Are you currently (or have you been) in a Clinical Trial?
Comments
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CBL & Luce, Agree completely! The NIH administrators are very well connected with senators and have strong supporters. They have a huge battle over RFK coming as well, I'd expect them to move cautiously but deliberately. I don't imagine/hope any of this will spill over to clinical trials, which are really more the arena of big Pharma, with mega $$$ on the line.
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Yes, Big Pharma will be the saving grace for trials, I agree. But the research in the infancy stages will be affected if it goes on too long. This is going to be a long four years. I hope we survive it. Literally.
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Hey, More Good News!!!
I just checked up on Pfizer/Arvinas ARV-471, the ER PROTAC, an engineered molecule that degrades ER differently than fulvestrant. The Phase 3 trial is now listed "Active, not Recruiting", which means primary completion of the trial- they will not take more patients, will follow up those still in the trial and submit to FDA for approval as soon as they got the stats to prove better than comparator control:
https://www.clinicaltrials.gov/study/NCT05654623
This trial is monotherapy and for secondline advanced cancer patients, comparing ARV-471 to Fulvestrant. Boy the data on this drug looks so good, at least in other trials on combos, will go find that and post
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That is great news! Yay!
Thanks for posting!
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This trial tho is for ARV-471 as monotherapy, and tested as secondline right after and AI plus CDK4,6i for first line, compared to fulvestrant alone. There are trials combining it with standard CDK4,6i and the new Pfizer CDK4i, both in early and advanced breast cancer, and depending how strong it was alone we might have to wait for data from one of those phase 3 trials to accrue before they decide to go to FDA. However, they are first in class for this new PROTAC therapy and FDA did give it FastTRack designation in 2023. At least we know Pfizer is gonna move heaven and earth to get this stuff out as fast as possible. And to be able to get it outside of a trial is so sweet, hope it comes sooner than later
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And then just to wrap up, Imlunestrant from Eli Lilly is in the same spot, just closed up a phase 3 trial for the Imlunestrant oral SERD, alone or with Verzenio:
https://www.clinicaltrials.gov/study/NCT04975308
as is also Camizestrant, another oral SERD in phase 3 alone and with Ibrance:
https://clinicaltrials.gov/study/NCT04711252
So this may be a busy year for submissions to the FDA, keep in mind they need 6-10 months to evaluate the data, but still, exciting!
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Dear Cureious,
Thanks for good news. I'd also like to add a bit more with inavolisib+palbociclib+fulvestrant in PIK3CA mutated vs palbociclib+fulvestrant in INAVO120 (NCT04191499). To be short: PFS doubled - 15 vs 7 mos, DOR doubled - 18.4 vs 9.6 mos. We need more of those trials with doubling - enough with these "improvements of 2 weeks"!
More details at:
Saulius1 -
Cure-ious, Luce, CBL & Bsandra thank you so much for all the information that you share and for being such smart people in so many ways.
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Chico: Thanks for your sweet words. I’m a total dumbass who didn’t even pass 9th grade. I do spend (and probably waste, given that there are no real answers to be found for us yet) a lot of time googling breast cancer, though.
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Dear Chico, I am definitely not smart but inquisitive for sure (which not always is helpful in real life:) And… I could have never ever in my life have imagined that oncology science, taking int account how I got into it (:////), could be so exciting and… hopeful! Many hugs, Saulius
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Hi Chico:
Not sure about the smart part, haha, but it's good to know you find my ramblings helpful. My theory is the more information and real life accounts the better…that I can't stop talking in real life either, lol.
Thanks for the kind words!
CBL
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Good morning all,
Quick question on learning to search for trials. I see on clinical trials.gov they have a series of videos on how to search - is that what you all have done? Or are there other sites where you learned how to search and what to look for? As a life long learner I’m curious how you gained the wonderful skills you have and share here. -Rhonda
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Hi @rlschaller
I didn't know about the videos! Interesting find. I just bumbled around and probably wasted hours, haha. Sounds like a good start to me! I'm curious too about where to look for the great information others find.
One thing I do is set up google alerts for the drugs I'm interested in like TTX or the CDK2 trial I'm looking at for next time. I get as-it-happens news, which is mostly investor articles, but they have good info on the trials sometimes too.
Good luck searching!
CBL
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Thank you @luce for this link .
And thank you @cblaurenceauthor for the heads up to search for the specific drugs and trial names.
Here are the links I found and the main how to search page .fingers crossed these sites are not scrubbed given the current federal insanity of the incoming admin henchmen.
🤗 to all.0 -
Scientists at UCSF have found a way to engineer fat cells from patients so that they suck up nutrients cancers need, reimplanted in mice they kill the tumors even from a distance- love this!
https://scitechdaily.com/scientists-just-found-a-way-to-starve-cancer-using-fat-cells/
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Cure-ious-that's a very exciting development. Still hoping we might see a cure and be done with this cancer!
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Now in Nature a report of a personalized neoantigen vaccine in kidney cancers tried in phase one for 7 people with stage III disease and two metastatic patients- 42 months later, none of these folks have had the cancer recur. They do say that for metastatic disease with a high cancer burden, one would want to have Keytruda or other immunotherapy to boost the vaccine effectiveness, but these are exciting results!
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Very exciting!
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Here is a detailed review article from 2023 for the various treatments for MBC. It does have an error, the trials they mention for Enobosarm (androgen receptor booster) have now been terminated by the pharma, who instead are focusing on using enobosarm to build lean muscle mass in those taking Ozempic, and have said they don't have enough money to pursue both trials (and they weren't getting great results anyway).
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The Pfizer phase 1/2 trial that was testing their CDK2 inhibitor together with their new CDK4 inhibitor has closed recruitment early, and hopefully they will be moving this to phase 3… They have been studying that dang CDK2i forever and plenty of people here have been on that drug, so it would be good to see it get closer..
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@cure-ious I read the Nature article as best I could and felt a bit disheartened by this: "There is a pressing need to improve our understanding of resistance mechanisms to not only ET and CDK4/6i, but also other agents discussed in this review. With the loss of commercial interest in developing certain compounds after failure to meet the clinical efficacy endpoint(s), efforts to interrogate the discordance between preclinical and clinical activity have stalled, missing the opportunity to elucidate the biological underpinnings." Is it true?
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We need more basic research, absolutely! And we aren't getting it with the draconian cuts being applied right now to Universities and NIh-funded labs…
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Hey y'all,
I'm posting an interesting a new phase one trial that Luce sent out, for endocrine-resistant ER+ MBC, testing a new AI-generated KAT6-A inhibitor drug, as monotherapy or with Orserdu (Elascestrant).
Pfizer has a similar inhibitor that did well in phase one w/fulvestrant, with 30% responding (tumor shrinkage) and a PFS of 10.7 months, altho there were some major side effects- mostly altered sense of taste (which is common with epigenetic drugs, some immunotherapy, and some chemos), neutropenia and anemia.
Unlike oral SERDs or PI3KCA inhibitors, the cancer does not need to have a specific mutation to respond to these drugs, and they did see responses in cancers with ESR1m and PI3KCA mutations. the Pfizer drug had weak monotherapy activity, and worked better with fulvestrant. Recent update: "The good news is that the subsequent development of fresh responses to the Faslodex combo, hinted at during ASCO, appears to have materialised: among 23 second-line and 20 third-line HER2-negative breast cancer patients given PF-07248144 plus Faslodex, ORRs rose respectively from 22% and 40% at ASCO to 30% and 45% at SABCS" Pfizer is set to begin phase 3 trials on this drug sometime this year.
The new trial is for the MEN2312 KAT6A inhibitor, being testing with Elascestrant, and is scheduled to only run through October (or 7 months after the start date, which is not yet open)-It remains to be seen if there are fewer SEs with a KAT6A-selective inhibitor. To be eligible one must not have had more than 6 lines prior therapy, nor more than 2 that were with chemo or ADC, and will be offered in US, UK, France, Spain, Germany, Italy and Korea…
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Not a standard clinical trial, but hopeful new nonetheless. https://nicenews.com/science/hungry-fat-cells-fight-cancer/?utm_source=convertkit&utm_medium=email&utm_campaign=A+path+to+zero+anxiety+-+16630839
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In light of the proposed deep budget cuts to the NIH, from which clinical trials receive significant funding, I've written to both my Senators, disclosing my diagnosis and imploring them to fight these cuts. Today will start messaging Representatives.
Cancer doesn't care who anyone voted for. I wish medicine and science could be exempt from politics, but in the meantime, will keep trying to make my concerns heard!
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sfcakes, Agreed, they are slashing everything, everywhere, all at once, its so dangerous! I will write for the NIH (and all federal employees) as well, thanks!
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Eleanora, Yep, dang, I want my fat cells designer-engineered to fix my cancer and my metabolism!
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