Study on Hormone Therapy with Ribociclib vs. Chemotherapy Followed by Hormone Therapy with Ribociclib for High Stage Breast Cancer with Low Recurrence Risk

Program Overview

This study is exploring whether hormone therapy combined with ribociclib can work as well as chemotherapy followed by hormone therapy with ribociclib for treating high stage breast cancer that has a low chance of returning. Ribociclib may help stop cancer cells from growing by blocking certain enzymes. Hormone therapy reduces estrogen levels, which can help stop the growth of cancer cells that need estrogen. Chemotherapy works by killing cancer cells or stopping them from spreading. The study will compare the effectiveness and safety of these treatments.

Description

The main goal of this study is to see if hormone therapy with ribociclib is just as effective as chemotherapy followed by hormone therapy with ribociclib in preventing breast cancer from returning. Researchers will look at how long patients remain free from invasive breast cancer and compare survival rates between the two groups. They will also examine the side effects of each treatment.

Participants will first undergo a test to determine their risk of cancer recurrence. Those with a low risk score will be randomly assigned to one of two groups:

• Group A: Patients will receive chemotherapy followed by hormone therapy with ribociclib. Hormone therapy will be taken daily for at least 5 years, and ribociclib will be taken for up to 3 years.
• Group B: Patients will receive hormone therapy with ribociclib without prior chemotherapy. The schedule for taking these medications is the same as in Group A.

Throughout the study, participants will have regular scans and may provide blood samples to monitor their health and the treatment's effectiveness. Follow-up visits will occur every 3 months for the first year, every 6 months for the next 4 years, and annually for up to 10 years.

Eligibility Criteria

Locations