NOBROLA
OFFICIAL TITLE: A TWO-STAGE SIMON DESIGN PHASE II STUDY FOR NON-BRCA MBC PATIENTS WITH HOMOLOGOUS RECOMBINATION DEFICIENCY (HRD) TREATED WITH OLAPARIB SINGLE AGENT.
SCIENTIFIC IMPACT
NOBROLA SITES
CLINICAL TRIAL DETAILS
THIS IS AN INTERNATIONAL, MULTI-CENTRE, NON-CONTROLLED, OPEN-LABEL, SINGLE ARM, TWO-STAGE SIMON DESIGN PHASE II STUDY FOR NON-BRCA METASTATIC BREAST CANCER (MBC) PATIENTS WITH HOMOLOGOUS RECOMBINATION DEFICIENCY TREATED WITH OLAPARIB SINGLE AGENT.
THE MAIN OBJECTIVE IS TO ASSESS THE EFFICACY OF OLAPARIB SINGLE AGENT IN NON-BRCA METASTATIC BREAST CANCER (MBC) PATIENTS WHOSE TUMOURS EXHIBIT ANY CHARACTERISTIC RELATED TO HOMOLOGOUS RECOMBINATION DEFICIENCY (HRD), AS DETERMINED BY CLINICAL BENEFIT RATE (CBR) USING THE RESPONSE EVALUATION CRITERIA IN SOLID TUMORS (RECIST 1.1).
WITH AN EXPECTED DURATION OF 34 MONTHS, THE STUDY COMMITMENT IS 39 PATIENTS: 17 PATIENTS WILL BE ENROLLED AT THE FIRST STAGE AND 22 AT THE SECOND STAGE.
NOBROLA AT CLINICALTRIALS.GOV
TUMOR TYPE
PHASE
N
SITES
COUNTRY
STATUS
BREAST
II
39
18
Spain
Closing
AACR 2018 – DOWNLOAD THE POSTER
SPAIN
Hospital del Mar
SPAIN
Hospital Universitari Sant Joan de Reus
SPAIN
Instituto Valenciano de Oncología (IVO)
SPAIN
Hospital Universitario Ramón y Cajal
SPAIN
Complejo Hospitalario Universitario A Coruña (CHUAC)
SPAIN
Hospital Universitario Virgen de la Victoria
SPAIN
Hospital Universitario Virgen del Rocío
SPAIN
Hospital Clínico Universitario Lozano Blesa
SPAIN
Institut Català d' Oncologia L'Hospitalet (ICO)
SPAIN
Institut Català d' Oncologia Badalona (ICO)
SPAIN
Hospital Arnau de Vilanova de Valencia
SPAIN
Complejo Asistencial Universitario de Salamanca
SPAIN
Institut Català d' Oncologia Girona (ICO)
SPAIN
Hospital Universitario Doce de Octubre
SPAIN
Complejo Hospitalario de Jaén
SPAIN
Clinica Universitaria de Navarra (CUN)
SPAIN
MD Anderson Cancer Center Madrid