Study of Abemaciclib and Elacestrant in Participants With Brain Metastasis Due to ER+/HER-2- Breast Cancer
Trial Parameters
Eligibility Fast-Check
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Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. 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 \<60 years and amenorrhea for 12 or more months without an alternative cause) and follicle stimulating hormone and estradiol in postmenopausal ranges per local reference ranges 3. Documentation of prior bilateral oophorectomy, at least 1 month before first dose of trial therapy). * Pre-menopausal / peri-menopausal women and men must be concurrently receiving a luteinizing hormone-releasing hormone (LHRH) agonist starting at least 3-4 weeks before the start of trial therapy and is planning to continue LHRH during the study. 3. Participant must have ER-positive, HER-2 negative tumor status as confirmed by local laboratory testing in the followin