CAILA

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.

CLINICAL TRIAL DETAILS

PROGRESSION-FREE SURVIVAL (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 RECIST V1.1 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 ≥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 COMBINATION.

CAILA AT CLINICALTRIALS.GOV

COUNTRY

STATUS

TUMOR TYPE

PHASE

SITES

HER2-

Spain

Closing

TRIAL OVERVIEW

PRESS RELEASE

2021 Press Release

SCIENTIFIC IMPACT

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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) Institut Catala d’Oncologia - ICO Badalona (Spain) Hospital Universitario Miguel Servet (Spain) Hospital Quiron Dexeus (Spain) Hospital Regional de Málaga (Spain)

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