Hi All,
I have been given the chance, thanks to my hormone positive breast cancer and my age, to be part of the Optima Prosigna Trial, I have been given the blurb from the hospital (chemo has been arranged just incase anyways) and have to sign the consent form tomorrow but after reading through it my head is all over the place, I was just wondering if any of you lovely lot have had experience of being part of this trial.
Hi SummersetBunny
Sorry, I have not been part of this or any other trial. You could ask the research nurse for more information before you make your decision.
If it was me in your shoes, I would want to ask what the existing evidence of effectiveness and safety is for whatever drug or regimen they are testing, compared to the current best available treatment.
Also, not sure if your proposed trial is randomised or not. If randomised you might not actually get the novel treatment under test. Another issue would be around monitoring effectiveness and what the criteria would be for switching you from the trial treatment to the existing best treatment........
When you know the answers to these things you would be in a better position to make an informed decision.
You could also ask to talk this through with your GP
All the best in making your decision.
Wallydug
Thank you for the advise my lovely, this trial involves part of the tumour being analysed again to give me yet another score (It's already been oncotyped) to decide if chemo will be required or not but it is randomised so I may just have to have it anyways, only a 25% chance of avoiding this aggressive treatment. They do however monitor you for 10 years instead of the five following completion of treatment, I think I need to discuss the success rates and reliability of the test with the research nurse tomorrow. Really appreciate your reply
Hi
If you use the search facility on the top of the site you will get some hits on this trial - there is also information on Cancer Research about the trial https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-predict-when-chemotherapy-needed-breast-cancer-optima
Best wishes
Jo x
Hi Again
I had a search for Prosigna trial and found a published research paper from last year. Nature is a peer reviewed very highly rated scientific journal.
l Not sure if your proposed trial is for the same combinations of chemo drugs or different ones. There do seem to be some findings described that show that depending on what type of BC cells one actually had, one or other of the two chemo combinations tested would be best. If it were me, and given that I know from routine biopsy results I am HER2+, I would for sure be wanting the regime that contained epirubicin and would not be wanting to be randomised into the group getting the other chemo combination.......
https://www.nature.com/articles/s41523-020-0148-0
I know that randomised trials are necessary for treatment advances. But, I also believe in fully informed consent.
Wallydug
I‘m part of this trial. I expended a lot of time (and emotional energy) deciding whether or not to consent to it. I eventually decided that, as chemo would be the standard treatment if I was not in the trial, I basically had nothing to lose and might just be able to swerve chemo.
As it happened the trial indicated chemo as my treatment. What I had not anticipated was that this then left me wondering whether this was just because I was in the group selected for standard treatment or whether, in fact, I‘d been identified as being at a higher risk of recurrence etc
I also felt that taking part in the trial might be beneficial in terms of extra monitoring etc but, six months in, this has not really been the case - I‘ve simply filled in two questionnaires by post.
On balance the trial hasn‘t been as useful to me as I‘d hoped but it hasn’t added to my burden either - and it may yet prove useful in the treatment of others in the future.
If you consent but then have a change of heart you can pull out at any point without adversely affecting your treatment.
Good luck with whatever you decide!
(PS I‘m 50 with a strongly hormone receptive ER and PR positive diagnosis)
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