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

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

Ensayo de PUMA BIOTECHNOLOGY, INC. en Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer · Metastatic Cervical Cancer (del registro, en inglés).

Fase

no aplica

Estado

Interrumpido

Participantes

1.583

previstos

Centros

22

Fin del objetivo primario

ene 2021

fecha real

Qué significa cada fase y cada estado.

Estudio observacional. Comenzó en mar 2019.

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «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.».

Qué mide

Number of Participants Eligible for Neratinib Treatment (From enrollment date to identification of HER2 positive mutation, assessed up to five years) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis 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.

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Ficha completa en ClinicalTrials.gov (NCT03786107), actualizada en may 2021.