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OPHELIA

OFFICIAL TITLE: EFFECTIVENESS OF OLAPARIB PLUS TRASTUZUMAB IN HER2-POSITIVE BRCA-MUTATED OR HOMOLOGOUS RECOMBINATION DEFICIENCY (HRD) ADVANCED BREAST CANCER PATIENTS.

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CLINICAL TRIAL DETAILS

THE OPHELIA STUDY IS A MULTICENTER, OPEN-LABEL, SINGLE-ARM, TWO COHORTS, SIMON’S TWO-STAGE MINIMAX DESIGN, PHASE II CLINICAL TRIAL.

THE PRIMARY OBJECTIVE OF THIS TRIAL IS TO ASSESS THE EFFICACY – AS DETERMINED BY THE OVERALL RESPONSE RATE (ORR) AND PROGRESSION-FREE SURVIVAL (PFS) BASED ON RECIST V.1.1 – OF OLAPARIB IN COMBINATION WITH TRASTUZUMAB IN PATIENTS WITH HER2-POSITIVE, GERMINAL BRCA1/2 MUTATED ABC.

 

OPHELIA AT CLINICALTRIALS.GOV

TUMOR TYPE

PHASE

N

SITES

COUNTRY

STATUS

BREAST

II

33

17

Spain

Closed

OPHELIA SITES

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SPAIN

Hospital Arnau de Vilanova de Valencia

SPAIN

Complejo Hospitalario de Jaén

SPAIN

Hospital Universitario Virgen del Rocío

SPAIN

Onkologikoa

SPAIN

Hospital Clínico San Carlos

SPAIN

Hospital Son Llatzer

SPAIN

Hospital Universitario Virgen de la Victoria

SPAIN

Hospital Universitari Son Espases

SPAIN

Hospital Universitari Vall D'Hebron

SPAIN

Hospital Universitario Arnau de Vilanova de Lleida

SPAIN

Complejo Hospitalario Universitario de Santiago (CHUS)

SPAIN

Hospital San Pedro de Alcántara

SPAIN

Complejo Asistencial de Ávila

SPAIN

Hospital Clínico Universitario de Valencia

SPAIN

Hospital Universitario Reina Sofía

SPAIN

Hospital Universitario Ramón y Cajal

SPAIN

Hospital Universitario La Paz

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