Evaluation of Lasofoxifene Combined With Abemaciclib in Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation
Public ClinicalTrials.gov record NCT04432454. 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, Multicenter Study Evaluating the Safety of Lasofoxifene in Combination With Abemaciclib for the Treatment of Pre- and Postmenopausal Women With Locally Advanced or Metastatic ER+/HER2- Breast Cancer and Have an ESR1 Mutation ( ELAINEII )
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is an open-label, multicenter, single-arm safety study evaluating the safety and tolerability of the lasofoxifene and abemaciclib combination for the treatment of pre- and postmenopausal women with locally advanced or metastatic ER+/HER2- breast cancer who have disease progression on first and/or 2nd lines of hormonal treatment for metastatic disease and have an ESR1 mutation.
Study identification
- NCT ID
- NCT04432454
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 29 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- 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
- Sep 29, 2020 (Actual)
- Primary completion
- Jan 28, 2025 (Actual)
- Completion
- Jan 28, 2025 (Actual)
- Last update posted
- Feb 13, 2025
2020 – 2025
United States locations
- U.S. sites
- 16
- U.S. states
- 12
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham (UAB) - Comprehensive Cancer Center | Birmingham | Alabama | 35294-3300 | — |
| Yuma Regional Medical Center | Yuma | Arizona | 85364 | — |
| Compassionate Cancer Care Med Group - Clinic Aid USA - Fountain Valley | Fountain Valley | California | 92708 | — |
| St. Joseph Health | Santa Rosa | California | 95403 | — |
| Mayo Jacksonville | Jacksonville | Florida | 32224 | — |
| Illinois Cancer Care | Peoria | Illinois | 61704 | — |
| Beacon Health System Memorial Regional Cancer Center | South Bend | Indiana | 46601 | — |
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | — |
| New Jersey Cancer Care, PA | Belleville | New Jersey | 07109 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| The Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | — |
| Mary Crowley Cancer Research | Dallas | Texas | 75230 | — |
| MD Anderson Cancer Center | Houston | Texas | 77030-4009 | — |
| Oncology Consultants, P.A. | Houston | Texas | 77030 | — |
| Hematology Oncology Associates of Fredericksburg | Fredericksburg | Virginia | 22408 | — |
| Northwest Medical Specialists, PLLC (NWMS) | Tacoma | Washington | 98405 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04432454, 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 Feb 13, 2025 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04432454 live on ClinicalTrials.gov.