Are you currently (or have you been) in a Clinical Trial?
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Well that was fast!
I am 80% sure I will be starting ARV-471 trial (an oral estrogen receptor (ER)-targeting PROTAC® protein degrader), with Ibrance.
SCRI called this morning with the one trial that had a spot and will allow IVIG. https://clinicaltrials.gov/ct2/show/NCT04072952
Pharm site estrogen-receptor I am encouraged that they are studying my specific ESR1 mutation.
The trial intake nurse said they are still in dose escalation phase. They are proposing cohort 6 (not on the NCT page) to be a combo trial with Ibrance. Dr. Hamilton said that even though I failed on Verzenio and the CDK 2/4/6, combining the ARV-471 with Ibrance provides a "different backbone" and can be more effective together. It is the only open spot. It is a new arm and they won't know the dosage of either drug until next week. Usually they don't start Ibrance at the highest recommended dosage in trial doublets according to the nurse.
Trial Schedule – Paperwork, bloodwork and biopsy Dec. 14-15, Start the Trial drugs on Dec 21. Bottom line – I think this trial SERD is a good option to give a breast cancer drug one more shot and push chemo down the road. I will know in mid-February if it works. I see my local MO today to see what he thinks.
Dee
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Dee, fingers crossed for this trial for you!
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Wow, Dee, that WAS fast. But I'm so happy that your MO at Sarah Cannon is looking out for you and found this one slot. Best wishes for success on this trial.
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Dee this is fantastic news and very exciting for lots of people including me. I am 4 years plus stable on I/L (scan result today) and was talking with my Onc about what next when I have to change. We both agreed a SERD and stay on Ibrance would be worth considering. My Onc runs trials and currently is trialing a SERD which I understand is going well. Wishing you great success and an easy time on this trial
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Alabama Dee - how great that they have been able to line up a promising option for you so quickly.
BevJen - I started off with ductal breast cancer. My other mets have been in more usual ductal places - pleura & liver. Fortunately they seem stable right now. I've been doing this so long that I can now field a volleyball team with my former/current oncologists (7 so far). I moved a couple of times, one oncologist retired, and I've had two clinical trial oncologists. It now makes for easy 2nd opinions:) I have been fortunate as my oncologists have all been supportive in my search for the best available treatment, and have helped with transitions.
I just wrapped up my call with my oncologist. We're going to try for the abemaciclib route. I didn't even have to push...it was on his list already. Otherwise, he was leaning towards a "gentle" chemotherapy (eribulin or even CMF) as he doesn't want to layer on the toxicities too fast.
Have a good weekend everyone. Stay safe.
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NewGardener,
Yes, you've certainly had your share of oncologists. I'm only on my second oncologist with a third who I consult periodically.
Well, I think that's good news about abemaciclib/verzenio. I really think I'm going to ask my MO about that in January, because it's likely I will be changing treatments then based upon my rising tumor markers. I also have a CT on Dec. 23. You should read the Verzenio thread -- they have some good suggestions about potential diarrhea such as the use of Metamucil or Fiber Con, which I never would have thought to do. (I assume they sell those products up in Canada, but if not, I think they are psyllium-based so they are also used if you have the opposite problem -- but a number of the folks on that thread say it helps a lot with the big D.)
Good luck on this treatment. Maybe we'll be on it together and we can compare notes.
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BevJen - Thank you for the tip about the Verzenio thread. We definitely have Metamucil here, I don't recognize Fiber Con. I do hope you don't have to change treatments too soon.
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Wow, everybody seems to be in a pretty good space here, starting with Dee (!!!0 - this seems a better fit than the CDK2,4,6 for ESR1 mutation..
Chico- Waving hi to you!! Congratulations on four big years, party time!!
All this chat of Abemaciclib reminds me of Luce, who was on it very successfully as monotherapy- Luce, are you still taking it?!
Maybe we can get one of these SERDs approved so we can do secondline Abemaciclib-SERD without a clinical trial? Hope there is news soon, SABCS starts Tuesday...
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Dee so happy for you!!! I hope this is the ONE!!
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Today there was a report on a Her2 peptide vaccine (GP2) developed at MD Anderson that has been in phase 2 trials. The vaccine induced patients to generate their own anti-Her2 antibodies and completely prevented recurrences in a group of early-stage high-risk HER2-positive patients, reporting at a follow-up of five years (DFS 100%, compared to 89.4% for the control group). They will be initiating a phase 3 trial in 2021, again in high-risk early stage patients. They also had evidence of efficacy in Her2-low patients, however this group was not treated the same as the Her2 positive group (which were also given herceptin) and so cannot be compared directly. Stock in the company (Greenwich Life Sciences) went soaring today.
https://www.businesswire.com/news/home/20201209005...
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trial update-
I have had too many lines to be in the ARV-471 with ibrance arm of the trial but they found a spot in the single agent arm. Forgot to ask the dosage.
Entrance requires a echo cardiogram, bone scan and biopsy. Doing all that next week.
Hope this is the one to get some response.
Dee.
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Good luck, Dee. Wow, is this all through Sarah Cannon? They really seem to have their act together.
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Good Luck Dee!! Where is Sarah Cannon located TN??
Curious...thats great...for...HER2+....
. But us HER2- seem to always be left out in the cold...0 -
Nicole, They say Her2 will be first to be cured, whenever that comes. Maybe by preventing recurrences in the first place. But whenever there is success, there will be a template they can adapt for the rest of us. If for no other reason than we are just too big a market to be ignored :-)
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Cure...you mean HER2+ right?
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BevGen, Nicolerod
Sarah Cannon is my research center in Nashville Tn. Only 2 hour drive for me. They have a lot of MBC trials for ER+, her2+ and triple-
I had to press hard to get them to take me at first because they wanted to disqualify me from all trials due to my IVIG infusions. A trial intake person at MDACC actually helped me get in to SCRI. Once I got in, they have been great.
I see my study doc Erika Hamilton, about once a month- her assistant the other times. The trial nurse is who I stayed in contact with online during the last trial. He was great and said I should get him again for this SERD trial.
Dee
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Yes, Her2+... I posted this already in another thread (liver mets thread) - Dana Farber is planing a clinical trial to go for a cure for Her2+ stage IV treatment naive patients... There's a drug-scheme already in place. As you know, Her2- tumors are also not homogeneous, and her2+ is one of the known escape pathways for this population, and with Her2+ drugs that have a good bystander effect, Her2- will also benefit a lot, maybe even be cured in the future. Another big data in Destiny-Breast-01, as trial goes on - PFS goes up to 19.4 months, and DOR to >20 months after average 6 PREVIOUS LINES OF TREATMENT. That is simply... wow...
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Thanks, Saulius!! Finally something exciting from SABCS . It seems anybody w/early-stage HER2-positive should want that trial, just a vaccine with some herceptin. Could there be some benefit to metastatic HER2 patients or to HER2-low (HER2-mutant) ER-positive cancers?
What about that new universal cancer neoantigen they found last year- is anybody making a vaccine against that?!
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Also, they updated results from a trial of Enhertu (ADC targeted to HER2) together with immunotherapy (Nivolumab)
Preliminary efficacy results for 48 evaluable patients found that patients in the HER2 positive cohort (n=32) and the HER2 low cohort (n=16) showed a confirmed objective response rate of 59% and 38%, respectively. Disease control rates of 91% and 75% were observed in the HER2 positive and HER2 low cohorts, respectively. Median duration of response has not yet been reached in either cohort.
(meaning that, for Her2-low patients, 38% saw tumors shrink and 75% got at least stable disease with this treatment. Majority in this trial had four or more prior treatments) Looks good but this is phase 1 with no comparison arm so they can't say how much the immunotherapy is boosting the response
https://www.businesswire.com/news/home/20201209006...
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Thanks for all that info Cure-ious and thanks for putting it in "layman" terms for us! You are such a blessing!
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I was just offered a trial from MDACC. It is an antibody- drug conjugate. I'm not familiar with this class of drug. Anyone here offer some light? Cure-ious??
VLS-101 is an antibody- drug conjugate (ADC) that targets receptor tyrosine kinase-like orphan receptor 1 (ROR1) on cancer cells. https://clinicaltrials.gov/ct2/show/NCT04504916There is no qualification to see if patient cells express ROR1. It has a 1 week flush😳and very few exclusions. Only 4 weekly trips then just every 3 weeks. It is an infusion.
FYI-I am going with the SERD trial at SCR, but its good to know the MDACC tumor board actually found one for me. This trial may be an option in 9 weeks if I fail the SERD. I let MDACC know I will be in touch.
Dee.
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Dee wow that you got offered another trial your doctors are awesome!! I don't have any answers to your questions but hopefully Cureious will chime in.
So ladies I had a question...and I am going to cross post... but I read in a facebook group that if a person is ER+ PR- HER2- they are likely to go to Triple Negative..... That is what I am and I am pretty concerned now about that. Did you all hear anything like that? Also ** there were women on there and more than a few that this actually happened to
My hope was actually that I would eventually become HER2+ to get herceptin and all the great life extending drugs that come with HER2+ ...I geuss that will not ever be a real possibility now...especially since when I was diagnosed stage 4 and found out I am PR- my HER2 was 100% negative... NO positive.... 0 -
Nicole, I wouldn't say it's likely but it's relatively common. Going positive is more rare but still not zero chance.
In this study, 2% of women went from HER2- to positive https://www.ncbi.nlm.nih.gov/pmc/articles/PMC67693...
so yeah, not likely but hope floats until it sinks. I too would love a switch to HER2+
Oh & about losing the ER+, this study said that none of the Luminal A became triple neg, ~12% of Luminal B did. SO it's not like it's a given that you will lose the ER+.
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wow thank you Moth...you really gave me a sigh of relief
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NR,
When my liver mets were discovered in 2016, I was ER+ (66%), PR-, HER2- (IHC showed 1+).
With progression in 2020, I became ER+ (strong at 96%), PR+(weak) and HER2- (IHC 0).
So..just..crazy. Who knows what next bx will show.
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Yes...so my 2014 Stage 0 I was 100% ER+ 85% PR+ HER2- 2019 95% ER+. 0%PR+ HER2-....
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Well for that matter, when we biopsied my lung met it's faintly ER+ so I've gone from triple neg to maybe a bit ER+ and starting letrozole next week. It's a weird disease ....
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I found this article about the trial drug company for the MDACC trial I was offered. Sometimes when you know the story behind the drug you get an eye opener to future possibilities.
Merck inks $2.8B VelosBio buyout to snag anti-ROR1 ADC
The trial includes ER+Dee0 -
Dee,
That does sound like an interesting trial. Unfortunate that it's only being offered at MD Anderson. I just read the trial writeup on clinical trials.gov.
I wonder why they don't test first for that ROR1 factor?
Hopefully, they will expand this trial at some point. It sounds promising.
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