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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.
CLINICAL TRIAL 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
Closing
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