Purpose of this Study
Everyone who joins this study will take a medicine called ribociclib by mouth once a day for 21 days, then have a 7-day break. This makes a 28-day cycle. They will also take hormone therapy (endocrine therapy) every day. This treatment will last for about 3 years (around 39 cycles).
After finishing treatment or stopping early, patients will have a visit called End of Treatment and then a safety check 30 days later. After that, doctors will keep track of their health and survival for a long time—up to 4 years after the last person starts treatment.
Who Can Participate?
Eligibility
This study is for women (both before and after menopause) and men who have early breast cancer that is HR-positive and HER2-negative. The cancer must be in stage IIA (part of it), IIB, or III. Patients must have already had surgery and, if needed, radiation or chemotherapy. They also need to be able to take hormone therapy for at least 3 years after starting the study treatment.
Age Range
18-110
Sex/Genders
Female (cisgender)
Non-binary or gender fluid
Looking for Healthy Participants
No
What is Involved?
Description
This study wants to find out if taking ribociclib together with hormone therapy can help lower the chance that breast cancer comes back after treatment.
Locations
Other
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
A phase IIIb study to characterize the effectiveness and safety of Adjuvant ribociclib in a wide patient population with HR+ HER2? early breast cancer (Adjuvant WIDER)
Principal Investigator
Madhu
Chaudhry
Protocol Number
PRO00115262
Phase
III
Enrollment Status
Pending Open to Enrollment