ABIGAIL

A RANDOMIZED, 2-ARM, OPEN-LABEL, PHASE II STUDY OF ABEMACICLIB COMBINED WITH ENDOCRINE THERAPY (LETROZOLE OR FULVESTRANT) WITH OR WITHOUT 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

https://clinicaltrials.gov/study/NCT04603183

HR-positive/HER2-negative

160

Spain, Portugal, Italy

Analysis

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

SITES

COUNTRY

STATUS

PRESS RELEASE

Press Releases: https://www.medsir.org/post/abigail-study-breast

SCIENTIFIC IMPACT

ESMO 2024 presentation: https://www.medsir.org/_files/ugd/39f166_bd02b9be7a254a80952c28cecf429de3.pdf | ESMO 2024 lay language summary: https://www.medsir.org/_files/ugd/39f166_3d216c0856ed4eb5bd1bfddd666631ff.pdf | SABCS 2021 poster: https://d9ec78c0-6610-4e58-b628-a2262f2019e2.usrfiles.com/ugd/39f166_50f0531581f94248a5a2dd9f20c6a00a.pdf

BLOG ARTICLES RELATED

Spotlight: Abigail breast cancer trial: https://www.medsir.org/post/spotlight-abigail-breast-cancer-trial | MEDSIR’s On Site Experience from SABCS 2021: Update on our 5 studies presented: https://www.medsir.org/post/medsir-s-on-site-experience-from-sabcs-2021-update-on-our-5-studies-presented | MEDSIR is heading to SABCS 2021!: https://www.medsir.org/post/medsir-is-heading-to-sabcs-2021 | New trial to evaluate abemaciclib and endocrine therapy vs. chemotherapy in advanced breast cancer: https://www.medsir.org/post/new-trial-to-evaluate-abemaciclib-and-endocrine-therapy-vs-chemotherapy-in-advanced-breast-cancer

PHERGAIN SITES

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 (Spain) | Ospedale da Saliceto (Italy) | Azienda Ospedaliero-Universitaria Cittá de la Salute e della Scienza (Italy) | Ospedale San Gerardo (Italy) | Istituto Europeo di Oncologia (IEO) (Italy) | Hospital de Santa Maria - Centro Hospitalar Lisboa Norte (Portugal) | Hospital Fernando da Fonseca (Portugal) | Hospital Beatriz Ângelo (Portugal) | Hospital do Santo Antonio (Portugal)

Dr. Cortes and Dr. Llombart PHERain interview

Beyond Chemotherapy

Dr. Vanes Quiroga

Dr. Sofia Braga

Dr. Silvi Antolín

Dr. Escrivá de Romaní

Dr. Philipp Aftimos

Dr. Manuel Ruiz

Prof. Daniele Generali PHEGain interview

Dr. Jacques Medioni

Dr. Dunca Wheatley