drugset / Trial / 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)

NCT04546009

Phase 3 Active not recruiting 992 enrolled Hoffmann-La Roche
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2020-10-09
Primary completion
2026-01-30
Completion
2028-03-25

Drugs

EvaluationDrugModalityDoseRoute
Subject Giredestrant Small molecule Oral
Comparator Letrozole Other / unclassified 2.5 mg Oral
Background Palbociclib Small molecule 125 mg Oral