Are you currently (or have you been) in a Clinical Trial?
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Hey, CBL, I've been wondering how you were doing on this trial, and I'm sorry to hear if its not in fact working… I forget what you have and haven't tried before, but I have been wondering if Bria-IMT works primarily because it expresses some Her2 to direct the immune system to attack (evidenced by the strongest shrinkage is in Her2-positive patients. If so, would Enhertu be an option? have you tried Elascestrant? and my last question was did you say that MD Anderson was an option for you?
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Hey @cure-ious
I’m hoping I’m wrong and just overreacting but we’ll see Wednesday with tumor markers.
I’ve already tried Bria-IMT and that slowed it down but I still progressed. I haven’t tried elacestrant yet but that will likely be next.
I’m HER 2 (0) so no Enhertu.
MDA is an option but would require air travel and I’m not sure I have enough time to wait for that process. I’ve been there before and I did not like the trial process. They basically sent me paperwork for a trial and that was that with no opportunity to ask questions or request a different trial.
I will be switching primary oncologists to UT Southwestern. They don’t have any trials for me right now but I feel better about SOC with them moving forward.
If I can squeeze in one more trial before I need to return to SOC, then Ill try for an Aurora A inhibitor or something I haven’t heard of yet. I don’t know if that KAT6 one will work and that would require air travel so I probably won’t do it.
Maybe I’m totally wrong (again) and this is working fine. Or if it hasn’t gone up over 100 points I’ll stay on it. Over 100 I’ll wait two weeks and scan. Over 200 immediate scans.I’ll keep everyone posted.
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Fingers crossed for your TMs!!! Also, Elascestrant is of course great, plus FDA approved Enhertu for both low and ultralow, which I thought meant basically zero? It works about the same in both groups, subdetectable Her2 expression can be sufficient…
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ooh I’ll ask about enhertu. That would be awesome.
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Hey everyone,
Okay, here's the deal: (for now)
—Tumor markers jumped 250 points to 810. The highest they've ever been is 1200 and I landed in the hospital. The doctor gave me the 'tumor die-off' song and dance so we agreed to scan at 8 weeks (23 more days) instead of 12 unless something happens before then (liver pain comes back, etc.)
—My alk phos DROPPED 55 points from Monday to today (day after treatment) but my AST jumped 24 points. I got them to agree to ordering a CMP in two weeks instead of four so I can at least have a little peace of mind that my liver isn't being shredded
—I have an appointment lined up already for the week after my scans with a new doctor at UT Southwestern. He specializes in metastatic breast cancer and runs phase 1 clinical trials. I think with my markers getting so high, trials are on hold until SOC can beat it back.
That's what I know so far. It's still possible TTX could pull through for me but it's not looking good.
Thanks for the support!
CBL
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CBL, maybe the new MO can order some new genomic testing as well, to look for actionable mutations? depending on when you were last tested, the newer tests may check for more mutations…
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Dear CBL, uhh, I am always wondering why it is not a common practice to just send you for 10 minutes to ultrasound department and check the tumor situation. I am repeating but in LT we always have ultrasound checks and then records - easy peasy, quick, non-invasive, cheap… one of the best approaches we have faced - very simple and effective, and the record tells you where to look. It would make it so much easier and quicker to follow the disease and make decisions… ehh… Many hugs to you, Saulius
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On another note - in Lithuania we just got Enhertu, Lynparza, Tukysa, Piqray, Verzenio and Trodelvy approved for compensation in one batch - biggest approval in years. So great for our patients, I am celebrating tonight!:) Saulius
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Hi Saulius,
It's so funny, I was thinking this exact same thing yesterday. Just do an ultrasound! But no, I had to wait 11 hours in the ER to get any answers. And how wonderful for you to have all of those drugs now! Yay!! It must've been frustrating to know they exist and have trouble utilizing them.
Thanks for the support!
CBL
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Update: I'm never going to the ER again.
I woke up yesterday with more liver pain under my sternum. The trial nurse and my new MOs nurse both said go to the ER. I did NOT want to go—the pain wasn't that bad and I already knew what was causing it—but I went anyway. Figured I could at least get the CT that my trial doctors are hesitating on.
11 HOURS LATER, I finally learned, "Your liver lesions have grown and that's what's causing the pain."
I will never go to another ER again unless it's on a stretcher or the doctor has called to admit me. Never again.
To top it off, they used the scan from 12/24 instead of 1/25 so I don't even have an exact comparison. From Dec '24 to now, the tumors have grown quite a bit, but I need to do some math to figure out how much they've grown since the trial baseline. I think it might be less severe than I thought, However, when you have innumerable lesions and they all grow half a centimeter, that's a lot of dang centimeters!
I moved my appointment up with my new MO to March 14th to discuss the trial and new treatment. I told the trial I wasn't comfortable waiting until week 8, because the MO is only in the office on Fridays (his staff is there all week) and that would delay SOC for 40 days and I can't wait that long. The trial people said they couldn't get a scan approved that early, so if we can get the right images together and compared then I'll have my answer by the 14th.
That's the update for now.
CBL
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Dear CBL, uhh, tough tough days for you:/ My heart bleeds when I read what patients have to go through - to keep people with liver pain in ER for 11 hours just to tell them what is known to them is not right. We are with you and fingers crossed for tomorrow. Please let us know how your appointment went. Hopefully some decisions will be made asap. Many hugs, Saulius
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Hi @bsandra Saulius and everyone,
It has been a time, I'll tell you that!
In recent news, the day after my last post, I cleared my throat (I'd been slightly hoarse for a week or so, but 95% fine) then my voice was gone. Went to an ENT—I have a paralyzed right vocal cord—he said we need to check for cancer growing in my neck compressing the nerve. I have a ton of cancer in my neck nodes that has already knocked out my right arm and given me Horner's Syndrome in my right eye. Why not take my voice too? Sure, go ahead.
At last check, all the cancer in my neck was dead, so I don't know what the hell is happening there. Sure hope it's not brain. I have a neck/chest CT scheduled for Monday to check it out.
I had an appointment with my new oncologist on Friday, and he has prescribed Orserdu, and wants to biopsy any new tumors I might have in a search for HER2 and mutations (I'm currently HER 2 (0)). Of course, I STILL don't know how badly or even if I've progressed to go off trial, but I'm guessing since my voice is gone, I have progressed considerably. I want to just say to hell with TTX regardless of progression, but then I read the press release and think maybe I should give it more time. But how can I (if) it's damaging me and growing?
The problem is I can't go officially on Orserdu until I'm officially off the trial and I won't know anything even tentatively until Wednesday. I have another appointment with my new oncologist on Friday to discuss biopsy/progression.
I also have Signaterra results due on Tuesday. They were 65 last time. I anticipate a ginormous jump.
So I'm still in limbo waiting…waiting…waiting. But I will have a clear path by Friday. The real plot twist would be if this damn stuff is suddenly working.
Oh, and I landed in the ER again Friday night (a freestanding facility that I was in and out of in 2 hours, not 11) for bronchitis. Apparently, with a paralyzed vocal cord, you can't cough properly. I sound like a 90-year-old man. Another clue to the ineffectiveness of the trial is my liver numbers are up again, and I think my alk phos as well. Sigh.
Sorry to complain, but thought I'd give an update on where I am in the trial process.
CBL
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Oh, CBL, you have truly been through the wringer!!! I'm not sure I even follow all of what you have been through in the past few days. Obviously, you are off the trial if you want to be, so it will be your call, but what is it you want to know? Didn't they already do the scans to check for progression (or you mentioned getting a comparison to the last scan?)
Orserdu is great, there are many who have been on it a year or more just as monotherapy esp those who did well on CDK4,6i. What is the press release about TTX that makes you want to stay on it? have they now identified a therapeutic dose? Can you ask for more info from the pharma on exactly what they have measured in terms of pharmacokinetics of the miRNAi in your system and your TMs and other responses from their blood draws?
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I wanted to mention I have joined a clinical trial at MD Anderson w/ Dr Timothy Yap, who heads their phase one studies division. I was on Orserdu since last August, but TMs were going up, which is not particularly surprising because my cancer has both ESR1 and PI3KCA mutations, and the mutant Pi3KCA kinase shortens the time to progression on Orserdu, as well as many other endocrine therapies. I was actually the first patient dosed (!!) in a new trial testing a mutation-specific PI3KCA inhibitor, SNV4818. I thought about everybody here as I downed the first two baby pills, happy to be moving drugs through the system when so many are waiting, and hoping its a success. They will do scans are every two months, and don't book out further than that until they see if there is a response. So, its just their starter dose, but happily no side effects so far, just a couple of weeks in.
Here is a link to the trial. There are sites at MD Anderson and Sarah Cannon (Nashville), as well as Ontario, Canada and a couple in Australia.
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woohoo!! Best of luck cureious!
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@cure-ious Oh yes, I was following Dr Yap's promising research. That's exciting. Sorry to hear about the hell you are going through @cblaurenceauthor
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CBL, Inspired by you!!!
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Hello and thanks for the support, everyone:
So the scan situation is confusing. I had scans in 12/24 and 1/25 and 3/25 (ER). But the comparison report was from 12/24 and the ER. So I don't know how much or if I've progressed since 1/25 (the TTX baseline). So in theory, the TTX might be working, I can't prove it either way.
In reality, I believe it's not—tumor markers up 250, loss of voice, liver numbers up—but I can't say for sure and I won't know about the possible neck mets until Wednesday and liver mets until Friday.
Before this latest vocal cord situation, I'd told the trial people I'd consider staying on TTX at a higher dose. So now that cohort 4 has been cleared, I might have that option. And the person who's been on it for 7 months might actually be at my facility—they told me they have a man who'd been on it for 5 months already and that was a while ago. (prostate cancer I believe).
No one wanted this trial to work more than me, and I don't want to give up too early, and I definitely can't give up without knowing for sure that I've had significant progression. Then I won't have a choice but to drop out and start Orserdu.
I've asked about the miRNA-10b levels they found during screening but they won't share that info.
So happy to hear that Orserdu could be a good one for me—I was on Kisqali for 23 months I believe, so I did well on it.
I might not be the best trial candidate because the waiting and wondering makes me crazy!
Best of luck on your new trial and believe me when I say you are a huge inspiration to all of us here!
CBL
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Oh, that's VERY good news that somebody has had success with TTX at the dose you are taking (or at all, given it is an entirely new class of drug!), and that you might be able to get a higher level if you stay-surely the scans will make things clearer..
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@cblaurenceauthor so sorry to read about your vocal cords, and all of the physical and emotional ups and downs. You have been through so much. So much to carry, sending hugs and more hugs to you as you wait to figure out the best steps to take. Perhaps your new MO has the recent scans to compare and can best advise whether to stay on the trial and for how long based on what they see. Then you can decide with the most up to date info you have, weighing the pros and cons with your MO and the trial doctor. Waiting is so hard on the mind and the body.
@cure-ious that’s great news, so glad to hear about this trial. 🙌
❤️ to all. Rhonda
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@rlschaller Hi Rhonda,
Thanks for the hugs! Yep, the plan is the new MO will discuss the scans on Friday. If my tumor markers weren't so high right now, I'd consider staying on, but they're over 800 and I received my Signatera test results today:
At my sickest last year, my ctDNA was 1500. Now it's 2500.
So I will prepare the trial people on Monday that I want to be taken off and will do what I need to do (give final blood or sign papers or whatever) on Friday/Monday after I speak to my new MO.
Tom Petty was never my favorite, but he was dead right when he said, "The waiting is the hardest part." :)
CBL
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Uhh, dear CBL, the voice chord… could those be some side effects from TTX? I completely agree with you that the waiting is the hardest part:/ My god, I am so frustrated when I know a simple ultrasound could answer these questions in minutes:///
Dear Cureious, all the best in SNV4818 trial! We are all looking forward to hearing from you about good results in the nearest future.
Hugs to everyone and happy Monday,
Saulius
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On today's episode of Cancerland…
tl:dr—I still have no idea what's happening.
So the neck scan came back: from what I can tell there is NO cancer. Apparently (if I'm reading correctly) there is soft scar tissue compressing the blood vessels and nerves coming out of my neck. Great news, right? It points to no progression, but how do I get rid of the scar tissue? Can I have surgery while on trial/Orserdu? If I wait will the vocal cord paralysis become permanent?
The chest scan came back clear, except there are numerous lymph nodes that have grown around my lower abdomen/liver that weren't there 9.03.24. Were they there at TTX baseline? Hell if I know. I brought them the 1.23.25 scan disk to compare to but they didn't use it. So I'm waiting again for the right information to come together.
Also, my Signaterra jumped from 65 to 2500. But I read that it could also be cell die off. So for all I know, TTX is working like gangbusters (which is obviously the best case scenario). They've dragged their feet so long giving me an answer for the liver progression, I might as well stay on trial and wait for the 12-week scan, or if the liver scan I had earlier this month is bad, then get one at 8 weeks and give dose 2 a chance to work. Dose 3 is only 2 weeks away. I've waited this long, maybe I should give it another go.
The chest CT said my liver was less than 10% tumor in September, but is now 30-40%. At my sickest, it was 60-70%. (that means Halaven knocked the cancer back like a boss) I'd prefer to stop it now, but technically, I have room to grow.
Everything has double meaning, and I'm jumping to all kinds of conclusions. I tried to be proactive and advocate for myself, but I wound up wasting people's time and jumping the gun. It's been an extraordinarily frustrating two weeks and I still don't have answers.
Moral of the story: Don't panic, be patient, don't jump to conclusions, and don't freak out. In other words, do the complete opposite of what I've done.
Thanks for listening to the rant—I'll try to restrain from ranting and let you know what's happening with the trial on Friday.
CBL
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@cblaurenceauthor, Barging in here but your vocal chord paralysis sounds like it could be fibrosis caused by radiation (if you had it) or drugs (chemo, immunosuppressants, tamoxifen, biological agents that treat cancer.) I simply had whole breast and axillary radiation. The scatter managed to get my right lung, esophagus, thyroid, intercostal and bracheoplexus nerves and, most recently, possibly my liver. Someone else who posted a while ago had one side of her diaphragm paralyzed due to rads.
My thyroid surgeon sent me to a specialty ENT surgeon at the laryngeal surgery and voice rehabilitation clinic (at Mass General but such departments probably exist at other large hospitals.) I can speak, not to my thyroid doc's standard, but no longer can sing due to areas of fibrosis on my right vocal cord.
I did vocal rehabilitation which can help but surgery doesn't solve the problem because it is systemic and can spread. My pulmonologist said this rare reaction is due to an over response to TGFB1, transforming growth factor beta-1, which heals injury but in certain people can go wild, scarring tissue in a cytokine storm so that it loses its ability to function. Steroids can heal it during early stages (like pneumonitis) and may prevent it from spreading. I use a steroid inhaler, fluticasone propionate 880mg/day, which helps my horrible cough but I'm hoping it will also prevent pulmonary spread. Clinical trials in China and Mexico were proposed to test this but never ran due to lack of participants. My reasoning is if two different research groups thought it was a good idea it may work. I think the mist hits my vocal cords on the way down to my lungs. Of course, steroids have their own side effects.
I hope you can find a doctor to help you get your voice back. You are certainly due a break from the universe.
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@maggie15 Oh wow! Thanks for posting. I still haven't heard from the ENT, but yes I had a ton of radiation on my neck nodes in Feb 2024, so over a year ago. That side of my neck is very hard and scarred. That is definitely one of my questions: will this continue to scar or can I have surgery to remove it?
What spreads and is systemic exactly? The scar tissue?
How awful that you had that much scatter! Wow! I'm sorry to hear about your voice. So you were diagnosed with scar tissue as well?
The coughing is horrible. My lungs are totally irritated because I can't cough anything up.
Thank you for posting your story. I have good questions now to ask the ENT…if he ever freaking calls.
CBL
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The over reaction to TGFB1 is called Radiation Induced Pulmonary Fibrosis if you want to read about it. In some unlucky people that gene over produces the protein of the same name which signals proliferation, differentiation, motility and apoptisis of cells. It is necessary for healing but if protein production doesn't stop when the wound is healed the continuous production of collagen also turns uninjured tissue into scar tissue. That means lung tissue can't expand and contract, vocal cords lose their ability to vibrate, and tissue becomes hard and presses on nerves. How to turn TGFB1 on and off is still a research project. According to my pulmo it can start (or restart) many years after rads. The diagrams of the biochemical processes are some of the most complex I've ever seen. Cure-ious could probably follow them better than I can.
Most doctors aren't familiar with this but my RO referred me to an ILD specialty pulmonologist who knew what was going on. The ENT might be familiar with it as RIPF is a common side effect in head and neck cancer treatment. I don't know if a steroid inhaler would help but it may be worth a try. Incidentally, the wall at the MGH clinic was covered with signed photos from many famous performers who were thankful for their vocal rehabilitation (I'd have never known they had issues.)
Fingers crossed that the ENT gets back to you soon.
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Great information, thank you so much. Hopefully good news soon!
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Does anyone have any experience/info on the Serena-6 trial? This is a recent press release https://www.astrazeneca.com/media-centre/press-releases/2025/camizestrant-improved-pfs-in-1l-hr-breast-cancer.html
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Hi everyone,
Here's the final word on the TTX trial:
My RECIST score from the baseline to 2 days after my second dose was 12%, so considered stable. If I'd had that information two weeks ago, I'd probably still be on the trial, but as it is I am off trial officially on Tuesday.
I'll be starting Orserdu tonight.
For all I know the trial is working, so I don't want to discourage anyone from trying it if you can. It was extremely easy with no side effects. I just don't think I have the temperament for trials—I'm too high-strung to be patient. Maybe I don't have the temperament for cancer in general…so there's that too.
My new oncologist said it was up to me, and as a trial doctor, he'd say stay on, but as a patient advocate, he said quit the trial. I hope I didn't make a bad decision, and if I did, I hope I never find out. :)
If I had bone only cancer or node only cancer, I might have stayed, but it's in my liver, and liver can go fast. I may do another trial as a last ditch effort, but I think for now, SOC is best for me and my mental health.
Thanks for all the support and patience in this thread. Hope my crazy posts were helpful! Best wishes for all of our health and some kind of treatment that will work for all of us.
CBL
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@cblaurenceauthor I really thank you for your willingness to go on a trial and add to the knowledge. I wish you a very effective treatment on Orserdu.
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