Evaluation of Lasofoxifene Combined With Abemaciclib Compared With Fulvestrant Combined With Abemaciclib in Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation
Public ClinicalTrials.gov record NCT05696626. 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
An Open Label, Randomized, Multicenter Study Comparing the Efficacy and Safety of the Combination of Lasofoxifene and Abemaciclib to the Combination of Fulvestrant and Abemaciclib for the Treatment of Pre- and Postmenopausal Women and Men With Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation
Study identification
- NCT ID
- NCT05696626
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- LeonaBio
- Industry
- Enrollment
- 500 participants
Conditions and interventions
Conditions
Interventions
- Fulvestrant in combination with abemaciclib Drug
- Lasofoxifene in combination with abemaciclib 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 30, 2023
- Primary completion
- Mar 31, 2027
- Completion
- Mar 31, 2028
- Last update posted
- Apr 20, 2026
2023 – 2028
United States locations
- U.S. sites
- 36
- U.S. states
- 20
- U.S. cities
- 28
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinic - Scottsdale | Scottsdale | Arizona | 85259 | Recruiting |
| University of Arizona - Cancer Center | Tucson | Arizona | 85719 | Recruiting |
| Providence Medical Foundation - Santa Rosa, CA | Santa Rosa | California | 95403 | Recruiting |
| Mayo Clinic - Jacksonville | Jacksonville | Florida | 32224 | Recruiting |
| Miami Cancer Institute | Miami | Florida | 33143 | Recruiting |
| Miami Cancer Institute Plantation | Plantation | Florida | 33324 | Recruiting |
| Emory University School of Medicine | Atlanta | Georgia | 30322 | Recruiting |
| Norton Cancer Institute | Louisville | Kentucky | 40202 | Recruiting |
| Johns Hopkins Kimmel Cancer Center | Baltimore | Maryland | 21231 | Recruiting |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | Recruiting |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02115 | Recruiting |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | Recruiting |
| Cancer and Hematology Centers of Western Michigan | Grand Rapids | Michigan | 49503 | Recruiting |
| Allina Health System DBA Virginia Piper Cancer Institute | Minneapolis | Minnesota | 55407 | Recruiting |
| Mayo Clinic - Rochester | Rochester | Minnesota | 55905 | Recruiting |
| Saint Luke's Cancer Institute | Kansas City | Missouri | 64111 | Recruiting |
| Washington University School of Medicine | St Louis | Missouri | 63110 | Recruiting |
| Renown Regional Medical Centre | Reno | Nevada | 89502 | Recruiting |
| Cancer Care Specialists | Reno | Nevada | 89511-2250 | Recruiting |
| New Jersey Cancer Care, PA | Belleville | New Jersey | 07109 | Withdrawn |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08901 | Recruiting |
| Presbyterian Kaseman Hospital | Albuquerque | New Mexico | 87110 | Not yet recruiting |
| Presbyterian Rust Cancer Center | Rio Rancho | New Mexico | 87124 | Recruiting |
| The Blavatnik Family - Chelsea Medical Center at Mount Sinai | New York | New York | 10011 | Recruiting |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | Recruiting |
| David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | Recruiting |
| Duke University Medical Center | Durham | North Carolina | 27705 | Recruiting |
| Altru Health Systems | Grand Forks | North Dakota | 58201 | Completed |
| University Hospitals Seidman Cancer Center | Cleveland | Ohio | 44106 | Not yet recruiting |
| Cleveland Clinic | Cleveland | Ohio | 44119 | Withdrawn |
| The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Richard J. Solovev Research Institute (OSUCCC - James) | Columbus | Ohio | 42112 | Recruiting |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15232 | Completed |
| Baylor College of Medicine | Houston | Texas | 77030 | Recruiting |
| MD Anderson Cancer Center | Houston | Texas | 77030 | Recruiting |
| Harris Health System - Smith Clinic | Houston | Texas | 77054 | Recruiting |
| Swedish Cancer Institute (SCI) | Seattle | Washington | 98104 | Withdrawn |
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 188 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05696626, 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 Apr 20, 2026 · Synced May 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05696626 live on ClinicalTrials.gov.