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

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.

Trial Details

NCT ID
NCT05386108
Phase
PHASE1 / PHASE2
Sponsor
Stemline Therapeutics, Inc.
Status
RECRUITING
Cancer Type
HER2 Positive Breast Cancer
Interventions
  • Elacestrant
  • Abemaciclib
Locations (sample)
  • Fullerton, California, United States|33.87029,-117.92534
  • Urbana, Illinois, United States|40.11059,-88.20727
  • Boston, Massachusetts, United States|42.35843,-71.05977
  • Detroit, Michigan, United States|42.33143,-83.04575
  • Centerville, Ohio, United States|39.62839,-84.15938

Key Eligibility Criteria

  • Participant has the signed informed consent form before any study-related activities according to local guidelines.
  • Women or men aged ≥18 years, at the time of informed consent signature.
  • Female participants may be either postmenopausal or pre/perimenopausal. Postmenopausal status is defined by:
  • Age ≥60 years

For full eligibility, visit ClinicalTrials.gov.

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