drugset
drugset / Trial / NCT05306340

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)

NCT05306340 ↗

Phase 3 Active not recruiting 373 enrolled Genentech, Inc.
RandomizedParallel-groupOpen-labelTreatment

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

Drugs

EvaluationDrugModalityDoseRoute
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

Indications

estrogen-receptor positive breast cancer