Elacestrant vs SOC for treatment of ER+/HER2- Breast Cancer
Research type
Research Study
Full title
Elacestrant Monotherapy vs Standard of Care for the Treatment of Patients with ER+/HER2- Advanced Breast Cancer Following CDK4/6 inhibitor Therapy: A Phase 3 Randomised, Open-Label, Active Controlled, Multicentre Trial (EMERALD)
IRAS ID
256280
Contact name
Shaun Godwin
Contact email
Sponsor organisation
Radius Pharmaceuticals, Inc
Eudract number
2018-002990-24
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
124748, IND Number
Duration of Study in the UK
2 years, 10 months, 8 days
Research summary
Breast cancer is the leading type of cancer in women and second leading cause of all new cancers worldwide. It is the 5th leading cause of death in women and most common cause of cancer related deaths in women.
Current treatments prolong survival and improve quality of life, however the death rate remains only second to lung cancer for women in the U.S. There is therefore a need to improve treatment of breast cancer patients.
Elacestrant is a novel endocrine therapy being developed by the Sponsor, Radius Pharmaceuticals, Inc. Elacestrant has been tested in patients with advanced or metastatic breast cancer whose tumours demonstrate the estrogen receptor (ER+) in 2 clinical trials and has demonstrated promising anti-tumour activity.
This study is aimed at evaluating elacestrant compared to current standard of care (SOC) endocrine therapies in the treatment of participants with advanced or metastatic breast cancer whose tumours are ER+ and negative for human epidermal growth factor receptor 2 (HER2-), another protein found on some types of breast cancer cells. Participants will be randomly assigned to one of 2 treatment groups:
-Arm 1: Daily oral elacestrant at 400 mg per dose
-Arm 2: SOC endocrine therapy consisting of fulvestrant (given by intramuscular injection) or an oral aromatase inhibitor (anastrozole, letrozole or exemestane). The SOC therapy will be chosen by the doctor based on the clinical situation.The goal of the study is to determine if elacestrant improves progression free survival (how long participants live before the disease progresses) compared to SOC therapies. Treatment will continue until the disease progresses, participants have side effects that require therapy be stopped or participants withdraw consent. It is anticipated that 466 participants will be enrolled worldwide.
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
19/SC/0172
Date of REC Opinion
7 Jun 2019
REC opinion
Further Information Favourable Opinion