Are you currently (or have you been) in a Clinical Trial?
Comments
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Yes, thanks for the news cure-ious even though it is not what we wanted to hear. Glad to see you back here!
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Cure-ious - Thanks so much for taking time to make your way through the bco site to keep us informed. We all appreciate you sharing your info! yeah, this news is not what we were hoping for. I hope elacestrant keeps moving forward.
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Well that’s a huge disappointment. I have been hoping that it would open up an additional option for me, particularly ARV-471. However, not sure as I was on Faslodex for three years. Thanks for the update Cure-ious.
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How wonderful to see a post from you, Cure-ious!
So many SERDs in the pipeline and we were all wondering what was taking so long. I hope that some of these other SERDS will be able to pass:
OP-1250 CERAN by Olema Pharma - complete estrogen receptor (ER) antagonist (CERAN) and a selective ER degrader (SERD)
AZD9833 - Oral SERD. Trials with Ibrance and vs. Fulvestrant
G1T48 (Rintodestrant) - Phase I trial showed superiority and safety as a monotherapy or combined with Ibrance
LSZ102 - Just completed Phase II trial including arms with Ribociclib and Alpelisib
LY3484356 - Early phase II data showed efficacy.
Hugs, Susan
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Cure-ious, that is a huge bummer, indeed. Thanks for posting.
Apparently there will be no oral SERD in my future anytime soon. My only consolation is that I can still salute fellow members of the Fasodex Fanny Pack with our time-honored motto: Bottoms Up!
Tina
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Cure-ious- I heard a talk recently where they said that the Fulvestrant doesn't really last 4 weeks and throught the oral SERDs might succeed in that they can be given at higher doses and more frequently, They said receptor starts to work again about 2 weeks after the fulvestant shots- I was so hopeful!
Hope Susan is right and some of these other drugs pan out-
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So, I'm calming down a bit, of course pharma never expected the SERDs to be used as monotherapy anyway, and we do still have access to some of them in clinical trials when combined with other targeted drugs. But now pharma is more interested in marketing these for early stage or firstline, and all of them will want to enrich for ESR1 mutant cancers, so this slows it all down again. And clearly, its not easy to make something that works better than Faslodex..
Susan, you are such A Shining Ray of Hope!!!, thanks, and you are right, this is a huge category of drugs and ARV-471 is in an even different category, so there is no way some of these won't end up being very useful backbones for combination endocrine therapies. Considering just an ARV-471+Verzenio combo, for example, given that Verzenio has activity on its own, even in later lines, works well on liver mets,etc how could that not be a viable combo?! One problem may be too many cancers are fully endocrine-resistant after I-F, making it hard for the trials to have sufficient responses to meet their endpoints, so they will focus on trials for first or secondline, plus load up on ESR1 mutations...
Here is the Giredestrant Combination Clinical Trial, lots of combos there, actively recruiting. Giredestrant was measured to have 7-15x more activity than SERDs in the lab, so no way this won't be an effective treatment if the cancer is still dependent on estrogen receptor:
https://clinicaltrials.gov/ct2/show/NCT04802759
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cure-ious,
That Giredestrant trial has so many arms and the estimated completion date is 10/31/2026. 24 sites around the world. Hoffmann-La Roche seems to be betting big on the success of this drug. To qualify as a patient, you can't have been on ANY cytotoxic chemotherapy. How many patients would fit that criterion and be willing to participate in a Phase I trial?
Interesting... Thanks for sharing.
Hugs, Susan
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Yes, that trial is designed for people who progressed on I-F and are looking to continue endocrine therapy in second- or thirdline, prior to moving to chemo...
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Big advance for solid tumor immunotherapy in Nature. Looking at regulatory T cells in human head & neck cancers, the group unexpectedly noticed that 75% of T-regs had two surface proteins that would not normally be there, and went on to show that co-expression of those two turned the cells into protectors of the tumor. This surprising discovery had not been made previously because these odd cells are not found in mouse tumor environments, which is what most research uses, and could be, for example, part of the reason why some drugs that work great in mice don't do so in humans. They made a tag they could use to stain specifically for these cells, and found they are not in normal tissues or in blood cancers, but were there in 19 solid tumors they looked at, including breast cancers. They are making a bivalent antibody that will target both proteins and be used to specifically take out these tumors and allow the immune system to get at them for better immunotherapy. You can read the whole paper in the PDF link at the bottom. Excellent progress!!!
https://www.sciencedaily.com/releases/2022/05/2205...
https://www.nature.com/articles/s41586-022-04718-w...
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Cure-ious good to see back. Most of the old firm seem to have thankfully either stoically remained or are drifting back to the forum. Some great new members too but I still miss Z
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Thanks Cure-Ious, that is so important finding and interesting info...hopefully this will move forward immunoterapy also for cancers that previously did not respond.
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Hi Chico & Maaki!!! Yes, the site is truly broken but I can't help but jump in if I see some exciting new report. I'd bet that antibody-immuno combination makes it into some big clinical trials, esp since it should work on all solid tumors, within the next two years. Also, that Giredestrant combo trial mentioned above is being offered in Spain, not sure where you live Maaki, but that might work for you, and maybe Chico will be wanting a summer vacation sometime in the distant future, and can keep it on her list. Also, for Susan, tho it is designed for right after I-F treatments, obviously if any of those work and get FDA-approved, it would then be available for those who are on later lines but want to give endocrine therapy another shot. Whatever the route to get to FDA approval the fastest is what we want! And they are still saying a similar kind of combo trial will open up in second half of 2022 for ARV-471...
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For all who are following the Rosenberg TILs trial at NIH, which cured Judy Perkins as well as possibly two other women with MBC, he recently published a large study characterizing the best metastatic tumor-reactive TILs in Science- Feb 2022
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC89966...
A summary of this work: Until now, to maximize the potential of TIL therapy, Rosenberg's team had to look at every potential mutation in a tumor that could be a target. But after years of effort, the team developed this new assay that identifies the gene expression profiles of a few rare lymphocytes that recognize mutated cell surface proteins of cancerous cells, thereby negating the need for a mutation-by-mutation search.
This should expedite the painstaking process underlying this trial, Great Progress!!!
https://www.nih.gov/news-events/news-releases/gene...
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Hey Cure, Ive been meaning to ask, I skipped from I-L to Lynparza, with no stop for I-F. Based on your extensive research, does that give me any sort of potential benefit having not been exposed to F and not having had I fully fail? (BRCA1 for reference). Was moved on due to primary progression on one scan and progression in one bone met at the next scan.
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Hi Sondra, Sure, there have reports suggesting that resistance to CDK4,6 inhibition is fairly quickly reversed, and anyway we don't have biomarkers to track that, so when there is progression on I-L, the letrozole has failed but Ibrance may still work fine. I went from I-L to I-F and am coming up on seven years next month, having never left Ibrance.
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Hi Cure.... quick question I just wanna be sure I am understanding correctly about the TIL's trial. Are they basically saying that instead of it taking like 3-4 weeks to find out all the mutations that your tumor has...they can now do it faster than that? However, all the other parameters of the trial are the same (from what they told me in Feb)... 1. You must have a new tumor 2. it must be in an easily resectable location 3. It must be the right "TYPE" of tumor.... etc...
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Hi Nicole, The study means they have a faster way to identify tumor-fighting TILs, but I've no idea how easy or hard it would be (or if its even ready) to change their existing clinical trials procedure in the short term. But with these guys, just be sure keep in touch, and let the rest of us know too!!
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Yes will do. They have all my scans and records just waiting for next scan end of June.
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Cure-ious-- Like Sondra, I too went from I/L to Lynparza when I had progression (BRCA mutation). I wonder about trying I/F next when I have my next progression???
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Sure, or a SERD/ARV-471 trial, no reason why not, but it sure would be great if we all could readily get FES-PET scans to confirm cancer is still endocrine-sensitive, rather than having to take these crap shoots! But anyway, Faslodex combos are great options.
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Sure, or a SERD/ARV-471 trial- it would help if we could readily get FES-PET scans to confirm that the cancer is still endocrine-sensitive, rather than having to take these crap shoots- But anyway, Faslodex combos with Ibrance or Verzenio etc are great options.
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Cure-ious,
That's amazing that you've been on Ibrance for close to seven years! Hope you will be able to continue on Ibrance for many more years!
Hugs, Susan
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Just listened to a talk by Wayne Tilly, Ph.D. He's a researcher from Australia.
His topic was, "Agonising Over Antagonising the Androgen Receptor in Breast and Prostate Cancer". He showed how using an Androgen antagonist like Enobosarm can improve outcomes. We knew that. He also showed some studies (not in humans) that demonstrated even better efficacy when combined with Tamoxifen or a CDK 4/6 inhibitor. It seems to reinstate the ability to get a response from a CDK 4/6 inhibitor so it should work even if you have already failed on one or two of those drugs.
On the downside, he mentioned that the company running the Enobosarm trials, Veru, was closing up shop. I took a look at the stock and it seems to be doing very well. Not sure where he got this info. Maybe I misheard. There are a couple of other companies working on androgen agonists but no trials from them yet.
Enobosarm was fast-tracked by the FDA for the treatment of MBC. There are two Phase 3 trials of Enobosarm going on now. One is as a monotherapy, the other is combined with Verzenio. Both don't allow participants with > 1 systemic chemotherapy excluding immuno or targeted therapies.
Of course, you can also buy it online outside of a trial.
Hugs, Susan
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I had a meeting today with a doc up at Memorial Sloan Kettering in NYC. If I understood her correctly, they will shortly start up a new clinical trial for a new piqray drug (supposed to have fewer side effects) and a new drug that affects a very specific MAP mutation. She was very excited about both drugs. I don't really know much more, but perhaps someone else does. The kicker with these drugs is that they require very specific mutations.
Perhaps someone will know more about these clinical trials and can share more. I have seen some press about the piqray drug, but not the other one.
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My wife is taking enobosarm (9mg daily) along with her verzenio, and it has really improved her energy levels. It's hard to say it has had an impact on her cancer, as her cancer has remained stable, tumor markers now stable. They did go down when she started the enobosarm, but it's impossible to honestly attribute it to the enobosarm, as she was early into her treatment with verzenio, following palbociclib (during which tumor markers were steadily rising). I don't want to make claims I can't substantiate. The improvement in sense of physical well being is about the only tangible improvement.
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Husband, Happy to hear that she is feeling better. Thank you for posting this update, and I hope she continues to feel well and energized!
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Today I declined joining a Phase 2 clinical trial for ARV-471. The contract was 25 pages long with a duration of 6-9 months; the inflexible terms regarding numerous CT scans, bone scans, office visits, ECG/ekg, blood work, urinalysis, all at the expense of MY insurance. Their contract covered none of those expenses!
I would have been required to show up at the medical facility weekly, sometimes daily, several times 10 to 12 hours at a crack. I just do not have enough energy to meet their demands and I also do not wish to spend what may be the last days or months of my life as a pincushion for the pharmaceutical industry. It was tantamount to holding down a full time job as a cancer patient and i don't feel very good most of the time. Couldn't do it.
The clinical trial contract is a doozy, I'd attach it here if I knew how.
I'm going on Xeloda instead
Previous treatment: Ibrance, Letrizole, Lynparza
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PNW- That is insane. Thanks for letting us know!! Its hard enough to find a trial that seems like it could really work, then wait to see if you are eligible, and now the new criteria, where the conditions have to not be insane. No wonder these trials accrue so slowly... Pfizer paid 2.3B for rights to this drug, they should be treating you to every scan on the books
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On the other hand, years ago I was asked to do a trial of tamoxifen. It probably wouldn't have worked for me, because I have lobular, but even then the contract was in excess of 20 pages. Yesterday I talked with a doc at Memorial Sloan Kettering about several trials, one of which sounds like like its conditions are similar to what PNW describes. But the doc explained that on the "long" days, with loads of tests, they would provide overnight housing, etc. We didn't get into the insurance question, but I have Medicare so I suppose that that would cover such expenses.
The trials were such that if the trial drugs work, they would benefit me but also benefit others. For me, that's a personal decision -- do I want to go through this (and the doc was very candid about the time involved) or do I not want to. I'm no fan of big Pharma either, but no trials means no new treatments means no further progress on solving the puzzle of cancer.
I think we should not throw the baby out with the bath water here or our next discussion will be that there are no new drugs for any of us. Unfortunately, that's the process for drug approval in this country.
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