The monarchE trial is studying if adding abemaciclib (Verzenio) to hormonal therapy will help lower the risk of cancer returning for people with early-stage , hormone receptor -positive breast cancer.
Researchers are looking for men and women with hormone receptor-positive, HER2-negative breast cancer that have a high risk of recurrence to participate.
Abemaciclib is a medicine that blocks two specific proteins, cyclin dependent kinases 4 and 6. Medicines that block these proteins are known as CDK 4/6 inhibitors. There are three CDK 4/6 inhibitors currently approved by the FDA to treat metastatic breast cancer. Palbociclib (Ibrance) was the first medicine of this type approved in 2015. It was followed by ribociclib (Kisqali) and abemaciclib in 2017.
Because these medicines improve outcomes for people with metastatic breast cancer, researchers want to know whether using abemaciclib with hormonal therapy for early-stage breast cancer will lower the risk of recurrence for certain people.
The monarchE trial is studying the possible benefits of giving abemaciclib to people with early-stage, hormone receptor-positive, HER2-negative breast cancer with a high risk of recurrence. Factors such as the size of the tumor , Ki-67 proliferation index and whether cancer cells were found in the lymph nodes are used in measuring the risk of breast cancer returning. This study will also be looking at the quality of life of participants taking abemaciclib with hormonal therapy compared with those taking hormonal therapy alone.
MonarchE is a phase III, open label trial. People in the trial will be randomly assigned to take hormonal therapy alone or take it with abemaciclib, the medicine being studied. Open label means participants will know which treatment they have been assigned. Researchers are hoping to recruit 3,580 people to participate.
There are multiple study locations throughout the United States. Visit the trial listing on CancerTrials.org for more details and speak to your healthcare team about your interest in participating.