OASIS 4
Research type
Research Study
Full title
A double-blind, randomized, placebo-controlled multicentre study to investigate efficacy and safety of elinzanetant for the treatment of vasomotor symptoms caused by adjuvant endocrine therapy, over 52 weeks in women with, or at high risk for developing hormone-receptor positive breast cancer
IRAS ID
1006034
Contact name
Lineke Zuurman
Contact email
Sponsor organisation
Bayer Consumer Care AG
Eudract number
2022-000095-18
Clinicaltrials.gov Identifier
Research summary
This study will include women with or at high risk for developing hormone receptor positive breast cancer who are experiencing frequent Vasomotor Symptoms (VMS), also known as hot flushes. Hot flushes are a common symptom in women while going through menopause, but they can also be caused by taking hormonal therapies for breast cancer like tamoxifen or aromatase inhibitors.
In this study, the researchers will learn how well elinzanetant works compared to placebo, how safe and affective it is for reducing hot flushes and if it improves participant's sleep and overall quality of life.
The study medication, called elinzanetant is a non-hormonal therapy that helps minimising hot flushes, by blocking a protein called
neurokinin from sending signals to other parts of the body, which is thought to play a role in starting hot flushes.
In this study, the efficacy of elinzanetant will be compared to placebo. A placebo capsule looks like the study medication but does not have any medicine in it. Study participants will take two capsules of either elinzanetant or the placebo once a day before going to bed; with or without food. To compare these study treatments, the participants will record information about their hot flushes in an electronic diary and answer questions about their symptoms. The researchers will study the number of hot flushes the participants have and how severe they are. They will compare the results from before start of treatment and after 12 weeks of treatment. For the first 12 weeks participants will not know which medication they are taking and will have 2 in 3 chances of getting elinzanetant and 1 in 3 chance of getting a placebo. After first 12 weeks, all participants will receive elinzanetant for 40 weeks until end of study treatment visit. Participants will take study treatment for 52 weeks in total and will have approximately 12 in-person visits and 6 phone visits. Each participant is expected to be in the study for approximately 62 weeks.REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
22/EE/0229
Date of REC Opinion
3 Nov 2022
REC opinion
Further Information Favourable Opinion