Roll-over Study to Allow Continued Access to Ribociclib (NCT05161195) | Clinical Trial Compass
Active — Not RecruitingPhase 4
Roll-over Study to Allow Continued Access to Ribociclib
United States, Argentina, Brazil134 participantsStarted 2022-07-07
Plain-language summary
The purpose of this study is to assess the long-term safety of ribociclib (LEE011) in combination with other drugs and provide post-trial access (PTA) to participants who are currently receiving treatment with ribociclib in combination with other drugs and continuing to have clinical benefit in a Novartis-sponsored global study that has reached its primary objective(s).
Who can participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Exclusion criteria
. Total abstinence
. Female sterilization
. Male partner sterilization
. Placement of an intrauterine device (IUD)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a roll-over study, does that mean it's only open to people who were already in a previous ribociclib trial, and would that affect whether I might be considered for it?
2The main thing being measured in this study is the rate of side effects — what does that tell us about how much is still unknown about ribociclib's long-term safety, and how should that factor into my treatment decisions?
3Since the trial is no longer enrolling new participants, what are my other options for accessing ribociclib, such as approved treatments or other ongoing studies?
4Given that this is a Phase 4 study, which happens after a drug has already been approved, what does the existing safety data on ribociclib look like for someone with my specific situation in metastatic breast cancer?
5How does continued access to ribociclib through a roll-over study compare to simply receiving it as a standard-of-care prescription, and is there a meaningful difference in how I'd be monitored or supported?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of participants with treatment-emergent adverse events (AES)
Timeframe: From day of first dose of study medication to 30 days after last dose of study medication, up to 8 years