CAILA

OFFICIAL TITLE: MULTICENTER, SINGLE ARM, OPEN-LABEL, PHASE II CLINICAL TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND EFFICACY OF CB-103 IN COMBINATION WITH A NON-STEROIDAL AROMATASE INHIBITOR (NSAI), ANASTROZOLE OR LETROZOLE, IN HORMONE RECEPTOR-POSITIVE AND HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE ADVANCED BREAST CANCER PATIENTS WHO HAVE ACHIEVED CLINICAL BENEFIT DURING PRIOR NSAI-BASED TREATMENT.

PROJECT DETAILS

PROGRESSION-FREE SURVIVAL (PFS) [ TIME FRAME: FROM TREATMENT INITIATION UNTIL OBJECTIVE TUMOR PROGRESSION OR DEATH ]


PFS, DEFINED AS THE TIME FROM TREATMENT INITIATION UNTIL OBJECTIVE TUMOR PROGRESSION OR DEATH FROM ANY CAUSE, WHICHEVER OCCURS FIRST, AS PER INVESTIGATOR ASSESSMENT BY RESPONSE EVALUATION CRITERIA IN SOLID TUMORS (RECIST) VERSION (V) 1.1 IN THE SUBGROUP OF PATIENTS WITH EVIDENCE OF NOTCH SIGNALING PATHWAY ACTIVATION.WE HYPOTHESIZE THAT EXCLUDING A MEDIAN PFS OF 2 MONTHS WHILE TARGETING AN IMPROVEMENT OF THE MEDIAN PFS GREATER THAN OR EQUAL TO 4 MONTHS (HR = 0.50) IN PATIENTS WITH EVIDENCE OF NOTCH PATHWAY ACTIVATION IS AN OPTIMAL APPROACH TO EVALUATE THE CLINICAL ACTIVITY OF THE CB-103 PLUS NSAI (ANASTROZOLE OR LETROZOLE) COMBINATION.

CAILA AT CLINICALTRIALS.GOV

TUMOR TYPE

PHASE

N

SITES

COUNTRY

STATUS

HER2-

II

80

15

Spain

Approved

CAILA SITES

SPAIN

Hospital La Paz

SPAIN

Hospital Universitario Ramón y Cajal

SPAIN

Hospital Universitario Arnau de Vilanova

SPAIN

Hospital Universitario Sant Joan de Reus

SPAIN

MD Anderson Cancer Center Madrid

SPAIN

Hospital Universitario La Ribera

SPAIN

Hospital Ruber Internacional

SPAIN

Hospital Nuestra Señora de Sonsoles

SPAIN

Hospital Virgen del Rocio

SPAIN

Hospital Complejo Hospitalario de Jaén

SPAIN

Hospital Universitario Cruces

SPAIN

Hospital Quiron Dexeus

SPAIN

Hospital Regional de Málaga