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Are you currently (or have you been) in a Clinical Trial?

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  • blainejennifer
    blainejennifer Member Posts: 441
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    Yesterday, I sent off blood to the Mayo Clinic to see if I produce mesothelin, a protein that a trial at MSK is running a CAR-T trial for.

    Fingers crossed. It's only the first hoop, but the absolutely necessary one.

    I've been noped out of two trials so far for not producing the necessary element they were looking for.

    Jennifer

  • Parrynd1
    Parrynd1 Member Posts: 343
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    Good luck! Trials can be tricky to get in to & you’d think they would jump through hoops to study us

  • JFL
    JFL Member Posts: 1,373
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    I received word I have been officially accepted into the NCI basket trial for the FGFR amplification basket and will start a drug called erdafinitinib on February 22. Not too jazzed about the required 4-week washout (2 weeks longer than my scheduled Halaven 2-week rest period) but hoping nothing crazy happens inside my body during that time. In November-December, I initially did a 7-week washout waiting to be approved for this trial (3 weeks longer than my scheduled Doxil 4-week rest period). Finally, I realized I was not going to be starting the trial any time soon and insisted I be put back on treatment. I don't like being off treatment for any reason. I have turbo-charged cancer that can explode very quickly.

    I had various bloodwork done last week and next week will need to get an eye exam, CT scan and some additional bloodwork next week. I also signed my third NCI consent this week. So much paperwork - really, the first consent I signed at the beginning of December should have been enough! I read up on erdafinitinib and it is a pan-FGFR inhibitor, is currently pending FDA approval for urothelial cancer. It is supposedly pretty tolerable with the most notable side effects / risks being high phosphate levels and a small risk of retina detachment. I will be required to have monthly eye exams at the NCI's expense. From what I understand, the trial intentionally increases phosphate levels (increases the medication dose until the phosphate level reaches a certain threshold). I presume this is linked to making the drug more effective?

    As for scans, I don't know what I am going to do. The trial only permits monitoring via CT or MRI scans. I have had a bad history with CTs as they are unreliable for me due to the nature of my cancer. I routinely have PET-CTs every 3 months. My cancer starts lighting up on the PET before it starts growing on the CT and my cancer goes inactive on the PET before it shrinks on the CT. I am concerned that the CT will not tell the full or accurate story of what is going on - leading to perceived false positive and false negative results. I have a lot of liver lesions but most of them have been inactive since I did Y90 in April and June 2018. All the lesions treated with Y90 are inactive. However, I had some cancer cells hybernating when I had the Y90 - and thus, did not receive the Y90 treatment - that reawakened in December. (Think of whack a mole - if the mole doesn't pop his head up, he will not be whacked by Y90.) Anyway, a CT will simply show a lot of liver involvement when what is important for me is that most of the liver shows no evidence of active disease. When I first had Y90, some of my liver lesions increased in size due to common post Y-90 swelling/edema but all these lesions were 100% inactive. A CT would interpret the increased size as "progression" when in fact Y-90 was working. Also, I would like a PET scan to confirm the Halaven I started at the end of December is working on the two active liver lesions I had when I stopped Doxil. I believe Halaven is working but would like to know for sure. If it is working, I will probably go back on it after I finish the trial.

  • cure-ious
    cure-ious Member Posts: 2,735
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    JFL, You are just amazing! This drug showed high rates both shrinking tumors or keeping things stable. As I recall Zar had FGFR amplifications as well. This is a tyrosine kinase inhbitor specific for all four FGFRs. If its successful without too many SEs, you may also one day come back to take it in combination with other drugs.. Please update how you find the trial and good luck!!

  • ShetlandPony
    ShetlandPony Member Posts: 3,063
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    JFL, is it really the case that the trial does not permit PET scans, or just that they are not the way the monitoring will be done at the trial institution? When I was considering a trial, my onc said I could still check in with her and she would order scans we wanted if they were not done as part of the trial. I think your reasons for wanting some PET scans are good reasons and I would not want to go without them, either. I have lots of dead or dormant liver tumors and it takes a PET-CT to show if they are active.

  • theresa45
    theresa45 Member Posts: 238
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    JFL, Congrats on being accepted into the NCI basket trial! I'm sure it took a significant amount of work to locate and apply for the trIal. Great job! The PARP inhibitor trial I was on required CT scans every 2 months. Like yours, my cancer shows improvement or progression much earlier on PET/CT than on CTs. I was able to get a PET/CT every 4 to 6 months in addition to the CT scan while on the trial. Of course, the drawback is that having both a PET/CT and a CT scan is a lot of radiation. Best wishes!! Theresa

  • Kattysmith
    Kattysmith Member Posts: 688
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    JFL, congratulation on your acceptance to the trial! That's so exciting!

    Katty

  • JFL
    JFL Member Posts: 1,373
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    Thanks, everyone! Will keep you posted on how it goes.

    Curious, I recall also that Zarovka had the FGFR1 alternation. I also have amplifications of FGF3, FGF4 and FGF19. I believe these drugs also have activity in amplified FGFs in addition to the FGF receptors (FGFRs). There is not as much literature on the FGFs. I have never heard about FGF19 in relation to breast cancer but just read it links up with the FGFR4 receptor.

    Shetland, yes, I can ask for scans myself to have with my doctor. I am concerned insurance would deny the PETs if I an getting regular CTs and would prefer to avoid too much radiation although I don't think that would stop me. I am also going to ask if the trial can simply take the CT portion of my PET-CTs. The one time years ago when my MO ordered a CT, it was without contrast, I believe the same or similar to the CT portion of the PET.

  • Kattysmith
    Kattysmith Member Posts: 688
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    GREAT NEWS...I AM SHOUTING THIS FROM THE ROOFTOPS! I saw my doctor today and after two 28-day cycles of immunotherapy, my latest scan on February 1st shows a 25% overall decrease in tumors, and in the liver, it is even more dramatic - he showed me the scan comparing the one I had in November and the one I just had; remarkable! Some tumors have dropped off the map - poof! - even tumors that have not decreased have stabilized; and there has been no progression!!!

    My Onc was thrilled, as I am the only breast cancer patient in this study and the only one in MD Anderson. The study sponsors should be really pleased. There is no way of telling at this point which drug is doing the trick or if it is indeed the combo. He is sending my tumor sample off to Foundation One for further testing.
    Since the scan results were so good, I will be moving on to cycle 3 of the trial tomorrow, which is MUCH less rigorous appointment and time-wise. Walking on air down here in Texas! I can finally stop holding my breath!

    WOO HOO!!!

    Katty

  • MuddlingThrough
    MuddlingThrough Member Posts: 655
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    Wow, Katty!!! So glad for you. Great news. 😁

  • Parrynd1
    Parrynd1 Member Posts: 343
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    That’s awesome news!!!! Woo hoo!!!

  • Chemokaze
    Chemokaze Member Posts: 177
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    oh WOW! Congratulations Katty! This is terrific news!

    What trial are you in?


  • JFL
    JFL Member Posts: 1,373
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    Great news, Katty!

  • ShetlandPony
    ShetlandPony Member Posts: 3,063
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    JFL, I was told that the CT portion of a PET-CT is a poor-quality CT, useful for orientation reading the PET, but on its own not as good as a CTwith contrast. I understand your concern about insurance, but I would hope your onc could explain why a PET is needed based on your history. Maybe your onc and radiologist can together come up with a good plan and schedule. Definitely get an expert radiologist to weigh in.

    Katty, that’s marvelous. May I ask if its IDC or ILC?

  • JFL
    JFL Member Posts: 1,373
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    Shetland, my MO ended up changing my CT to a PET-CT. Very happy about that. Apparently, the trial doesn't require a CT with contrast and the non-contrast CT will be sufficient.

  • ShetlandPony
    ShetlandPony Member Posts: 3,063
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    I’m glad there was a great solution for you, JFL!

  • Kattysmith
    Kattysmith Member Posts: 688
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    Someone asked about my trial; this is the one. https://clinicaltrials.gov/ct2/show/NCT03369223

    Shetland, I was IDC. I am still ER/PR+ and Her2-

  • Kattysmith
    Kattysmith Member Posts: 688
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    Cure-ious, I think I did copy the wrong link. There isn't an NCT# on my informed consent. This must be the one. https://clinicaltrials.gov/ct2/show/study/NCT03661...

    I am in a Phase 1/2 study of BMS-986310 administered alone and in combination with Nivolumab in participants with advanced solid tumors.

    I take 2mgs of BMS-986310 per day and a 30 minute infusion of Nivolumab (Opdivo) on the first day of each 28 day cycle.


    Shetland, I was IDC.

  • cure-ious
    cure-ious Member Posts: 2,735
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    Yes, yes, yes!!! In this case, the trial makes all the difference. I hope its this one!! Otherwise, your MO was confusing you with another patient- this is AWESOME!

    Responding to IO as you are also means you should also get a bouncy overall survival benefit from this- the subsequent treatments you get will all do better than they would have.

    Can you pls check with your MO if you have high PDL1 expression, because if not, we all need to get on his trial, and the sooner the better!!!

    Are scans every three months or six months? thanks!!

    Oh, and any side effects still?

  • Kattysmith
    Kattysmith Member Posts: 688
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    Scans are every two months. The only noticeable side effect has been some manageable patches of rash. My blood work including my neutrophils and hemoglobin have been normal!

  • husband11
    husband11 Member Posts: 1,287
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    That is fantastic news Kattysmith!!!

    Did you stop Ibrance / letrozole because it quit working? How about Faslodex? I am curious about your treatment history leading up to the clinical trial.

  • Kattysmith
    Kattysmith Member Posts: 688
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    Husband 11, I was stable on Ibrance/Letrozol from 2/16 - 4/18 when scan revealed progression into the liver, so I stopped. After that, I was briefly on Carboplatin/Etoposide, but it didn't have the response we were hoping for, so I stopped that. My MO wanted to try Faslodex, which I did , but showed continuing aggressive progression in my liver and other areas. We had previously discussed moving on to Xeloda, but he thought that wouldn't help. Instead, he had been conferring with a colleague in Clinical Studies and they had at least three trials that they thought might be beneficial, so here I am. And this trial wasn't even one of the initial three that they talked about. They already had someone lined up for this one spot, but he failed to return their phone call and they offered it to me instead!

    Cure-ious, some new testing was just requested and results won't be back for a while, so I don't know about the high PDL1 expression yet. When I meet with the doctor again in early March, I will have more information.

  • husband11
    husband11 Member Posts: 1,287
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    One of these new treatments could be the cure. Kudos to you for signing up and lighting the path to a cure.

  • Chemokaze
    Chemokaze Member Posts: 177
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    These recent posts just made my day! Go Katty!

  • cure-ious
    cure-ious Member Posts: 2,735
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    Katty- Let's just assume you don't have some rare features like high PDL1 expression, which would make the cancer respond to immunotherapy. Maybe the EP4- Opodivo combo is really going to work for some signficant set of ER-positive breast cancer patients. The trial sponsors might decide to open up an arm of the trial specifically for ER-positive MBC, the market is very large and you would think Opodivo-Bristol Myers would want to jump ahead in the race to get FDA approval for our type of cancer. Especially since Keytruda announced they will be doing a Keytruda- EP4 trial as well.

    It will be interesting to see if they decide to write up your case for the scientific literature- there is next to nothing in PubMed about immunotherapy plus EP4 inhibitor, so these trials must be coming as part of the big pharma in-house studies. If they don't write it up, it may be because they want to broaden the scan of their trial and get more patients in the pipeline for testing before letting the competition know what they are finding.

    You said your doctors were thinking of several different trials- did they all involve immunotherapy? Were they surprised this trial is working as well and as fast as it is, given your cancer was already resistant to some other treatments?

    The nice thing with immunotherapy is that the cancer can't mutate to resist it- it is very unlike a targeted drug. And for as long as it works, the response will continue to improve, because the longer you go the more the immune cells destroy the cancer- not like a drug where the cancer often is just arrested in growth, put in a sleep state The longer you go, the more cancer cells get destroyed and lower your overall tumor burden becomes. And immune cells eat cancer stem cells, whereas sometimes drugs inhibit the bulk of the tumor but not the cancer stem cells, which are the ones that go on to form new mets.

    My last question here- do they keep giving you injections or at some point do you go off of the immunotherapy altogether and take nothing until they have evidence the cancer is firing up again? Once they have boosted your immune system, I'm not sure if it has to be done continuously- for example Jimmy Carter had immunotherapy for melaoma mets, and at some point they decided enough is enough, and he is not continuing to have any more treatments at present, at least as I understand it..

  • Kattysmith
    Kattysmith Member Posts: 688
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    Cure-ious

    In answer to these questions: You said your doctors were thinking of several different trials- did they all involve immunotherapy? NO, but I don't remember what they were other than the first one I was originally supposed to try was Taxol + something. Were they surprised this trial is working as well and as fast as it is, given your cancer was already resistant to some other treatments? YES, he was very excited and VERY pleased.

    And: My last question here- do they keep giving you injections or at some point do you go off of the immunotherapy altogether and take nothing until they have evidence the cancer is firing up again? I don't know, my hubby and I were discussing that very thing after I got my results Monday. That's a question I'll get into with them a little further down the road.

  • novagirl
    novagirl Member Posts: 82
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    Kattysmith, I’m thrilled you are having such good results. I hope they continue!

    JFL-I hope you will see similar results in your NCI trial.

    My MO just called me and gave me Foundation One results. He said I have a couple of mutations that are under investigation. One of which he said was the FGFR amflication.

    I will get a copy of the report when I see him on March 11th


  • Kattysmith
    Kattysmith Member Posts: 688
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    In 2015, when I was diagnosed with a Stage IV recurrence after twelve quiet years since Stage1B in 2003, I set one firm goal.

    I reached that goal today, and am CELEBRATING my milestone 20th wedding anniversary!

    Hubby and I have known each other since 1978 when we were in our mid-20ies, but due to trials, tribulations, and life in general, we didn't get married until we were well up in our 40ies, and darn it, I want as many years together as we can get!!!

    CELEBRATE! CELEBRATE! DANCE TO THE MUSIC!

  • Kidmanliang
    Kidmanliang Member Posts: 72
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    :) happy anniversary!

  • moissy
    moissy Member Posts: 371
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    Katty - Wishing you a wonderful anniversary! Have a wonderful day together! Happy celebrating