Are you currently (or have you been) in a Clinical Trial?
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A paper in Nature from researchers at Stanford & UCLA reports that T-cells engineered with an IL-9 receptor are superior to natural T-cells in fighting tumors and can competitively take-over the immune system, meaning that they could eliminate the need for protocols that use chemotherapy and/or radiation to get rid of the immune system before introducing engineered T-cells in CAR-T or other immunotherapy regimens.
https://www.sciencedaily.com/releases/2022/06/2206...
https://www.nature.com/articles/s41586-022-04801-2
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Good afternoon. What are the treatment options for the PIK3CA mutation? I got my test yesterday and this is the result... I understand that the frequency of the appel is negligible?
What does it mean? I'm on ribociclib/letrozole and my doctor wants to change the protocol to piqrey/faslodex. But is it worth it? Or to hand over analyzes on other mutations? Just a little grown tumor in the mammary gland.
Moreover, the main tumor of the mammary gland, which was back in 2019, has decreased and is stable to this day. But next to her, two incomprehensible gizmos became visible on her chest. And I don't know what it is.
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Had my CT scans yesterday, my third since being on ARX-788. It wasn't good. Progression in my lungs and one of my two liver tumors. Haven't spoken to my MO yet about it but I think it is likely I will have to switch treatments. The thing is, I've been feeling great. Taking four dance classes and five yoga classes a week. Walking the dog in the hills of SF every day. Grateful for the five months I've been able to build my strength back but wish it could have lasted longer.
Been combing through Phase I trials and haven't seen anything very promising that is within driving distance. Would love to hear any suggestions about promising trials.
Hugs, Susan
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Susan are you trying to get into the T-Cell NIH trial?? I thought you were currently in a trial and the driug was working?
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Susan, Sorry to hear about the lung and liver progression. Maybe there’s a chance you won’t have a treatment change yet? It stinks that you’re feeling so well on the trial, and weredoing well but you may have to leave it.
I start my trial on Monday. Feeling hopeful it can work on both my liver mets and bone mets The bone mets (ER+) increased on my recent chemo and the liver mets (ER-) were stable overall. I have increasing nerve pain in my legs and have had to up my gabapentin.
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Results from CT scan on Tuesday are still showing stable, liver numbers are still going up but MO feels that the liver is probably being taxed by trial drug & chemo, TM's have been rising as well, so it will be interesting to see what they are next week. They have always been quite accurate for me but the CT shows very stable.
I am the last patient on the trial drug & the drug co isn't particularly happy that they have to jump through so many hoops to keep me on it. They have no idea how many hoops I have to jump through just to be on the trial. Travel alone is 6 hours each way.
Health Canada, Stand up to Cancer and BC Cancer agency are finally working together to keep getting the drug to me. Tomivosertib along with Taxol or Abraxane has been approved & should be available soon as the trial met their goals several weeks ago. I will be starting cycle 16 next week. SE's are getting harder the longer I'm on it, neuropathy in the week of chemo is a bit brutal & I'm loosing my hair for the fifth time, but I'm still able to get out in the garden and do what I love so I will take. 7 years with bone, liver & retinal mets. 14 years with bilateral breast cancer.
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gg27, So happy for you that you are still stable after 15 cycles! I hope we will be able to get access to Tomivosertib in the US.
rosie24, What trial are you going to be on?
Nicole, ARX-788 worked great but didn't last long. My first scan was great, second mixed, third unequivocal progression. I've only experienced tumor shrinkage on three treatments, Tamoxifen, Piqray, and ARX-788 but all three only lasted for five months. At this point, I'm grateful to have had five months of feeling great. And, despite the progression, I still have a lower tumor burden than when I started the drug.
Sent all my then-current records to the NIH for the T-cell trial but my MO said it would be too difficult given the ~4 month period that they need to create the medication.
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Susan (and others here), this is the trial I'm going to be on:
https://clinicaltrials.gov/ct2/show/NCT04972981
I'm the first one on it at my location. Not sure I'm crazy about that, but I've jumped through the pretesting hoops and I'mready to get going.
GG, Great news on being stable. That's quite a drive to your trial location. Do you make it an overnight pre and post treatment? Do you still have your S2000?
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Susan, sorry to hear about progression, that is always so hard to hear & to try something new yet again.
Rosie, I have been the first one on a couple of trials & it's very scary, not sure I would do it again. I was first on the alpelisib and they wouldn't let me mitigate any of the SE's so I only lasted 10 days on it. If only they allowed what they allow now, I probably could have tolerated it longer, but I wish you all the best as the other 3 I've been on have been very good to me.
Yes, we still have our S2000, the weather has no been very condusive to getting out top down but fingers crossed, soon. Our travel luckily isn't all driving, 40 min drive, then sitting in a ferry line up, 2 hours on the ferry & then an hour or so driving. We stay with good friends overnight if we have to, but we have done there & back in a day, a long day but sleeping in your own bed is the best.
Savaloko, I can't say if it's worth changing treatments or not, but I wouldn't want to be rushed into changing unless we knew for sure that it was something. Could it wait til the next scan?
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gg27, interestingly, the Cancer Agency is no longer testing for PIK3CA as they found that Alpelisib didn’t live up to expectations so you may not have missed out on much. I recently had a biopsy and my MO is holding tissue in reserve as he indicated there was nothing targeted to look for at the moment. Remind me… what is timoverstib targeting? I’m looking ahead just in case Capecitabine fails (on it for the third time after back to back fails - TM looks optimistic but some liver pain - scan on Monday so will know then). List of options is very short here…
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Susan they allow you to do chemo while u wait the 4 months
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Susan, I'm sorry to hear you have to change again! In addition to the NIH Rosenberg trial, I like the TREM2- Keytruda immunotherapy trial. TREM-2 is a monoclonal antibody that gets rid of macrophages that surround many solid tumors and prevent them from responding to immunotherapy. For that reason, this trial is open to ER-positive MBC in addition to TNBC. The trial does not limit prior treatments, but does say you had to have progressed on some prior immunotherapy trial "if indicated for the tumor type", which I think does not apply to us since we don't have other immunotherapy trials open to us. The closest for west coast folks would be OHSU in Portland or Mayo Clinic in Scottsdale AZ.
Update: The trial has been going on for a year, and they presented an abstract at ASCO 2022 (third link below). They treated 28 people with a variety of different cancers types; 15 had TREM-2 antibody alone and only 13 had TREM-2 plus Keytruda. The TREM-2 monoclonal appears to be safe without major SEs. Of these, 11 had a stable response, ranging in duration from 9-42 weeks; 6 subjects with stable disease have now progressed and 5 remain on treatment.
https://clinicaltrials.gov/ct2/show/NCT04691375
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Sadiesservant, Honestly I can't remember what the trial drug is targeting. All I remember about that time is all the blood draws over 2 days (I think there about 15+ as they were every hour) and 2 liver biopsies. I'm not even sure I ever had that information but I'm sure you can look it up when the time comes. I think it will be a long time before BC Cancer covers it as the trial is closed.
good luck on Monday. I know how you feel, list of options is getting short for me as well, but MO says we will circle back to things that worked well for me in the past & see if they do anything for me.
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GG, I am glad to see that you are still doing well in the trial, even if you are the lone participant left. I know you don’t post often these days, but it is always good to hear from you.
Sadiesservant, I hope you have good results from Monday’s scans. Do you know how soon you will receive the results? Waiting can be hard.
Lynne
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Thanks all. My MO is pretty responsive so I imagine I will hear from him as soon as the results are available. It’s elms to be taking a couple of days so I expect Thursday or Friday. Hopefully worrying for nothing. As to circling back, so far only endocrine treatments and Capecitabine have been effective. My MO feels I’m now endocrine resistant but I’m hoping, based on the biopsy results which came back as strongly ER+, that I can squeeze out a couple more hormone based treatments.
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rosie24,
Is this a variant of ADC Therapeutic's earlier drug, ADCT-502? That trial was terminated due to high toxicity. Hopefully, they went back to the drawing board after learning something from that trial.
Please keep us informed of how it is going. Hope you do well on it!
Hugs, Susan
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Thanks for the heads up on the earlier ADCT trial. I don't know if they're related
Edited to add: Susan, I read up on the earlier trial and the same chemo drug will be used in my study, PBD for short. This one is targeting TNMBC, along with some other cancer types. I do hope they've made some progress since 2018 when the earlier trial was stopped. I didn't see whether the antibody was named.
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Cure-ious,
Thanks for the advice on PY314! Portland, OR is a plane ride away but not too far. I had it on my list of promising trials but ranked lower down because there is no CA site. I may be able to get on Enhertu soon but will talk to my MO about PY314.
Hugs, Susan
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Susan,
My doc is trying to get approval for compassionate use or off label on enhertu. So confident is she that I've got my first infusion scheduled. I have two Erbb2 mutations but show up as HER2 0. Just a thought.
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Bevjen,
Appreciate your information. I feel pretty confident she can get it done. She got me onto Keytruda and Trodelvy though those were only approved for TNBC. The results are already out that Enhertu works on HER2 low and I am HER2 2+.
Crossing my fingers!
Hugs, Susan
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Hey folks,
Just a short update that my second set of CT scans were good enough to keep going on the enfortumab vedotin trial, although my oncologist will be reducing the dose for the second time. I'm still crazy fatigued and sporting the Pleurx catheter (fluid is down but persistent). I have to say this isn't my favourite treatment. But, hey, its keeping me going.
Key recap - enfortumab vedotin is an ADC (like Enhertu/Trodelvy) that is used in urothelial cancer and is now being tested in other cancers. I've now had 4 cycles (a cycle is 4 weeks).
GG27 - Great news that the tomivosertib is keeping you stable and gardening, but frustrating that it's now hard to get the drug. Hopefully we'll see the published results soon.
Sadiesservant - Hope the scan results from today are okay. FYI. My trial may be going on in B.C. https://clinicaltrials.gov/ct2/show/NCT04225117 Though I recognize I haven't given the drug a glowing review.
SusaninSF - I'm sorry that you have progression again and are back looking for your next treatment.
Rosie24 - good luck as you start your new trial
Everyone - thank you for your updates and sharing of information - I really appreciate it!
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Day 15 of cycle 15, Abraxane cancelled due to severe neuropathy in my feet. Nothing seems to be helping at this point. I've tried ice socks at chemo, acupuncture, cool water baths with massage afterwards. Dr's recommend keeping my feet warm, well, my feet are burning hot, so that's not happening. We'll see what an extra 2 weeks off does for me. Staying on the trial drug.
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GG27 that sounds horrible.
At one point can you just stop the Abraxane because of the side effects but stay on the study drug? Are they synergistic? Can they reduce your Abraxane dose?
I've been lucky with neuropathy - just pain and numbness but nothing like what you describe. And my feet are cold not hot. I had it during the 8 months I was on weekly paclitaxel, and it improved once I stopped but I do have it again on this trial.
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Just today the first SERD was filed for FDA approval, Elascestrant- they request priority review, if accepted then the drug could be available in doctor offices in about eight months. In the trial, Elascestrant beat Fulvestrant on ESR1 mutant cancers, however, they never released the data for non-ESR1 cancers, which makes this kind of a mess and so will be interesting to see if the FDA considers this as a drug for all ER-positive MBC, or just ESR1 mutant cancers, or maybe make them go back and do another trial? (surely not)...
https://www.medscape.com/viewarticle/975720
https://www.onclive.com/view/dr-lin-on-the-advanta...
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Cure-ious, forgive me for my ignorance but I thought this drug had failed or do I have it mixed up with another oral SERD?
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newgardener
I am already quite dose reduced on the Abraxane, down to 65% I think. The trial won't let me stay on it without either Abraxane or paclitaxol, I think I can take 28 days off, just shy of the 30 day cycle. I had anaphylaxis on paclitaxol 4 times, so not going back on that. I guess I'll see how this 2 weeks goes. Cold feet, OMG, I would kill for cold feet!!
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Cowgal, Elascestrant was the first SERD to finish its trial, and it was a positive outcome, if only barely. It's hard for these trials to show benefit because the SERDs are being tested as monotherapy, in second or later lines for people who already took AI and/or Faslodex with CDK4,6i- and the SERDs are being tested against standard-of-care, which in most cases would have been an AI alone or fulvestrant alone, for which there is no reason to think those would even work in that situation. In those conditions, those taking elascestrant got an average 2.8 months PFS, compared to 1.9 months for standard-of-care endocrine therapy. What really saved this particular trial was they had a subgroup with ESR1 mutant cancers, which do not respond at all to AIs, and are only weakly inhibited by Faslodex (which varies, depending on the particular ESR1 mutation). When they pulled out the data for the ESR1 group only, the results were better, 3.8 months PFS vs 1.9 months with standard-of-care. Because these ESR1 mutant cancers were included in the data for the overall group, this means that those with cancers that did not have ESR1 mutations did worse than the 2.8 months PFS, but the company did not tell us what their numbers were, or if the benefit was statistical. Hence, the discussion of whether elascestrant would be approved for all ER-positive MBC or just for the ESR1 mutant MBCs.
After this trial, several other SERDs failed their phase 2 trials, and it was pointed out that these trials did not specifically recruit an ESR1 subgroup. Therefore, the results from these trials may have looked more like what happened with Elascestrant in non-ESR1 mutant cancers, and any benefits they showed over AI/Faslodex alone weren't big enough to be statistically meaningful. But these PFSs are low because they are being tested as monotherapy, and the benefit is of course in combination with CDK4.6i or other targeted drugs. So we wait and hope the numbers with SERDs are big enough to pass muster in combination trials.
https://www.onclive.com/view/fda-approval-sought-f...
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A new study shows that in lobular cancers, a specific Her2 gene mutation (L755S) contributes to aggressiveness of lobular cancer cell growth. Interestingly, the same mutation did not have this effect in ductal tumors. They go on to show that this mutation is resistant to Neratinib but is very sensitive to the drug Poziotinib.
https://www.sciencedaily.com/releases/2022/06/2206...
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Thanks Cure-ious! so glad they are finally looking at some drugs for metastatic ILC.
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A recent Nature paper reports MBC mets are predominantly released and migrate into bloodstream during sleep (thanks to Luce for pointing out this paper!). Most circulating tumor cells (up to 80%) were present in nighttime blood collections, there was a large dropoff in CTCs collected during the day. Researchers are assessing whether this is true of all cancer, or is somehow specific to MBC.
"Our research shows that the escape of circulating cancer cells from the original tumor is controlled by hormones such as melatonin, which determine our rhythms of day and night (melatonin levels increase at nightfall and plays a role in turning on genes that are active at nightime)".. Levels of certain other hormones, like Insulin and glucocorticoids, are higher in the daytime than at night, and when the researchers introduced these hormones at night, they found a drop in the release of metastatic cancer cells. So its helpful to know that anti-cancer drugs are most effective during sleep.
The mechanism is not know, but one possibility is that it involves EGFR signaling, which is active at night and has been shown to stimulate metastasis. Studies are needed to look at the tumor microenvironment in day versus evening.
https://www.sciencealert.com/breast-cancer-spreads...
https://www.sciencedaily.com/releases/2022/06/2206...
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