hi everyone! I just wanted to reach out and discuss any potential new advancements in MBC treatments that you are aware of. I figured it would be a source of hope to communicate about them.
new meds in the pipeline! : hi everyone... - SHARE Metastatic ...
new meds in the pipeline!
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Hi there! The latest treatments that I am aware of are ERX-41, which is supposed to cure MBC, ErSO, which also is supposed to cure MBC, ERX-41 is going into human trials early next year and ErSO had a few hiccups but the last I heard, is they are applying for FDA human trials for next year. ERX-41 is promising a cure for both hormone positive and triple negative MBC and they are looking closely at it for HER 2+ as well. SERDS have been in trials for a while now and they have been promising approval by the FDA this year, and it keeps getting pushed out, so I'm not sure when they will be approved. Oral Fulvestrant has been in trials but I haven't heard anything new on that one. FES PET scans are out in many places, and in some still in trials....unfortunately I don't have any near me, and would assume then it is scanty to find. There is also a new CDK/7 inhibitor, Samuraciclib, that looks very promising and will hopefully go into human trials early next year as well. I know there are a couple of immuno therapy cross overs from other cancers that are being used for some MBC subtypes with specific mutations now, but the information is dicey on well they are working. One in particular is being used in the UK and other areas of Europe but just got banned in the U.S., and I can't remember it's name.....too many things to remember! I hope this helps, I have a CT and a PET scan scheduled for tomorrow, and my mind is scrambled and going in a million directions right now, midnight, and I still can't sit still. I'd love to hear from more people, and see what else is in the works!! It always seems too far away with everything, but I do know things are moving along with new meds.
Marvellous summary Ff13! Good luck with those scans… oh the nerves! Is the drug you couldn’t remember Piqray? X
Piqray is approved and running in the U.S. , and may actually be my next stop if more progression occurs. It is a PIK13 inhibitor, but not immono therapy, I think Keytruda is one of the immono therapy drugs being used and I still can’t remember the name of the second one that was blocked by the FDA. My mind is in knots!! When I remember it I will post it here. Oh boy 2 scan morning for me, yikes!
Thanks for all this; its very encouraging. Its great to know that there are new treatments and potential cures in the pipeline. We all just have to stay alive long enough now to benefit from the new treatments - that's my plan anyway!
Thank you for all of the wonderful information about possible new treatments. Good luck with your CT and PET scans. I hope you receive good news!
Thank you! I’m trying so hard to stay calm! But not doing a very good job of it!
Good luck tomorrow! Sending the positive thoughts!
It is hard to stay calm. Scanxiety is a very real emotion. I have been lucky that my doctor's office usually calls me the next day with results. However, the time leading up to the scan and scan day are nerve wreckers for me, too. I try to stay busy though. I play golf or work out the day before making sure it is more than 24 hours before the scan so as not to increase muscle uptake. The day of the scan, which I usually schedule for the afternoon, I look through photographs on my computer and delete ones I don't want or read a good book or do some other project that does not require strenuous activity. Sending hugs and prayers.
Thank you! I'm home now and only the CT was able to be done, and the PET was rescheduled for the 15th in the morning. Somehow, something was wrong with the PET machine.......so a second time I go. It was a waste on the strict diet yesterday and what miffs me the most was not being able to have coffee or tea all day to sip on, bah!! I'm so high on Lorazepam from the CT, I can't muster up much energy about the whole thing, I'm sure I will later!!
I'm glad you are home, but so disappointed for you. I would be upset, too. Knowing you can't have carbs, coffee or tea makes you want them even more. When I have my scan done, they do a CT and PET at the same time with the PET scan machine. They give me the IV of glucose for the PET part and a fizzy drink for the CT part. That way they can see my organs, too. I really like being able to do it that way. Hope you get good CT results and that your PET scan goes well on the 15th. Praying for you.
Thank you!! If I have it all done at my hospital they do it all together like you were saying. My doctors office has the CT and PET machines separate. Unfortunately, I always choose the doctor’s office over the hospital because of Covid. Yes, this was very disappointing!! Oh well, time to wait for some results and then the PET again!
I thought the drink was the glucose. What I get by IV for the PET is radioactive isotopes. You don't get that?
I get glucose in the IV and some type of a lemony flavored drink for the CT part. The first time I had a PET scan they only did the IV (it was a different facility). The new place does both a PET and CT.
Turns out we are talking about the same thing. The glucose in the IV has radioactive materials. Here is a description of a PET:
Before your PET-CT scan, you will get an injection of a small amount of a radioactive sugar called fluorodeoxyglucose-18. This substance is sometimes called FGD-18, radioactive glucose, or a tracer. The cells in your body absorb sugar. Areas that use more energy pick up more of the sugar. Cancer cells tend to use more energy than healthy cells. The PET scan shows where the radioactive tracer is in your body.
Yes that is correct! I am not sure what is in the drink other than it is radioactive and tastes pretty good. I don't mind that at all and it gives them a good view of the organs. The IV is a pain for me as they have a hard time finding a good vein to put it in. It mostly ends up going in my hand as my arm veins roll!
I think the iv is the radioactive glucose, and the drink is contrast. (I have great veins. They stick up, very accessible and don't roll.)
That sounds right Tammy. Glad you have good veins, mine have always been small and only one arm can be used as I had a mastectomy on the other side. Even though they only removed 2 lymph nodes at the time (which was 9 years ago) and I have never had lymphedema, they won't use that side. Of course, that arm has the good veins!
hi. so just an fyi. it is fine to use your mastectomy side arm for IV's, even if you had lymph nodes removed. the 'not using' rule of thumb is old school but will take a long time before nurses accept that....as that is how they were taught. the only determining factor that precludes you from using that arm is if you have lymphedema. I was an IV nurse for 3 years and received specialty training....peripheral IV's, ports, central lines, picc lines etc. so I am confident in passing this along. I too had a mastectomy on R side and lymph node removal...but no lymphedema....just like you. I tell my nurse that it is fine to use my R arm for IV's if they see/feel a better vein. don't expect you to change what you have been told but just sharing some intel😉. and sometimes the best veins can't be seen but can be 'felt' (palpated).
carole XO
Thank you Carole. Some of the nurses say it is okay to use, as long as they don't put a tourniquet on to make it pop up, but my oncologist says no they cannot use it. The veins in my hand are so tiny that I worry that one day they will not be usable either. I don't want to do a port as I play a lot of golf and am afraid it would interfere with my ability to do that. I wish they would use the right side as it would give them more options.
hi again. no disrespect intended to your oncologist. don't understand his rationale but doctor trumps nurse....lol. was only trying to help. wishing you continued success with the 'one' arm. so nice you have a hobby that you love.
best wishes....
carole💛
No worries, I also think it would be okay to use the other arm or at least the other hand maybe just for blood draws, but since she says no I know her nurses won't use it. So I guess I'm stuck with just using the one side. Thanks for your well wishes!
I always have an issue with this subject because I had many lymph nodes taken out, well 14 on left side and 4 were positive, 2 Sentinel and 2 aux. Did not have any problems, until I lifted something heavy after nearly six years knowing I should not and bang, got lymphedema in left arm. It is not bad and is not that bad when I fly, as I use lemongrass and lavender essential oils often. Right side, I developed phlebitis in right arm after chemo and even after trying everthing, it is till there. It is like a cord in my vein where they used to take the blood from. Now they take it from my hand. You can actually see a vein which used to be blue and now is white, because it is damaged. If I need a lot of blood work done and then a ct or pet, they have actually taken the blood or have given me the contrast/radioactive glucose from my foot. Hey whatever works!
Not palpitated?
🙃
Similarly, nurses/techs always ask on which side they can give injections or test bp - or draw blood. I always tell them the left, even though that is the side on which I had lumpectomy and 3 lymph nodes removed. I still do IV for PET on the right. I guess I can stop that -- except the left is a pin cushion from all the blood draws. The right is fresh.
Good luck tomorrow! I pray for good results for you. Yes, they do always sound out of reach time wise!
Thanks so much for all the info on the possible treatments coming our way- hopefully soon
🙏 And absolutely wishing you all the best on your scans!
Good news, good summary. I know about the ERX-41 trials that are supposed to start next winter, out of Texas.
Didn't realize the ERSO was back on track and has a pharmaceutical company to run the trials. Is that confirmed?
As for SERDS and oral Fulvestrant, I believe that oral Fulvestrant is a SERD. I mean, Fulvestrant is a SERD, and oral versions that have better absorption and can deliver a higher dose are in clinical trials by several companies. I think at least one of them is going for FDA approval. I was on one -- an oral SERD -- in a clinical trial and it eliminated all my mets. For a while. As a keynote speaker at an mbc conference said about new treatments, the oral SERDs are really promising, but she didn't rank them high because their effectiveness is short-lived. I got a year. A breast oncologist at MSK said that was actually a good run; typical is 6 months. Too bad. It was so effective and no side effects for me.
I have had one FES PET scan. Really interesting. Showed different things than regular PET. Showed I had no circulating estrogen. (This was when I was on the oral SERD and had NED.)
Haven't heard of the CDK/7 inhibitor. Have read that there have been attempts to develop inhibitors of CDK1-13, but only the CDK4/5 inhibitors that most of us are taking as targeted therapy have worked out. The others have been too toxic at therapeutic doses, but that is where much of the new work is being done. There is a trial coming up of a CDK/2 inhibitor.
Hi there! I read, somewhere and now I can't remember but it was very recent, that ErSO was back on track requesting FDA approval to start trials. No pharmaceutical companies picked it up and if my memory is correct the university will be running the trials. As far as confirmed, I don't think anything is really confirmed until it happens since situations with pharmaceuticals can change rapidly due to so many circumstances. I do believe it is going to go to trials once the FDA approves it to run. On the SERD front, I think your getting a year is actually spectacular. My doctor did say they are predominantly short lived, so a year sounds great! I think most of us would love a good long year with no troubles from these creepy mutant cells running around our bodies.
The FES PET scans sound really wonderful, especially for those of us with lobular, since FDG PET scans don't pick up activity well. Lobular is a low sugar processing form of cell...damn! I'm still trying to find a relatively or reasonably close FES to me but haven't found anywhere yet that is feasible distance wise.
The CDK 7 inhibitor is Samuraciclib. It looks very promising and more importantly, it is promising to be less caustic than the CDK 4/6 inhibitors, and more effective. However, like I said before, things change quickly in the pharma world, and it all remains to be seen. Nothing is said and done until it is in place and done, or as my partner always says, don't count your money until it clears the bank and you can actually hold it in your own hand. Interestingly, Verzenio does hit the CDK 2 and 9 sites.....don't quote me on that one because I can't remember if it is 2 and 9 for sure, but there are two other CDK sites it definitely hits as well. I read this in some Dana Farber journals. The problem was that it was unknown if it carried sufficient power over those two sites.
I also found out today from another source that the U.K. is running trials on Crizotinib with Fulvestrant. No trials in the U.S. with this one, but it is FDA approved for certain lung cancers.....interesting!
I'm in the middle of a "progression" crisis at the moment. First one, and it looks like progression from bone to gastric. Honestly, I think it was there all along and got pushed back with my first line therapy. Lobular in visceral organs hardly ever gets picked up on PET, or any other scans. Time to switch things up, I really hate cancer.
Good to hear your input, more good news on the forefront for all of us!! This post request was a great idea, since knowledge is power, and I think we all got a chance to learn a lot from this thread!! Take care!!
So that would be the University of Illinois, I think. I believe that is where the biochemists who were developing ERSO were. Someone on this site will know; there is someone who is in touch with those scientists.
That was one great year. It was my second line of treatment and I thought this was the nature of mbc: feeling great, no side effects, no cancer. Now I am on my third in 3 years and it doesn't seem so great.
I got the FES at Columbia Presbyterian, where I get treatment. No fasting! Much easier. Drink different stuff. But, because I was in a clinical trial that required the same PET to match to baseline, I had to go back and have another one. Now I can't seem to get the FES. That makes me think it was a clinical trial. I have to ask.
I also have to ask about Verzenio, which I am on now, and CDK/2 and 9. Don't know if it is working yet. Tumor marker tests next week, but no scan until October, to give Verzenio a chance.
I think that about my progressions, too. I think they were there all along, not detected, and then got big enough to see and measure.
Yes, it was a good idea.
FF13, yep, you nailed it on the head. I worry about progression to the organs as well and not sure if this xeloda is working as after 3 cycle my tm's doubled. Still on it though and now in the 4th. See doc on the 12th iwth tm's and a pet is scheduled. I too was under the impression that all the gofundme pages for ERSO would go to marketing attention and the media wouldpick it up and the FDA would fast track it since it showed such wonderful promise. Plus, we really do not know why Bayer backed out. I too thought I read that the University of Ill and Dr. Shapiro were moving forward. Hoping to be kept alive long enough to be able to take ERSO. Man, I hope it works. Not just for MBC, put potentially for all cancers. PP
Samuraciclib has gotten FDA fast track approval and is in phase 2 trials.
Good to know about Samuraciclib! As we go along the progression road, knowing more medications are out there, being developed and fast tracked is great news. Unfortunately, the worry begins with quality of life balanced with the side effects of the medications in the pipeline. I'm hoping to do as well on Fulvestrant as I did on Letrozole. For me, Verzenio was a Godsend compared to Ibrance. I'm on Verzenio, and have no side effects whatsoever. My low WBC and RBC counts are back to normal from Ibrance. For some reason I always felt flu like and very sick on my week off time on Ibrance. But yes, I do agree, I'm on my third year starting second line treatment, and things are getting harder to deal with. I'm scared of shots, but no choice for now. Getting my first of loading doses of Fulvestrant on the 19th.
I would love a good medical explanation of our different responses to treatments. For me, life on Ibrance was pretty good. Verzenio has been rough. My wbc counts are elevated, though.
Fulvestrant is challenging -- but just once a month. Be sure to use the tricks we have arrived at: warm it so it goes in more easily (in your armpits, under your thighs), make sure they inject it very slowly, and on the hip, not in the butt. I couldn't walk because of huge mass in my chest. Four days after fulvestrant, I could jog up hill. (I was so gung ho, I tripped and broke my knee. My docs were disgusted with me.) I hope it works miracles for you.
Oh my gosh!! I hope Fulvestrant works a miracle for me like it did for you, but I'll definitely skip the broken knee!! It's so strange how all of us react so differently to all of these medications!! I did really well on Ibrance, and thought I wasn't having any side effects, except that darn week off (and the low blood counts). I was expecting all hell to break loose with Verzenio. I bought five boxes of Imodium, bought Dulcolax, just in case it went the other way. My doctor prescribed Sofran for nausea, just in case and I started taking it, and with each pill thought, "o.k., let's see what this does to my stomach." But, nothing, nothing at all, my stomach feels great...both ends! Which is doubly confounding being that they think the progression is gastric. Nothing about this disease makes any sense in any way, not the disease, not the medications, not the protocols. My doctor says I'm on outlier with Verzenio, even called Eli Lilly, and they and she agreed that just because I have no side effects, doesn't meant it's not working....but makes me wonder? I never had side effects from Letrozole, I've never had a hot flash in my life......again.....makes me wonder? I have no ovaries due to a hysterectomy (lobular strikes yet again, doctor wanted them gone), nothing makes sense. I have taken notes from your advice on the shots, and will do. Someone also mentioned standing on tip toes while getting shot, not sure why that helps. Again, nothing makes much sense to me anymore!
Tip toes? I had them with a knee on a chair, to relax the muscle when they were injecting; then I would switch knees. Some people get to lie down so they can inject in the hip. That is better. Depends on the nurse. Main thing is to make sure they are nowhere near the sciatic nerve.
So good to know! When I was little I was given a penicillin shot for a throat infection, and I bent the needle with my glute muscle!! My doctor told me to take a dose of Lorazepam 1/2 hour before the shots to help me keep my muscles relaxed. Hopefully the nurses will help this along, I have a phobia about shots below the waist. Arms? No problem, IV’s, no problem, shots below the waist and I turn into an hysterical crying 6 year old all over again.
Traumatized! Those are some powerful glutes you had. Do you still have a power butt? I did a lot of research on this in nursing magazines when I was getting fulvestrant, and went on a campaign. I found that nurses trained abroad were more likely to give it correctly, in the hip and not the glutes. I found articles on training nurses to give intramuscular injections further forward, surveys showing that most nurses don't get that, and a letter by a nursing administrator saying it is safer to have them give it where they are used to doing than to have them try something new. I used to go to my appointments with an article and diagram of the correct placement. I am now notorious at that hospital.
Hi there! Yes, very traumatizing, I was only 4 and the nurses were angry and yelling at me, making things so much worse! My youngest daughter is registered nurse and she was showing me where the injections should be given. It's not her specialty, she is earning her PhD to become a nurse anesthesiologist, but she knew exactly where they go....and I honestly trust my girl with my life! I'm going to have her mark an X on both sides with a maker for me the day that I go. I don't want to bring her with me because I don't want to bring my own "expert" in and agitate the nurses at my clinic. But, thinking about it, X marks the spot may get me some brownie points. My oncologist has assured me that the nurses at Compass are absolute experts in what they each specialize in doing. My doctor says she's been at the clinic for 13 years and never had a complaint on the Fulvestrant shots, but did get quite a few complaints at her previous clinic.....
You really made me laugh saying you are now notorious at your hospital! I think I'm headed to the notorious "side" as well, if I haven't gotten there yet! Between my degree in microbiology and my daughter's input as an RN, I'm always coming in with my own ideas of how, what, when, and where things need to be done. I love this site because it gives me patient's perspectives to bring along with me as well. I really believe we have and must with no exception be our own advocates. Our doctors can be excellent and wonderful and all that, but at the end of the day, our bodies, are "our bodies" and it's our ultimate job and right to take care of ourselves first and foremost. They probably roll their eyes every time I'm on the appointment list roster! I think you and I might be kindred souls Take care!
Sorry Tammy, I jumped in too fast to help and then saw your response below. Yeah, why do some of us go from treatment to treatment. What is different with OUR cancer? Luminal A - estr/proge +, her2 neg. Luminal A is suppose to be easiest to treat and then only a few years later, wham, MBC? I do not get it.
The nurse practitioner said to me, when I complained about developing resistance, that "cancer is smart; it finds ways to work around the treatment." So then I began to think my cancer is smarter than other people's, and that is not a good thing. I mentioned this theory to the rheumatologist who is self-appointed to act like my primary, whom I see briefly once a year whereas I see him every three months and he reads my oncology reports and explains them to me. He was quite disgusted with this explanation. He said that there is constant mutation, it is random, and sometimes the mutation works for the cancer in that it overcomes the treatment. So it is random, luck. I am like you, have the "best" kind with no mutations, supposedly the easiest to treat, yet it keeps developing resistance.
It is hard to get explanations for how things go for each of us. I think they really don't know much. My oncologist just goes to vague when I ask. "Well, sometimes this works when that doesn't." My second opinion oncologist at MSK said, "We don't really know. We just have anecdotes, not data." Seat of the pants oncology. That is not comforting!
Right! That is why the term is his/her medical practice. Hence, they are all practicing on us. Trial and error. But when it is the most common (luminal a) it does not take a rocket scientist to assert that we in this group, should not be jumping from med to med. I just don't get it. I think about all the female tv people that had the same and we do not hear about their cancer progressing. Olivia NJ too had hr+, and was doing everything right - diet, photon rads-but, I did not read if she was TAKING meds. Cannabis oil - which one cbd or thc? These trials can't come fast enough. PP
FF13, I did that mix in Dec of 2019, Ibrance and fasledex, only lasted about 15 months. Had no problems with the 500 2x injections either. Just make sure that you warm them up prior to the nurse injecting them. Secondly, make sure the nurse has experience in doing this as the injection site should be to the side of your rump and no where near your sciatica and so there is no pressure, I had to lie down on the table and it should be done slowly, min of 2 minutes for each side. Hope it helps.
I did some research directly from AstraZeneca and found out that the shots should specifically be given in Ventrogluteal muscle and never given in the dorsogluteal muscle. You are correct, it's on the side of the hip, not the back portion of the rear. I confirmed this with my daughter who is an RN, and she said no injection should ever ever be given in the dorsogluteal muscle, that this is outdated and dangerous due to the highly vascular and nerve tissues in the dorso. Having so much great information from so many people on this site, plus some extra research I now know to say no to anywhere near the back or rear. I'm hoping the nurses at my clinic all know and are well trained with these shots. My doctor says they are the "best", but I will know once I'm there. I'm on countdown to the shot, Friday this week is my first set....I'm dreading it.
Oh dear, you will be just fine. After a few months of injections, you will start to develop tiny sore spots or not. Then when you go in you can feel around and tell them where and where not is a good spot. I had to actually show a nurse the information in the box, because I had to pick them up every month prior and clearly stated how important it is to inject in the correct area and slowly, min of 2 minutes on each side. You may have tenderness that last a bit, but nothing bad. Take the bull by the horns!
I will take that bull by the horns!! Too bad I feel like a small child about this, but I will put on my big girl panties, and get it done. I have a plan, my daughter will be marking the proper placement with criss cross band aids before I go in, right in the center of the Ventrogluteal muscle (She's an RN). I will also time each shot, make sure they are warm, and I will be asking the administering nurse a few questions that I need satisfied before moving forward, or I will ask for a more seasoned nurse. Luckily, I know them all by now because of the Xgeva shots. I've been at this clinic for 3 years now, and they know me, I know them, and they are all very kind and understanding (for now.......) Hopefully they will understand my phobia and be patient with me. I will get through this indeed, the anticipation just makes it that much worse......four more days to shot day
I went on an all out campaign. Took an article with a diagram with me to get the injections. Talked to the head of nursing. Can't say it worked. Maybe they went a little further forward. Good luck with it. Warming it and making sure they did it slowly -- I timed them -- helped the most. Getting them to do something different from what they believe is correct is an uphill battle. My oncologist was no help. A different department, she said.
I'm right on board with your strategy! My daughter (she's an RN) is going to criss cross two band aids on each side of my ventrogluteal muscles, x marks the spot! I will also be timing the nurses and have a list of questions I want answered by the administering nurse. If her answers don't suit me, I'll ask for another nurse. I'm going Rambo on this one, nothing less. I know it sounds a bit like overkill, but if we don't take precious care and all precautions with our own bodies, who will? We have to live with walking around with the procedures and medications we have to take, so we must advocate for ourselves, like we would for a child of ours, or a pet or ours, or anyone else we love who can't advocate for themselves. Ugh......It's Monday, shot is Friday, I'm down to counting hours.....My oncologist will mix right in the middle if I ask her to, she's a super advocate as well. I just don't want to take her time with these things, but I will if pushed to. The nurses so far in the chemo room of my clinic have been exceptional and kind. One new nurse came one day and screwed up my Xgeva shot, and I complained to my doctor.....the nurse was gone the following month. Fingers crossed and a prayer, it will all work out o.k.!!
TammyCross - Campaign message -Oh man, you are so right. I have been down that road way too many times. Especially when they tell you to let them do their job and that they know best, etc. Nope, not my body and if I tell you that my doc said not to take blood here or there and they get nasty, I just ring it up as karma. It might not be right away, but it will come around.
I’m done with faslodex now but I calmed myself by Changwon’s my attitude… decided to be happy this was JUST a quick shot and not hours in the chair with chemo going in my port like before. I then felt lucky.
That is an amazing way to look at the whole thing! Yes, I have to agree, looking at it from this perspective definitely gives all my panic and hesitations great pause. Out of all the advice I have gotten so far (and all of it has been so great), this attitude adjustment and the reasoning behind it, is absolutely the wisest thought I have heard. Thank you so much, you really put it all a perfect perspective! Shots coming my way on Friday morning, and I will definitely be thinking of this perspective!! I am so grateful for your wisdom!!
Enhertu (a drug that was only used for those that are HER2 +) has now been granted approval for those that are HER2 low. This cld be a game changer because I believe about 50% of breast cancers are HER 2 low. Herceptin will probably be approved for HER 2 low soon as well.ARV-471 trial is using a Protac protein degrader and I believe cld pave the way for another type of treatment.
ERX 41 will start in first quarter 2023.
AMXI-5001 trial is another one I’m following.
Keep doing your research and remember you are your own best advocate!
Mandy
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Isn't that the Phase 1 trials of ERX 41 that start in 2023? Not available to us for a couple of years, if it passes?
When the drugs going from pre-clinical to clinical (human) trials, they’re presented at the clinicaltrials.gov site. It’s include a lot of information, but limited to the trials conducted in US. Just keep in mind that Ph1 objective is safety and identifying the right dose through dose escalation. The detailed indication is typically identified in Ph2 trials. Hope it helps.
Anything new these past 2 months?