ABIGAIL
OFFICIAL TITLE: A RANDOMIZED, 2-ARM, OPEN-LABEL, PHASE II STUDY OF ABEMACICLIB COMBINED WITH ENDOCRINE THERAPY (LETROZOLE OR FULVESTRANT) WITH OR WITHOUT A SHORT COURSE OF INDUCTION CHEMOTHERAPY WITH PACLITAXEL AS FIRST-LINE THERAPY IN PATIENTS WITH UNRESECTABLE LOCALLY ADVANCED OR METASTATIC HR-POSITIVE/HER2-NEGATIVE BREAST CANCER WITH AGGRESSIVE DISEASE CRITERIA (ABIGAIL)
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ABIGAIL SITES
SPAIN
Institut Català d' Oncologia Girona (ICO)
SPAIN
Hospital Universitari Sant Joan de Reus
SPAIN
Complejo Asistencial Universitario de León
SPAIN
Hospital Clínico Universitario de Valencia
SPAIN
Hospital Clínico San Carlos
SPAIN
Hospital Quirónsalud Valencia
SPAIN
Hospital Universitario Miguel Servet
SPAIN
Hospital Universitario La Paz
SPAIN
Hospital Universitario de Basurto
SPAIN
CO Galicia
SPAIN
Complejo Hospitalario de Navarra
SPAIN
Hospital Arnau de Vilanova
SPAIN
Complejo Hospitalario Ruber Juan Bravo
SPAIN
Hospital General Universitario de Alicante
SPAIN
Hospital Universitario Clínico San Cecilio de Granada
SPAIN
Consorcio Hospitalario Provincial de Castellón
SPAIN
Hospital Universitario Reina Sofía
SPAIN
Consorcio Hospital General Universitario de Valencia
SPAIN
Fundació Althaia
SPAIN
Hospital Quirónsalud Sagrado Corazón
SPAIN
Hospital Universitario Arnau de Vilanova de Lleida
SPAIN
Hospital Universitario Ramón y Cajal
ITALY
Ospedale da Saliceto
ITALY
Azienda Ospedaliero-Universitaria Cittá de la Salute e della Scienza
ITALY
Ospedale San Gerardo
ITALY
Istituto Europeo di Oncologia (IEO)
PORTUGAL
Hospital de Santa Maria - Centro Hospitalar Lisboa Norte
PORTUGAL
Hospital Fernando da Fonseca
PORTUGAL
Hospital Beatriz Ângelo
PORTUGAL
Hospital do Santo Antonio
CLINICAL TRIAL DETAILS
THE PRIMARY GOAL IS TO COMPARE THE EFFICACY, AS MEASURED BY 12-WEEK OVERALL RESPONSE RATE (ORR), OF ABEMACICLIB COMBINED WITH ENDOCRINE THERAPY (ET) (LETROZOLE OR FULVESTRANT) VERSUS PACLITAXEL IN PATIENTS WITH UNRESECTABLE LOCALLY ADVANCED OR METASTATIC HR-POSITIVE/HER2- NEGATIVE BREAST CANCER WITH AGGRESSIVE DISEASE CRITERIA.
IN ADDITION, TO EVALUATE PREDICTIVE AND/OR PROGNOSTIC AND/OR PHARMACODYNAMIC BIOMARKERS ASSOCIATED WITH DISEASE ACTIVITY STATUS OR RESPONSE TO STUDY TREATMENTS ON ARCHIVAL AND/OR FRESH TUMOR TISSUE AND BLOOD SAMPLES.
TUMOR TYPE
PHASE
N
SITES
COUNTRY
STATUS
HR-positive/HER2-negative
II
160
24
Spain, Portugal, Italy
Recruiting