With the enrollment of two patients at the Universitario Doce de Octubre Hospital in Madrid, we have reached the first milestone of the LUZERN study!
This is just the beginning in reaching our goal of enrolling of 23 patients in 23 months at 10 random sites throughout Spain.
LUZERN is focused on ER+/ HER2-, locally advanced or metastatic breast cancer patients harboring either germline BRCA (gBRCA) mutations or wild type BRCA with homologous recombination deficiency (HRD). Patients will be treated with Niraparib (PARP inhibitor) in combination with aromatase inhibitors to evaluate the efficacy and safety of this strategy (The LUZERN Strategy).
Some inclusion/exclusión criteria are:
~ Patients evidence of inoperable, locally recurrent or metastatic breast cancer (MBC) that are not candidates for curative intent.
~ [Cohort A]: Patients with documented germinal mutation in BRCA1 or BRCA2 genes that is predicted to be deleterious or suspected deleterious
~ Patients with either germinal BRCA1/2 wild-type (gBRCAwt) or gBRCAms that are considered to be nondetrimental and homologous recombination deficiency (HRD) based on the HRDetect predictor test.
~ At least one, and up to two prior lines of endocrine therapy (aromatase inhibitors [AIs] or fulvestrant)
~ Confirmed disease progression while in the last AI-containing régimen
~ Patients must have evaluable or measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1
~ ECOG 0-1
~ Patients that have previously received any PARP inhibitor (PARPi), including niraparib, in a metastatic setting.
~ Patients with symptomatic uncontrolled brain metastases or leptomeningeal metastases.
The participating sites of the study are:
Instituto Valenciano de Oncología (IVO)
Hospital Universitari Vall D'Hebron
Hospital Clínic i Provincial de Barcelona
Complejo Asistencial de Ávila
Hospital Universitario Reina Sofía
Hospital Universitario Virgen de la Victoria
Complejo Hospitalario Universitario de Santiago (CHUS)
Centro Oncológico de Galicia
Hospital Universitario Doce de Octubre
Hospital Clínico San Carlos
We truly appreciate the entire investigator team’s involvement in the LUZERN study.
Author: Maria del Mar Zafra