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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

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Trial Profile

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

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 19 Jun 2026

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At a glance

  • Drugs Giredestrant (Primary) ; Anastrozole; Exemestane; Letrozole; LHRH receptor agonists; Tamoxifen
  • Indications Advanced breast cancer; Early breast cancer; HER2 negative breast cancer; Male breast cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms LidERA Breast Cancer
  • Sponsors Roche

Most Recent Events

  • 02 Jun 2026 According to a Roche media release, the United States Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) under Priority Review for giredestrant as an adjuvant treatment for adults with oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, stage I, II, and III breast cancer, based on data from this trial. The FDA has set a Prescription Drug User Fee Act date of 30 November 2026.
  • 02 Jun 2026 Results presented at the 62nd Annual Meeting of the American Society of Clinical Oncology
  • 02 Jun 2026 According to a Roche media release, data from this trial were presented at the 2026 American Society of Clinical Oncology Congress.

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