Are you currently (or have you been) in a Clinical Trial?
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Well, here is something exciting, just published in Nature Communications:
This is preclinical (studies in mice)- researchers treated TNBC with radiation and immunotherapy (anti-CTLA4) and saw T cells enter the tumors, but nothing much else happened to shrink the tumors. They then added on Keytruda, which didn't help. they then added a CD40 agonist antibody- these antibodies stimulate dendritic cells, which are the first step in the killing of cancer cells- these are cells that eat the tumor cells and extrude cancer proteins on their surface to activate and target nearby T cells. the results were dramatic and most of the tumors went away.The three-pronged therapy resulted in complete or almost complete elimination of targeted tumors, as well as partial control of tumors that were not targeted by the radiation. However, the approach was not effective in eliminating micrometastases that had spread to the lungs. So not a cure but maybe a big step forward to make immunotherapy work in TNBC. A clinical trial is planned for MBC as the next step forward.
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And we have not discussed yet that there was big news in Sept when BioNTech's bispecific PDL1/VEGF antibody beat out Keytruda when combined with chemo as first line treatment for metastatic TNBC…
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Quick question about adding on Celebrex - can I do that if I am on blood thinners? Im desperate for an anti-inflammatory of some, any kind to reduce the hip swelling at night and NSAIDs are a no go (look, Ill admit to using Voltaren gel and when I really could care less, Ill sneak two Advil, which do more for me than all the stupid opiates) due to bleed risk. Onc mentioned Celebrex possibly waaaaaayyy back in January but that got lost amongst the other issues this year.
Ive also not been offered any sort of clinical trial but Im still bone only and my cancer center works pretty exclusively with AZ. I went through some of the back pages of this thread to October, but it doesnt look like there is anything good testing in the UK coming along for ER+ /HER2+ cancers?
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Sondra- Celebrex is an NSAID, so probably not good with blood thinners? - you might try MSM supplement as a safe anti-inflammatory?
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Dear Cureious - regarding the Patina trial: yes, it is for HR+/HER2+, and the choice to block additionally ER was so obvious but it needed proof. Some patients that I know get tamoxifen in addition to HP but getting palbocyclib is something much better. Everyone was afraid triplet would cause huge SE, as for some palbocyclib alone is not a gift but this study did indeed prove that it is not the case. Human body is amazing and so unpredictable that it is really hard to know what would be that universal magic bullet. I am also very happy that treatments start to interchange - HR people benefit from HER2 treatments, and HER2 people - from HR! That is the way to go! Hugs,
Saulius
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2023: The median cost for a pivotal (i.e., phase III) clinical trial is $48 million, with an interquartile range of $20 million to $102 million. The same study calculated the average cost per patient to be $41,413 in pivotal clinical trials….
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MommaCJ- I wonder if you are still considering immunotherapy? A PDL1 score of 100% is super-rare! I forget if the cancer is ER-positive or - negative, and did they measure the tumor mutation burden. I was thinking of you when I read about a bispecific PDL1 antibody (binds to both PDL1 and Her2) that attached to cancer cells through both protein interactions as a result it binds more tightly, is targeted to the cancer more precisely, and is more effective. Stronger than Keytruda with fewer side effects! I was thinking maybe they could use that for Her2-low cancers also?
PS Were there any other mutations that might give a clue as to why the PDL1 levels are so high?
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@cure-ious thank you for the 2 articles on news highlighting research with TNBC. As a TNBC / MBC gal, I am particularly on the lookout for clinical trials in this area. I am working with a doctor at MSK, who is looking should my current treatment stop working. So far so good though, love learning and appreciate your knowledge, and everyone’s comments and contributions here. Happy holidays everyone.
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Sondraf
I have been on Celebrex (100mg 2x/day) for 2.5 years for arthritis pain. Almost 2 months ago, after reading Chicagoan's and cure-ious' discussions about it, I added 2000 mg of MSM with my MO's approval. I take it in capsule form as I never believe the ads that say to mix it in a liquid and you won't taste it. I think that I'm beginning to feel some subtle improvement in energy levels and decrease in skeletal pain. I have been on Kisqali/faslodex/xgeva for 2.5 years and hope to stay on it longer - fingers crossed for February scans - as I am able to lead what I think is an active, normal life for a 74 year old.
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Eleanora, Yaay for being an active 74 y/o!!! I hope to be able to say that one day, a few years down the road…
I thank very much whoever (Chicagoan?) suggested MSM supplement- after years of ET plus CDK4,6i and moving to Elascestrant, taking MSM has done a miracle on my nails- they are growing like crazy, no peeling, deep ridges almost gone and indeed they are longer and much stronger than they were before cancer, its a bit hard to trim them…MSM supposedly also has some anti-cancer and anti-inflammatory activity..
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rlschaller, will keep an eye out for TNBC stories, there's a lot going on right now in that area, obviously
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Cure-ious-My nails are still a problem. How much MSM do you take and in what form? Thanks!
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Wow! Great stuff for TNBC!
I have my Bria-IMT treatment this week and scans on Friday 27th, so I'll have lots of news after the first of the year. Hopefully about moving to a new trial, or in what would be a total shock to me, news that this one is working. :) My liver numbers are all normal/dropping except bilirubin which went up from .3 to .8 and my ALP jumped another 20 points, so I don't know what the heck is going on in there. Tumor markers will be in Thursday and that might be a doozy.
I have an iron in the fire about this one:
Apparently, I have quite a few oncogene amplifications: FGFR1 for sure and indeterminate MYC & EGFR. My problem is a history of pneumonitis, so I have a question in about it. It was 2.5 years ago, so maybe they have some wiggle room. Also, a lady in my Facebook group is on this trial, and said she had "slight reduction in lesions" on her first set of scans and it's the best result she's had since going metastatic. So I'm definitely interested in in. It started in 3/2023 so it's been around a little bit. And it's a pill and 15 minutes from my house, so thumbs up all around.
The TTX-MC138 trial is screening for its third cohort. The article said, "Despite the fact that responses have not been observed yet, and some investors might be disappointed, H.C. Wainwright notes that the initial cohorts are likely below therapeutic dose levels. It is also highlighted that the study is still in the early stages of dose escalation with only three patients enrolled in each cohort."
So if it's not yet at therapeutic doses, and I don't know if anyone knows when that might be, then I'd rather wait and try something else.
That's the update for now.
A very Merry Christmas to all of you and let's all hope we get a big fat break this year from Santa, and the happiest and healthiest of New Years!
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Chicagoan- I take the crystals, a teaspoonful (about 3.5g), 3-4 x week, and it took awhile because my nails were in really bad shape
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Cure-ious-Thanks for your response. I take the same amount, 7 x week but my nails really struggle. They keep cracking off so I have to keep them very short. But, in the grand scheme of things, the appearance of my fingernails is the least of my worries! Happy Holidays everyone!
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Hi Everyone. Would anyone have a recommendation for a second opinion ideally with an MO active in clinical trials. I'm at Msk and trust my MO but things have taken a downturn with my liver in the last month and I want to be proactive.
I did quite well on a clinical trial (rly2608) for almost 2 years, went on Truqap which failed after 5 months (liver #s blew up) my MO wanted me on Xeloda asap. It's only been 4 weeks but not feeling positive. Liver pain and tightness. Mentally, I'm trying to push through (always a challenge with discomfort). I've lulled myself into forgetting that things can change so quickly. My MO's office has been very responsive despite busy holiday hours (I got an abdominal scan 2 days ago and waiting for results).
Any recs would be so appreciated
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Thanks for the cheer! I hope you get to have an active life for many years. After reading the messages between you and Chicagoan, I realized that I'm not taking a large enough dose of MSM and so have increased it to 3 capsules= 3 grams every day. My nails are exactly where yours were - deep ridges, cracking and splitting. While I agree with chicagoan that it's not a terrible problem in the overall scheme, I would be grateful for some improvement.
Happy New Year to all.
Eleanora
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SmallMoments,
Enhertu might do well to get things under control till you can get in another trial? Hope someone has a second opinion referral at MSK, Good Luck!!!
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Eleanora and Chicagoan,
While MSM has been a godsend for fixing my nails (and then some!) I have been taking it while on Elascestrant without any CDK4,6 inhibitors, which surely were part of the problem
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Cure-ious-That's probably it. I am still on a CDK4-6 inhibitor, which I think is a big part of the problem. But, I'll take it over the alternative! I'm still hoping for a cure in our lifetime where we can go off the drugs eventually.
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I'm with you, Chicagoan!!!! Where is the big fix for this? This no-fun "cancer game" has us jumping all over the place, twisting ourselves into pretzels trying to figure out what might be a best next step or a fix for side effects. I'm sure the MSM is responsible for fixing my nails, because they are way stronger than they ever were in life before cancer. So, at least appreciate that you can and will fully recover your nails, without peeling, breaking, deep ridges, once you are off CDK4,6i (and before later CDK2,4i therapy!)
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SmallMoments, Wanted to add that my MO says they have seen some remarkable responses to Enhertu. Is the cancer still endocrine sensitive? If so there are a couple of trials with new CDK2 and CDK4 inhibitors that could be useful, and I am looking around for any extension of the observation that PI3KCA inhibition combined with PARP inhibition works on many MBCs regardless of whether they have PI3KCA or BRCA mutations. The issue was the way it was discovered was using drugs where the combination was too toxic. But I hope they follow up that combination idea. And there are other experimental things, but it sounds like you need to get more stable first?
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Cure-ious,
A possible big fix…..Just listened to an interesting discussion between Dr. John Campbell and Dr Angus Dalgleish on YouTube about a type of treatment developed from mycobacterium that boosts the innate (cell-mediated) immune system.
https://www.youtube.com/watch?v=EIEC6L9ZK0c
Dr Dalgleish is an immunologist and oncologist whose practice has focused on melanoma, but he says this immune boosting product is expected to be effective against several different solid tumors. He makes clear it is not a cure, but by boosting natural immunity it makes other treatment modalities like surgery, radiation, and chemo more effective. Unfortunately, he reports the company that was ready to start production has run out of money.
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Hello all and Happy Healthy New Year!
I had my second set of scans from Bria-IMT trial and as expected mild progression. I won't have an official RECIST score until Tuesday, but I'm done with the trial. At least it might have slowed it down some.
I don't know what my next move will be—mostly depends on what's open. I'm sure I've said all this before, but my preliminary options are:
TTX-MC138: They just opened their third cohort, but they only take 3 patients I think, so probably out of luck there.
BG-68501 (CDK2i): This was an option, but I just read they had anti-tumor activity in CDNE1 or RB1 cancers, both of which I don't have. There was a 1% response in ER+ so it's a no-go for me.
JAB 2485 (Aurora A): I'd love to be on this one. It's Phase 2 and I might have an AURKA amplification.
BBI 355 (FGFR1): I've had pneumonitis, so probably won't get on this one, but I have EGFR and FGFR1 and MYC, so I'd love to be on this one too. Also, anecdotal evidence from a lady in a FB group of efficacy.
CT-7439 (CDK 12/13): Per cure-ious this is on my list. Will do more research.
KT-253 (MDM2): I know nothing about this one.
NUV 1511 (ADC): I was preapproved for this one but had already signed on for Bria. Don't know much else.
I will be researching what I can and alternatives as well this weekend. Things won't be 100% back to normal for another week, but I hope to know something soon. My tumor markers only went up 13, so I'm a bit more calm than I was 3 weeks ago. :)
CBL
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WendyinWI:
Thanks for that link! In a similar vein, there are a flurry of stories out now about a poster presented at SABCS, in which they looked at the effect of tumor mutation burden (TMB) on responses to Keytruda, and found for Er-positive MBC patients with TMB of 10 or higher, taking Keytruda was as good or better than taking chemo, and reminding people to not automatically discount that they might benefit from immunotherapy. I also saw a paper that indicated that people with TMB over 14 had a 60% response rate to immunotherapy (not sure how many of those were ER-positive v ER-negative).
https://www.medpagetoday.com/meetingcoverage/sabcsfuturefocus/113567
So keep an eye on the TMB number in the genomics reports, as it can go up with time. My latest cancer biopsy came back with TMB 39, very rare, so I will definitely want to give it a shot at some point. And MommaCJ's report came back with a surprising 100% PDL1 positive, very rare, so while it is true that most Er-positive MBCs do not respond to immunotherapy, there are some responders (including kattysmith who started this thread, who got 7 months on Keytruda) as well as Keytruda combinations with other drugs that are improving the results.
Also, there is a new antibody that binds HEr2 and PDL1; might be more specific than Keytruda with fewer side effects, and some speculate it might make a new Enhertu-type drug
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Happy Healthy New Year, CBL!!!
Great that it was "mild progression" and not freak-out-time!
Let us know what you find in the world of clinical trials…
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@smallmoments I don’t know if this is helpful, as you are already at MSK. But I’m working with Dr. Pedram Razavi at MSK, who runs a few clinical trials . I went to him for a second opinion ( my main MO is at Northwell) and to be on his radar for clinical trials, and I see him monthly, as a consultant for my care. I really like him and his expertise is in liquid biopsies, if that is helpful. Here is a link
Wishing everyone a happy new year and a joy filled start to the year. ❤️ Rhonda0 -
To All,
I just read about Zanidatamab/Evorpacept combo for Her2+ breast cancer as reported at the San Antonio Breast Cancer Symposium in Dec 2024. Read more at ClinicalTrials.gov NCT05027139. I also talked with a pharmacist at JAZZ, the pharmaceutical company that developed Zanidatamab. He described the drug as a Her2 directed antibody. The medical facility where I get care (UW Wisconsin Madison) is running one of the Phase 1b/2 studies. I think I might be eligible, but as far as I can tell recruiting is closed. I see my oncologist tomorrow Jan 7 and I'll ask about the study.
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Hi WeninWI,
I was just reading about ZW-25 a few days ago, it is a bispecific antibody (ie, binds to two different sites on the Her-2 protein, so very precisely targeted) and it clusters the Her2 on the cell surface which can lead to it getting degraded or internalized back into the cell and be inactive. How interesting that it is being tested for Her2-low cancers, I have put it on my list for whenever they announce their next trial…
A somewhat similar trial I am following is DF1001, which also targets Her2-low (and Her2-positive) and is offered at Madison, I think this is a tri-specific antibody that then engages Natural Killer Cells so has immunotherapy activity too:
https://www.clinicaltrials.gov/study/NCT04143711
The company is Dragonfly, founded by Tyler Jacks, one of the most highly-respected cancer biologists in research circles.
Its in phase two, here is phase one summary:
DF1001 was well-tolerated with no dose limiting toxicities during dose escalation in the Phase 1 study. The study showed encouraging pharmacodynamic effects including infiltration of NK cells and T cells into tumors. DF1001 also demonstrated clinical response as a monotherapy and in combination with nivolumab or nab-paclitaxel, with tumor burden reductions across several solid cancer types representing both HER2-low and HER2-high, and heavily pre-treated patients.
Dr. Emanuela Romano, Director, Center for Cancer Immunotherapy at the Institut Curie in Paris "These early signs were seen at doses notably below the dose recommended for Phase 2."
"For example, we have seen RECIST responses in multiple tumor types from patients receiving DF1001 monotherapy and in combination with Opdivo and Abraxane, starting at very low doses, including in patients with low HER2 expression or in patients with high HER2 expression who had progressed after they received a full series of other treatments including ADCs such as Enhertu®."
It would be great to learn any recent info about this trial!
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Dear WeninWI, dear Cureious, I have also been observing ZW and DF platforms for some time and am happy they are moving to phases 2/3 but, actually, I expected them to go into phase 1-3 clinical trials much much earlier, as both platforms are way pre-Covid. It is interesting though that Dragon Fly has always done it on their own, without cooperation, and maybe that is why it all takes so long. I am not very good at markets and finances but I know people look directly into market/share values of these companies to check and compare how much prospect a drug/platform has, and some of the platforms that seemed pretty cool (I do not want to mention here for obvious reasons), were worth not that much and sponsors/investors were not fighting for them. I do not particularly like this approach, of course, as for sure some very good drugs do not reach us at all because of that (too cheap to research, produce, sell) but in this cruel world one of the approaches could be to… "follow the money", right? It would be interesting if someone who knows these things, could check what happens with ZW and DF looking from this perspective? Hugs,
Saulius
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