A Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared With Physician's Choice of Adjuvant Endocrine Monotherapy in Participants With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer (lidERA Breast Cancer)

Official Title

A Phase III, Randomized, Open-Label, Multicentre 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

Summary:

This is a Phase III, global, randomized, open-label, multicentre, 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.

Trial Description

Primary Outcome:

• Invasive Disease-Free Survival (IDFS), Excluding Second Primary Non-Breast Cancers

• Overall Survival
• Invasive Disease-Free Survival (IDFS), Including Second Primary Non-Breast Cancers
• Disease-Free Survival (DFS)
• Distant Recurrence-Free Interval (DRFI)
• Locoregional Recurrence-Free Interval (LRRFI)
• Mean Physical Functioning Scale Score at Specified Timepoints, Assessed Using the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
• Change from Baseline in the Mean Physical Functioning Scale Score at Specified Timepoints, Assessed Using the EORTC QLQ-C30
• Mean Role Functioning Scale Score at Specified Timepoints, Assessed Using the EORTC QLQ-C30
• Change from Baseline in the Mean Role Functioning Scale Score at Specified Timepoints, Assessed Using the EORTC QLQ-C30
• Mean Global Health Status/Quality of Life (QoL) Scale Score at Specified Timepoints, Assessed Using the EORTC QLQ-C30
• Change from Baseline in the Mean Global Health Status/Quality of Life (QoL) Scale Score at Specified Timepoints, Assessed Using the EORTC QLQ-C30
• Change from Baseline in the EQ 5D-5L Index-Based Score at Specified Timepoints
• Change from Baseline in the EQ 5D-5L Visual Analogue Scale (VAS) Score at Specified Timepoints
• Incidence and Severity of Adverse Events, with Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI-CTCAE v5.0)
• Plasma Concentrations of Giredestrant at Specified Timepoints

View this trial on ClinicalTrials.gov