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) 

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

Consorcio Hospitalario Provincial de Castellón

SPAIN

Hospital Universitario Reina Sofía

SPAIN

Consorcio Hospital General Universitario de Valencia

ITALY

Ospedale Guglielmo da Saliceto

ITALY

Azienda Ospedaliero-Universitaria Cittá de la Salute e della Scienza

ITALY

Ospedale San Gerardo

ITALY

Instituto Europeo di Oncologia

FRANCE

Hôpital Tenon AP-HP

FRANCE

Hopital Europeen Georges Pompidou

PORTUGAL

Hospital Fernando da Fonseca

PORTUGAL

Hospital Beatriz Ângelo

PORTUGAL

Hospital de Santa Maria - Centro Hospitalar Lisboa Norte

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.

ABIGAIL AT CLINICALTRIALS.GOV

TUMOR TYPE

PHASE

N

SITES

COUNTRY

STATUS

HR-positive/HER2-negative 

II

160

26

Spain, France, Portugal, Italy

Start-up

ABIGAIL SITES

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