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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 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. The trial reports 20 study locations across 11 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05306340
The ClinicalTrials.gov registry entry for NCT05306340 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 373 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genentech, which has 332 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 11 distinct geographic areas - top geographies include 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.
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