Are you currently (or have you been) in a Clinical Trial?
Comments
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GG27-so glad for abraxane approval and no reaction. ๐๐ป๐๐ป๐ช๐ป
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 donโt 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. ๐ Getting a speech evaluation tomorrow for word retrieval issues. I requested a referral from my PCP after reading an article on palliative care. Iโm 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.
Dee
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kinda surprised by this because pembro and abemaciclib was a bust:
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wondering if that means low-carb diet or metformin could increase response or delay or reverse resistance:
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this is what I'm planing to try next. My oncologist is intrigued and willing to help:
Batshit author and def full of questionable ideas but raises some interesting points:
http://haidut.me/?p=1380&fbclid=IwAR2o9Z5jOoQ-nK8TYOUrWZk12FUcEwdWUfSAAY6W-8pAhJvnn_h0diRocrU
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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. ๐
Dee
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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?
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- I would just get it off label or buy it, not join a trial. Or try Masteron. Iโm currently pausing Verzenio but I may restart and combine. Or combine with AI.
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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!
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I did not respond to Verzenio unusually long. Iโm 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.
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Oh, I see, since you said you were now pausing V, I thought that meant you'd been on it continuously...
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yes, Iโd been on it until recently because one of the oncology strategies post-progression is staying on it while adding other drugs
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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.
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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...
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Cure-ious - With the statin/PTEN research, have you come across any data that compared difference in effectiveness between pitavastatin and other statins?
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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.....
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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
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Thanaks for your helpful info as always, Cure-ious
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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
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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.
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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.
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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.
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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.
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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 ๐ค๐๐
I go to my trial check on Monday. I will see what the Dr Hamilton says about how this will affect the timeline
Dee
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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...
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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?
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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
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oh Dee that report must have felt like a gut punch. I hope you get a good plan forward.
AlabamaDee -
(((((GG27))))) please keep us posted. We're routing for you and sending good energy.
Your Mods
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Dee, Iโm 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
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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
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