue with this particular single-gene screening protocol
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 suspectedconfirmed 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None