Clinical study - Sein métastatique RH+

HerSeq (PUMA-NER-9501)
Sein métastatique RH+
Essai clinique fermé
Public cible
Adulte
HER-Seq: A Blood-based Screening Study to Identify Patients with HER2 Mutations for;Enrollment into Clinical Research Studies of Neratinib
Description de l'essai

This is a multi-center, observational genomic screening study. Patients with histologicallyconfirmed;HR+, HER2-negative metastatic breast cancer (HR+, HER2- MBC) who have received or are currently;receiving cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy; or patients with metastatic cervical cancer;(MCC) may be enrolled to detect the presence of somatic HER2 mutations in ctDNA from plasma. Blood samples;will be collected from eligible patients and ctDNA sequenced using targeted next generation sequencing (NGS) at a;central laboratory. A certified molecular test report will be issued from the central laboratory and provided to the;investigators and the study sponsor. For those patients identified as having an eligible activating HER2 mutation,;further information on available study treatment protocols will be provided in the molecular report. Patients enrolled;in participating institutions who are identified with HER2 mutations by this screening protocol will have potential;access to neratinib treatment protocols.