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Study of Abemaciclib and Elacestrant in Participants With Brain Metastasis Due to ER+/HER-2- Breast Cancer

NCT05386108

This study is recruiting at 8 US sites in 7 states, according to its ClinicalTrials.gov record last updated .

Summary

This is a multi-site, global, open-label study that includes a phase 1b evaluation of elacestrant in combination with abemaciclib in women and men with brain metastases from estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER-2) negative breast cancer. Phase 1b was designed to select the recommended phase 2 dose (RP2D) and is followed by an ongoing phase 2 evaluation of elacestrant in combination with abemaciclib in participants with active brain metastases from ER-positive, HER-2 negative breast cancer.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

  • Breast Neoplasms
  • Brain Neoplasms
  • Neoplasms by Site
  • Neoplasms
  • Breast Diseases
  • Central Nervous System Neoplasms
  • Brain Diseases
  • Central Nervous System Diseases

Eligibility basics and study details

Study type
Interventional
Phase
Phase 1/2
Ages
18 years and older
Sex
All
Healthy volunteers
Not accepted
Sponsor
Stemline Therapeutics, Inc.
Last updated on ClinicalTrials.gov
October 9, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites

California · 2

  • Providence Medical Foundation · Fullerton, CA
  • California Research Institute · Los Angeles, CA

Illinois · 1

  • Carle Cancer Center · Urbana, IL

Massachusetts · 1

  • Dana-Farber Cancer Institute · Boston, MA

Michigan · 1

  • Henry Ford Hospital · Detroit, MI

Ohio · 1

  • Miami Valley Hospital South · Centerville, OH

Texas · 1

  • University of Texas MD Anderson Cancer Center · Houston, TX

Virginia · 1

  • Virginia Cancer Institute · Norfolk, VA

Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.