NCT04546009

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)

A Phase III Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of GDC-9545 Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Patients With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 992 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Giredestrant	Giredestrant is taken orally once per day on Days 1-28 of each 28-day treatment cycle.
DRUG	Giredestrant-matched Placebo	Giredestrant-matched placebo is taken orally once per day on Days 1-28 of each 28-day treatment cycle.
DRUG	Letrozole	Letrozole 2.5 milligrams (mg) is taken orally once per day on Days 1-28 of each 28-day treatment cycle.
DRUG	Letrozole-matched Placebo	Letrozole-matched placebo is taken orally once per day on Days 1-28 of each 28-day treatment cycle.
DRUG	Palbociclib	Palbociclib 125 mg is taken orally once per day on Days 1-21 of each 28-day treatment cycle.
DRUG	LHRH Agonist	Only premenopausal/perimenopausal and male participants will receive a luteinizing hormone-releasing hormone (LHRH) agonist on Day 1 of each 28-day treatment cycle. The investigator will determine and supply the appropriate LHRH agonist locally approved for use in breast cancer.

Timeline

• Start date: 2020-10-09
• Primary completion: 2026-01-30
• Completion: 2028-03-25
• First posted: 2020-09-11
• Last updated: 2026-02-20

Locations

256 sites across 30 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Denmark, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Japan, Mexico, New Zealand, Peru, Poland, Portugal, Russia, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study