Are you currently (or have you been) in a Clinical Trial?
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does anybody know where to access SABCS abstracts? they should be online, meeting starts in 3 weeks-
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Hi cure-ious, I don’t know but I’ll ask my oncologist on Tuesday if you don’t find them first. :) I developed a mild pneumonia which I don’t think was bacterial because it started to resolve when I held the Afinitor with no antibiotics. My trial onc said it did not look like pneumonitis on a scan because there were no ground glass opacities. She had me hold the Afinitor and now my cough has pretty much resolved so I will restart tonight. I’ve stayed on the ARV-471 because I was sure Afinitor was the culprit. It appears to be working as my tumor markers have gone down and my ER chest CT showed stable since Sept. but I will have to wait and see next week when I do all my official trial scans.
I’m kinda nervous about restarting the Afinitor… I know it might sound silly because it’s not even the trial drug… the ARV is and I’m not in a dose escalation trial. But I found out yesterday sadly that believe60 passed. I know she was active on this thread during her trial and I was so upset to find out about her passing yesterday. We were diagnosed at the same time last September and often compared notes because we had similar biomarkers and mutations. We texted often often, and she was a good friend. I’m pretty gutted and I’m so mad at these dose escalation trials that look for the maximum “tolerable” doses. I don’t have the details but she never seemed to recover from her trial event. I wish there was a better way. I continue to pray for her family and friends.
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I’m gutted to hear that believe60 passed. Her MBC journey was short but she had to endure a lot during that time. Rest in Peace Believe60.
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Well, Xeloda is out for me. I don't really think it worked but recent scans show significant progression. Most worried about the liver tumors. My oncologist is suggesting this trial. Mostly because I will likely qualify and this is the only one her hospital is offering. Do you guys know anything about this new drugs? What do you think of the trial as a next treatment?
I did really well with Ibrance and Faslodex but Afinitor and Xeloda were both short lived.
Thank you so much for your insight, research skills and all your knowledge you guys share!
CDK4-selective inhibitor - PF-07220060
-KAT6A-KAT6B-inhibitor - PF-07248144
https://clinicaltrials.gov/study/NCT04606446?intr=PF-07248144&rank=1#locations
https://ascopubs.org/doi/abs/10.1200/JCO.2023.41.16_suppl.3009
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I'm so shocked and saddened by the news about believe60. . . .I really just can't comprehend she has passed. We were in the trial together and messaged each other quite a bit. How could the adverse effects of this drug have escalated to such a runaway degree??!! I'm so sorry that Believe60 had to go through this and can only hope she was surrounded by loved ones and that she was comfortable.
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whoa - I didn't see that news. Must have come in overnight, and that is why Mel's is hopping. I remembered her challenges and unfortunately I didn't have to go back so many pages on here to re-read what happened :( I hope she is at peace now.
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We are so sorry to hear about the passing of believe60. It's heartbreaking news… May she rest in peace.
The Mods
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I am sad to read the news about Believe60 - it seems like it was just yesterday that she joined our discussion about trials. She should have had tons of more time (and lines of treatment). My condolences to her family and friends.
Perky2020, I've not come across KAT6A-KAT6B-inhibitors so I can't help there (I will start looking for it as your post has me intrigued). However, I'm in a different trial with the CDK4 inhibitor PF-07220060 combined with a CDK2 inhibitor (NCT05262400). Because it's a combination, we're not sure what caused my WBC, platelets etc.. to tank, but the trial team reduced the dose of the CDK4 inhibitor in the second month and I've been okay since. By the time I started the doses had been set - I believe I was among the last of the Part 1 patients before they moved to Part 2.
Sorry I don't have any more insight. I would be asking tons of questions about the KAT6A etc.. inhibitor - how have others done, what are the expected side effects since it is SO new. Dose escalation phases of trials are so tricky - too low and it doesn't work (likely my experience with a CDK7 drug trial I was in briefly in 2019). Too high and one can have adverses effects that can require hospitalizations. I would want to be really comfortable with how to access care in those situations.
Good luck with your decision making.
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New gardener I agree. I think questions are so important. :) I’m in a phase one trial as well but one of the drugs Afinitor has been around awhile and the ARV-471 the trial drug has been moved to phase 3 trials as a mono therapy so I felt comfortable with it. I sure hope I didn’t offend anyone with my comments about dose escalation the other day. I totally realize we need to come up with an effective dose and that is done through trial and error. After having more time to reflect I was just broken hearted and angry to lose a friend. I am so grateful to all the brave people who have gone before us without which we wouldn’t have the treatments we have today. I just wish there was an easier way. I have my first trial scans on Tuesday so that has me a little frazzled as well. It’s my third line and nothing has worked yet. But I know sometimes it just takes a few to find one that will provide some stability or regression and there’s a lot left to try.
Perky2020 I don’t know anything about those trials but there might be a FB group with people on it? I found one for ARV-471. There are only 18 of us in the group but the information has been helpful.
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The FDA has now approved the AKT1 kinase inhibitor, Capivasertib (now called TRUQAP), and interestingly, they put a requirement that only those cancers with a mutation in PI3KCA, AKT1, or PTEN. Although this restriction makes sense, because activation of AKT1 or PI3KCA, or inhibition of PTEN, all cause high levels of AKT1 kinase and should respond to the inhibitor, the trial did not find that these biomarkers had any predictive value, ie the drug worked well whether or not these genes were mutated, so the company was hoping the drug would be approved for everybody. However, the the trial had an unexpectedly large number of patients (almost 20%) for whom the mutation status of the cancer was not known or could not be determined, or for whom they did not have tumor samples for whatever reason, so actually if many people in this group actually did have a mutation, then the study might have concluded that one needs one of these mutations for a good response. OTOH, there are other cancer gene mutations that can also lead to over-active AKT1 kinase, so probably some people who might benefit from this drug will not be able to access it, however without any biomarker to identify these folks, the FDA decided to be just conservative and restrict the drug to those they know are most likely to respond.
Capivasertib is given with Fulvestrant/Faslodex, but as the authors of the study noted, most people on the trial had already progressed on Ibrance-Faslodex, and at that point they saw that Faslodex was not very effective anymore, so they expect that Capivasertib will be even better when combined with one of the new oral SERDs, or a PROTAC like ARV-471. There are some combination trials testing this idea, but we have no idea when those other combinations might be ready for FDA approval. The drug does have some significant SEs like diarrhea, etc, and so is given on a four days on, three days off schedule.. We shall see what people taking it have to say about it soon enough..
https://www.fiercepharma.com/pharma/astrazenecas-first-class-truqap-approval-breast-cancer-marred-surprise-restriction
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I had my first CT yesterday scans since starting the ARV-471/ Everolimus trial. I am so thrilled that I finally got a stable scan!!!! I was diagnosed with mets in September of 2022 and this is my third line of treatment. I started with Ibrance/Faslodex which gave a mixed response… bones were better but liver progressed with several new tumors. Then I went to Enhertu which was really tough for me to tolerate and I had progression on that as well. I started the trial at UCLA the end of September and this was my first 8 week scan. My 2 target liver lesions shrank by 23% and my bones are stable. My mediastinal and hilar lymph nodes have improved since diagnosis. No new lesions praise the Lord! The combo has been much easier for me to tolerate than Enhertu except I have a nagging cough which is a side effect of the Everolimus. I had a rash for a little bit but that has resolved. And my taste buds are off which is from the Everolimus as well. There were no signs of pneumonitis on my scans but we are monitoring closely. I am thankful and praying to get a good run but at this point I am just happy for my first good scan. :)
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Fantastic news, MommaCJ, and good on you for being brave enough to go through full scans right before the holidays, especially when you've had troubles before!!! the reward is now you can relax and really celebrate!!!
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Thank you so much cure-ious. I’m feeling thankful today for sure. Have a happy thanksgiving.
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Great news about your scans, mommacj. Hope you are feeling ok on the trial.
Does anyone here have advice or insight on preserving veins while on clinical trials? I've been on a trial for a year which requires an IV for CT contrast and Bone scan injections every 8 weeks and 2 separate blood draws every month.
Today, while getting an IV for scans, one of my "dependable" veins failed/blew out. This also happened the last two scans. The nurse who was doing the IV (not my usual person) said one option would be to get a metaport if I were to remain on the trial . Of course, no one knows when a trial will end for them. I'm seeing the trial.team this week but I was wondering if anyone who has been on trials have experience with this. Thanks, as always.
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@smallmoments Due to a lumpectomy, I can only use one arm. Scar tissue was building up in my veins making hem harder to access. Then while getting my blood drawn on a clinical trial, I mentioned to the nurse that I was worried about the condition of my veins. She said I should get a port. My research oncologist also thought it was a good idea. This way my arm could be saved for the occasion when the port couldn’t be used. I knew eventually I’d be on IV meds anyway so I went ahead and did it. Very glad I did.
@mommacj Fantastic news! I hope you have many more good scans.
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Thanks so much rk2020! i'll bring it up with the research oncologist.
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smallMoments: Is this the RLY-2806 trial, the mutant-specific P3KCA inhibitor that you are still on? If so, its been a good long time, no? Any comments about tolerating the drug, what dose did you get? Do you take it with an oral SERD?
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Hi cure-ious - yes this is the RLY-2608 trial. I'm on the 800mg twice a day and take monthly fulvestrant shots. It has been great so far, reduced liver lesion size by 30% in the first 3 months (with continued reduction until a couple of months ago). Hardly any SEs associated with Piqray (my glucose has been normal, occasional GI issues but very minor, no rash).
But wouldn't you know? I had my monthly appt today and there is a small increase in the liver lesions they use as guides. TMs are not in yet. I had a long talk with the trial doc and decided to continue until my next scan in mid January. This has happened twice before, size went slightly up, then went down the next scan. I'm hopeful but it sounds like I'm the only patient left in the trial in this location so I'm gearing up for reality. This drug allowed me to have a wonderful summer with my husband and 9 yo daughter, and for that, I'm grateful.
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smallmoments, It could be that the fulvestrant is starting to crap out, there are reports that post-CDK4,6i, fulvestrant is much weaker, they see a large drop in efficiency as monotherapy compared to before CDK4,6i. There is a new drug, Capivasertib, just FDA approved, which is for PI3KCA mutant cancers. The authors there say the PFS is good but would be significantly better if it could be combined with an oral SERD, rather than Faslodex. But we don't have any options beyond taking Elascestrant as monotherapy, and that's apparently rather weak tea, as it were.
You could try adding Celebrex to see if it helps, it is an NSAID for arthritis, but also is a specific inhibitor of PI3KCA mutant cancers.
In the meantime, you could ask for Guardant testing to see if the PI3KCA mutation still persists, or perhaps it is gone following the RLY-2608 treatment. I'm sorry you are dealing with this so young, my daughter was 8 when I was first diagnosed w/BC, and I held my breath through an awful lot of scans. Well, I still do, but she's a young adult now…
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Cure - did you ever get hold of those SABCS abstracts? My MO is headed out as someone on her team is presenting, though I forgot to ask on what. I suspect its something to do with ctDNA, but Ill ask when she gets back.
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Thanks so much, Cure-ious. Capivasertib is on my list to ask my MO. The trial oncologist also mentioned possible trials I could try. I'll come back here once I find out more. Wishing you and everyone a restful weekend.
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Hi Sondra, Nope, just the titles, such BS! The site has language that the abstracts will be available to the public next spring, but I thought they had the same in previous years and yet you could get at them once you had the link, I think I got them through peoples twitters or company's news releases, but I haven't found any way. Ridiculous, the people who need them the most can't see them…
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Hi Cure-ious, I think I found it. It’s over 3000 pages but I believe this is it.
https://atgproductions.net/atgclients/sabcs/2023_SABCS_Abstract_Report-12-1-23_Compressed.pdf
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Oh, MommaCJ, Excellent Job!!! I will enjoy reading all the little bits and look hard to see if there are any rainbows hidden in the shadows… Thank you!!!
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MommaCJ, so far as I can see, the clinical trial you are taking is perhaps the only one right now that can hit both an ESR1 and Pi3KCA mutations. Can you give us any more information about how this trial has gone for you? How is the team at UCLA, what is the workup required, any idea of how others in the trial are faring? Many thanks!
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SmallMoments- did your genomics test show an ESR1 mutation, or just the PI3KCA mutation? I saw a poster that suggested that RLY-2608 might also be able to inhibit ESR1 mutations, tho I don't know how that would be (it was a cell line they were using)…
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Cure_ious : wasn’t the poster you found the LOXO one?
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Hi cure-ious, honestly the worst part about the trial for me has been the LA traffic. But the team has been amazing and once I figured out the best times to go they scheduled my appointments so I could avoid it. I live about 74 miles from UCLA which is about an hour and a half drive but during traffic it can be 3 hours. So they have been super helpful with that.
Before the trial I had labs, an ekg, CT of chest/pelvis/abdomen and a bone scan since I have bone mets. The trial coordinator Bhavisha is amazing and scheduled it all in one day so I could avoid several trips. I had a liver biopsy done on my target lesion at Ronald Reagan and it was a great experience as well. Well as great as a liver biopsy can be. That was done on a separate visit.
My first two trial appointments were longer about 4-5 hours being the longest. I did labs then dosed (both drugs are oral) then safety labs at 2 hours and 4 hours. Then I could leave. They also did ekgs after each safety lab. Since the first two appointments I just do labs, dose, ekg, see the dr, and go home. It’s about and hour to an hour 30. I go every 2 weeks for the first 3 months and then once a month after that. I do scans every 8 weeks for the first 6 months and then it moves to 12 weeks.
The team has been excellent. I see Dr. Mc Cann. Originally I was supposed to see Dr. Hurvitz but she got a promotion and is at Fred Hutch U of Washington as clinical research director. Dr. Mc Cann and her team have been excellent. They are so knowledgeable and they have explained things in great detail. Dr. Slamon the dr who raised funds for and did the original Herceptin clinical trial and research is on their team. My jaw dropped when I saw his name on the door. I don’t know if you’ve seen Living proof but they said he is an excellent doctor but bears no resemblance to Harry Connick Jr lol.
This is my 3rd line in a little over a year and I have yet to have a first scan that didn’t show progression. So the stable scan I got after my first 2 cycles has me extremely grateful.
In terms of efficacy I am one of the first on the Everolimus arm at UCLA but they are doing the Ibrance and ARV-471 monotherapy arm there as well. I asked last time and they said there are still people from the monotherapy arm that have been on it over 2 years. I believe there are 7 of us on my trial but there are other patients on the same arm at UCSD etc.
The side effects for me are mostly from the Everolimus. In the beginning I had a mild rash and a few small mouth sores which cleared with the dex mouthwash pretty quickly. Not many side effects after two months except a cough which they are following closely but no signs of pneumonitus. It’s been the best I’ve felt so far. I pray it lasts. Hope this helps!
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MommaCJ, Thanks for that, if I went to UCLA it would be about 2.5-3 hr drive, so that's very useful info!! I had read about Dr Hurvitz getting tapped for Fred Hutch, which I think is very exciting for their future, and I met Dr Slamon a few years ago ( when I was an advisor for the Johnsson UCLA cancer center), he is truly special. Not only was he instrumental in the original development of Herceptin, but his group also had a huge role in developing Ibrance (as I recall, they showed the drug companies that they needed to be looking at longer time periods, like over days, in order to see that Ibrance has a huge benefit- moreover they showed the benefit was only in the ER-positive cell lines).
Fantastic care team, and I hope you get a good run on this combo, you sure deserve a break! Well worth keeping an eye on any future trials this team is considering as well…
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Luce, you are right, it was for LOXO-783! MommaCJ, did your cancer have any other mutations beyond the PI3KCA?
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