
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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TRIAL RESUME


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.
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TUMOR TYPE
PHASE
N
SITES
COUNTRY
STATUS
HR-positive/HER2-negative
II
160
24
Spain, Portugal, Italy
Analysis