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

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  • Kattysmith
    Kattysmith Member Posts: 688
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    Hi Daniel,

    I'm in my 4th 28 day cycle of my trial and am still feeling fine. The proof will be in the pudding after my next scans in April.

    Katty

  • ann1999
    ann1999 Member Posts: 88
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    Hi all. I’ve been on the Alisertib/Fulvestrant trial for seven months. I was randomized to the Alisertib only which lasted six months before progression so now starting to get both. I was very skeptical at first about going on a trial but since hormonal and chemo hadn’t worked I guess I was hoping for a miracle. I was more than shocked when I got to “stable” disease right away! My MO and I go over each scan etc every 2 months and I feel confidant about pulling the plug whenever I want to and assured my health is the priority

  • cure-ious
    cure-ious Member Posts: 2,735
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    Excited for you guys!!

  • JFL
    JFL Member Posts: 1,373
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    As for the MATCH, erdafitinib trial, I went back to have my labs redone after 6 days off the medication. My hypercalcemia is gone and liver enzymes still out of normal range but dropped significantly and alkaline phosphatase remained about the same, slightly higher. Overall, good news. My MO told me the trial sponsor confirmed that increased liver enzymes are a direct cause of the medication. Not sure what is going on with the alkaline phosphatase. I was cleared to restart at a lower dose but the research team at my cancer center has to order pills for the new dose and took my current pills, which I could have used to get myself to the lower dose. Super annoying. They should have the pills on hand. I had to be pretty firm to let them know I can't have a two-three day break any time I need to switch doses. The two research team members that come to my appointments seem a bit clueless and don't understand where they have flexibility within the trial parameters and where they don't.

  • JFL
    JFL Member Posts: 1,373
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    Ann, great news about your status in the arm with Fulvestrant added!

  • thrivingmama
    thrivingmama Member Posts: 133
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    JFL - glad that most of your labs came back improved! and that you got the info about the drug causing LFTs to go up. sounds like the re-dosing and getting a hold of the medication is frustrating, but I am glad you got cleared to go back on.

  • likestobike
    likestobike Member Posts: 10
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    Hi all, Just posted this on the Alisertib topic, but thought I would cross post here as well:

    I have been reading and following several threads ever since my mom progressed on Ibrance / Faslodex in Feb. She then had a liquid biopsy sent to Foundation One with ESR1 and PIK3ca markers

    I am so thankful for everyone who posts about their experiences and especially the research posts and links from Cure-ious. Based on this research we are looking into 2 trials:

    Alisertib clinical trial: NCT02860000 or Alpelisib: clinical trial NCT03056755

    We are soliciting a 2nd opinion and are hoping to make a decision very soon. Alpelisib seems like it may have more potential SE than Alisertib? Definitely interested in hearing what others would recommend or other's experience.

    thanks!

    Andrea

  • cure-ious
    cure-ious Member Posts: 2,735
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    Andrea- Alpelisib-Faslodex could get approval from the FDA any time now, maybe more likely in the summer, so if she starts in the trial, she still could switch over and get the drugs from her oncologist once she knows they are working (ie wouldn't even have to stay in the trial the whole time). for me i would try Alpelisib first, then move to Alisertib, because Aurora A kinase levels often go up when the cancer becomes resistant to Alpelisib.

    With her PI3K mutation, she should also ask her doctor if she should take a COX-2 inhibitor (Celebrex or one of the newer NSAIDs) because it has been shown that cancers with PI3K mutations strongly benefit from those drugs, but not cancers lacking the mutation.


  • cure-ious
    cure-ious Member Posts: 2,735
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    But also, Andrea, she may have more options to consider. Does her Foundation One test indicate whether or not she is likely to remain sensitive to a CDK4,6 inhibitor? Because, if so, she can consider the PACE or JPCE trials, which would essentially "add-on" some immunotherapy to an Ibrance-Faslodex regimen.

    Here are those trials, if there is a site near you, it is something else to discuss with her doc:

    https://clinicaltrials.gov/ct2/show/NCT03147287

    https://clinicaltrials.gov/ct2/show/NCT02779751

    the thing about these trials, is the therapies aren't really "either-or" but in what order to take them? And of course, depends on location, whether slots are open, and whether one "qualifies" for the trial, so its good to have a list of options..


  • JFL
    JFL Member Posts: 1,373
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    Cureious, intersting, I knew COX-2 inhibitors did favorably impact breast cancer results but didn't know that they had a larger effect in persons with a PI3K mutation.

  • likestobike
    likestobike Member Posts: 10
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    Kathy-Thanks for info! We are leaning towards Alpelisib-Femara combo. My mom is mainly concerned about the SE of high blood sugar, since she's already at risk for diabetes. We will defiantly look into COX 2 inhibitors.... she says she is highly allergic to Celebrix so I'm not sure if that would mean the whole family of drugs?

    The foundation one didn't mention anything about CDK4/6 inhibitors. Would that be some kind of biomarker?

  • likestobike
    likestobike Member Posts: 10
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    Cure-ios,

    I'm wondering how do you know if you have developed resistance to the CDK 4/6 inhibitors or if you are still sensitive to them? I have read your posts that mention that you want to exhaust your options of CDK 4/6 inhibitors before moving to the PIK3 inhibitors, but would that be true if you have the PIK3ca mutation? We have mentioned to the MO about trying another CDK 4/6 inhibitor, but the dr indiciates there's no research supporting switching CDK 4/6 inhibitors will be effective.

  • ann1999
    ann1999 Member Posts: 88
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    Welcome likestobike.   

    About the trials - Alisertib is only stage II.  Your mom will be randomized to either Alisertib alone or with Fulvestrant - it is a risk you have to feel comfortable with.  I had the Alisertib alone for six months until there was slight progression and now taking both. I was disappointed initially when I only got Alisertib as findings to date indicate it works better with the Fulvestrant (although it it seems to be working as a monotherapy also but again limited statistics out yet).  Alisertib SE weren't too bad but now with the Fulvestrant there are a few more. 

    The Alpelisib trial is phase III and sounds like it will be in the market "soon" or so I have heard.  The findings are impressive and it is certainly a drug I am considering in the future.  Hope this is helpful in your decision making and maybe the 2nd opinion will give you options you and your mom feel comfortable with. 

    Cure-ious - thanks again for all the info.  I didn't know about the COX-2 inhibitors or the effect of Alpelisib on Aurora A kinase levels. One would think the COX-2 thing would be something the MOs would talk to patients about.  Your posts are truly helpful.

  • newgardener
    newgardener Member Posts: 97
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    Hi likestobike - there's a thread on the alpesib trial too if you would like to check it out.

    https://community.breastcancer.org/forum/8/topics/865451?page=7#idx_184

    I'm in a different trial for a pik3ca inhibitor - GDC-0077. The drug did make me hyperglycemic/diabetic, but my blood sugar levels have been kept to high normal with metformin and Januvia. I'm on my 16 4 week-cycle. https://clinicaltrials.gov/ct2/show/NCT03006172

    Good luck to your mom.



  • blainejennifer
    blainejennifer Member Posts: 441
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    I have been accepted into this trial: NCT02792114, T-Cell Therapy for Advanced Breast Cancer at Memorial Sloan Kettering in NYC. I thought I hadn't a chance as I sent them mesothelin blood test results about three weeks ago, and hadn't heard anything back.

    The trial nurse called today, and said that I produced enough mesothelin to be accepted. I have to go to MSK for a confirming blood test next week. There is a very small chance that I will not have enough mesothelin in their testing, as it is more sensitive. But, what the heck, so far - so good.

    This is immunotherapy, where they harvest T-cells from me, train them to be super ninja mesothelin seeking cancer killers, infuse them back into me, and . . . . Hopefully, I get better in some way. Really better, kind of better, or stable, with a small chance of not doing so well at all.

    Scared, excited, and all the feelings in between.

    Jennifer

  • ann273
    ann273 Member Posts: 122
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    Congratulations Jennifer! I hope you get good results from this trial and that it’seasy on you!

  • cure-ious
    cure-ious Member Posts: 2,735
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    Jennifer- Congratulations!!!! Actual CAR-T therapy, very exciting! These are the kinds of trials where you might get a long-term response, and potentially even end up off of all therapy for awhile, no? I think there is not much in the way of side effects either, here a summary from some earlier unrelated trial: https://www.targetedonc.com/publications/targeted-...

    does the protocol add on checkpoint immuntherapy drugs too?

  • ann1999
    ann1999 Member Posts: 88
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    Fantastic news Jennifer!!!

  • ABeautifulSunset
    ABeautifulSunset Member Posts: 600
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    Jen, that is so awesome! Can't wait to follow you on this journey !


  • newgardener
    newgardener Member Posts: 97
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    That is very exciting news Jennifer. Congratulations on your perseverence

  • illimae
    illimae Member Posts: 5,572
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    Congrats! Following this for sure.

  • cure-ious
    cure-ious Member Posts: 2,735
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    likesbikes, There are several different ways the cancer can become resistant to Ibrance, for example loss of the RB gene, or upregulation of CDK2 or CDK6. However, at ASCO 2018 they reported that most of the time when there is progression on firstline I-F, it is because of an ESR1 (estrogen receptor) mutation or upregulation of the PI3K kinase, and 80% of patients had no changes that would suggest resistance to CDK4,6 inhibitors.

    However, that doesn't mean your onc would agree to continue with the CDK4,6 inhibitors- for the same reason they are not going to go around suggesting that their patients that have PI3K mutations take Celebrex/NSAIDs. They almost never act based on pre-clinical lab findings, because their training is to follow FDA-approved guidelines ("first, do no harm!") and they strictly follow recommendations based on actual data on human patients coming out of the clinical trials. For us this is a problem, because these trials take years if not a decade to complete, and often aren't even testing the specific question we want answered. So, while its helpful to understand what the current scientific literature suggests, don't expect that sharing it to you doctor would ever change their recommendation.

    In terms of next steps for your mom, many of the phase I and II trials require that the patients have already moved through the standard FDA-approved treatments, and often they require you have tried chemotherapy in the metastatic setting, so she might not yet be eligible for some of these trials you are considering. Some trials tho look like they are aiming for secondline treatment, like adding a PI3K inhibitor to Ibrance and Faslodex, or immunotherapy combo with CDK4,6 inhibitor, etc..

  • thrivingmama
    thrivingmama Member Posts: 133
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    Jennifer - congrats! That is so exciting. I have just started to explore the MSK t-cell trial as well as the Fred Hutch one for TNBC. I think this type of immunotherapy treatment has the potential for a true long-term response, and it's very exciting. Fingers crossed for you as you go through the final steps to begin the trial. May it be wildly successful for you!! I'll be sending lots of positive thoughts your way. Please keep us posted :)

  • Kattysmith
    Kattysmith Member Posts: 688
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    What spectacular news, Jennifer! I'm so excited for you!!!

  • blainejennifer
    blainejennifer Member Posts: 441
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    Cure-ious,

    The MSK trial is run by one of the doctors in the article you referenced, Prasad Adusumilli, so I will be sure to ask them about the checkpoint inhibitors.

    You are an Information Queen - thank you so much!

    Jennifer

  • theresa45
    theresa45 Member Posts: 238
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    Jennifer - Congrats! I'm excited for you and will be praying that you are accepted on the trial and get a remarkable and durable response! Thanks for keeping us posted! Theresa

  • JFL
    JFL Member Posts: 1,373
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    Great news, Jennifer! Will look forward to hearing your updates.

  • HLB
    HLB Member Posts: 740
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    That is exciting indeed! The hospital where I work just started doing CAR-T but it's only for certain blood cancers. 

  • likestobike
    likestobike Member Posts: 10
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    My mom has decided to do the trial with alpelisib. She will be taking it with letrozole, since she had already progressed on fulvestrant. We will keep everyone posted on the alpelisib thread.

    In getting a 2nd opinion, and asking several MO, we found that they weren't up to date on the latest info with clinical trials. Where is the best place to learn about trials and get objective opinions comparing them? Here on this forum? :) Are there MO who keep up to date on clinical trials and who objectively compare them?

  • blainejennifer
    blainejennifer Member Posts: 441
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    Go to https://clinicaltrials.gov/ct2/home, and enter your search parameters on the right hand side of the page under "Find a Study".

    That should get you started on finding a trial. As for getting an objective opinion, this is a great forum for discussing the plus/minus of different trials. As is talking to your medical team. Ultimately, it will come down to what trial will fit your Mom, will she meet the trial requirements, and can she manage the trial logistics.

    As much as I love my MO, they don't keep up on with all the latest trials. They told me, with humor, that between keeping up with all the journal reading and maintaining a practice, they barely have time to eat and sleep.

    However, they have a nurse, whose sole job is to guide patients through the trial process. This nurse is up on all the trials available and which of the practice patients would suit which trial, and they will help you navigate the trial entry process (gathering medical records, assessing the trial, etc.) It's a new position, and about darn time.

    edited because grammar is hard