A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer)
Public ClinicalTrials.gov record NCT06065748. 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, Open-Label Study Evaluating Efficacy and Safety of Giredestrant Compared With Fulvestrant, Both Combined With a CDK4/6 Inhibitor, in Patients With Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer With Resistance to Prior Adjuvant Endocrine Therapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a Phase III, randomized, open-label multicenter study that will evaluate the efficacy and safety of giredestrant compared with fulvestrant, both in combination with the investigator's choice of a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib), in participants with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer who have developed resistance to adjuvant endocrine therapy.
Study identification
- NCT ID
- NCT06065748
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,050 participants
Conditions and interventions
Interventions
- Giredestrant Drug
- Fulvestrant Drug
- Abemaciclib Drug
- Palbociclib Drug
- Ribociclib Drug
- LHRH Agonist Drug
- FoundationOne Liquid CDx Assay (F1LCDx) Diagnostic Test
Drug · Diagnostic Test
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
- Dec 11, 2023 (Actual)
- Primary completion
- Apr 20, 2028 (Estimated)
- Completion
- Feb 12, 2029 (Estimated)
- Last update posted
- Sep 14, 2026
2023 – 2029
United States locations
- U.S. sites
- 40
- U.S. states
- 24
- U.S. cities
- 37
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Southern Cancer Center | Daphne | Alabama | 36526 | — |
| Marin Cancer Care Inc | Greenbrae | California | 94904 | — |
| Kaiser Permanente - Harbor City | Harbor City | California | 90710 | — |
| Oncura Health | Los Angeles | California | 90017 | — |
| USC Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | — |
| The Lundquist Institute for BioMedical Innovation at Harbor-UCLA Medical Cente | Torrance | California | 90502 | — |
| Rocky Mountain Cancer Centers | Littleton | Colorado | 80120-4413 | — |
| Georgetown University Medical Center | Washington D.C. | District of Columbia | 20007 | — |
| MedStar Washington Hosp Center | Washington D.C. | District of Columbia | 20010 | — |
| AdventHealth Altamonte | Altamonte Springs | Florida | 32701 | — |
| Florida Cancer Specialists - Broadway | Fort Myers | Florida | 33901 | — |
| Cancer Specialists of North Florida | Jacksonville | Florida | 32256 | — |
| Florida Cancer Specialists - North;725 6th Ave South (St. Petersburg) | St. Petersburg | Florida | 33701-4553 | — |
| Comprehensive Hematology Oncology | St. Petersburg | Florida | 33709 | — |
| Florida Cancer Specialists - EAST - SCRI - PPDS | West Palm Beach | Florida | 33401-3406 | — |
| Winship Cancer Institute of Emory University | Atlanta | Georgia | 30329 | — |
| Baptist Health Louisville | Louisville | Kentucky | 40207 | — |
| New England Cancer Specialists | Scarborough | Maine | 04074 | — |
| Maryland Oncology Hematology | Annapolis | Maryland | 21401 | — |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | — |
| Henry Ford Hospital | Detroit | Michigan | 48202 | — |
| HCA Midwest Division | Kansas City | Missouri | 64132 | — |
| Oncology Hematology West - Grand Island | Grand Island | Nebraska | 68803 | — |
| Oncology Hematology West - Legacy | Omaha | Nebraska | 68130-2042 | — |
| Astera Cancer Care East Brunswick | East Brunswick | New Jersey | 08816 | — |
| Duke Women Cancer Care | Raleigh | North Carolina | 27607 | — |
| Asante Rogue Regional Medical Center | Medford | Oregon | 97504-8332 | — |
| Alliance Cancer Specialists | Bensalem | Pennsylvania | 19020 | — |
| Ann B. Barshinger Cancer Institute | Lancaster | Pennsylvania | 17604 | — |
| Abramson Cancer Center; Univ of Pennsylvania; Clinical Research Unit | Philadelphia | Pennsylvania | 19106 | — |
| Brown University Health | Providence | Rhode Island | 02905 | — |
| Avera Cancer Institute | Sioux Falls | South Dakota | 57105 | — |
| West Cancer Center | Germantown | Tennessee | 38138 | — |
| SCRI Oncology Partners | Nashville | Tennessee | 37203 | — |
| Texas Oncology Cancer Center | Austin | Texas | 78731 | — |
| Texas Oncology - DFW | Irving | Texas | 75063 | — |
| Virginia Cancer Specialists, PC | Fairfax | Virginia | 22031 | — |
| Virginia Commonwealth University - Massey Cancer Center | Richmond | Virginia | 23219 | — |
| Northwest Medical Specialties | Tacoma | Washington | 98405 | — |
| West Virginia University Hospitals Inc | Morgantown | West Virginia | 26056 | — |
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 271 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06065748, 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 Sep 14, 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 NCT06065748 live on ClinicalTrials.gov.