This phase 2 trial will evaluate the safety and effectiveness of ribociclib (Kisqali) combined with hormonal therapy in patients with estrogen receptor-positive (ER+) breast cancer (BC). The main outcome will be the number of patients that complete 1 year of treatment and survival without signs of cancer. The trial will take place in Massachusetts, United States.
ER+ BC is a form of BC that responds to the female sex hormone, estrogen. Patients with this type of BC are commonly treated with hormonal therapy. This treatment lowers the amount of estrogen in the body. Aromatase inhibitors are a type of hormonal therapy. Some cancers do not respond to hormonal therapy only.
New drugs are in development that target specific proteins on the tumor.Ribociclib is such a drug. Blocking these proteins slows cancer growth. Ribociclib is already used to treat metastatic (spread) BC in combination with another drug. It is unclear if RBC is also safe and effective in early-stage BC.
This trial will evaluate the safety and effectiveness of ribociclib with aromatase inhibitors in patients with ER+ BC. The main outcome will be the number of patients that complete treatment.
Who are they looking for?
This study will recruit 120 female participants with ER+ BC. Participants must also have HER-negative tumors and should be within 10 years of diagnosis. Patients must have completed surgery and at least 6 months of hormonal therapy. Patients must have adequate blood cell counts, kidney and liver functions and normal levels of blood glucose, calcium, magnesium, and potassium.
Patients cannot take part in the trial if they have had chemotherapy or radiotherapy within 4 weeks of the trial. Patients must not have brain tumors or any other cancer. Uncontrolled illness including active infection, cardiovascular disease, and psychiatric conditions are excluded. Patients with gastrointestinal conditions cannot take part in the trial. Patients must not be on other targeted therapies or experimental drugs for BC. Patients must not be pregnant or breastfeeding and should be using effective contraceptive methods during the trial.
How will it work
Patients will be assigned to one of two groups. Each group will take a different dose of ribociclib. One group will receive ribociclib over 21 days. The second group will receive ribociclib over 28 days. Both groups will also receive daily hormonal therapy. The study will last for up to 2 years.
The main outcome will be the number of patients that complete treatment at 12 months.