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

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  • [Deleted User]
    [Deleted User] Member Posts: 760

    GG27-so glad for abraxane approval and no reaction. ๐Ÿ‘Œ๐Ÿป๐Ÿ™Œ๐Ÿป๐Ÿ’ช๐Ÿป

    Cure-ious, according to my trial NP the CERAN drug OP 1250 is doing well and has very good tolerability. She said my trial and the CERAN trial are good for those who have failed other serd trials because of the novel mechanism.

    I did not get Dr Hamilton today so I donโ€™t have statistics like know how long some of the patients have been on it. Here is a link to a video she did on OP 1250

    https://www.onclive.com/view/dr-hamilton-on-the-mechanism-of-action-of-op-1250-in-hr-her2--metastatic-breast-cancer

    Update- Bloodwork was good today and no new issues. ๐Ÿ˜Š Getting a speech evaluation tomorrow for word retrieval issues. I requested a referral from my PCP after reading an article on palliative care. Iโ€™m not in a crisis so now is the time to build myself up and take care of problems I have put off like getting counseling and assessment for coping and training for word retrieval. image

    Dee

  • luce
    luce Member Posts: 359

    wondering if that means low-carb diet or metformin could increase response or delay or reverse resistance:

    https://www.practiceupdate.com/content/18f-fdg-petct-for-assessing-early-metabolic-response-in-hrher2-mbc-treated-with-cdk46-inhibitors/119680

  • [Deleted User]
    [Deleted User] Member Posts: 760

    Luce- I was on keto for a year prior to metastasis and when I started verzenio and faslodex. At 3 months scan my tumors grew/one had slight necrosis. my case does not support low carb making a difference. I stayed on keto through 2 more lines that failed then decided to enjoy carbs again. ๐Ÿ˜‰

    Dee

  • cure-ious
    cure-ious Member Posts: 2,891

    Hey Luce!! How high AR expression does one need to be eligible for enobosarm? And does the trial allow for a CDK4,6 inhibitor also?

  • luce
    luce Member Posts: 359
    1. I would just get it off label or buy it, not join a trial. Or try Masteron. Iโ€™m currently pausing Verzenio but I may restart and combine. Or combine with AI.
  • cure-ious
    cure-ious Member Posts: 2,891

    Luce, V has been like a wonder drug for you- how long have you been on it? I like the idea of mixing in some Enobosarm. Unfortunately this may not be a treatment for me, because my F1 report found an SF3B1 mutation, and I was reading those cancers fail to express BRD9, which is required for AR signaling. So maybe one reason that mutation gives breast cancer is because AR can't do its thing as a tumor suppressor... OTOH, maybe BRD9 is just low levels and Enobosarm would boost AR and be just the thing I need, there is no way to tell!

  • luce
    luce Member Posts: 359

    I did not respond to Verzenio unusually long. Iโ€™m not sure why you keep thinking that. I was treatment naive, it was my first line, and I got about a year before my tumor markers went up again.

  • cure-ious
    cure-ious Member Posts: 2,891

    Oh, I see, since you said you were now pausing V, I thought that meant you'd been on it continuously...

  • luce
    luce Member Posts: 359

    yes, Iโ€™d been on it until recently because one of the oncology strategies post-progression is staying on it while adding other drugs

  • cure-ious
    cure-ious Member Posts: 2,891

    Yep, I'm trying to do that too, switched in March from an AI to Faslodex, keeping with the Ibrance (now six years on). Added pitavastin, since it kills PTEN-neg cells that can be a problem for progression. Keeping an eye out for what next steps would be, some kind of SERD/CERAN/PROTAC trial, maybe with some V added to it.

  • cure-ious
    cure-ious Member Posts: 2,891

    A new ER-based therapy is under development, called ErSO. This drug works differently than endocrine therapy, rather than modulate estrogen signaling, it puts a chemical tag on the ER that supercharges an "unfolded protein response" in the tumor, causing the cells die but not affecting healthy cells. In mice, the drug kills both primary tumors and mets, and they have some suggestions it may work better than SERDs- tho still in early stages and not yet in trials, it has been licensed to Bayer..

    https://www.fiercebiotech.com/research/bayer-s-bre...

    some videos of cell killing here:

    https://medicalxpress.com/news/2021-07-approach-er...


  • moissy
    moissy Member Posts: 371

    Cure-ious - With the statin/PTEN research, have you come across any data that compared difference in effectiveness between pitavastatin and other statins?

  • cure-ious
    cure-ious Member Posts: 2,891

    Moissy, Pitavastatin does show some anti-cancer activities that are not seen with other statins. In addition, it does not compete with Ibrance to use the Cyp3A enzyme to be degraded, so there are no problems with cross-reacting with Ibrance, which was a problem for me when I developed an atorvastatin-exacerbated frozen shoulder and had to go off of atorvastatin completely. Pitavastatin has been no problem.

    Pitavastatin can block cells with low/no P-TEN. P-TEN is a tumor suppressor that often gets switched off in breast cancer, and those are some of the cells that can develop resistance to endocrine therapy. Pitavastatin also reduces AKT and ERK signaling. Pitavastatin comes in 1-4mg doses and I am on the 1mg dose, (since I only take it for anti-cancer therapy), and have to hope it has some anti-cancer activity, but of course it might not be doing anything. I've only been on it for about eight months now.

    https://pubmed.ncbi.nlm.nih.gov/33953560/

    https://www.futurity.org/statins-kill-cancer-cells...

    its anti-cancer effects should be strongest in a diet low in geranylgeraniol, tho I haven't done that

    https://www.sciencedaily.com/releases/2017/07/1707...

    https://www.bbc.com/news/uk-england-stoke-stafford.....




  • bsandra
    bsandra Member Posts: 1,030

    Wow, Cureious, you are even faster than me (time difference?) - I also saw this ErSO thing in fiercebiotech:) Seems even too good to be true... maybe we need to write to prof. Shapiro and ask when they expect human trials to begin (his contacts were officially given in https://scienmag.com/new-approach-eradicates-breast-cancer-in-mice/)? Saulius

  • moissy
    moissy Member Posts: 371

    Thanaks for your helpful info as always, Cure-ious

  • cure-ious
    cure-ious Member Posts: 2,891

    So, I've been wondering where the new trial is for ARV-471, the company (arvinas) said they were going to come out with one combining this drug (ER-PROTAC) with CDK4,6 inhibitor or Piqray or Everolimus, for 2nd-3rd line patients, was supposed to be out in the spring. Just read where they have now partnered up with Pfizer to get the drug through clinical trials and onto the market. Hope it goes faster now, tho its not surprising they would need a major pharma involved to push it into the clinic


  • elenas401
    elenas401 Member Posts: 170

    pounds very interesting about ErSO but why can't they move things along a little faster to save lives? They got the covid vaccines out for emergency use in a hurry but money must be involved in cancer research so it goes at a snails pace. They should let people who are desperate take a chance as they did with the vaccines.

  • nicolerod
    nicolerod Member Posts: 2,877

    elenas...I am NOT getting political here ...but with the previous administration there were A LOT of things approved and pushed through for us...and now...nothing it's like things have come to a complete stop.

  • elenas401
    elenas401 Member Posts: 170

    Just saw a BBC article on ErSO from today that said next step is human trials and if all goes well it could be available in A DECADE!! Seriously depressing to think it has to take that long.

  • elenas401
    elenas401 Member Posts: 170

    what if they would've taken a decade to get the covid vaccine out? Too many were afraid of getting the virus to take that long.

  • [Deleted User]
    [Deleted User] Member Posts: 760

    cure-ious

    Wow. You are on top of things with my trial. Pfizer just paid 2 BILLION dollars for arv471. They must really believe in this drug.

    https://www.thepharmaletter.com/article/arvinas-pens-2-billion-deal-with-pfizer-on-arv-471

    I was supposed to be the arm with Ibrance but there was an eligibility issue with me taking faslodex 2 separate treatment times. I asked if I could switch to that arm to see if I got even more response with Ibrance and was told no. (I imagine they want to keep their single agent statistics looking good)

    since I failed Pfizer's cdk 2/4/6 trial, I am not as concerned about missing Ibrance

    FYI- I decided to invest a little in arvinas when I started to show stable disease. Good thing I bought some stock when it was lower ๐Ÿค‘๐Ÿ˜Š๐Ÿ˜‰

    I go to my trial check on Monday. I will see what the Dr Hamilton says about how this will affect the timeline

    Dee

  • cure-ious
    cure-ious Member Posts: 2,891

    And Dee, they should be treating you like royalty, as you are contributing to the great response numbers coming out of their early trials, attracting all the interest (and now big bucks) from the major pharmas...

  • sondraf
    sondraf Member Posts: 1,682

    In reading the Fierce Biotech article about ErSO there was another about a whole range of second gen SERDs in Phase III trials already which was relatively interesting, but probably old news to Cure-ious!

    ErSO - looks like Bayer licensed it last September (based on their corporate news site), but Systems Oncology is interesting as they are using AI and large data sets to find and develop potential therapeutics in a faster way than more traditional approaches - e.g. fishing faster in less busy pools. Why is this news being recirculated 9 months after the original agreement was signed? New outcomes come to light or PR push in advance of paper publication or what?

  • GG27
    GG27 Member Posts: 1,308

    not great news today about ct scan. Liver mets are still growing one from 26 x 18 mm to 27 x 24 mm other from 23 x 16 mm to 31 x 27 mm and they brought along some friends. The plan is to keep on the trial for 2 more cycles as I had a hard time with the chemo end of it and had to change to the trial drug to 50%.

    So the trial RN is trying to find out if they will let me stay on the trial or not. Either way, chemo tomorrow

    Cheers dee

  • [Deleted User]
    [Deleted User] Member Posts: 760

    oh Dee that report must have felt like a gut punch. I hope you get a good plan forward.


    AlabamaDee

  • moderators
    moderators Posts: 8,613

    (((((GG27))))) please keep us posted. We're routing for you and sending good energy.

    Your Mods

  • d37
    d37 Member Posts: 73

    Dee, Iโ€™m sorry to hear about your scan results. I hope your doctors can set you up with a plan to take care of your liver mets. Denis

  • GG27
    GG27 Member Posts: 1,308

    thanks Dee, D37 & Mods for the kind words.

    They are allowing me to stay on the trial at this point, yay, I really need to get these liver mets under control. My TM's went up a little bit, 20 points, my MO says it's basically stable. Chemo went fine today except for sitting around waiting for the pharmacy to get around to it for 90 minutes. MO is going to schedule a follow up CT for 5 weeks from now, not part of the trial protocol, she just doesn't want to leave things too long in case it's not working.

    cheers, dee