A Study Evaluating the Efficacy and Safety of Giredestrant Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Participants With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (persevERA Breast Cancer)
Public ClinicalTrials.gov record NCT04546009. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase III Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of GDC-9545 Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Patients With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer
Study identification
- NCT ID
- NCT04546009
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Hoffmann-La Roche
- Industry
- Enrollment
- 992 participants
Conditions and interventions
Interventions
- Giredestrant Drug
- Giredestrant-matched Placebo Drug
- LHRH Agonist Drug
- Letrozole Drug
- Letrozole-matched Placebo Drug
- Palbociclib Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 8, 2020
- Primary completion
- Jan 29, 2026
- Completion
- Mar 24, 2028
- Last update posted
- May 18, 2026
2020 – 2028
United States locations
- U.S. sites
- 37
- U.S. states
- 18
- U.S. cities
- 35
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Orange Coast Memorial Medical Center | Fountain Valley | California | 92708 | — |
| Long Beach Memorial Medical Center | Long Beach | California | 90806 | — |
| Kaiser Permanente - San Leandro Medical Center | San Leandro | California | 94577 | — |
| Stanford Univ Medical Center | Stanford | California | 94305 | — |
| Kaiser Permanente - Walnut Creek | Walnut Creek | California | 94596 | — |
| University of Colorado | Aurora | Colorado | 80045-2517 | — |
| Rocky Mountain Cancer Center | Denver | Colorado | 80218 | — |
| Florida Cancer Specialists - Fort Myers (Broadway) | Fort Myers | Florida | 33901 | — |
| Memorial Regional Cancer Ctr | Hollywood | Florida | 33021 | — |
| University of Miami | Miami | Florida | 33136 | — |
| SCRI Florida Cancer Specialists North | St. Petersburg | Florida | 33705 | — |
| SCRI Florida Cancer Specialists PAN | Tallahassee | Florida | 32308 | — |
| Kaiser Permanente - Moanalua Medical Center | Honolulu | Hawaii | 96819-1469 | — |
| Mercy Medical Center | Baltimore | Maryland | 21202 | — |
| Maryland Oncology Hematology | Silver Spring | Maryland | 20902 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | — |
| HCA Midwest Division | Kansas City | Missouri | 64132 | — |
| Memorial Sloan Kettering Cancer Center Basking Ridge | Basking Ridge | New Jersey | 07920 | — |
| Astera Cancer Care East Brunswick | East Brunswick | New Jersey | 08816 | — |
| Memorial Sloan Kettering Cancer Center at Bergen | Montvale | New Jersey | 07645 | — |
| San Juan Oncology Associates | Farmington | New Mexico | 87401 | — |
| MSKCC @ Commack | Commack | New York | 11725 | — |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | — |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| Providence Portland Medical Ctr | Portland | Oregon | 97213 | — |
| Roper St. Francis Healthcare | Charleston | South Carolina | 29414 | — |
| West Cancer Center | Germantown | Tennessee | 38138 | — |
| Sarah Cannon Research Institute / Tennessee Oncology | Nashville | Tennessee | 37203 | — |
| Texas Oncology - DFW | Dallas | Texas | 75246 | — |
| The Center for Cancer and Blood Disorders - Fort Worth | Fort Worth | Texas | 76104 | — |
| Baylor St. Luke's Medical Center | Houston | Texas | 77030 | — |
| Houston Methodist Hospital | Houston | Texas | 77030 | — |
| Inova Fairfax Hospital | Fairfax | Virginia | 22031 | — |
| Virginia Oncology Associates | Norfolk | Virginia | 23502 | — |
| Northwest Medical Specialties | Tacoma | Washington | 98405 | — |
| University of Wisconsin | Madison | Wisconsin | 53792 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 219 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04546009, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 18, 2026 · Synced May 20, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04546009 live on ClinicalTrials.gov.