Elacestrant and Abemaciclib in brain metastases from breast cancer
Research type
Research Study
Full title
An Open-label Multicenter Phase 1b-2 Study of Elacestrant as Monotherapy and in Combination with Abemaciclib in Women and Men with Brain Metastasis from Estrogen Receptor Positive, HER-2 Negative Breast Cancer (ELECTRA)
IRAS ID
1005373
Contact name
Carlo Palmieri
Contact email
Eudract number
2022-001087-10
Clinicaltrials.gov Identifier
Research summary
This Phase 1b-2 study aims to determine the safety and tolerability of elacestrant when given with or without abemaciclib in patients with brain metastasis from breast cancer. Elacestrant is a new drug, while abemaciclib is approved by the authorities for the treatment of certain type of breast cancer. This study includes 2 parts and patients will only participate in one of these parts. If chosen to participate to the first part (Phase 1b), they will be treated with elacestrant combined with another drug called abemaciclib. If chosen to participate to the second part (Phase 2), they will be randomly assigned to treatment with elacestrant alone, or elacestrant combined with abemaciclib (with 50% chance of being assigned to either group). This study is “open-label,” meaning that the study doctor will know which group the patients have been assigned to. The study consists of a Screening visit, a Treatment Period of up-to 6 months and a Follow-up Period of 18 months. This is a global study and is planned to run to up to 4 sites in the UK.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
22/NW/0326
Date of REC Opinion
25 Jan 2023
REC opinion
Further Information Favourable Opinion