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)

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

Outcome

Missed primary endpoint

release “persevERA Breast Cancer study did not meet the primary objective of a statistically significant improvement in progression-free survival” gene.com ↗

Drugs

Indications