Are you currently (or have you been) in a Clinical Trial?
Comments
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lafsunshine, cure-ious,
Laf, in your message you say you're ER+. But I read that Keytruda is used for Triple-negative. Please explain further. Thank you
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WeninWI, KattySmith started this thread when she entered a clinical trial for Keytruda together with a Celebrex NSAID, and got I think it was about 9 months on that treatment, which I think is really good. One can also get Keytruda for any kind of cancer if the tumor mutation burden is over 10, and long time on CDK4,6i can push TMB numbers up, suggesting one might be responsive after that. Different cancers need different TMB levels to respond to Keytruda as monotherapy, and a recent report found that for ER+MBC, a high response rate (60%) requires a TMB of 14 or better, whereas TMB levels between 10-14 had a response rate of only 6%. However lafsunshine here is responding well with a TMB=11!!!, which may be pushed up based on good PDL-1 expression.
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Apparently ESMO screwed up and released a late-breaking abstract early, and so now they have had to release all their late-breaking abstracts.
So far I only found a pokey way to access these, for example here's an update on the SERD OP-1250:
March 17, 2023, of 86 pts on OP-1250 (120 mg), 66% had ≥2 prior lines of ET, 30% prior chemotherapy, 67% prior fulvestrant, and 98% prior CDK4/6i; 45% (34/75) had ESR1 mutations. There were 4 partial responses with a clinical benefit rate of 40% (23/57). In pts with an ESR1 mutation, CBR was 50% (11/22).
Conclusions: OP-1250(120 mg qd) was well tolerated with promising efficacy in heavily pretreated pts, including pts progressing on fulvestrant and CDK4/6i. A phase 3 monotherapy study in metastatic BC (second/third line) is planned in 2023.
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Another ESMO abstract update on the Imlunestrant SERD:
Imlunestrant is an investigational, next-generation, oral SERD designed to deliver continuous ER target inhibition, including in ESR1-mutant BC. We present the first clinical data of imlunestrant with everolimus or alpelisib and updated imlunestrant monotherapy data from the EMBER study (NCT04188548).
As of 6 Oct 2022, 114 pts received imlunestrant monotherapy, 42 pts received imlunestrant + everolimus, and 21 pts received imlunestrant + alpelisib. Baseline characteristics were similar across combination cohorts; 46% pts had visceral disease and 46% had an ESR1 mutation at baseline. Median number of prior aBC therapies in combination cohorts was: 1 (range 1-2); including prior ET (100%), CDK4/6i (100%), fulvestrant (35%) and chemo (17%). No cardiac or ocular toxicity was seen.
Monotherapy: ORR 9%; CBR 42%. With Everolimus: ORR 21%; CBR 62%. With Alpelisib: ORR 50%; CBR 62%
Conclusion: Imlunestrant with everolimus or alpelisib demonstrated robust efficacy in pts with pre-treated ER+, HER-2 MBC.
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cure-ious- THANK YOU so much for the links about boosting immunotherapy and for ALL your knowledge and research that you do and sharing it here!!
weninwi- cure-ious is right, because of my high TMB I was able to receive immunotherapy, even though I am ER+.
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laf and curi-ious,
Thank you for those explanations. My tumor burden is low = 7. My notes say "usually does not change over time". My PD-L1 is low = 9.8. Unless these factors change doesn't look like this drug will be in my future. Always learning. Thanks again.
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A new phase 2 clinical trial is opening up to test Elascestrant (SERD) in combination with a CDK7 inhibitor- multiple sites are available in the US, UK, France, and Spain. The trial requires the previous treatment to be AI+CDK4,6i (ie, it is designed to be tested as a secondline treatment). The primary results should wrap up at the end of next year, so hopefully this will go quickly and they can move to a larger and more inclusive phase 3 trial.
They will also be monitoring the response of ESR1 mutant cancers as well as those with p53 mutations. In the lab, both mutations are sensitive to CDK7 inhibition. However, those with non-mutant (wild-type) p53 respond to the CDK7 inhibitor by increasing p53 levels, and because p53 is a very strong tumor suppressor, this increased level might give an even stronger response to the drug. So they will be comparing the response of cancers that do or do not have these mutations.
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Really interesting study there Cure - Im not eligible for it (though i see they are taking bone only) and the UK sites aren't anywhere near me, but this is something that would absolutely fit my profile in the future.
For the study it has to be exactly after people are coming off AI+CDK 4/6 + mutations or just having had that combo at one point in the future? No wonder the enrollment is only 46.
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Sondra, Correct, its small for phase two, and they put up so many sites, must be just a couple openings at each site, and the way its written you'd have to have the AI+CDK4,6 as the previous treatment. I don't know how clinical trials are designed and why they vary so much in terms of numbers. At least this one will be over quickly- perhaps they want to see if their subsequent trials should exclude or enrich for those mutations?
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Hello, ladies. I am here for my mom. She has a long history with breast cancer with many recurrences. I just tried to fill the profile, but I do not remember all the treatments and she does neither. We have to go through all the reports.
Since she was diagnosed with liver mets in June 2023 I have been reading this thread and the liver mets thread, as well as the Verzenio thread but never felt I could contribute.
After failing Verzenio she has been offered to enter this clinical trial.
It is combining Active Immunotherapy + PAClitaxel. She will be in the phase 2: eftilagimod alpha 90mg + paclitaxel.
To be honest I have no idea about trials. Just that she will be in the Phase 2. I think it is good to have the chance to try something that is new that might benefit her and also contribute to future research, and she agrees that too. Also, we are in Spain and new drugs take longer to be available than in the USA.
The thing that is confusing is that as far as I know paclitaxel is the same as taxol. Isn`t it? And she has been on that already. She things she was on taxol in 2008 and in 2021. She tolerated it quite well, but know she is pissed off she is going to lose her hair for the fifth time.
After so many recurrences and treatments her case is complicate to treat.
I also wanted to post here because I recently read a disccussion on Immunoteraphy for MBC HR+, Her2- and it might helps other. But I am still confused is immunotheray not so effective on breast cancer ER+? Or is it that they still don't know because there has not been enough trials?
I would very much appreciate your comments.
Alicia
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sorry, I don´t know what her bio does not show under my post. I will copy it here:
My mom:
02/2006 - Stage II BC (right breast, ductal) . lumpectomy+ Quemo + radiation + femara. She was 49
10/2008 - Local recurrence (right breast lobular, multicentric). mastectomy + Chemo (taxol) + radio + tamoxifem
01/2011 - Ovarian mets. Both ovaries and fallopian tubes removed + amomasin
07/2019 - Another local recurrence netx to the scar (right breast, but this time is Ductal, so from the cancer in 2006). Surgery to remove the tumor + chemo + another AI (sorry, I don´t know the name)
10/2021 - Contralateral lymph node recurrence (left). Left mastectomy + chemo (taxol) + tamoxifem.
06/2023 - Liver mets. No biopsy and no surgery. Verzenio + faslodex. Failed within 4 moths. She is now 670 -
Hi @alicia_en_madrid! We're sorry you're having problems with your mom's bio. Here is some information on How to create and edit your diagnostic and treatment post signature, How to adjust signature view settings and How to edit and display your custom tagline.
Hope this helps! You're a fantastic daughter, and your mom is lucky to have you by her side. 👩❤️💋👩
The Mods
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Hi Alicia! Thanks for bringing in this interesting new clinical trial, which just started in May 2023, and has a phase 2 arm designed to optimize the dose of eftilagimod plus paclitaxel (the chemo-immunotherapy arm, which is followed by immunotherapy alone) and then phase 3 uses the optimal dose and has a control arm which is just placebo and Paclitaxel. Anyone with MBC who progressed after firstline endocrine therapy is eligible, however no prior chemo in the metastatic setting is allowed, due to the control arm being paclitaxel alone. So, only in phase two are you sure to get the efti, which is a soluble LAG-3 protein that stimulates the immune system. An earlier phase two trial was successful:
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UCSF specialists are reporting at ESMO 2023 that they have identified a biomaker signature that allows them to predict which early-stage ER-positive, Her2-negative breast cancer patients will respond well to immunotherapy. The bottom link is the write-up of the data published recently in Cancer Cell. They are working to put out a diagnostic test. For the many with MBC who do not respond to immunotherapy (IO) alone, many IO combination trials are in progress.
https://www.cell.com/cancer-cell/pdfExtended/S1535-6108(22)00216-1
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A lot of new interesting studies
I am in Hospice now with little energy to go on this site or even read much
good luck
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Sending you lots of love, @nkb ❤️
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Nkb, Hope that you will be comfortable and at peace in hospice. You will be missed. You have been a wise, supportive voice on these boards.
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Dear nkb, big big hugs to you. Please, write us here whenever you can - it is always so great to hear from you.
Saulius
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Clinical trial on the use of psilocybin for cancer related depression and anxiety:
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@nkb - Sending you lots of love. You have shared so much on this board, and I truly appreciate it.
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Does anyone have the latest info on Cytodyn / CCR5 / leronlimab? I thought I read somewhere that you could contact the company to try to get tested for CCR5 to possibly get access to leronlimab. I have tried messaging and calling the company. They only seem to be taking voicemails (and not responding). I know the company had some issues. The contact info for Cytodyn on clinicaltrials.gov seems to be missing.
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NkB, I am gutted to hear you entered hospice, how is it possible it goes south so fast?!, I'm sending huge hugs and hope you have some amazing quilt you are working on, and mostly that they find something to turn this around, fast!!!
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Nkb - I'm not on the boards too often and just saw your message. I'm so sorry to read this news and hope that you are comfortable.
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Here is a recent evaluation of ARV-471 (ER degrader) from the investor side of things, not to discourage anyone but this does not sound promising:
"Unfortunately, ARV-471 had a lackluster 3% response rate in 71 heavily pretreated ER-positive/HER2-negative breast cancer patients in the VERITAC Phase II single-arm trial investigating ARV-471 in combination with Pfizer’s CDK4/6 inhibitor Ibrance (palbociclib). All patients had received CDK4/6 inhibitors, and 79% had received AstraZeneca’s ER non-PROTAC degrader Faslodex (fulvestrant). Among 44 patients with measurable disease, two had confirmed partial responses. The primary endpoint was clinical benefit rate, which came in at a mediocre 38%; Faslodex had demonstrated a clinical benefit rate of 54.9% in the second-line setting in the FINDER1 randomized Phase II trial. Surprisingly, ARV-471 has progressed to Phase III to be evaluated in a less heavily pretreated population where all patients have received CDK4/6 inhibitors, but unlike the Phase II, patients who have received Faslodex or chemotherapy for advanced disease will be excluded. Faslodex will be administered in the control arm of the Phase III study, allowing for direct comparison between the two ER degraders."
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Leptomeningeal control and trial:
Saulius
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Thank you cure-ious for the ARV info. That does not sound good… I have my scans in 2 weeks and I am in the Afinitor arm of the trial. I didn’t respond to faslodex or iBrance either so I’m praying the estrogen degrader in ARV works well with the mTor inhibitor in Afinitor to at least keep me stable for a little bit since I haven’t found anything to work yet. The side effects are way better for me than Enhertu. But that won’t mean much if there’s progression. Interestingly, my bone pain has been significantly better. I can’t remember when I last took anything for pain so that is definitely improved. I don’t know how my liver is doing because I don’t have side effects from it and my AST and ALT numbers are back in range. The worst has been this itchy rash which seems most likely to be from the Afinitor but Claritin and OTC cortisone cream help. I have a dry cough which I will talk to my doctor about Wednesday. A cough is a side effect of Afinitor as well but so is pneumonitis. So I am being vigilant about that. I will keep you posted. Thanks for the latest info.
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Thanks MommaCJ, Good to hear from you again! As I probably mentioned earlier, I keep a close eye on ARV-471 because I would like to try it or SERDs (like Imlunestrant or Camizestrant), although I'm sure I would need them in some kind of combination. We have had people here trying ARV-471 and getting at least a year on it as monotherapy. I could not take the UCLA LOXO-783 trial because they did not yet have an arm with a SERD, and have been able to get to stable just by adding Celebrex and pitavastatin to the faslodex and one 100 mg nightime Verzenio pill I am taking, but no idea how long this lasts. Please let us know how you respond!!!
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Has anyone heard of this trial?
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I think this is the trial: ClinicalTrials.gov ID NCT04432454. Active, Not Recruiting.
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