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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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SCIENTIFIC IMPACT

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SABCS 2021: - DOWNLOAD THE POSTER

TRIAL RESUME

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ABIGAIL SITES

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SPAIN

Institut Català d' Oncologia Girona (ICO)

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SPAIN

Hospital Universitari Sant Joan de Reus

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SPAIN

Complejo Asistencial Universitario de León

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SPAIN

Hospital Clínico Universitario de Valencia

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SPAIN

Hospital Clínico San Carlos

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SPAIN

Hospital Quirónsalud Valencia

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SPAIN

Hospital Universitario Miguel Servet

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SPAIN

Hospital Universitario La Paz

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SPAIN

Hospital Universitario de Basurto

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SPAIN

CO Galicia

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SPAIN

Complejo Hospitalario de Navarra

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SPAIN

Hospital Arnau de Vilanova

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SPAIN

Complejo Hospitalario Ruber Juan Bravo

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SPAIN

Hospital General Universitario de Alicante

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SPAIN

Hospital Universitario Clínico San Cecilio de Granada

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SPAIN

Consorcio Hospitalario Provincial de Castellón

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SPAIN

Hospital Universitario Reina Sofía

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SPAIN

Consorcio Hospital General Universitario de Valencia

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SPAIN

Fundació Althaia

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SPAIN

Hospital Quirónsalud Sagrado Corazón

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SPAIN

Hospital Universitario Arnau de Vilanova de Lleida

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SPAIN

Hospital Universitario Ramón y Cajal

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ITALY

Ospedale da Saliceto

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ITALY

Azienda Ospedaliero-Universitaria Cittá de la Salute e della Scienza

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ITALY

Ospedale San Gerardo

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ITALY

Istituto Europeo di Oncologia (IEO)

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PORTUGAL

Hospital de Santa Maria - Centro Hospitalar Lisboa Norte

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PORTUGAL

Hospital Fernando da Fonseca

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PORTUGAL

Hospital Beatriz Ângelo

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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

24

Spain, Portugal, Italy

Recruiting

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