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NCT05696626 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study of Metastatic Breast Cancer, sponsored by Sermonix Pharmaceuticals.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 500
- Enrollment target
- 20
- Study locations
NCT05696626: Recruiting Phase 3 study of Metastatic Breast Cancer, sponsored by Sermonix Pharmaceuticals.
NCT05696626 is a Phase 3 study of Metastatic Breast Cancer that is actively recruiting participants, run by Sermonix Pharmaceuticals. The registered enrollment target is 500 participants, above the 201-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (149% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05696626, a Phase 3 study of Metastatic Breast Cancer, is actively recruiting participants, sponsored by Sermonix Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 500 participants
- Enrollment target
- 20
- Study locations
Study Summary
The goal of this clinical trial is to assess the efficacy, safety and tolerability of the combination of lasofoxifene and abemaciclib compared to fulvestrant and abemaciclib for the treatment of pre- and postmenopausal women and men who have previously received ribociclib or palbociclib-based treatment and have locally advanced or metastatic estrogen receptor positive (ER+)/human epidermal growth factor 2 negative (HER2-) breast cancer with an estrogen receptor 1 (ESR1) mutation. The main question the study aims to answer is: • To compare the efficacy of the combination of lasofoxifene and abemaciclib with that of fulvestrant and abemaciclib Participants will receive either receive 5 mg/d of oral lasofoxifene plus oral abemaciclib 150 mg twice a day or the combination of fulvestrant 500 mg intramuscular (IM) on Days 1, 15, and 29 and then once monthly thereafter plus oral abemaciclib 150 mg twice a day.
Primary Outcome
PFS is defined as the time from the date of randomization \[Visit 0 (Day 1)\] to the earliest date of first documented progression per RECIST 1.1 as determined by BICR or death due to any cause.
Conditions Studied
Interventions
- DRUG Lasofoxifene in combination with abemaciclib
- DRUG Fulvestrant in combination with abemaciclib
Study Locations (20)
Florida
- Mayo Clinic - Jacksonville - Jacksonville
- Miami Cancer Institute - Miami
- Miami Cancer Institute Plantation - Plantation
Massachusetts
- Massachusetts General Hospital - Boston
- Dana-Farber Cancer Institute - Boston
- Beth Israel Deaconess Medical Center - Boston
Arizona
- Mayo Clinic - Scottsdale - Scottsdale
- University of Arizona - Cancer Center - Tucson
Minnesota
- Allina Health System DBA Virginia Piper Cancer Institute - Minneapolis
- Mayo Clinic - Rochester - Rochester
Missouri
- Saint Luke's Cancer Institute - Kansas City
- Washington University School of Medicine - St Louis
Nevada
- Renown Regional Medical Centre - Reno
- Cancer Care Specialists - Reno
California
- Providence Medical Foundation - Santa Rosa, CA - Santa Rosa
Georgia
- Emory University School of Medicine - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2023-10-31 |
| Est. Completion | 2028-04 |
| Phase | Phase 3 |
What NCT05696626 shows while recruiting
NCT05696626 is an interventional study that assigns participants to a tested intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap, above the 201-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (149% higher).
The record links to 1 condition, with Metastatic Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Lasofoxifene in combination with abemaciclib is the first listed.
NCT05696626 names 20 study sites across 12 states, led by Florida, Massachusetts, Arizona.
Frequently Asked Questions
What is clinical trial NCT05696626 about?
NCT05696626 is a clinical study titled "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". The goal of this clinical trial is to assess the efficacy, safety and tolerability of the combination of lasofoxifene and abemaciclib compared to fulvestrant and abemaciclib for the treatment of pre- and postmenopausal women and men who have previously received ribociclib or palbociclib-based treatm...
What is the current status of trial NCT05696626?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 500 participants. The study started on 2023-10-31. Estimated completion is 2028-04.
What conditions does trial NCT05696626 study?
This clinical trial studies the following conditions: Metastatic Breast Cancer.
What interventions are being tested in trial NCT05696626?
The interventions under investigation include: Lasofoxifene in combination with abemaciclib (DRUG), Fulvestrant in combination with abemaciclib (DRUG).
Who is sponsoring clinical trial NCT05696626?
This trial is sponsored by Sermonix Pharmaceuticals, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05696626 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Georgia, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05696626's enrollment target sits among peer trials
500 11th of 139 higher than 127 of 139 other Metastatic Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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