The ADELA Study
Research type
Research Study
Full title
A randomized phase 3, double-blind, placebo-controlled study of elacestrant plus everolimus versus elacestrant in patients with estrogen receptor-positive/human epidermal growth factor receptor 2-negative, ESR1-mutated, advanced breast cancer progressing to endocrine therapy and CDK4/6 inhibitors. (The ADELA Study)
IRAS ID
1008117
Contact name
Carlos Martinelli
Contact email
Sponsor organisation
MEDSIR
Eudract number
2024-512926-27
Clinicaltrials.gov Identifier
Research summary
This study examines advanced breast cancer in both adult (+18) male and female participants that are oestrogen receptor-positive, human epidermal growth factor receptor 2- negative or oestrogen receptor 1 mutation. The study aims to address the unmet medical need in patients who experience progression following endocrine therapy by evaluating the advantage and safety of using elacestrant plus everolimus compared to using elacestrant plus a placebo. By directly comparing these two the study will provide valuable insights into the potential benefits and risks. Participants will be randomly allocated to either the arm A which will dispense elacestrant in combination with everolimus) or arm B: which is the the control arm in which patients will be administered elacestrant in combination and a placebo.
Inclusion into the study requires participants to be over 18 years of age, open to both male and female, have been diagnosed with advanced breast cancer which is oestrogen receptor-positive, human epidermal growth factor receptor 2- negative or oestrogen receptor 1 mutation in origin and have received at least one and no more than two lines of endocrine therapy.
Only one NHS hospital site has been selected to participate in the study (Barts Health NHS Trust) and one private Hospital (Genesis, Oxford). These sites have been chosen for their experience in the treatment of the above mentioned cancer type and Barts Health accommodates the chief investigator of the study.Typically Participants enrolled onto the study will undertake a full screening visit, CT scan, haematology, blood chemistry, Medical history review, physical examination, a review of current medications, ECG and and adverse events that the participant may experience during the course of the study. Once enrolled the patient attends clinical on day 1 and day 14 of cycle 1 and cycle 2 after which this reduces down to only day 1 of each cycle until the end of treatment or discontinuation.
REC name
London - City & East Research Ethics Committee
REC reference
24/LO/0651
Date of REC Opinion
22 Oct 2024
REC opinion
Further Information Favourable Opinion