Are you currently (or have you been) in a Clinical Trial?
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Dear Dee, of course your brain is alright! And you have a super good team around you which is a big thing, believe me. Saulius
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Glad to hear that Dee.
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California peeps - the IMX-110 chemo - which is apparently doxorubicin with curcumin (?!) bound in a nanoparticle - is recruiting in Encino & Santa Monica. It's an extenstion of Phase 1b/2a running in Australia. Early signs are greater cell apoptosis .
presser about first US pt enrolled https://pharmaceutical-business-review.com/news/im...
Trial page https://clinicaltrials.gov/ct2/show/study/NCT03382...
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Thus one is in my bucket. clinical trial for breast cancer VLS-101
https://clinicaltrials.gov/ct2/show/NCT04504916
Report onsame drug-different cancer study looks good-
VLS-101 Safe, Effective in Heavily Pretreated MCL and DLBCL | MedPage Today
https://www.medpagetoday.com/meetingcoverage/ashvi...It’s hard to believe how few people are in these studies. 🤭
Dee
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new trial just enrolling, open to mTNBC & er-/pr-/HER2+ https://clinicaltrials.gov/ct2/show/NCT04296942
totally new agents (open label, phase 1b trial)
It's a vaccine BN-Brachyury & immunotherapy Bintrafusp alfa
for the lucky ones that live near Bethesda
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Dee & Moth, You both are treasures!!!, thanks for bringing these interesting trials! Definitely there are too few people enrolled sometimes in trials that look very promising, but there also are a lot of people reading here who would like to know about them and have no-one in particular to recommend them, or have MOs saying they are running out of options. Maybe you guys (and anyone else researching these trials, like SP and BevJen) could create a list of your "top five trials I'm considering for 2021"; and post them together like twice a year (June and Dec?) for those of us wondering what to try next?
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Cure-ious,
Happy to post trials that I see, but I think SP, Dee, and Moth are much better about looking at all aspects of breast cancer and passing info along about clinical trials. Right now, since I"m on immunotherapy, I'm kind of just waiting to see if that works for me before I go back to making a list of "possible" clinical trials for ER/PR+, HER2- BC.
Generally, though, I think that many of the people on this particular thread are very helpful in passing along info for all of us.
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It seems some SERDs are now (finally) entering phase three trials and gunning for firstline treatment, competing directly against Ibrance-Femara. That's fine, but what about those of us who need these drugs now, for a later-line? These are estrogen receptor degraders, and we need them to replace Faslodex, so why are they being tested against an AI? Altho when compared, AIs were somewhat better than Fas when combined with Ibrance, so I guess they have set themselves a high bar here.
GIREDESTRANT (GDC9545)-Ibrance versus Femara-Ibrance Oct 2020 - Apr 2024 https://clinicaltrials.gov/ct2/show/NCT04546009
CAMIZESTRANT (AZD9833)-Ibrance versus Arimidex-Ibrance Jan 2021- Nov 2025 https://clinicaltrials.gov/ct2/show/NCT04711252
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Dear Moth, wow, interesting trial. It is phase 1 but is there some initial "promising" data somewhere?
Saulius
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Had to got off of Trodelvy since my scan on Monday showed a new liver tumor, 1.1 cm. Will get a liver biopsy on the 24th and had blood drawn for a Guardant 360 test. After that, the plan is to get SRT to the liver met. I will be going on Verzenio + Exemestane. Thank goodness, my new insurance company, Cigna, approved the Verzenio. BC/BS of Massachusetts denied Verzenio for me last year. This is an untrialed combination, but Hope mentioned that Tamoxifen can cause blood clots. So I opted for Exemestane. I was on Letrozole two years ago with Piqray. Was last on Tamoxifen in 2013. Also, was on Ibrance + Faslodex just before Piqray. So it's my first experience going back to treatments similar to the ones I had before. No new promising trials. Nothing left but old-school chemos. It will be nice to be on oral meds again after two years of infusions but I hope the combination will at least keep me stable for awhile.
Dee, I had over a dozen brain tumors at first mets diagnosis and to this day have not had any brain met symptoms. They did a brain MRI because I had an eye tumor.
Hugs, Susan
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Susan,
Wishing you good results with Verzenio and exemestane. So sorry that you had to come off of the trodelvy trial. Thinking of you.
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Susan
I care that you are off the trial. Hoping your srt treatment knocks down that new bugger and your new oral meds give you many happy easy years. Thanks for the brain met encouragement. Did you know they think Verzenio crosses through the brain barrier?
<<<<Hugs>>>>>
Dee
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SusanSF- so sorry Re the progression and hope the local treatment works. I’ve never been on abema but, I found the exemestane (taken with Everolimus ) very tolerable. Fingers crossed that Abemaciclib works very well.
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Susan, Damn for progression, but glad you will be going back to targeted therapy and Verzenio is very powerful!! With respect to trials, there is the ARV-471 Dee is on, and the androgen agonist Enobosarm- in their report someone got 27 months on that in phase two.. Would love to hear what Hope suggests for Verzenio dose and how to handle possible rash or other SEs..
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Susan,
Sorry to hear about your progression. Good luck with the local treatment.
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Thanks to all of you wonderful women for your good wishes!!!
Dee, Hadn't heard about Verzenio crossing the blood brain barrier. That's great news! Appreciate the information.
Cure-ious, The only site conducting the ARV-471 trial in California is at UCLA. Enobosarm sounds very promising but I couldn't find an actively recruiting trial. The Veru Pharma website says they will do a Phase III trial in the first half of 2021 so will keep an eye out! I don't normally get tested for AR+. I wonder if I can request that as an add-on.
Hugs, Susan
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Oh, yes, Susan, I forgot these trials did not start up yet and are for second/thirdline, however the phase two Enobosarm got good activity regardless of other lines of therapy, so it will be available eventually one way or the other- just keep them on your list! And ER-positive cancers ( 90% or so) have androgen receptor, AR is more common in breast cancers than ER is...
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susan,
ARV-471 -> is opening @ Stanford in April also Stanford has BDC-1001 which i think is open for Her -low.
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Hi, I emailed to Veru asking about enobosarm in Europe, they say there will be phase 3 trial soon. Potential countries in Europe are Spain, France, Czech republic, Poland and Ukraine. They wrote me back very fast, so you can ask about locations in US.
Susanin - Verzenio is good drug to me, still on 150 mg 2x daily since december, I have diarhea one every two-three weeks for two days, strange. My neutrofils are much better than on Kisqali. I will have first Astra Zeneca vaccine today and did not stop the drugs. And yes it crosses the BBB barier. Did you take Trodelvy for Er pos BC? I thought it is only for triple neg
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I wish I could contribute more about specific trials, but I'm in a coasting phase right now. But I love the idea of folks posting their top five trials when they are doing research.
Susan, I love that your onc is willing to try a non-standard but sensible combo for your specific situation; that is the art of oncology, and it takes an experienced and confident oncologist, I think.
Was that eye tumor a bc met? I have an eye that won't stop watering; it is much worse than the other eye. And my eyeglass prescription changed for the better in that eye, which the optometrist suggested could be the beginning of a cataract (thank you anti-estrogens). But you know where our minds go. I'm afraid to go the ophthalmologist until I get a covid vaccine. (Congrats on your vax, Maaaki.) I don't think I would have an eye met when the rest of me is NEAD, but you know.
Cure-ious, I agree that we need the oral SERDs to replace Faslodex. I figure as soon as one is approved for anything, I will campaign to get it on compassionate use or off-label or whatever, in order to ... save my ass! (Sorry guys, I don't know why I like saying that so much.) To answer a question you asked about my trial, it is only for Her2 mutated, not Her2 low. I seem to remember these two categories appear to be mutually exclusive.
Moth, how interesting. Ima keep drinking my ginger-peach-turmeric tea.
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So excited to hear these trials are coming! Now we are going to have SERD/ARV-471, Her2(low) Her2 active (mutant), and Androgen Receptor as new targeted therapies. Maybe we can all go visit Prague to get Enobosarm!!!
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FYI- I asked Dr Hamilton how well others were doing on ARV-471, especially since I got my first notable response of stable disease. She said “I wish everyone could respond to a trial drug, but some do and some don’t.” The best part is those that do respond are also tolerating it very well. My main issue with ARV-471 is the achy joints and muscles like being on an AI.
So, I am interested in the real statistics update when it comes out next quarter. And I’m glad to see it is opening up in other areas.
Dee
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Dear Cureious, please also don't forget Trop-2 for ER+ (TROPICS-02 trial [NCT03901339])! Saulius
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Cure-ious: you mentioned above a report where someone got 27 months on a phase 2. Was that the sarm enobosarm? Can you help me find the report?
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Maaaki, I was on the TROPICS-2 trial to gain access to Saci. So happy to hear that your diarrhea wasn't too bad. Some people told me they couldn't go anywhere because they would have a sudden need to go.
Shetland, I found my eye met, and the rest of my metastases because there was a region in my vision that seemed to be clouded over. So not a watery eye.
werone, Thanks for the ideas. Will look into those two trials at Stanford.
Cure-ious, Appreciate your list of promising new treatments. I always tell new intakes to our support group, "You just have to stay alive long enough to keep the runway of new treatments ahead of you. There are a lot of new, promising drugs in the pipeline." Sometimes, I think that doesn't apply to me since I have been on so many treatments. You reminded me that there is potentially more runway even for me.
Hugs to all of you!
- Susan
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Some of you mentioned being taken off of Ibrance and switched to Verzenio. Does Verzenio target certain genetic mutations? I was taken off Ibrance and am now on Afinitor and exemestane. ER+ (85%) HR2- , no mention of any drugs that targeted the cancer. This is the 3rd BC, she is convinced that each one has been a "new" one. She mentioned chemo, but it seemed like it did not shrink the tumor in BC2.
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Husband, It just comes from the report Veru issued in Dec on Enobosarm and their plans to open another trial in the second half of this year. They had also just published a paper showing that for breast cancer, opposite to prostate cancer in men, you want to increase Androgen signaling, not inhibit it as was thought previously. I pasted most of the report above, but the 27 month response I referred to is in the data from the phase two trials (pasted below), where they report an overall PFS of (only) 5.6 months, but that is followed in parentheses that by the range of different responses, and there you can see that one person got a greater than 27.5 mo response. These numbers will be from small patient sample size and we have to wait to see what "real" numbers look like from a larger cohort, but I always look to see what best response they got was, because for at least one person, this drug was awesome!!!
The Phase 2 primary endpoint demonstrated clinically meaningful clinical benefit rate of 32% and 29% in the 9mg and 18mg daily enobosarm AR+ cohorts, respectively. At the time the study was terminated, the median duration of clinical benefit was not reached (NR) in the 9mg group (range 8.2 months to NR) and 14.1 months (range 11.0 to 16.5) in the 18mg group. Best overall response rates, AR+ patients that had complete or partial responses, were 35.3% and 25.6% for 9mg and 18mg, respectively. The median progression-free survival was 5.6 months (2.9 to >27.5) and 4.2 months (2.8 to 11) in the 9mg and 18mg groups AR+, respectively. Women being treated with 9mg or 18mg of enobosarm also reported significant improvements in quality of life measurements including mobility, anxiety/depression and pain discomfort.
https://www.globenewswire.com/news-release/2020/12...
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Susan, You have lots more runway!! In addition to the new targeted drugs and new ADC chemos that Saulius was adding to the list, we should be getting updates on bunches of others that looked promising at earlier stages- was just reminded about the ARK5 inhibitor Jen mentioned, CDK12 inhibitors, PARPi combos, etc. Starting to get to be so many that maybe its not too long now before we can be a bit picky about what we take
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Oh my, Cureious, "being picky about what we take" sounds so cool! Like being in a candy store or at baker's shop:) Cannot stop smiling:) Saulius
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Saulius...you just made me smile so big. Thank you
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