Forum Discussion

Pinkcloverss's avatar
5 years ago

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? 
  • @Pinkcloverss
    Yes I would!
    If you are able then perhaps look at it as a part time job.
    Being asked to be part of a trial will be of benefit for research and you personally. 
    Today in the Melbourne paper is a BCNA story about this drug and it is mentioned in the Friday update.
    Best wishes and take care
  • @Pinkcloverss  - are you guaranteed to receive the Ribociclib?  I was offered a clinical trial re my Hormone tablets, with no guarantee that I would RECEIVE the real deal - so I declined.

    Here is the link to the Friday Update info .... 
    https://onlinenetwork.bcna.org.au/discussion/22413/friday-update-5-june-2020#latest

    If you ARE receiving the real deal - and they believe it will benefit you (you are so young & still have many more years ahead of you than me, nearing 70 .....) I reckon I'd go with it!

    If you find it causing a problem - you can always ask to stop ..... 

    All the best xx
  • IF you are still interested can you  ask the name of the trial, i can look up the link for you on the Clinical trials registry that will inform  you what the trial consists of. Or you can ask your doctor for this link.

    Lots of love Tinks  xx
  • @Pinkcloverss
    What a question to be asked.  I hope it was asked with lots of information to help you to make your decision ?
    All medical trials are important and people have differing reasons for taking part.
    I know a gentleman who took part in a trial however the time commitment just got to be too much for him.  This may be something for you to really consider.
    How would it impact your 'normal' life ?  Your age, employment and family circumstances also play a part.
    Are you a worrier ?  If you were part of the group who received the placebo would this then play on your mind too much ?
    As participants are not told who gets the real deal or who gets the placebo you would not have this information in order to decide your participation.
    I am glad I am not in your shoes but in the end whatever you decide has to be right for you.
    All the best.
  • I have had the full discussion with the doctor and been given all relevant details. Like all clinical trials it also does have a group who will get the placebo tablet..So no there is no guarantee I'll be given it. 
  • I agree that it's important that you are able to meet the commitments as outlined.  Ask what happens if you find you can't.  I think the basic advantage is that you will be monitored closely regardless if which group you are in.  As long as your treatment is in no way compromised by being in either group.
  • You could be randomised to the intervention (ribociclib) or the placebo. Ricociclib is a CDK4/6 inhibitor like palbociclib (Ibrance). Used to treat metastatic BC, these drugs are undergoing trials to demonstrate their ability to reduce recurrence risk and improve disease-free survival in early BC patients.
    Importantly, ask your oncologist about the recent early termination of Pfizer's PALLAS trial. PALLAS's termination was announced about two weeks ago. Its termination is BIG news in the early BC research universe.
    PALLAS was designed to assess palbociclib's ability to reduce recurrence and improve disease-free survival in early BC patients. PALLAS enrolled over 5,000 Stage II (Stage IIA was limited to 1,000) and Stage III patients worldwide. Patients took palbociclib for two years with adjuvant endocrine therapy.
    A futility analysis determined that the trial goal would not be achieved,i.e. palbociclib added no benefit to standard adjuvant endocrine therapy. Patients still taking palbociclib were informed by their doctors to cease. Pfizer will continue to collect follow-up data from patients who agree.
    You raise legitimate concerns about the demands (regular tests, logistics & travel, time commitment, emotional investment, etc.) of participating in a clinical trial. Ask your oncologist their thoughts about the early termination of PALLAS and if there are similar implications for the trial they have suggested to you.
  • Ask your oncologist's opinion about the recent early termination of the PALLAS trial, which evaluated if palbociclib (Ibrance) could delay/prevent recurrence and improve disease-free survival in early BC patients,  Palbociclib is a CDK4/6 inhibitor like ribociclib, and is effective in metastatic patients.  Over 5,000 Stage II (IIa was limited to 1,000) and Stage III patients were enrolled - Stage I was excluded.  Trial participants took palbociclib with endocrine therapy for two years, then continuing on endocrine therapy only.

    PALLAS had been underway for about five years.  The early termination, announced about two weeks ago, is due to a futility analysis determining the trial would not meet its objective.  The failure of PALLAS has sent early BC researchers reeling because it's been thought that CDK4/6 inhibitors, impressive in the metastatic setting, could benefit early BC patients too.

    You raise legitimate concerns about participating in a trial - travel and logistics, time commitment, tests, side effects - and as PALLAS demonstrates, perhaps with no benefit.  Ask your oncologist's opinion about the commonalities and differences between PALLAS and the ribociclib trial offered to you.  Best to you with your decision-making.  
  • WOW!  @NoShrinkingViolet - welcome to the Forum!!  It sounds like you are a professional medical person?   

    I hope you are travelling well in your own BC event xx

  • @Giovanna_BCNA My attempts last night to post about the early termination of the PALLAS trial for the benefit of @Pinkcloverss kept disappearing - BCNA's system did not save them to Drafts even though your system advised it had.  There were no saved Drafts in my account.  They disappeared forever.  My third attempted post was successfully uploaded but today, inexplicably, it was joined by the other two attempts which had disappeared from your system!  The forum technology is buggy and I don't think I'll be bothered to post again because it wasted a lot of my time.  Now this thread has three repetitive posts.