A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus a CDK4/6 Inhibitor and Letrozole Versus Placebo Plus a CDK4/6 Inhibitor and Letrozole in Patients With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus a CDK4/6 Inhibitor and Letrozole Versus Placebo Plus a CDK4/6 Inhibitor and Letrozole in Patients With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer
This study will evaluate the efficacy and safety of the combination of inavolisib plus a cyclin-dependent kinase 4 and 6 inhibitor (CDK4/6i) and letrozole versus placebo plus a CDK4/6i and letrozole in the first-line setting in participants with endocrine-sensitive PIK3CA-mutated hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), advanced breast cancer (ABC).
Inclusion Criteria:
Exclusion Criteria:
global-roche-genentech-trials@gene.com888-662-6728 (U.S. Only)
Jacksonville, Florida 32207, United States
Grand Rapids, Michigan 49503, United States
New York, New York 10011, United States
Portland, Oregon 97225, United States
Pittsburgh, Pennsylvania 15213, United States
Salt Lake City, Utah 84113, United States
Caba, C1426AGE, Argentina
Capital Federal, C1414, Argentina
Porto Alegre, Rio Grande do Sul 90020-090, Brazil
São Paulo, São Paulo 01317-001, Brazil
Dresden, 01307, Germany
Hanover, 30625, Germany
Meldola, Emilia-Romagna 47014, Italy
Bolzano, Trentino-Alto Adige 39100, Italy
Novara, Umbria 28100, Italy
Hokkaido, 060-8648, Japan
Distrito Federal, Mexico CITY (federal District) 14000, Mexico
MexicoCiudad de México, Nuevo León 6726, Mexico
Ciudad de Huajuapan de León, Oaxaca 69007, Mexico
D.F., 04980, Mexico
?ód?, 93-338, Poland
Lublin, 20-090, Poland
Rzeszów, 35-021, Poland
Wroc?aw, 53-413, Poland
Dongnam-gu, Cheonan-si, 31151, South Korea
Pamplona/iruña, Navarre 31008, Spain
Madrid, 28007, Spain
Málaga, 29011, Spain
Ankara, 06200, Turkey (Türkiye)
Bakirkoy / Istanbul, 34147, Turkey (Türkiye)