Ribociclib, exemestane, everolimus clinicial trial

Following. This trial (TRINITI-1) was just proposed to me yesterday as an option. My gut says "no" -- partly b'cuz I live a good 3 to 5 hrs. from UCLA, depending on traffic, and not enthused about the time & travel commitment when I have other logical options. But I'm still gathering every bit of info I can find, so very happy to see this discussion.

For anyone who chose the TRINITI-1 trial over a more standard option, could you share what influenced your thoughts? Thanks so much. Deanna

Thanks so much for your comments, Pam. I've just PM'd you with a few more questions.

Alissa, I really appreciate your comments and updates too. Can I ask you how far you have to drive? And if you had to drive at least 3 hrs. o/w, depending on traffic -- knowing what you do now about the need for EKGs, blood work, etc, would you still be willing to do the trial? That is one of my biggest concerns -- living that driving distance from UCLA. Just don't know if the stress will be a factor!

Davenport, same question for you... Would a 3-hr drive impact your thoughts on doing the trial, especially with the pre-testing, etc., you've described?

Davenport1: you asked about being on the three drugs of Ribociclib, exemestane and everolimus so thought I would chime in with a question. After being on Ibrance and letrizole since August, I am moving on to everolimus and exemestane daily with Herceptin infusion every three weeks. The everolimus should come tomorrow and I will start the two oral drugs on Saturday

IT took ten days to get approval from insurance to cover the $13K per month cost of everolimus, so I cannot imagine that any insurance would cover the cost of ribociclib at $10 K per month in addition to the cost of the everolimus. Do others have any experience in getting this financial issue covered, or is it paid for because of it being a clinical trial? I am not on a trial. I would appreciate hearing about others experiences with this,

Nanc

At the moment, triplet therapy with a CDK 4/6 inhibitor could be hard get covered. There are no robust clinical trial results proving its efficacy. Ribociclib is not approved yet, so it would never be covered today. Doctors could try to make a case for "off label" use of ibrance with exemestane and everolimus now. That argument may work if there is no reasonable alternative.

It should be relatively easy to get the triplet therapy approved by insurance if this trial is completed and successful and Ribociclib is FDA approved. I agree there will be push back from insurance companies, but they generally have to approve protocols that have been demonstrated effective. The real question is when the price of ribociclib and ibrance will drop. They seem very similar and therefore directly competing with each other. Also, they have priced themselves out of all markets outside the US.

>Z<

Good luck Tamera - It's a powerful combination. Should knock your mets to the curb. You have approached this very thoughtfully, I think you should be confident in your decision. Let us know how you are doing.

>Z<

yes. It is very important to forget you have cancer as much as possible.

Looking forward to good news from you on your next scan ... keep us in the loop.

Z

I've been at this ten days. 125 Ibrance, 25mg Aromasin and 5 mg Affinitor (half the usual dose). No problems whatsoever. I suspect it's because I'm only on half the dose of Affinitor. I won't know for a while whether it's working.

When I saw the nurses and said I was on the placebo arm they gave me the incredulous stare. Maybe it's too early and the effects will appear over time.

What I'm getting at is, don't be afraid. It might be easy. [Or it might not but don't borrow trouble]

No placebo arm. But it feels that way. Which is great. Hoping it keeps up.

Good morning ladies. I realized I had not checked in in quite awhile. Davenport, I am the only one on the Huntsman TRINITI_1 trial right now, that's me!! When I was in on Friday I learned that while they want 6 people, the national study is almost full. Once the numbers have been reached, they won't be able to enroll anyone else. I have started my 2nd cycle. The Affinitor is at 2.5mg as stated above and you are issued a mouth wash. I have had one tiny sore on the tip of my tongue and it is gone. I made it 15 days and had to hold drug for a week to allow my counts to come back up. I never had to do that once with Ibrance. The Dr assured me that this is very normal. I am back on all the drugs and still feel good. I noticed that ribo was FDA approved yesterday. I had asked how this would impact the trial and was told that I would be allowed to remain on it as long as it benefited me. Longer appointments, but the drug company is paying for the drugs!! I hope everyone is feeling well and having a good day!!

Alissa

Thanks for the updates ladies!

>Z<

hang in there! Thanks for the update.

Alissa - good to hear from you. Thanks for the update. Not on this trial, but following ...

>Z<