Spots Global Cancer Trial Database for ABemaciclib, ET ± paclItaxel in aGgressive HR+/HER2- MBC trIaL
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Trial Identification
Brief Title: ABemaciclib, ET ± paclItaxel in aGgressive HR+/HER2- MBC trIaL
Official Title: A Randomized, 2-Arm, Open-Label, Ph-II Study of Abemaciclib Combined With ET w/ or w/o CT With Paclitaxel as 1L in Patients With Unresectable Locally Advanced or Metastatic HR(+)/HER2(-) BC With Aggressive Disease Criteria
Study ID: NCT04603183
Conditions
Study Description
Brief Summary: This is a multicenter, randomized, 2 arm, open label, phase II study. It is designed to compare the efficacy and safety of abemaciclib combined with ET (letrozole or fulvestrant) versus a short course with induction chemotherapy with paclitaxel followed by maintenance therapy with abemaciclib combined with ET (letrozole or fulvestrant) in patients with previously untreated, unresectable locally advanced, or metastatic HR positive/HER2 negative breast cancer with aggressive disease criteria.
Detailed Description: The ABIGAIL study aims to provide consistent evidence that the combination of abemaciclib with ET -consisting of letrozole or fulvestrant-as first-line regimen is non-inferior to the optimal first-line chemotherapy -consisting of weekly paclitaxel-in terms of early ORR after the first 12 weeks of treatment in patients with HR-positive/HER2-negative ABC and at least one feature of aggressive disease associated with poor prognosis.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Instituto Europeo di Oncologia, Milano, , Italy
Ospedale San Gerardo, Monza, , Italy
Ospedale Guglielmo da Saliceto, Piacenza, , Italy
Azienda Ospedaliero-Universitaria Cittá de la Salute e della Scienza, Torino, , Italy
Hospital Fernando da Fonseca, Amadora, , Portugal
Hospital de Santa Maria - Centro Hospitalar Lisboa Norte, Lisboa, , Portugal
Hospital Universitario Virgen del Rocio, Sevilla, Andalucía, Spain
Fundación Althaia Manresa, Manresa, Barcelona, Spain
Hospital Universitario Reina Sofia, Córdoba, Cordoba, Spain
Centro Oncoloxico de Galicia, A Coruña, Coruña, Spain
Complejo Asistencial Universitario De León, León, Leon, Spain
Complejo Hospitalario de Navarra, Pamplona, Pamplona/Iruña, Spain
Hospital Universitari de Sant Joan de Reus, Reus, Tarragona, Spain
Hospital General Universitario de Alicante, Alicante, , Spain
Hospital Quiron Salud Dexeus, Barcelona, , Spain
Hospital Universitario Basurto, Bilbao, , Spain
Consorcio Hospitalario Provincial de Castellon, Castellón De La Plana, , Spain
Institut Catala D'Oncologia Girona - Hospital Josep Trueta, Girona, , Spain
Hospital Universitario San Cecilio, Granada, , Spain
Hospital Universitario Arnau de Vilanova, Lleida, , Spain
Hospital Ruber Juan Bravo, Madrid, , Spain
Hospital Beata María Ana, Madrid, , Spain
Hospital Universitario Ramón y Cajal, Madrid, , Spain
Hospital Universitario Clinico San Carlos, Madrid, , Spain
Hospital Universitario La Paz, Madrid, , Spain
Hospital Quirónsalud Sagrado Corazón, Sevilla, , Spain
Hospital Clinico Universitario de Valencia, Valencia, , Spain
Hospital Quironsalud Valencia, Valencia, , Spain
Consorcio Hospital General Universitario de Valencia, Valencia, , Spain
Hospital Arnau de Vilanova, Valencia, , Spain
Hospital Universitario Miguel Servet, Zaragoza, , Spain
Contact Details
Name: Antonio Llombart-Cussac
Affiliation: Arnau de Vilanova Hospital, Valencia (Spain)
Role: PRINCIPAL_INVESTIGATOR
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