This phase 3 trial will investigate the effectiveness and safety of ribociclib (Kisquali) in breast cancer (BC).
The main outcome will be the rate of survival without disease.
Breast cancer (BC) is a common form of cancer. Cancers, including BC, can be categorized depending on certain proteins. Some BCs are responsive to hormone or endocrine treatment (ET). This is called hormone receptor-positive (HR+). ET is an effective option for this type of BC. However, there are other drugs that may improve the effectiveness of ET. Ribociclib is a drug that slows down the growth of cancer cells. It does not kill cancer cells but it may allow treatments like ET to work more efficiently.
This trial will investigate the effectiveness and safety of Ribociclib in BC. The main outcome will be the rate of survival without disease.
Who are they looking for?
This study will recruit 4000 participants with confirmed BC. Patients must have had surgery to remove the breast tumor. A sample of the tumor must be available for analysis. Patients that were prescribed radiotherapy and/or chemotherapy must have finished treatment.
Patients cannot take part if they have previously been treated with a drug that works in the same way as ribociclib. Patients with active infections, gastrointestinal disease, uncontrolled heart disease or any uncontrolled conditions cannot take part in the trial.
How will it work
There will be two groups in this study. Patients will be assigned to either ET alone or ET and ribociclib treatment. Ribociclib is administered as 400 mg per day. This continues for 21 days and then a 7-day break is taken. ET is administered once daily for the whole study.