A Study Evaluating the Efficacy and Safety of Giredestrant Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Participants With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (persevERA Breast Cancer)

NCT04546009 PHASE3 ACTIVE_NOT_RECRUITING

This Phase III, randomized, double-blind, placebo-controlled, multicenter study will evaluate the efficacy and safety of giredestrant combined with palbociclib compared with letrozole combined with palbociclib in patients with estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER2)-negative locally advanced (recurrent or progressed) or metastatic breast cancer.

Details

Lead sponsor	Hoffmann-La Roche
Phase	PHASE3
Status	ACTIVE_NOT_RECRUITING
Enrolment	992
Start date	Fri Oct 09 2020 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Sat Mar 25 2028 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer

Interventions

• Giredestrant
• Giredestrant-matched Placebo
• Letrozole
• Letrozole-matched Placebo
• Palbociclib
• LHRH Agonist

Countries

Belgium, New Zealand, Japan, Hong Kong, United States, Italy, Mexico, Peru, Taiwan, Australia, Canada, Argentina, Hungary, Poland, Portugal, Thailand, South Korea, Brazil, Spain, Israel, Austria, France, Turkey (Türkiye), Germany, Ukraine, Greece, United Kingdom, Russia, China, Denmark