Are you currently (or have you been) in a Clinical Trial?
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@cure-ious Yes, a lady in my trials FB group posted this study
that showed the monotherapy results. I think I did get lucky on the arm selection, so I'm trying to stay cautiously pessimistic. She also said that the 10% ORR didn't include those who stayed stable, so maybe this will work for me at least until something else opens up.
I'm anxious to start! I don't have scans until 8 weeks unless necessary earlier, but I'll post the process and side effects, etc. Prepare for the worst, hope for the best!
CBL
P.S. - I started taking 400mg of ibuprofen twice a day, so fingers crossed that helps. Thanks for posting!
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@bsandra Hi Saulius
Yes, it is interesting! I can't believe of the four locations, I'll be at one of them (of course they're not recruiting yet, :/) and my current trial doctor is the same as TTX. So I'm cautiously pessimistic about maybe having a shot at it. They're only taking 20 people - they've dosed two and have more screened, so I don't know about my chances. Maybe they'll expand it if the results are solid.
I think though many, many drugs have a good response with animals but can't translate it to humans. A friend of my mother's who had two boys with muscular dystrophy said they healed it in animals 12 years ago but haven't been able to make it work with humans. So again, cautiously pessimistic.
Good luck scientists!
CBL
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CBL and NewGardner, Is pelareorep an option? And CBL, any trial you are eligible for with a PARP inhibitor? Those were always only for BRCA1 mutant cancers but now they seeing it works in a broader population if combined with paclitaxel or PI3KCA/AKT inhibitors…
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@cure-ious I think I looked at the pelareorep locations and there was nothing close by, but I'll look for PARP inhibitors. The trial doc didn't mention one being on my list, but there could be one at a different local facility. I could (and would) go to San Antonio NEXT oncology, UTSW, or MD Anderson Houston (I'm in DFW area) if there were a super promising trial, but I'd rather not. Thanks for the info!
CBL
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oops, right I keep forgetting they are filing to do a phase 3, it is not in place yet:
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Dear CBL, yes, humans are unlucky in that sense - very small animals are cured, and large animals don't have to be cured as they get cancer but don't die of it. We are just right in the middle, and, as we are complex, we face many drug delivery to cancer sites problems but… science is moving forward and many cancers are already cured, so cures for mBC are coming, and are already happening in some limited cases. But just to make sure, again, not many drugs completely cure mice, just a few, and therefore TTX-MC138 is even more interesting! Hugs, Saulius
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So I'm supposed to start the trial tomorrow and they just called and said they don't have the drugs yet from the sponsor and they're expecting them tomorrow, but they could be late. No action on the tracking number…all it says is the label has been printed. Fabulous. I've been off treatment for 33 days and I'm freaking out as it is…to wait a few more days is annoying as hell.
Just ranting…it'll probably be fine, but I really didn't need this extra stress.
Big heavy sigh.
Will update when I know.
P.S. - yes, Saulius. It is interesting! I watched a video of the CEO yesterday and it was tested on a woman with MBC. He didn't say if it worked, but the drug was delivered to the tumors, so apparently that's a big deal. Yay!
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Dear CBL, these delays are always so annoying and bring more anxiousness, uh, I know it. But if you wait just a bit… imagine these drug particles walking through your body, singing tam tadam tadam, with minimal side effects, putting bad cells into the basket and throwing them into trash bin every evening, wouldn't that be nice, m?:) Hugs,
Saulius
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Home from Day 1: Drugs arrived around ten, all is well. Good news is my liver mets didn't grow in the month off treatment (whew!) and my liver numbers are still normal (but creeping up slowly) So far so good. I did ask about the other two trials just to have something lined up and will hopefully get that information this week. (the Aurora A inhibitor and the TTX). If I progress at the six-week scan, I can switch arms to get the immune booster drug, but unless they have some impressive data, I'll probably jump to a different trial.
@bsandra I love the visualization!
CBL
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CBL- What a relief on all counts!
What do you think about this trial? Keytruda, radiation and PARP inhibitor, for TNBC or ER-positive MBC.. only available at MSK tho
https://www.cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2021-03576&r=1
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Thanks, @cure-ious !
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I just saw that the trial VELA for blu-222 is now available near where I live.
There are 4 arms: blu-222 in monotherapy, blu-222+fulvestrant, blu-222+ carboplatin, and blu-222 +ribociclib+fulvestrant.
I'm wondering wich of the options is the better one, and if the oncologist have the power to choose, or the arm is assigned randomly?
Also I read on this thread that the cdk2i are better in combination with a cdk4 alone, not cdk4/6 right? Is there such a trial?
Anybody here did the VELA trial and have some experience to share?
Thank you
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@cure-ious i can't make your trial link working, can you please post the name of the trial, I like to give a look.
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Hi all,
Cureious wrote: What do you think about this trial? Keytruda, radiation and PARP inhibitor, for TNBC or ER-positive MBC.
I can tell you what I think. Just dx with new primary. TNBC early stage. Sounds like something I may use in the future. I've been thrilled with all the studies and progress made treating this sh*t. Treating this one with curable intent. Still no progression of the ER+ cancer since 2017.
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Gail, you're hysterical!!! What a great attitude you have about this…
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Pembrolizumab, Ablative Radiotherapy and Olaparib for the Treatment of Metastatic Triple-Negative or Metastatic ER Positive Breast Cancer
Trial Status: active
This phase II trial studies the effect of pembrolizumab and ablative radiotherapy in combination with olaparib in treating patients with triple-negative or estrogen receptor positive (ER+) breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Pembrolizumab is an antibody, like the proteins made by the immune system to protect the body from harm. Pembrolizumab blocks the protein PD 1 (programmed cell death receptor 1) that usually acts as a “brake” on the immune system. Blocking this protein is like releasing the brakes, so that the immune system can target tumor cells and destroy them. Stereotactic ablative radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Olaparib is a type of medication called a PARP inhibitor. PARP is a protein that helps repair damage to deoxyribonucleic acid (DNA), the genetic material that serves as your body’s instruction book. Changes (mutations) in DNA can cause tumor cells to grow quickly and out of control. But PARP inhibitors have been shown to prevent PARP from working, so tumor cells can’t repair themselves, and they stop growing. The combination radiation with pembrolizumab and olaparib may activate the body’s immune cells to travel to and attack and destroy other sites of triple-negative or ER+ breast cancer in the body.
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Wow this combination look like a crazy simultaneous bombing. I was waiting for something like this for er+.
I hope it will give good results, as there is no much immunotherapy out there for er+...
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Amel, It is a tiny trial, but my reaction was much like yours- bring on the bold combinations for immunotherapy in ER-positive MBC, at least try to get something going here.
Another gripe I have is that most of the new drugs offered in trials are combined with Faslodex, when trial after trial have shown that Faslodex is next to useless after CDK4,6i. Must be much cheaper to use Fas than an oral SERD or PROTAC as the endocrine partner…
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Two new studies in Nature are showing that the IL-4 cytokine is needed for long-lasting immunotherapy responses in blood cancers. The first paper looks at the CAR-T cells in Emily Whitehead and other long-lasting responders and note the presence of IL-4 marks responsive long-lasting cells. The second paper compared CAR-T cells engineered to express IL-4 with normal CAR-T cells (which do not), and found: "The mice receiving the combined treatment not only had a greater curative response rate (86%), but also showed improved survival even after their immune systems were re-challenged with cancer cells, thanks to immune memory."
Progress from studying exceptional responders! We need more of this…
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I'm realky struggling on deciding what to do, i feel like my liver is a little hard and enlarged (it never felt that way before), fortunately I was able to ptrogram an urgent mri tomorrow morning.
Before i got in too much trouble and get a liver feilure (that will exclude me from all trials) i want to decide what to do, and fast!
I'm eligible for blu-222, but I'm wondering if there is any cdk2 test before i jumping in, to know if this therapy will work? Or should I do a genetic test before to see if I have developed some other mutations? May be than Capivasertib could be an option...
My next onco appointment is the 16 of October, but if tomorrow the mri is going to be troubled i will ask to anticipate it as soon as possible.
Anybody have a suggestion? Anybody ever tested for cdk2?
What scarry me about the VELA trial (blu-222) is that I can't find too much about this med...does it really work? I would like to use it as a monotherapy, i'm not ready for chemo...
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Amel, Here is a link to a BLU-222 poster, and you can see there have been some good responses. However, in a situation as you describe, Enhertu ADC might be a stronger bet, and give you some time to investigate your options? Good luck!
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Ok thank you for the link!
About Enhertu I was her2 negative score 0 my last biopsy, i will see my status next biopsy...
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Oh, or Trodelvy, etc- I just meant any ADC with a strong record of success. I wish we had more help making these decisions!
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I got a mri and fortunately my liver is ok (not really ok but stable), I'm so happy I just can't believe it. They were my muscle I was feeling, not my liver...silly!!
But I was so scared that I contacted to make liquid biopsy, i contacted the oncologist responsable for the trail VELA, and overall just took a huge panic attac.
Aniways now I know that I'm eligible for the trial VELA at progression , and this give me a little bit of mental rest.
And in the meanwhile i will keep an eye for other trial as well.
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Great news @amel_83 ! What a huge relief. Wishing you continued stability and peace.
CBL
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Thank you! Hugs 😊
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CBL, Wow, I was just reading TTX-MC138, had also not heard of it before, it does look promising; is there a link for the write-up for the new clinical trial? All I see is the prior Phase 0 trial, where they labelled the drug to see how it distributes in the body, and that trial is now completed. They said the new trial will open this quarter, sounds like it already has but on a small scale?, which, if so, is probably appropriate given its status as a first-drug-of-its-kind trial…
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Try this NCT06260774
There was also a video by the ceo I watched recently. I’ll see if I can find the link
@cure-ious1 -
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so interesting! wonder how long these particles persist, and how they are targeted to cancer cells, etc, etc- love that the approach is completely different from anything the cancer has seen or is likely to see, and that it is targeting miRNA rather than proteins…
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