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  • cure-ious
    cure-ious Member Posts: 2,762
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    Keris, Here you go- Piqray (PI3KCA inhibitor) and Fulvestrant have been shown to work on FGFR1 cancers in clinical trials, so there is one option, and also if Capivasertib gets approved (presumably with Fulvestrant), then that also is a good option (it hits Akt, but the approval is likely to be for anyone, not just those with Akt mutations, because so many pathways end up turning on Akt)

    https://www.onclive.com/view/biomarker-analysis-confirms-benefit-of-alpelisib-plus-fulvestrant-regardless-of-mutation-status-in-hr-her--breast-cancer

  • keris113
    keris113 Member Posts: 45
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    Thank you, this looks like it could be promising so hopefully it is approved soon.

  • mommacj
    mommacj Member Posts: 52
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    Cure-ious I am so happy to hear your great news!! Thank you so much for the great info. you gave me. I have been meaning to log in and reply but every time I do I start falling asleep lol. I was so wiped out after 2 days at UCLA meeting with the trial people and 4 scans, meeting with trial doctor and blood tests, ekgs etc. I was so happy they could get it done in such a short time frame because less trips to LA in the crazy traffic is better for me. They scheduled my liver biopsy for Tuesday back at UCLA to get a trial sample and she is going to send it for more generic testing. We spent time talking about my PDL1 mutation and she wants to send the liver sample because my original caris testing was done on a mediastinal lymph node. As I understood it she said lymph nodes can have a much higher PDL1 mutation so she wants to check the liver to see if it’s there too. I’m glad she is being so thorough. I’ve already had one liver biopsy and I asked my oncologist to send it for genetic testing to see if the receptors and mutations were different than the ones in my lymph node biopsy because I keep having only a partial response to the treatments we try. She said she wasn’t sure she could send it again so soon. When I was originally diagnosed in 2014 my breast cancer biopsy was her2neg but after neoadjuvant chemo and surgery I had 15 lymph nodes still with cancer. I said can we retest the receptors in the lymph nodes so she sent them off. The lymph node receptors were triple positive and I started a year of Herceptin because of it. I was cancer free for 8 years after that. So my cancer has always been multifocal. The trial doc agreed to send the liver biopsy for genetic testing so I’m very happy about that. She thinks the ARV-471 will be good because it will be potent against the ER. The Afinitor will go after the mTor pathway and I can still try Piqray, Capivasertib when approved, and Xeloda and others down the line and we can look at Immunotherapy if my liver is high PDL1 as well.

    I am so encouraged with your celebrex response. I have a prescription for it for my bone mets. I have never taken it because my bone mets improved on faslodex and Ibrance and Tylenol or Motrin was all I needed intermittently. I was really bummed to see my CT results last night from the trial. Enhertu helped my liver some on my first scan but my bone mets have gotten much worse. It said multiple new spots. So I will try the celebrex. Do you know if I have to wait until after the biopsy to take it? I know I can’t have NSAIDs but I don’t know what category celebrex falls under? Thanks!

  • cure-ious
    cure-ious Member Posts: 2,762
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    MommaCJ, I contacted UCLA last month about the LOXO PI3KCA trial, and I agree with you, those guys are really at the top of their game!!! They weren't recruiting yet for the arm with a SERD, so I will contact them later if the PI3KCA mutation persists. I also considered your trial, esp because the LOXO trial is phase one and nothing is known about the SEs of that drug, but in the meantime, the statin/Celebrex combo did a number on my TMs, so now I don't have to change anything other than re-scan to see if everything really is stable.

    So I think Celebrex would be a great way to augment the PI3KCA/mTOR/AKT inhibition by Affinitor, it inhibits AKT as well as COX-2, which is turned on by the pathway. In addition, it inhibits PDK1, which is a way that cells progress from these inhibitors, so you might go longer on treatment. Celebrex is an NSAID, and usually prescribed for arthritis/joint pain- why can you not take it?

    And lastly, yes, Bring on immunotherapy!!! We have been waiting so long. Do you know the tumor mutational burden of the cancer (TMB)? that is a separate sensitivity factor from PDL1 that predicts response to immunotherapy, and it can go up after a long time on CDK4,6i. Also, KattySmith, who started this thread, had ER-positive MBC and got 7 months on a clinical trial that combined Keytruda with a next-gen version of Celebrex, because another feature of Celebrex is that it helps the immune system go after the cancer.

  • mommacj
    mommacj Member Posts: 52
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    Cure-ious I asked about the LOXO too.

    My TMB was 5 on my original Caris. I’ll be curious to see if it’s changed when they send my liver sample. I have celebrex at home I can take it. I just didn’t know if it was ok to take before my liver biopsy Tuesday since they said no NSAIDs for a week before the biopsy? I will definitely be taking it after and if I can take it before I’ll start now. Thanks again for all of your insight.

  • irishlove
    irishlove Member Posts: 531
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    Hi everyone. Not clinical trial related but looking for help interpreting spinal fluid report. Good news, I am negative for paraneo plastic syndrome. Bad news, (I can't see MO till Oct. 2nd to go over this to understand meaning) Polynuclear cells %, CSF Value 100.0 HIGH Normal range below 0.0. Everything else is within normal range. I tried to interpret google, not having much luck. I want to mention that I have MS for 22 years, MRI of brain looked good per neuro in August. I wish they had done an MRI of the spine. Also, wanted to mention, I have developed hearing loss and tremors, head and hands with severe burning pain in spine over hiney cheeks and upper back of legs, severe weakness and horrible depression (never had before).

  • cure-ious
    cure-ious Member Posts: 2,762
    edited September 2023
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    MommaCJ, Oh, that's fine, just skip it till after the surgery (they always say no NSAIDs because of the increased bleeding risk, and actually Celebrex does not come with the (stomach) bleeding risk that aspirin does, but still, wait till you are recovered, try it and see if any help). my TMs went down with one 200mg Celebrex per day, tho normal use is two capsules, I figure it is acting with the other drugs so didn't want to take two a day..

    For TMB, one study found a level of 14 or higher in MBC patients gave a 60% response to immunotherapy alone, whereas for levels between 10-14 it dropped a lot, to just 8%. High TMB is also associated with poor response to CDK4,6i, however you are just in the middle, so not sure it means anything! Anyway, we don't want just immunotherapy alone, and perhaps intermediate TMB will be shown to help when taking immunotherapy combos.

  • cure-ious
    cure-ious Member Posts: 2,762
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    IrishLove I'm so sorry you are having all these problems!! No idea what polynuclear cells are in a spinal tap, will come back if I see anything…

  • sondraf
    sondraf Member Posts: 1,631
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    Cure, I forgot about your celebrex adventures, I have a load of inflammation in the hip but the blood thinners mean advil and the like are technically off the table (totally days when I cheat on that). However, that is more due to stomach bleeding risk, so I wonder if something like a celebrex would help there considerably on multiple angles. Something to ask next month when scans and all are in.

  • jsniffs
    jsniffs Member Posts: 136
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    I only found out about the below event by accident, and I thought I was on their mailing list, so I thought I'd share here. Dana Farber is having a general welcome session to kick off their 2023-2024 MBC virtual series and then breakout groups for ER+, HER2+, and triple negative to highlight what is new in research and treatment. I have found these EMBRACE webinars very helpful. If the mods see this, feel free to share wherever else it makes sense.

    Registration link and more info: https://t.e2ma.net/message/vu1u9ac/nglif1b

  • mommacj
    mommacj Member Posts: 52
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    Thank you for the info jsniffs.

    I completed my liver biopsy yesterday and I have to say that I have always loved my oncologist but wow the people at UCLA and in this trial have been so nice and so on top of everything. They are so thorough and it almost makes me want to switch. The liver biopsy yesterday was uneventful and I am feeling good today. The LA traffic is seriously horrible though and I am so glad to not have to go back to LA for a week. I start the trial next week pending approval. I am a pretty nervous about it but I feel good that one of the drugs Everolimus has been approved for years, and the second one ARV-471 is in phase 3 trials alone and the dose escalation part is complete for that drug. It seems well tolerated but you just never know. Anytime I start a new drug I feel that way. But I’m praying and hoping for some success this time. I’m waiting a day or two post biopsy to make sure there is no bleeding and then I am starting celebrex.

  • werone
    werone Member Posts: 16
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    @mommacj

    hope this helps. my wife has been on ARV-471(180 mg) + ibrance (100 mg) ( 2nd run with ibrance) since June 2022. 2 weeks back she had progression in her primary tumor (breast) .She is scheduled to get radiation to her breast and they are keeping her on the trial. She currently does not have any major side affects but noticing her feet and palms are very dry.

  • moderators
    moderators Posts: 8,287
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    When do you get your liver biopsy results, @mommacj?

  • mommacj
    mommacj Member Posts: 52
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    I should get the biopsy results within the next week hopefully but I think it’s just a trial formality. The liver biopsy I had done last April showed mets. They just did this so they would have a measurable tumor for the trial. I start the trial next Wednesday. They are also going to send it for tempus testing because my caris testing was done on my mediastinal lymph nodes and my liver mets vs my bone mets /mediastinal lymph nodes don’t seem to respond the same to any treatment I’ve been on.

    werone thank you so much for info. on ARV-471 I pray it works well for me and works well for your wife.

    Cure I think I am going to try the celebrex today. It’s been 48 hours since the biopsy. I had a lot of pain last night in my spine/shoulder blade area. I tried Tylenol… no help…a few hours later… ibuprofen 800 no help… then a couple hours later I took .25 mg of alprozolam and my pain was much better after about an hour and I fell asleep. I have no idea why alprozolam helps my bone mets pain but it does? It’s worked before during a flare. I just don’t want to take it too often so I’ll try the celebrex. Are there any side effects? It says take caution operating a vehicle on the bottle.

  • cure-ious
    cure-ious Member Posts: 2,762
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    Hi MommaCJ! That's exciting and boy I hope the trial works for a long time, we have only had one person post on ARV-471 (AlabamaDee) and that was for monotherapy, where as I recall, it worked and she got like a year on that. Hi to all from Stockholm, boy am I glad to get a fun break, I'm skipping the daytime dose of Verzenio and taking the Celebrex instead, which has done wonders for those SEs. So, yeah, MommaCJ, I do not have any SEs from Celebrex, and quite a bit of arthritis/joint pain relief!!! Please keep updating us on your trial experience!!!

  • luce
    luce Member Posts: 354
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    Mommacj: desloratadine or loratadine help anecdotally with bone pain.

  • bsandra
    bsandra Member Posts: 1,019
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    This is why we need long-term follow up clinical trials: https://academic.oup.com/oncolo/advance-article/doi/10.1093/oncolo/oyad258/7277176?searchresult=1&login=false People treated ~20 years ago with advent of today-common trastuzumab showed 10 % survival up to today. Cleopatra after 10 years also gives stunning numbers. And so many live today who were treated 10, 15, 20 years ago with stage III (who could exactly say non of them were stage IV???)! Future is bright. Let's just hope future is faster here for all of us.

    Cheers and toasts to trastuzumab that just got 25 years old after approval (Sept 25 1998)!

    Saulius

  • cure-ious
    cure-ious Member Posts: 2,762
    edited October 2023
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    A new Nature paper reports on a new inhibitor drug that potently activates the immune system through several routes, greatly increasing the ability of immune cells to get into tumors, prevents T cell "exhaustion", and has good activity (in mice) on its own or together with a checkpoint inhibitor like Keytruda. It is currently in a phase one trial for advanced cancers: NCT04777994 ( available at a handful of sites in the US as well as France, Spain, Israel, and Japan) https://classic.clinicaltrials.gov/ct2/show/NCT04777994?term=NCT04777994&cond=cancer&draw=2&rank=1

    https://www.nature.com/articles/s41586-023-06575-7

  • cure-ious
    cure-ious Member Posts: 2,762
    edited October 2023
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    Here is another press release about the Nature paper mentioned above. The story began when MIT researchers knocked out 2400 genes, one at a time, to see which genes control the anti-cancer activity of different immune cells. They published a paper in 2017 that they saw much stronger T cell and NK cell activity when they removed the phosphatase PTPN2, and this turned on the JAK/STAT pathway. Not only was the activity of these immune cells was much higher, but also the tumor cell microenvironment changed in a way that allowed the immune cells to get better access to the tumor. Then a group at Abbvie developed a drug that can inhibit the phosphatase, and in mice it works both on its own as well as in combination with checkpoint inhibitors to clear out a tumor, which is quite unusual for an immune booster. And now it has already moved into clinical trials for metastatic tumors of various types, which is just amazing progress! At some point, one of these immune breakthroughs is going to be a major game-changer for MBC, hopefully this turns out to be a big one…

    https://medicalxpress.com/news/2023-10-cancer-immunotherapy-candidate-provokes-powerful.html

  • luce
    luce Member Posts: 354
    edited October 2023
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    Cure_ious: The expansion arms of the study zero in on specific cancers, no longer all solid tumors (and not including MBC). Should we deduce that this drug is likely to work better in those cancers? Thanks!

    PS Somewhat incongruously, the call-center phone number listed in the trial is not in service.

    Also, projected primary completion date is October 30th. Still says “recruiting”, though.

  • cure-ious
    cure-ious Member Posts: 2,762
    edited October 2023
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    Hi Luce!! I think this is rather common, they expect and are targeting lung and other cancers that are already known to have some success with immunotherapy. ER-positive MBC is on nobody's radar for immunotherapy, so we are left looking for trials that nominally include all solid tumors. I noticed the quick turnaround for this trial, which I think is a good sign, but didn't mention it because so many of these trials seem to run well past their projected finish dates.

    Trials are so weird. I was looking into the LOXO-783 trial, which is really large and involves multiple countries. Every site had the same phone number as a contact, which was the pharma sponsor, however I couldn't get anybody to pick up the phone and to date nobody has ever called me back (?!?!), so instead I just dug up the number for the site I would have wanted to try. And even at that it took three weeks of call-backs to get to anybody who knew anything about the trial, just to find out they weren't even testing the SERD I wanted yet.

    Now that the Nature paper is published, the trial will presumably be more popular and it could finish up this year, so perhaps there will be phase 2 trials that are more inclusive for the expansion/combination phases.

    Are there ANY immunotherapy trials (beyond PACE) that are targeting ER+ MBC?

  • vlnrph
    vlnrph Member Posts: 493
    edited October 2023
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    There is a KEYTRUDA study, which I had to drop out of after a single dose this past summer NCT03393845. I got the last of 47 spots so enrollment is now closed. Also, in another thread from June 2023 novagirl describes Sacituzumab Govitecan +/​- Pembrolizumab In HR+ /​ HER2 - MBC, NCT04448886.

    Recently I ran across Common Sense Oncology, an international group founded by Canadian Chris Booth MD. He asserts that a worrisome trend has emerged: most new cancer medicines do not help people live longer or better lives and most of our older treatments improve OS and/or quality of life, but most new medicines do not.

    He also points out that “industry now funds about 90% of cancer drug trials”. In 2021 Del Paggio cited more of the history in JAMA. While government grants supported most RCTs (60%) in the 1970s-1980s, by the late 1990s and early 2000s, 57% of trials were funded by pharma. So, there has been a major shift in the past few decades, perhaps not for our benefit…

  • cure-ious
    cure-ious Member Posts: 2,762
    edited October 2023
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    vlnrph, Thanks for that info… Its interesting but maybe not surprising that the govt has stepped back and pharma has taken over most clinical trials. It stands to reason as they would benefit the most out of it. One benefit is that presumably they are the most aggressive to move drugs forward quickly, for the same reason. But at the same time, they will presumably be most interested in early-stage disease, or setting up a trial for first or secondline treatments, whatever would give them largest market, and so we have to be equally aggressive about finding out about, and getting access to, these drugs as best as we can. And then of course, the really innovative game-changing mind-numbingly expensive personalized medicine trials like the TILs is not going to be in their wheelhouse, so we need to push the NCI on that kind of thing…

  • cure-ious
    cure-ious Member Posts: 2,762
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    For those with TNBC- Moderna has made a vaccine that expresses three genes to boost the anti-cancer activity of the immune system. It works on multiple cancer types, works on metastatic lesions (tho there has to be some tumor mass they can get at to inject the vaccine into) and in models makes resistant cancers sensitive to checkpoint inhibitors. Happily they have been going for awhile with a large phase one clinical trial (264 ppl, various cancers), and though it was slated to finish last May there are multiple locations still recruiting in the US, Australia, and Israel. Hopefully they'll update the results soon and come back with a broader phase 2 trial…

    NCT03739931

    Here is the paper: https://www.science.org/doi/10.1126/scitranslmed.aat9143

  • sondraf
    sondraf Member Posts: 1,631
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    Any thoughts as to what surprises we may see at SABCs this year, Cure? I see the preliminary schedule is up, some real interesting stuff in there being reported out (answering a lot of questions I know we've asked on these threads), but Im curious about the mystery panelist guest and reporting on newer MBC drugs in first session.

  • cure-ious
    cure-ious Member Posts: 2,762
    edited October 2023
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    Oooh, oooh, are the SABCS abstracts up already?! Most meetings will post abstracts about a month in advance, if they show them to the public at all. I've been looking for ESMO2023 abstracts, the meeting starts in a couple weeks in Madrid, but haven't found any links yet…

    PS I do see the schedule- good there is a lobular session! It does look like they have a lot to discuss now

  • sondraf
    sondraf Member Posts: 1,631
    edited October 2023
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    Ohher forgot about ESMO - looks like you have to go to the calendar and click in which is… annoying

    https://cslide.ctimeetingtech.com/esmo2023/attendee/confcal/session/calendar/2023-10-21

    There is a drop down search box where you can click on topics. The mini-oral MBC session has a lot of Phase 1a/b five minute updates.

  • lafsunshine
    lafsunshine Member Posts: 50
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    Hello all,

    Just wanted to share my experience regarding the conversation about ER+ and immunotherapy. I was diagnosed MBC in June 2020, ER+ HER2-, cancer found in some lymph nodes, sternum and liver. The tumor from my liver was biopsied for genomic testing. I have the PIK3, TP53, FGFR1 mutations amongst many others. Negative for ESR1. It was found that I have a high tumor mutational burden, (11.1) and also was 50% PD-L1. My first line of treatment was Ibrance and Faslodex, which worked for about 9 months, progression in the liver. July 2021, I then went on IV chemo, (Abraxane) and immunotherapy, (Keytruda). IV chemo was 6 cycles, 12 infusions. PET scans looked good, so IV chemo was stopped Nov 2021. I continued on with the immunotherapy as monotherapy. This has been a successful treatment for me for about the past 2 years. I recently have had a new tumor pop-up in my liver, which has now been treated with SBRT. Fingers crossed that SBRT was successful. I am still currently on the immunotherapy.

  • cure-ious
    cure-ious Member Posts: 2,762
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    lafsunshine- Oh, finally, someone responding to immunotherapy!!! The high mutational burden could explain why you did not go longer on firstline, but you made up for it with the immunotherapy. Richard Finn at UCLA noted shortly after Ibrance was approved that those who became resistant to Ibrance tended to do well on immunotherapy, with the idea that the cancers fell into one or the other category. So many new immunotherapy combinations are coming along and there are TILs and CAR-Ts to watch, so its a huge help to know that you are a responder. I haven't heard of people getting resistance to immunotherapy, it must stop working at some point but I don't know the mechanism, other than they move to different combination therapies

  • cure-ious
    cure-ious Member Posts: 2,762
    edited October 2023
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    ooh, you could add some things, too. If you read the start of this thread, Katty Smith was in a trial where they added a Celebrex(NSAID) because it boosts the response to immunotherapy, and also it strongly inhibits the PI3KCA mutation (basically PI3KCA turns on COX-2 and uses it to boost cancer cell growth, and Celebrex inhibits that)- Here are a couple of links explaining this, it really could help your response!!

    https://news.cancerresearchuk.org/2021/05/26/common-anti-inflammatory-drug-could-boost-cancer-immunotherapy/

    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7056575/

    https://www.oncotarget.com/article/13200/