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
Secondary Outcome:
  • 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

Interested in this trial?

Print this page and take it to your doctor to discuss your eligibilty and treatment options. Only your doctor can refer you to a clinical trial.

Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society