Are you currently (or have you been) in a Clinical Trial?
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Grannax, Google MD Anderson clinical trial then the trial number and it will bring that page up.
I checked it out because I have the same mutation. I was on ibrance and letrozole for 2 years so that looks very similar.
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grannax
https://clinicaltrials.gov/ct2/show/NCT04256941
It is at MD Anderson. It is all the drugs I’ve been on but in different combos. Don’t think I will qualify since it is not a new drug
Dee
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Honestly, if that trial would have just included a third arm of adding faslodex to the AI and the CDK4,6 inhibitor, that could have potentially been a game-changer
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cure-ious
I think they are just trying to prove that ESR1 mutation is really resistant to AI’s. Tried all 3 of the ai's after 1st chemo. Terrible side effects.
I did verzenio and faslodex as 1st line metastatic. Had some necrosis but also growth.
On Faslodex again with afinitor. Doing OK scan is next week
Wish I could have got on the other ESR1 trial, but it limited prior chemo/lines to only 2.
Dee
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Hi Dee, Just hang in there, there are reports that some of the newer SERDs work well on ESR1 mutated cancers, so if you can't get into any of those trials now, hopefully they can finish up and get these new drugs FDA approved asap; it seems like these have been 'up and coming' treatments forever!
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i have no idea if capivasertib is of interest to anyone here (it's not particularly interesting to me because i don't want to go on an AI). fluttered into my inbox in the latest lancet.
https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(19)30817-4/fulltext
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Wow, Luce, thanks for that report!
So, they report a phase 2 study from Mar 2015-2018 which showed that adding the AKT kinase inhibitor Capivasertib, to Fulvestrant, worked for an average of 10.3 months (remember, half go longer, half go shorter than that), compared to 4.9 months on Fulvestrant with placebo. Preliminary data suggest also an overall survival advantage but its too early to get statistical significance on that point. Definitely increased toxicity (blood pressure, rash, etc) and 40% of these phase 2 patients had to do a dose reduction, although that did not seem to affect their response to the drug.It did not seem to matter if patients had a PI3K mutation or not. Heading for phase 3.
Here is the curve for PFS, you can see that at least some got 30+ months on the drug
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Cure-ious, on February 18 you asked, “Also Shetland, are you taking Celebrex or some other NSAID? these are anti-PI3K drugs, give an overall survival advantage to all with PI3K mutant cancers (I know I'm a broken record about this, but don't want people to forget)“ Thank you for this. It seems to me that the best thing for me would be to block three pathways at once: PI3K, ER, and Her2. My current trial addresses the second two with fulvestrant and neratinib. There is no way anyone will give me a TORC/PI3K inhibitor also at this point, untested. But when I have gotten the diarrhea, nausea, and vomiting under reliable control, I will ask about a NSAID. In the meantime I do have a list of foods that are natural PI3K inhibitors that I can emphasize in my diet. I do fear that having now acquired a PIK3CA mutation, the cancer will be resistant to the drug for the Her2 mutation. But this is my best shot right now. By the way, I have no ESR1 or other mutation to blame for resistance to endocrine therapy. It must be the Her2 mutation.
I met with my onc, onc NP, and the trial nurse at the same time this week. It was great because my onc outranks the trial nurse and was quite confident in prescribing the gut steroid budesonide and having me try again, second time at 120 mg (3 pills) of neratinib, which is half the original dose. They said to be aggressive with the anti diarrheals imodium and lomotil, but I find that with budesonide I have no diarrhea! Hoping that today's prophylactic zofran and scopolamine patch will keep the nausea and vomiting away. This is my third try and I know Imust not have any more weight loss or dehydration.
SUMMIT trial: fulvestrant, Herceptin, neratinib
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https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5736021/
Phytochemicals and PI3K Inhibitors in Cancer — An Insight
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3775843/
Inhibition of PI3K/Art/mTOR Signaling by Natural Products
My Selected PI3K/Akt/mTOR Inhibitors in Food:
Apigenin — oranges, apples, grape, cherries, onions, parsley, broccoli, green peppers, celery, tomatoes, wheat sprouts, barley, tea
Benzyl isothiocyanate — cruciferae e.g. garden cress
Capsaicin — chili peppers
Curcumin — turmeric
Diallyl trisulfide — garlic
ECGC — green tea
Ellagic Acid — strawberries, blackberries, raspberries, walnuts
Fisetin — strawberries, apples, persimmons, grapes, onions, cucumbers
Gingerols — ginger
Indoles — cruciferae e.g. broccoli, cauliflower, cabbage, Brussels sprouts
Luteolin — celery, peppers, rosemary, oregano, thyme, peppermint, olive oil
Phenethyl isothiocyanate — cruciferae e.g. cauliflower; olives
Piceatannol — grapes
Quercetin — red grapes, apples, green tea, buckwheat tea
Resveratrol — red grapes
Vitamin D
Avoid insulin spikers including caffeine
My Summary by food group:
FRUITS
Oranges, apples, red grapes, cherries, persimmons, strawberries, blackberries, raspberries
VEGETABLES
onions, garlic, parsley, chili peppers, sweet peppers, celery, tomatoes, wheat sprouts, cucumbers, olives, cruciferae
HERBS & SPICES
Peppermint, ginger, turmeric, rosemary, oregano, thyme
OTHER
Walnuts, barley, green tea, buckwheat tea, peppermint tea(?), olive oil, radish seeds, nigella seeds (?)
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Right, but Celebrex is a powerful inhibitor of COX2, which is turned on by PI3K and used to push for cancer cell growth, so what I was saying is that, in addition to being an NSAID signaling, it is a strong inhibitor of PI3K; at least that's why I take it
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Shetland,
Glad to hear that you had the big group meeting, and that your oncologist is taking the reins. I hope that the new focus is successful for you on this drug.
Thanks, too, for the PIK3 food list. When I read your first post, I was wondering what you were eating, and then you followed up. So thank you for that. Those of us who have that same mutation appreciate it!
Good luck on this new approach, and hopefully this will be your drug.
Bev
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Thanks so much for this information Shetland, and I'm sending as many well wishes as I can muster out your way!
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Thrivingmama,
I'm on the Sacituzumab Govitecan trial at UCSF. Scheduled to have my third infusion on Thursday. Had to postpone treatments for awhile because of terrible mouth sores probably brought on by an immune-response to Keytruda. Took some huge doses of Prednisone to get rid of my mouth sores but it worked and I am tapering down.
Haven't had a scan yet to know if it is working.
Hugs, Susan
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Shetland, thanks for the list of PI3K inhibitors. I had no idea all those foods and some supplements had inhibiting properties.
Susan, I hope this new trial goes well! What class is that drug in/what does it do?
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metformin inhibit mtor and Pi3k. Watch out if you have BRAF mutation since in that case, metformin can upregulate VEGF. VEGF inhibitors would fix that problem in that population.
Aspirin inhibits Pi3k.
There’s a rodent study that shows that perhaps Celebrex ought to be discontinued prior to surgery, and more cox-1 (rather than Cox-2) be inhibited.
Article on resensitizing to CDK 4/6 inhibition, apropos of nothing:
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Understood, Cure-ious. I will talk to my onc about Celebrex at my next appointment. I guess we could find a reason for me to take it?
Of course, my food list is one of those can’t hurt and might help things!
Susan, best of luck with your trial. I am so glad the steroids got rid of your mouth sores. Having mouth sores can make one truly miserable.
My re-start (third try) is going well. Half the original starting dose of neratinib, along with budesonide and Zofran 8mg is my winning combo. Just a little loperamide on some days. My CA 27.29 did not really signal the last progression as we had expected, so I am not sure how reliable it is at this point. However, I can’t help feeling optimistic that it went from 22 down to 8 in the last month. And that is with me actually on the drug only 2/3 of the time. I consider 14 my baseline; anything above that is worrisome. I think my first scan since starting will be in about six weeks.
One thing I did not expect, that surprised me on trial day one, is that I have to go to a different building that is just for research subjects. So I have to develop relationships with a whole new set of nurses, clerks, etc. It kind of shook me up, especially since unlike the nurses in my onc’s clinic, the nurses there do not give faslodex shots all the time. I had to advocate for myself to get the person who was most confident and experienced to come and give me the shots. She has been very kind and skillful.
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Supposedly-new trials:
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hi Susan - that's great that you were randomized into saci. Sorry to hear about the mouth sores, I hope that continue to improve. hopefully it works great for you
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Good Afternoon everyone, just a quick update on my trial. My third injection had scheduling problems, so was late by 5days. Had the 3rd of 5 today. Measurements of tumour are the same as 2 weeksplus 5 days ago. Injection was also not as painful this time as last 2. I hope the next injection and infusion of keytruda in 2 weeks will not be effected by the covid 19 virus. I know the weekly appointments will be cancelled and a dr will call to see how I am instead. Hope everyone is well and stocked up.
Kathy
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Thanks for the update, Kathy- I'm so glad you are getting the meds now and boosting up your immune system! Hopefully things calm down soon but I know those of you in clinical trials must feel extra-vulnerable about getting your treatments on time!!
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Kathy, I'm so glad that you finally got your third injection and that it wasn't as bad! And the non-progression is a good sign! I hope that all of us can get our treatments on time.
Take care everyone!
Katty
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I was randomized into a trial for metastatic TNBC. It's NCT04177108 and they're calling it IPATunity 170
I'm in the arm which is atezolizumab and paclitaxel, plus either ipatasertib or placebo.
Atezolizumab is an immunotherapy.
Treatment starts tomorrow. I'll report about s/e. Apparently diarrhea, mouth sores, rashes, and high blood sugar are the common ones.
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MOTH
great news. Keep us informed.
Dee
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This is exciting, moth. Don’t let those side effects get out of hand. Report to your onc and get meds if you need them. (Says the voice of experience.) Is the trial location where you have been treated up to now?
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shetlandpony - yes it's the same place I had treatment for stage 1. I've been told to report everything quickly and even have the direct line for the after hours on call oncologist who can access my file digitally and advise what the trial sponsor allows for symptom relief if something comes up that is not handled by the scheduled meds. I'm not feeling very stoic at all atm so I will be calling and complaining about everything
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Moth- Yay!!! I’m so glad to hear you got into the clinical trial. For mine I keep a daily log of how I feel and what I took....they will want specific dates/info when you had X, Y, Z Side effects. Please keep us posted. Take a deep breath, you can do this.
An
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Moth, that sounds like a good plan.
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Thrivingmama,
Thanks so much for the supportive words! My mouth is 100% healed now. I've been able to eat and gained back 5 of the 11 pounds I lost. Feeling good. Tapered off of the Prednisone.
My only problem is that, strangely enough, now that I'm off of the steroids, I can't sleep! I was sleeping 9-10 hours straight through when I was on 60 mgs of Predisone. From 10mgs down to 0, I haven't been able sleep. I probably got 2-3 hours last night. Haven't ever taken a sleep aid. Any recommendations for OTC sleep aids?
Hugs, Susan
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0.3 mg of melatonin has been shown to be best dose for sleep. i take much higher doses for breast cancer. but if you want to improve sleep, this timy dose is probably best.
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Diphenhydramine (benadryl, etc) is a popular otc sleep aid. My wife and I have been taking ashwagandha for a couple of months now, and it seems to help both of us sleep. I think it helps reduce anxiety during the day and night. We take one in the morning and one at dinner.
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