Ribociclib, exemestane, everolimus clinicial trial

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Davenport1
Davenport1 Member Posts: 32
edited June 2017 in Stage IV/Metastatic Breast Cancer ONLY

Bones met for 2 years, just went off ibrance + Letrozole (which worked great for 2 years by the way) due to progression, wondering if anyone has been on clinical trial for this new combination of Ribociclib, exemestane and everolimus? Would love to hear anything about this combo of drugs.

Thanks,

Davenport

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  • pajim
    pajim Member Posts: 2,785
    edited February 2017

    Hi Davenport, I'm about to enter the equivalent trial but with palbociclib. If I consent (I have until next Wednesday to change my mind). So I'll know much more about this in a month

    Actually I'll know more next week -- I have a lot of questions on the side-effects they've seen in women before me.

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  • Lyndal13
    Lyndal13 Member Posts: 9
    edited February 2017

    I have been on Everolimus and Exemestane for just over 12 months. Have had side effects over this period of time but nothing I couldn't handle. I used a steroid mouth wash for mouth sores. Haven't really had many mouth sores lately. The only down side I have is that all my food tastes bland. If that is all I have to put up with I am happy 😀 I have ct scans next month so will know if this combination is still working 😀

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  • Warrior_mom
    Warrior_mom Member Posts: 9
    edited February 2017

    Hi there, I'm going to be starting the trial next week at MD Anderson. I'm hopeful the side effects will be tolerable and the treatment will work for me. I just stopped ibrance + letrozole as well....didn't work so well for me, just 9mths. I now have mets in spine and liver. Getting scary!!! Hope I can avoid chemo for a bit longer....

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  • zarovka
    zarovka Member Posts: 3,607
    edited February 2017

    Thanks for the information about this trial. I am not on this combo but following the thread ...

    >Z<

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  • Davenport1
    Davenport1 Member Posts: 32
    edited February 2017

    Pajim....good luck on the Palbo trial...I'd be interested to hear how that goes. I really had great success with the letrozole/Palbo combo and even had some tumor shrinkage with that. I wish it would have worked a bit longer but we all know how this goes. Keep us posted!



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  • Davenport1
    Davenport1 Member Posts: 32
    edited February 2017

    Lyndal13,

    Sounds like the Everolimus and Exemestane has worked for you for quite a while! Glad to hear that. Would you be willing to share what your side effects have been? I think my Onc was going to put me on this protocol anyway so I'm thinking the Ribociclib addition for the trail (since it's already FDA approved for ovarian cancer) might be a limited risk trial but one never knows what combining drugs can do. Hope you CT scans go well next month. Keep us posted!

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  • Mama2twinsplus2
    Mama2twinsplus2 Member Posts: 120
    edited February 2017

    I just started the TRINITI-1 trial, same meds as described above last thursday. I have taken 6 days of the combo with few side effects. I have also been prescribed the mouthwash, which seems to help. I was on Ibrance for almost 16 months, had a 2 month break and just started this trial. I am so happy to be able to connect with others on this protocol!


    Alissa

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  • Davenport1
    Davenport1 Member Posts: 32
    edited February 2017

    Warrior_mom

    I'm going to make a decision on this in the next day or two. I happy to find someone who may be in the same trial I am. I'd be doing mine at the Huntsman.

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  • Davenport1
    Davenport1 Member Posts: 32
    edited February 2017

    Mama2twinsplus2,

    I am happy you found this thread as well! Glad to hear you have few side effects so far. It's good to have the mouthwash to avoid mouth sores if possible....

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  • Mama2twinsplus2
    Mama2twinsplus2 Member Posts: 120
    edited February 2017

    I am also in this trial at the Huntsman, small world!

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  • Lyndal13
    Lyndal13 Member Posts: 9
    edited February 2017

    I had alot of mouth sores to start with now only very occasionally the steroid mouthwash helps alot. I have had times where i get pimple/lumps on my head or around my neck but these go very quickly. I don't have much taste or smell. But everything has been reasonably easy for me. Just hoping that my next ct scan shows good results 😀

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  • pajim
    pajim Member Posts: 2,785
    edited February 2017

    Davenport, I read 24 pages of consent form that basically said nothing. This particular trial is dose-finding, so many women have already been in it. I plan to ask what the combo side-effects are. Do they find that the blood counts go down logarithmically? Or additively? Or not at all?

    I've been on Ibrance plus other drugs for more than a year without difficulty.

    Still haven't made up my mind but also haven't changed my mind.

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  • Davenport1
    Davenport1 Member Posts: 32
    edited February 2017

    Pajim,

    My consent form has pages of side effects listed for each of the protocols but not a lot about the study already. Do you know how long this has been going on? I would think given the relationship to Palbociclib if it were having great success it might have been fast tracked by now? I am still going back and forth on this myself.

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  • pajim
    pajim Member Posts: 2,785
    edited February 2017

    Palciclib trial is the study I'm probably signing up for. It's a single-arm single center study. They've been taking groups of women and increasing the dosages which each group. Then they'll follow me along until I progress or the side-effects are too bad.

    I don't know whether I'm in the 4th group, last group, whatever. I do know it'll be the standard 125mg dose of palbo. Apparently its 5 mg of everolimus which is half the usual dose? (according to label -- I don't know what clinical practice is)

    My consent also lists the side-effects of each med, directly out of the book. I ignored the ones on palbo because, well, I TAKE that drug.

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  • zarovka
    zarovka Member Posts: 3,607
    edited February 2017

    I can't find the original abstract from SABCS to verify this statement, but here is a comment from another forum. If this is true, a disease control rate of 71% in metastatic disease that is AI/endocrine resistant is a very good thing. I'd be curious if anyone can find the original article. I am not an Afinitor fan, but data is data. This is a good result.

    Preliminary data reported at SABCS 2016 from a two-arm trial of ribociclib combined with both the mTOR inhibitor everolimus (Afinitor) and exemestane (Aromasin) in postmenopausal women with metastatic disease that is AI/endocrine resistant, has found 1.8% CR, 9.1% (3.6% confirmed) PR, and a disease control rate (non-progressive disease of 70.9%.

    >Z<

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  • Davenport1
    Davenport1 Member Posts: 32
    edited February 2017

    thanks for the info Zarovka....if anyone finds the abstract please post link!

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  • pajim
    pajim Member Posts: 2,785
    edited February 2017

    This morning I signed on the bottom line for the Farber single center palbo/A/A dose ranging trial. I'll be getting 125 of palbo (no problem) and 5mg Affinitor. Word is it's way more tolerable than the 10mg [usual] dose.

    We'll see whether it does me any good. A zillion screening tests on Friday; start the drugs on Monday.

    Meantime I feel like I should brush my teeth every three hours :-)

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  • zarovka
    zarovka Member Posts: 3,607
    edited February 2017

    Good luck pajim. Let us know how it goes. At a minimum, you get good supervision when you are in a trial. You are lucky to be at Dana Farber.

    >Z<

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  • Mama2twinsplus2
    Mama2twinsplus2 Member Posts: 120
    edited February 2017

    Today marks 2 weeks I have been on A/A with ribociclib trial. I have had few side effects and am feeling hopeful. I gonna just in tomorrow for a day worth of labs and EKG's. I will keep everyone updated as I go. I hope everyone else is doing great!!

    Alissa

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  • zarovka
    zarovka Member Posts: 3,607
    edited February 2017

    Alissa - Awesome! We're rooting for you and interested in your reports!

    >Z<

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  • pajim
    pajim Member Posts: 2,785
    edited February 2017

    Alissa, I'm so happy to hear you have few side-effects. I'll assume the same for myself.

    Seriously, I believe in that. If you anticipate side-effects, you're more likely to get them. That's not saying that side-effects aren't real or that anything you do causes them. They totally are -- some women get none, some women get slammed. It's just that when you tell someone it's going to be hard, they can have a harder time.

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  • zarovka
    zarovka Member Posts: 3,607
    edited February 2017

    pajim- I believe that too.

    Z

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  • ShetlandPony
    ShetlandPony Member Posts: 4,924
    edited February 2017

    Agree. I always go in expecting to do great. So much of this game is mental.

    Note that I am not blaming the victim when side effects do happen, just recognizing that the mind is powerful.

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  • Davenport1
    Davenport1 Member Posts: 32
    edited February 2017

    Alissa - good to hear you are doing well on this protocol. I should start my testing for eligibility this week. They certainly do lots of scans for these trials.

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  • Mama2twinsplus2
    Mama2twinsplus2 Member Posts: 120
    edited February 2017

    Hi ladies, just wanted to check in. I spent Friday testing for the trial. You check in, have a baseline EKG and blood work, then take your meds right there. Everything is repeated 2 hours, then 4 hours later. Once you get past the 2nd month, the testing is much less, I had a minor rash on my left arm, but it cleared up with Benadryl cream. I have been feeling really good, which is a huge relief!! But I experienced my first set back. My WBC dipped a little too low. This never happened to me the whole time I was on Ibrance. I just have to hold the trial drug and get a repeat CBC on Tuesday. She said it is very common and not to be upset. More good news, my tumor markers dipped 5 points since we checked them last month!! So hoping for better counts Tuesday!!! I hope every One is having a great weekend.

    Aliss

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  • zarovka
    zarovka Member Posts: 3,607
    edited February 2017

    Aliss - Thanks for the update. Hoping this goes very well.

    >Z<

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  • pajim
    pajim Member Posts: 2,785
    edited February 2017

    Aliss, sorry about the low counts but lots of women get them.

    I arrived at the center this morning for blood work at 7. When all is organized, first dose of the three meds then PKs for 8 hours (pharmacokinetics).

    Unfortunately the usual snafus. . .time zero was at 10:30am. That means I'm here until 6:30pm. Sigh. And they don't want me to leave the building because it's the first dose. Double sigh.

    I'm trying to look on it as a day to get work done without anyone bothering me. But lo, I want to whine a little so I chose you all

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  • zarovka
    zarovka Member Posts: 3,607
    edited February 2017

    We hear you! But do get some work done so you don't feel the whole day wasted.

    >Z<

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  • Davenport1
    Davenport1 Member Posts: 32
    edited February 2017

    Alissa - sorry to hear about your blood count....hope that works itself out. I know low WBC was one of the most experienced side effects with Ibrance... I was lucky and never had that on Ibrance so I'll be interested to see if mine go up on this protocol.

    Because I had a PET scan just a few weeks ago I was trying to not have another CT scan for the trials. I have a bit of an unusual situation in that I took a 5 month break, once my Ibrance quit working, to do some alternative treatments that involved only natural protocol. While making me feel great this (unfortunately) was not a cure....but the 5 months off apparently won't be a trial qualification problem since I did not take any other standard treatment during that time frame. I have to say though, I do get frustrated with the clinic, as they seem to lose everything I give them. SInce my scan was taken in a test facility I had to take copies of the scans to the clinic for review. I handed the discs right to them...now they can't find them. I don't know about you ladies but sometimes I feel like I am pushing a string uphill with my nose and have to be very aggressive about getting anything accomplished with my cancer healthcare professionals! It seems like there is a whole area of cancer care that is missing...maybe a patient navigator...especially once you hit stage IV. Kind of a lonely feeling....

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  • zarovka
    zarovka Member Posts: 3,607
    edited February 2017

    Davenport1 - It's pretty common for the coordination of care to be poor. Unfortunately. Sorry you are dealing with this. One advantage of a trial is that you should get a navigator/coordinator assigned to you. They can generally kick bureaucratic butt.

    >Z<

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