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NCT03786107 · ClinicalTrials.gov registry record
HER-Seq: A Blood-based Screening Study to Identify Patients With HER2 Mutations for Enrollment Into Clinical Research Studies of Neratinib
A clinical trial, sponsored by Puma Biotechnology.
- Terminated
- Registry status
- 1,583
- Enrollment target
NCT03786107: Clinical Trial study, sponsored by Puma Biotechnology.
NCT03786107 is a clinical trial that was terminated before completion, run by Puma Biotechnology. The registered enrollment target is 1,583 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03786107 was terminated before completion, sponsored by Puma Biotechnology.
- TERMINATED
- Registry status
- 1,583 participants
- Enrollment target
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.
Primary Outcome
Identification of participants with somatic, activating HER2 mutations who might qualify for enrollment into neratinib treatment protocols
Interventions
- DIAGNOSTIC_TEST Almac HER-Seq Assay
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,583 participants |
| Start Date | 2019-03-14 |
| Est. Completion | 2021-01-21 |
Why NCT03786107 stopped before completion
NCT03786107 is an observational study that tracks outcomes without assigning an intervention. Its 1,583 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 1 intervention - of which Almac HER-Seq Assay is the first listed.
NCT03786107 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03786107 about?
NCT03786107 is a clinical study titled "HER-Seq: A Blood-based Screening Study to Identify Patients With HER2 Mutations for Enrollment Into Clinical Research Studies of Neratinib". 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 b...
What is the current status of trial NCT03786107?
This trial is currently terminated. The enrollment target is 1,583 participants. The study started on 2019-03-14. Estimated completion is 2021-01-21.
What interventions are being tested in trial NCT03786107?
The interventions under investigation include: Almac HER-Seq Assay (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03786107?
This trial is sponsored by Puma Biotechnology, which has 28 total clinical trials registered on ClinicalTrials.gov.
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