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NCT05306340 · ClinicalTrials.gov registry record · Phase 3
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)
A Phase 3 study of Estrogen Receptor (ER)-Positive, HER2-negative, Locally Advanced or Metastatic Breast Cancer, sponsored by Genentech.
- Active
- Registry status
- Phase 3
- Development phase
- 373
- Enrollment target
- 20
- Study locations
NCT05306340: Active Phase 3 study of Estrogen Receptor (ER)-Positive, HER2-negative, Locally Advanced or Metastatic Breast Cancer, sponsored by Genentech.
NCT05306340 is a Phase 3 study of Estrogen Receptor (ER)-Positive, HER2-negative, Locally Advanced or Metastatic Breast Cancer that is active but no longer recruiting, run by Genentech. The registered enrollment target is 373 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (52% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05306340, a Phase 3 study of Estrogen Receptor (ER)-Positive, HER2-negative, Locally Advanced or Metastatic Breast Cancer, is active but no longer recruiting, sponsored by Genentech.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 373 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
The Intent-to-Treat (ITT) population consists of all randomized participants, and the ESR1m subpopulation is defined as participants in the ITT population whose tumors harbor a detectable Estrogen Receptor 1 (ESR1) mutation at baseline as measured in circulating tumor DNA (ctDNA).
Conditions Studied
Interventions
- DRUG Tamoxifen
- DRUG Exemestane
- DRUG Everolimus
- DRUG Fulvestrant
- DRUG Giredestrant
Study Locations (20)
California
- Alta Bates Summit Medical Center - Berkeley
- Beverly Hills Cancer Center - Beverly Hills
- TOI Clinical Research - Cerritos
- Women's Cancer Care - Fresno
- Scripps Health - La Jolla
- Los Angeles Hematology Oncology Medical Group - Los Angeles
- University of California, Irvine Medical Center - Orange
Florida
- Mount Sinai Medical Center - Miami Beach
- Orlando Health Cancer Institute - Orlando
Georgia
- Northwest Georgia Oncology Centers PC - Marietta - Marietta
- Summit Cancer Care PC - Savannah
Illinois
- Northwestern University - Chicago
- Springfield Clinic - Springfield
Alaska
- Alaska Oncology & Hematology, LLC - Anchorage
Arizona
- Arizona Oncology Associates, PC-CASA - Tucson
Arkansas
- University of Arkansas for Medical Sciences - Little Rock
Connecticut
- Yale Cancer Center - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 373 participants |
| Start Date | 2022-08-03 |
| Est. Completion | 2026-10-15 |
| Phase | Phase 3 |
What the registry record for NCT05306340 still lists
NCT05306340 is an interventional study that assigns participants to a tested intervention. The registered 373 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (52% lower).
The record links to 1 condition, with Estrogen Receptor (ER)-Positive, HER2-negative, Locally Advanced or Metastatic Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which Tamoxifen is the first listed.
NCT05306340 names 20 study sites across 11 states, led by California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT05306340 about?
NCT05306340 is a clinical study titled "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)". 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 (HE...
What is the current status of trial NCT05306340?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 373 participants. The study started on 2022-08-03. Estimated completion is 2026-10-15.
What conditions does trial NCT05306340 study?
This clinical trial studies the following conditions: Estrogen Receptor (ER)-Positive, HER2-negative, Locally Advanced or Metastatic Breast Cancer.
What interventions are being tested in trial NCT05306340?
The interventions under investigation include: Tamoxifen (DRUG), Exemestane (DRUG), Everolimus (DRUG), Fulvestrant (DRUG), Giredestrant (DRUG).
Who is sponsoring clinical trial NCT05306340?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05306340 being conducted?
This trial has 20 study locations across Alaska, Arizona, Arkansas, California, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05306340's enrollment target sits among peer trials
373 991st of 2000 higher than 1,010 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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