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.

PROJECT 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

24

Spain, France, Germany

Recruiting

AACR 2018 – DOWNLOAD THE POSTER

NOBROLA SITES

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