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 (NCT05696626)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Mayo Clinic - Scottsdale — Scottsdale, Arizona
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (224 Sites)
Showing the first 25 of 224 sites.
- Mayo Clinic - Scottsdale — Scottsdale, Arizona
- University of Arizona - Cancer Center — Tucson, Arizona
- Providence Medical Foundation - Santa Rosa, CA — Santa Rosa, California
- Mayo Clinic - Jacksonville — Jacksonville, Florida
- Miami Cancer Institute — Miami, Florida
- Miami Cancer Institute Plantation — Plantation, Florida
- Emory University School of Medicine — Atlanta, Georgia
- Norton Cancer Institute — Louisville, Kentucky
- Johns Hopkins Kimmel Cancer Center — Baltimore, Maryland
- Massachusetts General Hospital — Boston, Massachusetts
- Dana-Farber Cancer Institute — Boston, Massachusetts
- Beth Israel Deaconess Medical Center — Boston, Massachusetts
- Cancer and Hematology Centers of Western Michigan — Grand Rapids, Michigan
- Allina Health System DBA Virginia Piper Cancer Institute — Minneapolis, Minnesota
- Mayo Clinic - Rochester — Rochester, Minnesota
- Saint Luke's Cancer Institute — Kansas City, Missouri
- Washington University School of Medicine — St Louis, Missouri
- Renown Regional Medical Centre — Reno, Nevada
- Cancer Care Specialists — Reno, Nevada
- New Jersey Cancer Care, PA — Belleville, New Jersey
- Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey
- Presbyterian Kaseman Hospital — Albuquerque, New Mexico
- Presbyterian Rust Cancer Center — Rio Rancho, New Mexico
- The Blavatnik Family - Chelsea Medical Center at Mount Sinai — New York, New York
- Icahn School of Medicine at Mount Sinai — New York, New York
📞 Contact the Study Coordinator
Phone: (909) 374-3793
Email: clinicaltrials@leonabio.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Metastatic Breast Cancer
- Assessing the Time Demands of Cancer — Birmingham, Alabama
- Niraparib in Combination With Trastuzumab in Metastatic HER2+ Breast Cancer — Birmingham, Alabama
- A Phase 1b Study of T-DXd Combinations in HER2-low Advanced or Metastatic Breast Cancer — Commack, New York
- Palbociclib With Fulvestrant for Metastatic Breast Cancer After Treatment With Palbociclib and an Aromatase Inhibitor — Washington D.C., District of Columbia
- A Study of Abemaciclib (LY2835219) Plus Tamoxifen or Abemaciclib Alone in Women With Metastatic Breast Cancer — Tucson, Arizona
- Roll-over Study to Allow Continued Access to Ribociclib — Chandler, Arizona
Explore by condition: All Metastatic Breast Cancer clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.