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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This Phase III, randomized, double-blind, placebo-controlled, multicenter study will evaluate the efficacy and safety of giredestrant combined with palbociclib compared with letrozole combined with palbociclib in patients with estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER2)-negative locally advanced (recurrent or progressed) or metastatic breast cancer.
Study identification
- NCT ID
- NCT04546009
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 992 participants
Conditions and interventions
Interventions
- Giredestrant Drug
- Giredestrant-matched Placebo Drug
- Letrozole Drug
- Letrozole-matched Placebo Drug
- Palbociclib Drug
- LHRH Agonist 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 9, 2020 (Actual)
- Primary completion
- Jan 30, 2026 (Actual)
- Completion
- Jul 31, 2027 (Estimated)
- Last update posted
- Aug 17, 2026
2020 – 2027
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 218 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 Aug 17, 2026 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04546009 live on ClinicalTrials.gov.