Early Access Program - Kisqali / Ribociclib for EBC
Hi there, My medical oncologist called me yesterday to discuss the issues with the current early access program for early BC and Kisqali / Ribociclib. Apparently, the current formulation contains very small quantities of 'nitrosamine' which have been shown in studies to potentially (in a very small number of cases) cause another cancer. The new formulation will not be available for a few months from the manufacturer. Has anyone else who is on Ribociclib had this discussion with their med onc / decided to pause the drug - or decided that the risks are OK and chosen to continue with the medication? Noting there is a BC conference in Berlin next week (my med onc is going but not presenting) and there are a number of sessions discussing CDK4/6 inhibitors for early BC with high likelihood of recurrence. Not sure also if this affects mets patients who are on Ribociclib already too? Just when I think I'm on a certain path things change ... again. Kelly (totally acknowledging personal choice etc - but keen to know what others have been told, and if anyone is OK to share, what they have decided to do).
Would you take part in a clinical trial?
So I've been approached by my oncologist to take part in a clinical trial of drug called Ribociclib- from my understanding it is one that has been used in the last few years to treat metsatic BC with good results. They are now trialling this with pre menopausal women like myself who have just finished treatment. Like all trials it entails many scans, appointments, time off work, blood work, having to deal with possible side effects.. all on top of looking after ny young family. And I just don't know if I can do it. I finally feel like I'm getting normality back in my life but I don't want to regret forgoing this opportunity (touch wood if I ever have a relapse..And then think how this trial could have helped me). This study is for 2 years. What would you do?