lidERA

Official Title

A Phase III, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared With Physician's Choice of Adjuvant Endocrine Monotherapy in Patients With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer

General Details & Status

Estimated Enrollment: 4100 participants
Allocation: Randomized
Actual Study Start Date: 27/08/2021
Estimated Primary Completion Date: 19/12/2025
Estimated Study Completion Date: 21/11/2023
Sponsor: Hoffmann-La Roche
Clinical Trial Link: https://classic.clinicaltrials.gov/ct2/show/NCT04961996

Brief Summary

This is a Phase III, global, randomized, open-label, multicenter, study evaluating the efficacy and safety of adjuvant giredestrant compared with endocrine therapy of physician’s choice in participants with medium- and high-risk Stage I-III histologically confirmed estrogen receptor (ER)-positive and human epidermal growth factor receptor 2 (HER2)-negative early breast cancer.