Are you currently (or have you been) in a Clinical Trial?
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Oops. Error. Sorry.
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Alabama Dee... Cure and JFL and Bev...
Ok saw MO today. Dee I told her what you are on...and how similar you and I were. She is open to doing Afinitor and Exemistan???? I know I am spelling that wrong so if someone knows what the heck that might be the correct name let me know lol . She said she wouldn't go with faslodex again since I did it... and that she doesn't feel I would need the Sandostatin. She also said that she might consider Verenzino...since there is that new info out that shows that Metastatic Breast Cancer especially in liver and lung Verenzio is showing to preform better than Ibrance. In people like me...she said it can sometimes do the trick. This all is of course if there is in fact progression at the July 13 & 14th scan (results 16th). I feel there is because I still have my pain in sacrum and liver. Anyway I thought she was gonna go right to Abraxane...but she said not necessarily, especially if I do not have a big amount of progression. SO that was interesting.
She also spoke to the Foundation One rep I want a blood biopsy. She said ok and spoke to him figuring out how we do it..but she cautioned that a lot of times if you don't have large tumor burden it doesn't always show much (paraphrasing).
I sent her 6 trials to look at ...I think 4 of them are immunotherapy..and it wont matter if I have Gilberts syndrome as long as my bilirubin is over 3.0.
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Nicole,
I responded to your PM, but here you also raise the Verzenio question, which someone is also raising on the Ibrance thread. I don't know much about Verzenio, but Cure-ious wrote in the Ibrance thread that it's like 14 times stronger than Ibrance? I also think that you take that without a break. So that's very, very interesting, I think, and I'm also going to raise that with my MO.
My consulting doc in Chicago was a big proponent of blood biopsies, but he uses Guardant360, not F1. F1 has one, but I think it's still being tested for concordance with the tissue test. I did talk with my MO about this the other day, bc Hopkins has a trial comparing the tissue biopsy with the F1 blood biopsy to see if they line up the same. My MO said that she took on that trial (and I think it's only open to Hopkins patients there) because they wanted to learn things about the blood biopsy. So far, her takeaway is that you find out a lot more with the tissue sample than the blood, but that's not her final word on it. She told me she would try to add a blood draw for that for me as soon as she can, but that right now, (as we all know), a lot of the clinical testing has been put on hold (including this one) because of Covid. She did add, however, that she thought that was easing, and so she would look into it for me. FYI, I do also remember ShetlandPony saying that at one point, not much showed up in a blood biopsy and they thought it was because she was in active treatment so not much floating around in her blood.
All good thoughts.
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One specific thing I did ask about verenzio is if it will make my neutrophils go really low like Ibrance did...I can't remember her exact wording but she said not necessarily no....so who knows.
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Bev, I had that issue you mention with a liquid (blood) biopsy - I had it during active treatment that was working and it showed 0 amplifications/mutations. However, F1 showed numerous amplifications/mutations both times.
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JFL,
Maybe it was you who I remember. It will be interesting to see what happens with mine, when I am able to get it (currently on hold due to COVID research, at least at Hopkins). Which blood biopsy did you have? Dr. Cristofanilli at Northwestern was a huge proponent of Guardant360, but at Hopkins, I guess they're all in with F1.
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Cureious...ya know when I failed a year ago on Ibrance/Let/Faslodex (my first line of treatment) I remember you saying...that doesn't mean endocrine therapy wont work....and that it can be revisited.... well who knows you may have been onto something.
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NicoleRod
Im gad your MO is talking to you. I may be responding to my current line because of the Neuroendocrine differentiation thus adding the sandostatin. you wouldn't use the sandostatin if you are not neuroendocrine.
I can't remember. Do you have any ESR1 mutation? If so, the current thought is AI's won't work well. Since you were on both an AI(letrozole) and Fazlodex with the Ibrance(cdk4/6) you don't really know which one was the culprit for failure. My home MO said that the CDK4/6 meds don't always work well on the liver. I failed on Verzenio, but it was a piece of cake to be on it for me. CDK4/6 + AI is the current first line standard of care meds. The good thing about Verzenio is it goes through the brain barrier and it is an every day pill with less neutropenia. BUT, your cancer has seen a CDK4/6 and an AI, so I would assume that your MO would move onto something your cancer has not seen. There is another thought that once a CDK4/6 fails after being on it a while, there is often a storm of new tumor growth. I read somewhere on these boards, that it doesn't actually kill the cancer but puts it to sleep.
Blood biopsies are to find the circulating tumor cells at that very moment in time - I had 2 blood biopsies (liquid biopsies) and both showed nothing (unusual but it happens), so I had to go onto the tumor tissue biopsy (my second one metastatic). My thoughts are to try the liquid biopsy, but realize the tissue biopsy is better. MD Anderson does their own blood biopsy and molecular profile so I have not used Foundation 1 or Gaurd360.
YAY! Afinitor(mTor inhibitor) is working for me for now and since I do have the ESR1 we stayed with faslodex for the estrogen blocking part of the treatment even though I used it with Verzenio. I believe Curious pointed out mTor is a good choice for the FGF19 mutations, but I am always cruising this area for new trials and asking my MO about which ones could be next in line for me. It's hard because most Neuroendocrine trials don't allow breast cancer even though I have an actionable feature called SSTR+. Some trials won't allow me in due to my low IGG from cytoxin/taxotere treatment 7 years ago (I get IVIG every 5 weeks) So much for precision medicine and MATCH trial - I'm tired of hearing Standard of Care - it is all a guess anyway because they don't know for sure which mutation/feature is driving the cancer. I have learned that you can request expanded access to a trial, compassionate care and Right to Try. I'm not there yet but I am certainly putting those in my arsenal for the future!
I found this site from a mBC patient, Christine Hodgen who is a BC advocate. She has a clinical trial quick search on her website. theStormRiders.org I found a few there that I did not have on my list. I just spent many hours compiling my list of trials to talk to my MO about. I am willing and able to travel to a clinical trial sight. I am blessed to live in Alabama near Nashville which has 2 centers that offer many trials, but I'm trying to get some at MD Anderson since that is my primary MO right now.
NicoleRod you are a fighter and you are educating yourself to learn more about cancer than you ever wanted to know. Even my husband does not understand why I spend so much time researching when I finally have something that seems to be working. But we all know in the back of our minds that this may not last long especially when our first 3 lines didn't work. Keep fighting and asking and researching because ultimately you will always be your own best advocate!! Prayers that you respond to an easy treatment with minimal side effects and ride it for a very long time. CANCER SUCKS but my hope is not in the doctors or treatments but in my GOD. Keep enjoying everyday for the gift it is! Hugs to you.
Dee
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Dee...thank you for the reply. I am now even more confused why my MO would even consider Verenzio..originally when I went to her she said no...but that she wouldn't rule it out for the future...but after I told her about you and what you were on she said we could try Afinitor..but with Exemstane? Here are my mutations or what they were a year ago with foundation: CCND1, FGF19, FGF3, FGF4, FGFR1, FLT3, GATA3, IKBKE, NSD3 (WHSC1L1), ZNF703. C11orf30(EMSY) amplification.
That is the issue...what you said about me having done Ibrance/Let/Faslodex all together we don't know which one or all failed....
Yes I have read numerous stories also on FB of women once Ibrance failed they had an "explosion of mets"...
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So there is a new report that a combination of two immunotherapies (anti-CTLA4 and anti-PD1) worked for a small number (3 out of 17) of Metaplastic Triple Negative patients, this being an aggressive and rare subtype of TNBC.
The eye-popping results being that the results are durable, and it is possible those three are now cured...
https://www.medscape.com/viewarticle/932634
They don't know why those three responded where the others didn't, but its these kinds of reports that provide some hope that genuine gamechanger treatments are possible, if they can just get this stuff to work for most of us
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Bev, I had the Guardant 360 blood test.
Alabama Dee, glad Afinitor and Faslodex is working for you! I am surprised that combo is not given more. It may work better than AIs for those of us who are resistant to them. I may keep that in mind. I did Afinitor with Exemestane for 3 months, unsuccessfully but the tumors slightly increased. Maybe it would work better with a SERM, SERD or similar drug. Keep us posted. I have never heard of anyone take Faslodex with Afinitor.
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I just don't see how much difference a hormone therapy agent Exemestane can make when someone has had their ovaries out..(like me) I get, that our body still makes some little bit of estrogen...but is it really enough to feed the cancer?
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Just thought I would post an update. I had progression and needed to change treatments. I am now in the Aviator Trial. (Link below.) I was randomized to the second arm and am receiving Vinorelbine, Trastuzumab, and Avelumab. Mostly sharing this FYI. Will be glad to share my experience if anyone has questions. Thanks.
https://clinicaltrials.gov/ct2/show/NCT03414658
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Lumpie,
Best of luck with the trial. Please do keep everyone informed as to how it goes.
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Good luck Lumpie. I hope you have a long run on that combo.
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Lumpie, Best Wishes for you on this trial. Please keep us posted. So does/is Herceptin working for you?? People get to live YEARS on that when they respond.
Nicole
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Dear Lumpie, all the best for the trial. Huge respect, as you not only try to help yourself but others too. I'd say it'd be great if you could post when you have any news. The Her2+ and PD-1 combo is super interesting. I remember SABCS19 presented her2 mabs and adcs with Atezolizumab, and results are very intriguing (there were even CRs), although maybe with big side effects but who would not suffer big SE for a year or so, if knew there's a chance to be cured? All the best Lumpie once again and let these suckers die... Saulius
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Yay Lumpie -Go girl!
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Oh my, some happy news about getting immunotherapy to work for "cold tumors", like MBC. We need as many "irons in the fire" as possible for this.
A new paper in Nature discusses how the IL-18 cytokine should be very useful for immune system killing of cancer. However clinical trials found it doesn't work-why not? This new paper reveals that tumors express high levels of a '"decoy" protein that binds up the IL-18 in an inactive state and prevents it from getting to the proper receptors on the surface of immune cells to start the "cell killing" signal. Kinda like when you toss a bunch of salt on the ground to kill slugs and stop them in their tracks. This is one mechanism the tumor uses to hide from the immune system. It's also super-effective: The "decoy" floods the tumor micro-environment and binds IL-18 10,000x stronger than does the natural receptor on the immune cells. Scary.
This team from Yale set up a screen of 300 million mutant forms of IL-18, and pulled out one that was able to bind the cell surface receptor on the immune cell but not to the "decoy protein" produced by the tumor. It preferred the natural receptor over the decoy by one-million fold. Cytokines are small secreted proteins that can be given to patients by IV. Therefore this resistant form of IL-18 can be used, as is, for a drug. A new company Simcha Therapeutics has been started and they hope to bring this drug (called ST-067) to clinical trials early next year.
From the press release:
"When Ring's lab tested the decoy-resistant IL-18 and compared it to natural IL-18 in mice, they found that — just as in human patients — natural IL-18 had little to no antitumor activity. By contrast, the decoy-resistant IL-18 had potent single-agent activity that inhibited tumor growth and even produced complete tumor regression in many animals, including in tumor types that are refractory to checkpoint inhibitors."
https://news.yale.edu/2020/06/24/blocking-jamming-...
https://www.tullahomanews.com/news/business/simcha...
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Thanks for that info Cure-ious and thanks for explaining it in Laymans terms!!
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I'm excited about this one! Of course cancer cells can try to mutate their IL18-BP gene to make it bind the resistant form of IL-18, but that may take them too much time, given that they will be under heavy attack by the immune system- and even if its possible, then you go back and treat the cancer with the normal IL-18, which the cancer can no longer resist- it's so clever
we shall see how this goes- at least the FDA fast-tracks all immunotherapy trials
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Yes I just sent my MO 6 trials...4 are Immunotherapy...the one I really want : here is what she said:
"The one with the tumor infiltrating lymphocytes. They are doing that more for malignant blood cancers and this is trying to see if it will work in solid tumors. I am not sure that would be my next go to since it is a lot of therapy for your disease which is pretty minimal, but you can definitely investigate it if you would like to learn more about it. It seems like you would be a candidate from what I could see. It would be at NIH at this time and is a phase II - so no randomization at this time."
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Nicole, that sounds promising that she says you have minimal disease and these early stage trials are generallty tyreating later stage patients- trials are adapting all the time and given how many hoops they make you jump there are only so many we can afford to try- you might want to wait & watch, depending on whatever it is she more strongly suggests for you at this point
and she may be concerned too that immunotherapy is rarely helpful for us so far; new stuff always coming along
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Nicole,
I also picked up on what Cure-ious says -- that your doc said you have "minimal disease." I don't exactly know how they make that determination, but that sounds pretty good to me.
Last week, my MO and I were kicking around next steps for me, even though we're not going there yet. Her reasoning for "ranking" them was amount of time/effort that each treatment would take -- sort of a risk/reward approach. I forget her exact words, but when we were discussing two different trials, she commented that they would be very time-intensive as to spending time at the hospital with infusions, etc. So perhaps that's also what your MO is thinking.
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Bev and Cure...thank you. She did say minimal disease...but then was based on having 2 bone mets and the 4 tumors in liver (2 of which were cryoblated) but I believe I am progressing not only am I have pain in the left sacrum and hip where the mets were but now my right sacrum is hurting too...and my liver is still hurting..so who knows what this next scan in July is going to show. I just don't see much promise. I mean can I try Afinitor next...yes..but I don't know that, that will work either due to the mutations I have and my "hail Mary" which I was saving was Abraxane and now..hearing it didn't even do anything for many people with my same disease...just discouraging...I don't see too many options..thats why I was looking at trials.
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nicolerod
If I were in your shoes I would at least contact them to see if you qualify and find out what is involved. It’s always good to have something on the back burner if possible.
I am doing that with one Neuroendocrine trial. They said I am a possible candidate and to continue to send them updates of scans and dr notes so that I stay on their radar. While I hope my current line lasts a long time, my MO told me 1-2 years is typical for Afinitor.
Dee
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Cure-ious -
a few pages ago you mentioned ipatasertib & wondered if anyone was on it. I'm in a clinical trial where this is one of the randomized drugs. NCT04177108
I'm PD-L1 positive so I'm in Cohort 2 but it's blinded whether I'm in Arm A or Arm B so I'm either getting Ipatasertib or a placebo.the drugs I know I'm getting are paclitaxel and atezolizumab (tecentriq).
First scans at Week 8 showed marked improvement of my necrotic lung tumor (which nobody cared about as it was just dead tissue - stupid thing had outgrown its blood supply, I guess. We keep hoping the rest of my cancer is equally dumb. But anyway something triggered my body to go & start to get rid of it) Liver mets were a mixed bag - some seemed smaller, one seemed a tad enlarged. I don't know whether she ended up classifying it as no progression or as an improvement.
Next scan on July 6.0 -
Hi Moth, I am amazed at all the stuff you guys. with TNBC can take, but then again with immunotherapy in the mix it has high potential
Anybody else out there on this (or any other) clinical trial?!
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First patient was just dosed in the phase 2 BRACELET-1 trial (which is trying to get immunotherapy to work for ER+ MBC)
https://clinicaltrials.gov/ct2/show/NCT04215146
The trial is using an experiment breast cancer vaccine (pelareorep) with chemo and immunotherapy. The three arms of the trial are: paclitaxel alone, pelareorep + paclitaxel, or pelareorep + paclitazel + avelumab (immunotherapy).
Only 48 patients and right now just at two sites- Indianapolis and West Virginia, although they will eventually be open at 20 places
Patients must have progressed on CDK4,6 inhibitor but not had chemo or checkpoint inhibitors in the metastatic setting. If you're disappointed by these criteria or locations, don't be- this trial is going to be a fast one! It will be finished by this time next yearThis is a follow up to a longer phase two trial that just finished in April testing paclitaxel with pelareorep. In the new trial they add immunotherapy, and they want to see if biomarkers can be used to show a stronger immune response The study of pelareorep and paclitaxel in previously treated mBC did not show a difference in PFS, but there was a doubling of OS for the combination. The FDA approved a Fast-Track Designation but told them to develope a biomarker that could be used to show the therapy is working
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Am I understanding correctly that the pelareorep & the avelumab are both immunotherapies? I read that pelareorep is a human reovirus?
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