EMBER-2
Research type
Research Study
Full title
EMBER-2: A Phase 1, Open-Label, Preoperative Window Study evaluating the Biological Effects of LY3484356 in Post-menopausal Women with Stage I-III Estrogen Receptor-Positive, HER2-Negative Breast Cancer
IRAS ID
289596
Contact name
Peter Schmid
Contact email
Sponsor organisation
Eli Lilly and Company
Eudract number
2020-002810-42
Duration of Study in the UK
1 years, 6 months, 14 days
Research summary
Summary of Research
Breast cancer is the most frequent cancer among women and is a major cause of cancer-related
deaths worldwide. It is estimated that more than 2 million new cases of breast cancer occurred
worldwide in women in 2018. Treatment options for women with breast cancer are largely determined by tumour ER (estrogen Receptor) and HER2 (human epidermal growth factor receptor 2) status. Over two-thirds of breast cancers express ER, which is a key driver of breast cancer initiation and progression. Therapies aim to reduce ER activity and include drugs such as tamoxifen and anastrozole.LY3484356 belongs to a group of drugs called selective estrogen receptor degraders or SERD’s. SERDs work by blocking and degrading the ER. Currently the only approved SERD for the treatment of ER+ metastatic breast cancer is fulvestrant which is limited by the fact it is highly dose dependant and its intramuscular route of administration further limiting the amount that can be given to patients. Therefore, developing a SERD with better oral bioavailability that could overcome the dose limitation of fulvestrant is highly desired. LY3484356 is an oral SERD that works by binding to and blocking the ER. LY3484356 also works by stopping the growth of ER+ breast cancer cell lines.
Study EMBER-2 is a Phase 1, open-label, randomized, pre-operative window study of
LY3484356 in post-menopausal women with Stage I to III ER+, HER2- breast cancer who are
scheduled for surgery with curative intent. Patients will receive LY3484356 for 15 days, up to and including the day of scheduled surgery or repeat biopsy. The study is designed to look at the movement of the drug within the body, how the body responds to the drug, biologic effects and safety of LY3484356.Summary of Results
A lay summary of study results is not available at this time, but will be provided for publication when available.
REC name
London - Central Research Ethics Committee
REC reference
20/LO/1183
Date of REC Opinion
4 Dec 2020
REC opinion
Further Information Favourable Opinion