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Comments

  • newgardener
    newgardener Member Posts: 103

    Hi Nicolerod, Believe60 has bone mets (just diagnosed) as described in her question. It's just impossible to update diagnoses and treatments on this site anymore. I gave up and just put it all in my signature.

  • believe60
    believe60 Member Posts: 86

    I didtry to update. Just wasn’t successful.

  • smallmoments
    smallmoments Member Posts: 42

    Hi Believe60,

    Would it be possible for you to get a second opinion? As newgardener points out, I would wonder if the Ibrance/Letrozole arm makes sense given the recent history with an AI. Would you be able to talk to your MO about how the oral SERD compares to Fulvestrant? I was also presented recently with the option to go into a clinical trial after progression on my first line of Letrozole/Ibrance. A Guardant test showed that I have the PIK3C mutation. But instead of going directly to the SOC Fulvestrant/Piqray combination, my MO suggested that I consider a phase 3 trial for Imlunestrant (LY3484356), an oral SERD. It's randomized Imlunestrant, Imlunestrant+Verzenio, Fulvestrant. I met with another MO for a second opinion since it's my first progression and I'm new to the trials process. He was very positive about joining the trial. Both MOs thought that I could go to Piqray when the trial stops working. Also, there's a good chance any of the arms would work for me. And the oral SERD seems to have a lower toxicity profile than Piqray. But the biggest reason I decided to go ahead is what newgardener already mentioned, it gives me access to another treatment that would otherwise be unavailable. I wish you all best in whichever direction you take.

    Newgardener, thank you for including your list of trials. It's really so helpful. This first progression has been hard mentally. I was feeling so well on I/F and was lulled by all those "unremarkable" CT scans. I was hoping I could stay on my first line longer. But seeing your list gives me hope that there are more options out there. Sending you all my best.

  • moderators
    moderators Posts: 8,615

    Thank you so much for posting Believe60. We are glad that you have found support within the BCO community. We apologize for the glitch and the challenges that are faced with the current system. We appreciate your ongoing patience.

    --The Mods

  • gigil
    gigil Member Posts: 916

    Smallmoments thank you for your post. My history is quite similar to yours. My oncologist feels I have also progressed based on my marker score although my scans have looked good and I have been feeling good. She first mentioned a study for oral Fulvesterant and later told me I didn’t qualify, but didn’t say why! I am not sure where to turn now. Should I look for a study? I have read about genomic testing. I feel a need to know so much more than my oncologist is telling me and I don’t know where to find the information. Feeling adrift right now. Any info would ne so welcome. thanks, GiG

  • believe60
    believe60 Member Posts: 86

    Thank you Smallmoments and Newgardener. I had started a typed up list of questions for my meeting with my MO next week, and I have incorporated a lot of your ideas and suggestions. I met with radiology today so that part will get started soon. I am also trying to pursue at least one second opinion, especially regarding clinical trials. I had a CA 27/29 test for the first time so I have no reference point for this reading. So much to learn. Thank you. (So far we know the Mets are ER+ and PR- like the initial tumor, but HER2 is out for FISH test.)

  • smallmoments
    smallmoments Member Posts: 42

    Hope you have a good meeting with your MO, Believe60!

    Hi GiG -- So sorry that you're feeling adrift. I've been there with my very first MO and it wasn't great. I really hope your MO takes the time to discuss options with you including trials. Were you on Ibrance and Letrozole? Just a note that my tumor markers did not go up with my progression (I was bone only and now 2 very small spots in liver). Although when I I first started I/L, both my CEA and CA took a dive so I knew something was working. But for the last year, they've been hovering slightly above normal.

    My treatment change was based on the CT scan. March results indicated something in the liver that was probably "benign" by June it was "suspicious". I then had a PET scan which showed very low uptake (as my MO said, slightly higher than "noise") in 2 areas of the liver. She recommended staying on Ibrance for another 3 months and do a follow up PET, which confirmed slightly higher uptake in the liver. During all this, I took a Guardant test (a genomic test using a blood sample) that looked for mutations that developed after 2 years on I/L. If your MO suspects progression, perhaps you can ask about this test in order to see biomarkers that may have approved treatments or have clinical trials available. I have PIK3C and ESR1, which are both linked to endocrine therapy resistance. (anastrozole, exemestane, letrozole).

    Here's the link to the clinical trial I'm joining, EMBER-3. I'm not sure which trial your MO mentioned. But this is also an oral SERD and if you scroll down to the eligibility section, you can read through inclusion and exclusion requirements.

    https://clinicaltrials.gov/ct2/show/NCT04975308

    Sending you all my best, GiG.

  • susaninsf
    susaninsf Member Posts: 1,099

    Nicole,

    I'm no expert but I did find an extensive paper on ATR combination therapies: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9029554/

    Looks like a very exciting area with lots of future treatment possibilities!

    Hope you find the right trial for you.

    Hugs, Susan

  • eleanora
    eleanora Member Posts: 301

    gigil:

    Thanks for posting your concern about your MO. I feel the same way about mine - she only mentions the treatment she favors, without discussing the alternatives, and frequently doesn't disclose SEs, then seems annoyed when I do my own research and pose questions. If she doesn't want me to turn to Google, she needs to be more informative.

    I will be watching responses to your post to see recommendations from more experienced members.

    Eleanora

  • weninwi
    weninwi Member Posts: 782

    smallmoments,

    I looked at the Ember-3 trial that you posted. If I'm reading it correctly, there seems to be three arms. Correct? Can you choose which arm you want to participate in or are participants assigned? Is your MO OK with the single agent arm with fulvestrant or exemestane given the two mutations you listed (PIK3C and ESR1)? I also have ESR1.

    Wendy

  • believe60
    believe60 Member Posts: 86

    My MO has been looking for clinical trials for me. But both trials that seemed like a really good fit (testing new oral SERDs) I don’t qualify for because I didn’t last 24 months on an AI before becoming metastatic. Kind of discouraging. But I will do the SOC of ibrance and fulvestrant. Hopefully will be able to go for a while on that

  • nicolerod
    nicolerod Member Posts: 2,877

    Hoping someone can help ASAP


    I would have messaged you sooner but was away. I am meeting with the trial coordinator for these 2 trials onTuesday morning

    PARP/ATR inhibitor trial. NCT04972110

    - Niraparib/carbo trial. PI Dr. Mike Pishvaian. NCT03209401

    I wanted to know if you could tell me some questions that I should ask I have never met with trial before. I did ask my MO but I don't know if she will see this message before the meeting I will also post in the clinical trial thread.

    Thanks,

    Nicole

  • susaninsf
    susaninsf Member Posts: 1,099

    Hi Nicole,

    Some questions I ask when looking at trials are:

    1. How many patients are on the trial now? How many have dropped out of the trial? Why did they drop out?
    2. What is the schedule for my treatments and tests?
    3. If it's at a different site than your usual treatment, "Can I get scans and tests at another facility or do I have to do them all at the study site?".
    4. What are the most common side effects?
    5. If it is at the dose-expansion phase, "How many dose escalations have there been, and will I be one of the first on a new higher dosage?".

    Hope you can find a good trial!

    Hugs, Susan



  • nicolerod
    nicolerod Member Posts: 2,877

    Thank you so much Susan..I really appreciate it.

  • newgardener
    newgardener Member Posts: 103

    Hi Nicolerod - I usually ask to see the consent document ahead of time so I can read over it - seeing the details helps prompt lots of questions. It's not always possible, but it is helpful. The clinical trial nurse will still go through the consent document(s) with you in detail. Good luck at your appointment on Tuesday.

    Believe60 - It took me 18 months to find my first trial (and 2 progressions/drug changes) - I am so impressed that you are already thinking of trials and that your medical oncologist is helping! But starting with standard of care is a solid approach. I hope you have a good long time without progression and you don't have to think about trials for awhile.

  • believe60
    believe60 Member Posts: 86

    Newgardener, thank you for the words of encouragement. I think being newly metastatic I am not realizing if I progress again it won’t be the end of the world. You are right, a different trial is hopefully down the road for me. It just scares me that the reason I don’t qualify for these new generation SERD trials is because I moved from stage 1 to stage 4 in less than 2 years.

    Susan, thank you for that list of questions to ask, I will hold on to them for the future.

    I’m nervous right now to be on nothing (except radiation) while we wait to get new treatments decided on and started. They are only radiating the bone met that was biopsied

    This thread about clinical trials has been helpful. Thank you all.

    Nancy

  • nicolerod
    nicolerod Member Posts: 2,877

    To bad this isn't being used in liver or lung....

    https://www.theguardian.com/society/2014/oct/08/ca...


  • weninwi
    weninwi Member Posts: 782

    Susan,

    Your list of questions when considering a trial are so helpful. I wonder if the moderators or someone would consider developing a list of questions when considering a trial and then permanently post the questions at the start of this discussion board in the shaded section so they don't get lost and can even be added to.

    It was your second question "What is the schedule for my treatments and tests?" that helped me decide to not apply for a trial that I was eligible for. I would have needed to repeat a liver biopsy shortly after just having had one and the study would have required two visits to the Chemo Unit every month - visits that often involve long waits (an hour or more) due to staffing issues...plus of course the drive time.

    As newgardener posted I also ask to the see the written consent form (the consent for study I considered was 26 pages).

    Wendy

  • bsandra
    bsandra Member Posts: 1,030

    Dear Nicole,

    Sorry I answer only now - I was away too:/ Anyway, Susan gave you an idea what main questions should be (guys, thank you - we learn from you every day). I just wanted to ask if your MO could find one more trial with immune-therapy for you? Pembrolizumab, atezolizumab, etc... I mean, I know your PD-1 score but still PD-1 is not the only factor that leads to good responses. Or are you looking at them as future therapies? Sometimes also therapies that did not work before, work very well after other therapies, i.e. disease under pressure open older pathways that were already closed: there was an article with Dr. Joyce O'Shaughnessy (I believe) where she had no therapies for mTNBC patient and gave her some chemo that was not working and the patient has progressed on it years ago, and that time it worked perfectly and patient is NED for years already. You have many more options than PARP inhibitors only...

    Saulius

  • nicolerod
    nicolerod Member Posts: 2,877

    Saulius..I agree with you. The problem with Immunotherapy is a lot of trials will not take you unless you are PDL1 positive. I am not even Completely CLEAR on how /if PARP inhibitors work or are any good for my cancer....so basically its all guess work. I mean generally PARP inhibitors are for BRCA...positive and I am negative.

    I asked my MO once about re-visiting Xeloda with this old school chemo called Ixempra ..... When I took the Xeloda I was ER+ HER2- I am now Triple Neg, a lot of TNBC patients take xeloda and do well.... she said we can possibly re-visit the xeloda and maybe combine with the Ixempra but .....we will see I think I am running out of time.

    I am guessing you are not crazy about the PARP inhibitor trial?

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

    Nicole, Altho PDL1 expression was often a criteria for I-O trials some years back, I haven't seen it listed recently, at least the I-O trials on my list don't mention it. Anyway, the PARPi trials seem to fall in two groups: 1) the patient has BRCA, PALB2, or some other known DNA repair mutation, and the trial is monotherapy or a combination w/I-O, or 2) TNBC w/no BRCA mutation, where they combine the PARPi with chemo (presumably relying on the chemo to do the DNA damage part and make the cancer more sensitive to the PARPi)...

    Here, for example, the combo trial of I-O with an antibody designed to open the cancer up to the immune system, it says that you had to have progressed on some prior I-O if the standard of care treatments would have included it (which is the case for TNBC but not for ER-positive), however it also says you can say you decide to bypass that requirement....

    https://clinicaltrials.gov/ct2/show/NCT04691375?te...


  • bsandra
    bsandra Member Posts: 1,030

    Oh no, Nicole, I am very much for PARP inhibitors, also for IO in your situation. As Cureious said, IO can be used to stimulate your immune system or your responses to other therapies. In the trial that Cureious showed you would be eligible for PY314+Pembrolizumab, whereas PY314 is a one of a kind drug that let's TAMs recognize your tumor, and the team behind PY314 is really strong - I have been following them for years. There are also individualized vaccines (like Moderna's mRNA-4157), different MABs targeting newly discovered expressions, CAR-Ts for solid tumors, bispecific antibodies, etc. I know it is overwhelming but someone has to help you find what, from the first sight, would fit best to you. Unfortunately our MOs have knowledge but don't have time for this "research"... I could post here links to IO programs/companies that I am "following", so you could research a bit.

    https://affinittx.com/science/

    https://eng.hospital-direct.org.il - check them for "cheaper" CAR-Ts and TILs

    https://www.modernatx.com/research/product-pipelin...

    https://agenusbio.com/pipeline/

    https://carismatx.com/pipeline/

    https://www.t-knife.com/pipeline/

    https://www.medigene.com/pipeline/immunotherapy-pi...

    https://www.zelluna.com/technology

    https://www.iovance.com/clinical-trials/

    https://www.gadeta.nl/pipeline

    https://tcbiopharm.com/pipeline

    https://immatics.com/next-generation-act/

    https://www.leucid.com/industries - led by Dr John Maher, UK based, very strong team...

    https://enarabio.com/technology

    https://elicio.com/programs/pipeline/

    https://www.pionyrtx.com/pipeline/

    https://www.cityofhope.org/research/car-t-cell-the...

    https://pactpharma.com/programs/#pipeline

    https://www.erasca.com/pipeline/

    https://windmiltx.com/science-technology/approach/

    https://www.oncolyticsbiotech.com/clinical-trials/...

    https://www.g1therapeutics.com/pipeline/trilacicli...

    It is also interesting what is the status of LERONLIMAB that showed very good activity in TNBC...

    Phew, a lot of links, sorry... but as Bubba (Forrest Hump movie) said after talking for a few days of how to prepare shrimp: "that's about it":)

    Saulius

  • nicolerod
    nicolerod Member Posts: 2,877

    Thanks Saulius...ref: LERONLIMAB....no go that trial is done...

    "NCT04313075

    Expanded Access Status : No longer available

    First Posted : March 18, 2020

    Last Update Posted : January 28, 2022"


    I met with trial ppl for the RP-3500 with Niraparib as of yesterday its done...NO Success for anyone. then the other trial was the Niraparib + Carboplatin.... not doing it..no one has had any success yet and they do 3 biopsies!!!! 3!!!! all with in a few weeks of eachother that is just too much.

    So...we are still looking.... I am open to any trial suggestions anyone has...Im at a loss at this point.

  • nicolerod
    nicolerod Member Posts: 2,877

    Curious..ironically that trial you posted is AT my cancer center but says NOT YET Recruiting!! I messaged my MO

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

    Great, Nicole, another option to check out! PY314 targets TREM2, which is a protein expressed on the surface of macrophages that protect (many kinds of) cancers, but not found on the macrophages in normal tissues.

    So, its a new trial and first patient was dosed in March this year: https://www.pionyrtx.com/news/press-releases/03082...

    And for your MO, here is a paper describing the PY314 monoclonal antibody (anti-TREM2): https://www.cell.com/cell-reports/pdf/S2211-1247(21)01308-5.pdf



  • susaninsf
    susaninsf Member Posts: 1,099

    I am hoping to get on the PY-314 trial which has just opened up at UCSF. The brain MRI I got at Stanford (that both the Stanford and UCSF MOs thought was just a difference in machines and not progression) may mean that I will have to wait until 3 months of stability or 3 months after treatment. I will get another brain MRI on 11/8 and hope that it will show that I haven't progressed.

    In addition to keeping a list of questions to ask before getting on a trial, it would be great if we could keep a list of promising trials. I have a list I don't mind sharing and a list I put together for TNBC.

    Hugs, Susan

  • bsandra
    bsandra Member Posts: 1,030

    I'd say that is not good news: https://www.biospace.com/article/ambryx-drops-lead...

    Saulius

  • susaninsf
    susaninsf Member Posts: 1,099

    Oh no! That was a miracle drug for me. Glad I was able to get it before they stopped the trial. But I wish others could have gotten it too. They say that the HER2+ space for drugs is too crowded but this drug worked for me and I am HER2-low 2+. There are a lot of ADCs for BC but most of them deliver similar toxic payloads. Patritumab Deruxtecan, Trodelvy and Enhertu all deliver Top I inhibitors. This is probably why Enhertu didn't work with for me after Trodelvy. I have the ERBB3 variant but I don't think Patritumab Deruxtecan will work for me for the same reason. ARX-788 was unusual and effective because it had two toxic payloads. I hope another company picks it up so they can continue the trial.

    Thanks for sending us this news, Saulius.

    Hugs, Susan

  • bsandra
    bsandra Member Posts: 1,030

    Dear SusaininSF, I know it worked very well for you and still cannot believe it is over:/ Maybe someone will buy the program? I would if I had... 1-2 billion:)P

    Saulius

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

    Some interesting news from a conference in Spain, a positive result in phase 1 trial for a small molecule peptide inhibitor of c-Myc, which is a protein (oncogene) that drives the growth of many different cancers. It's a weekly IV, and results are remarkable because c-Myc is an infamously "undruggable target", given that so many people have tried and failed to target it over the years. It will now move on to phase two, the drug is called OMO-103. In addition, there are efforts to try to degrade the c-Myc protein using the new PROTAC technology. Progress!!!

    https://vhio.net/2022/10/26/omomyc-as-the-first-my...




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