A Study Evaluating the Efficacy and Safety of Giredestrant Plus Everolimus Compared With the Physician's Choice of Endocrine Therapy Plus Everolimus in Participants With Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer (evERA Breast Cancer)
Summary
This Phase III, randomized, open-label, multicenter study will evaluate the efficacy and safety of giredestrant plus everolimus compared with the physician's choice of endocrine therapy plus everolimus in participants with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer who have had previous treatment with cyclin-dependent kinase 4/6 inhibitors (CDK4/6is) and endocrine therapy, either in the locally advanced/metastatic or the adjuvant setting.
Timeline
- Start
- 2022-08-03
- Primary completion
- 2025-07-16
- Completion
- 2026-10-15
Outcome
Met primary endpoint
release “evERA met its co-primary endpoints” gene.com ↗
release “evERA met its co-primary endpoints; giredestrant plus everolimus demonstrated significant benefit in intent-to-treat (ITT) and ESR1-mutated populations” roche.com ↗
release “Phase III evERA Breast Cancer study results, which showed that giredestrant plus everolimus reduced the risk of disease progression or death by 44% and 62%” gene.com ↗
release “The evERA trial demonstrated that the giredestrant combination significantly delayed disease progression” gene.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Exemestane | Small molecule | 25 mg | Oral |
| Comparator | Fulvestrant | Small molecule | 500 mg | Intramuscular |
| Subject | Giredestrant | Small molecule | 30 mg | Oral |
| Comparator | Tamoxifen | Small molecule | 20 mg | Oral |
| Background | Dexamethasone | Small molecule | 0.5 mg | Other |
| Background | Everolimus | Small molecule | 10 mg | Oral |