A Phase III Randomized, Open-Label Study Evaluating Efficacy and Safety of Giredestrant Compared With Fulvestrant, Both Combined With a CDK4/6 Inhibitor, in Patients With Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer With Resistance to Prior Adjuvant Endocrine Therapy
A Phase III Randomized, Open-Label Study Evaluating Efficacy and Safety of Giredestrant Compared With Fulvestrant, Both Combined With a CDK4/6 Inhibitor, in Patients With Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer With Resistance to Prior Adjuvant Endocrine Therapy
This is a Phase III, randomized, open-label multicenter study that will evaluate the efficacy and safety of giredestrant compared with fulvestrant, both in combination with the investigator's choice of a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib), in participants with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer who have developed resistance to adjuvant endocrine therapy.
Inclusion Criteria:
Exclusion Criteria:
global-roche-genentech-trials@gene.com888-662-6728 (U.S. Only)
Torrance, California 90502, United States
Washington D.C., District of Columbia 20007, United States
St. Petersburg, Florida 33701-4553, United States
West Palm Beach, Florida 33401-3406, United States
Philadelphia, Pennsylvania 19106, United States
Richmond, Virginia 23219, United States
Ciudad Autonoma Buenos Aires, C1426AGE, Argentina
Buderim, Queensland 4556, Australia
Ijuí, Rio Grande do Sul 98700-000, Brazil
Porto Alegre, Rio Grande do Sul 90020-090, Brazil
São Paulo, São Paulo 01317-001, Brazil
Mississauga, Ontario L5M 2N1, Canada
Thunder Bay, Ontario P7B 6V4, Canada
Chicoutimi, Quebec G7H 5H6, Canada
Montreal, Quebec H2X 0C2, Canada
Trois-Rivières, Quebec G8Z 3R9, Canada
Luoyang, 471031, China
Wuhan, 430022, China
Bogota, D.C., 110131, Colombia
Bogotá D.C., 51000, Colombia
Bamberg, 96049, Germany
Freiburg im Breisgau, 79110, Germany
Homburg/Saar, 66424, Germany
Mönchengladbach, 41061, Germany
Banglore, Karnataka 560027, India
Mumbai, Maharashtra 400004, India
Avellino, Campania 83100, Italy
Udine, Friuli Venezia Giulia 33100, Italy
Mexico City, Mexico CITY (federal District) 03240, Mexico
Mexico City, Mexico CITY (federal District) 06760, Mexico
Queréaro, Querétaro 76230, Mexico
?ód?, 93-338, Poland
Cluj County, 407280, Romania
Badalona, Barcelona 08916, Spain
Madrid, 28050, Spain
Xitun Dist., 40705, Taiwan
Muang Chiang MAI Delivery Branch 3, 50200, Thailand
Bakirkoy / Istanbul, 34147, Turkey (Türkiye)
Sihhiye/Ankara, 06230, Turkey (Türkiye)