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Clinical Trial ● Currently Recruiting Phase I NCT05386108

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

Study of Abemaciclib and Elacestrant in Participants With Brain Metastasis Due to ER+/HER-2- Breast Cancer — Recruiting • Phase I • Oncology • NCT05386108.

📅 06 Apr 2026 ⏱ 1 min read
Currently Recruiting
This trial is actively seeking participants in the UK. Discuss eligibility with your patient before referring.
Status
Currently Recruiting
Phase
Phase I
NCT ID
NCT05386108
Sponsor
Stemline Therapeutics, Inc.
Start
2022-08-31
ClinicaliQ Trial Snapshot
  • Study of Abemaciclib and Elacestrant in Participants With Brain Metastasis Due to ER+/HER-2- Breast Cancer — Recruiting • Phase I • Oncology • NCT05386108.
  • 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….
  • Sponsor: Stemline Therapeutics, Inc.

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Use This Page For
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  • Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying

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.

Eligibility Snapshot
  • :
  • Participant has the signed informed consent form before any study-related activities according to local guidelines. 2. 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: 1. Age ≥60 years 2. Age

Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.

Full Trial Details
View this trial on the source registry
Eligibility criteria, protocol, and results when available
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