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RECRUITING 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

NCT05696626 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 500 participants
Start Date 2023-10-31
Est. Completion 2028-04
Phase Phase 3

Sponsor

Sermonix Pharmaceuticals

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05696626

The ClinicalTrials.gov registry entry for NCT05696626 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 500 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sermonix Pharmaceuticals, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05696626 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Florida, Massachusetts, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05696626?

This trial is sponsored by Sermonix Pharmaceuticals, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial