Are you currently (or have you been) in a Clinical Trial?
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So, emac, I don't know if short time on Piqray could disqualify you, however I would think it would be actual progression on Piqray they would care about, I have seen some trials say they don't care if you discontinued other PI3KCA meds for reasons other than progression. The question I would want to ask is are they still trying to figure out the best dosage of RLY-5836 trial, since it is an early phase 1 trial. Would you qualify for the RLY-2608 trial, which has at least some data supporting it? Anyway, the person on the RLY-5836 did respond promptly to my email, so if you reach out to each trial you might be able to get some fast answers…
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@cure-ious. I was just looking at my Caris testing. I have the H1047R mutation of PI3Ka. I see this is one of the mutations the lady with 12 previous lines of treatment has. I have read about everything I can on RLY 2608; but I’ve learned even more from you. Can I ask about the kinase vs. helical? Thank you so much and I will update after my scans next Monday and Tuesday. Hoping we all can get some encouraging news.
Nancy
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Believe60, please keep us updated to your experience, because H1047R is the most common Pi3KCA mutation in MBC so a lot of people would like to know. Helical v kinase just refers to two different regions of the protein that are particularly important for its function. I think they are in the early stages of sorting out which mutants are more aggressive than others, but it may not matter much if these drugs can inhibit all of the various mutants. After trying for so long to get even one inhibitor of the pathway, it seems a plethora of options has just popped up recently. And in addition don't forget Capivasertib (Akt kinase) inhibitor that FDA may approve later this year, it hits a central part of the PI3KCA pathway.
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An update on the KEYTRUDA/fulvestrant trial I joined last month: we learned Friday that my labs are abnormal (enzymes+CA 15-3 up, bilirubin OK). So I started 50mg prednisone daily & need to have a liver MRI. Then we drove to OH for my mom’s memorial service, arriving at midnight EDT.
Having died on July 4, it was a lovely opportunity to remember her and see relatives however I keep thinking that I should be letting her know about my new health issues. With me wired up on the steroid dose, we return to Madison for another blood draw at UW this afternoon.
My status may actually signify a bit of success with the immunotherapy. As many of you know, tumor flare can occur as mutant cells are attacked and begin to die off. However, inflammation is a big concern right now. Viral infection has been ruled out. We’ll see what the week brings…
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@cure-ious . We are so lucky to have you here on board., someone can explain things in layman's term. I totally agree. Many clinical trials have requirements on your health condition. I don't want to use it as last straw.
I want to thank everyone on this forum by sharing your treatment and personal stories, tears and joys. I'm a single child. I don't have any brothers or sisters. After graduating from college I worked several different jobs before starting my own business with my husbands in 2013. Everything was heading to the right direction except I got sick very soon. It has been a very difficult 10 years. I've never exposed my disability/ vulnerability in front of others. Even my parents don't know my true conditions. I understand it very well this NIH trial is not a sure cure but I want to take my chance. I believe immunotherapy is the future.
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jsniffs and nikkiqh, I think I saw where NIH is opening another TILs trial for those who fail firstline therapy, ie right off the bat, haven't checked to see if that's true, but its such a complex process it makes sense they need to move it to earlier lines. Did you guys contact them directly (or thru your MO?) and what did they want to know to see if you qualify?
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Here's a positive trial- they are testing the eIF4A inhibitor, which some here have taken, was originally developed by Sonenberg in Canada as part of their Standup2Cancer initiative.
In this trial, they noted that they got 5 partial responses (tumors shrinking) out of 20 patients who tested the inhibitor together with Faslodex and Verzenio. They were of course worried about the toxicity of combining three drugs, but appear to have managed that and it was the 3-way combo that got them the great results…
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@cure-ious My MO is not very informative about this trial. I tried to bring up the topic several times but couldn't get much answer. My husband contact NIH as soon as I was off from the RLY-2608 trial, sending emails back and forth to set up my profile. So as soon as I failed Xeloda I sent over all my recent scans, reports and progression notes. They respond very fast. In about two weeks we have a screen test schedule. They even offer air ticket and $120 reimbursement per night. Yes they have several trials going on now. Once I pass the screen test they will discuss which trial benefits me the most. Thank you for the link. I'm happen to be treat in MSK. I'll update more details once I finish the screen test. Stay in tune.
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Hi Nikkiqh,
Wow, that's a wonderful husband you have there!!!
No surprise your MO might not have heard much about the trial, I imagine most of them have very little clue about what's going on in that world, unless they are involved directly in clinical trials. OTOH, when one's life in on the line, one is more than willing to do a lot more digging. Thanks for the info, and its great to hear that the NIH trial people were responsive and acted quickly. They must realize that they have to act fast, given that their approach takes a relatively long time and that they can only take people with large enough, accessible enough, tumors….
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@nikkiqh Hi. Is there anyone in particular you work with at MSK? My oncology practice is here in Virginia. But I have my second opinion MO at MSK. She agreed I should try this clinical trial for RLY2608. They run this trial there too. Just wondering if you have seen Dr. Modi also. Thank you.
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@believe60 This trial is done at MSK by Dr.Alison Schram and Komal Jhaveri. I was handled by Dr. Jhaveri. I heard Dr.Modi is one of the best doctors. You are so lucky to have her.
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I also contacted NIH directly, and my MO has been very supportive. My progress had been delayed because of trying to get an MRI of the head done. I could no longer easily get IVs in my arms, and I needed a port, went on vacation, scheduling issues, etc. I'm good now, and can start submitting all the required documentation.
I also recently went to MSK for a second opinion since I have a mix of ER+ and triple neg (both androgen receptor positive). I saw Dr. Traina and had a wonderful experience. She is so optimistic and knowledgeable. I wanted to see if I was on track, hear her thoughts on AR targets, and kind of plan for the future.
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jsniffs… Any info from MSK about how enobosarm is coming along? It's been awhile since it made any headlines, hoping its still on track…
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I want to add my thanks to cure-ious for sharing your knowledge and time on this forum. And thanks to everyone who has posted about their experience. I'm not on here often (had trouble logging after format change) but I wanted to add that I've been on the targeted PIK3CA clinical trial drug RLY-2608 for 8 months with good results so far (decreased liver lesions and stable bones) and not much SEs (although fatigue and GERD more pronounced in the last 2-3 months). Glucose (my biggest concern about Piqray) and all blood work has been normal. Like nikkiqh, I'm also at MSK with Dr. Jhaveri while on the trial. It's my first trial so there's a learning curve on how to navigate the system and of course, there's the anticipation of what happens when this stops working. . . But so far, QoL has been great and I'm hoping it continues to work.
Jsniffs, your post mentioned AR+ targeting and I was wondering if you or anyone else have heard of Bicalutamide. I asked about AR+ therapies for MBC at a Dana Farber Q&A last year and was told that they may be starting a trial with triple neg MBC with this drug (but I haven't seen anything on their site) . From my notes, I think this info was from Dr. Lynce. I'm always curious about this since I'm highly AR+ (also HR+, Her 2-) . Although from what I understand a clinical trial with AR+ would likely involve only TNBC (there's a relationship between AR+ and TNBC that I'm unclear about).
Thanks again and wishing the best for everyone on here.
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Me on the KEYTRUDA/fulvestrant study again. I was admitted to the UW Hospital in Madison yesterday & had my steroid therapy changed to IV. This is playing havoc with my blood sugars while attempting to calm the liver down a bit. In contrast to my alpelisib (PIQRAY) treatment, I’m now getting small doses of insulin. Hope to be discharged on the weekend.
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@cure-ious - Unfortunately, no talk of enobosarm at MSK. :(
However, @smallmoments asked about bicalutamide, and that was mentioned as a possibility for me if things quiet down a bit (I need to knock down some things that are growing more aggressively). It was mentioned that I could possibly use bicalutamide off-label as a break from chemo for a bit down the line. I'd have to use it off-label because I likely wouldn't qualify for the trial since I have a mix of ER+ and ER-.
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Enzalutamide inhibits AR signaling, whereas Enobosarm boosts it- I believe the former is used for TNBC and the latter for ER-positive MBC.
There are a couple phase 2/3 trials ongoing- one testing Enobosarm with Verzenio as second-line (ENABLAR-2) and the other testing it as monotherapy for third line (ARTEST). ENABLAR-2 is scheduled to end in late 2024, but maybe we will hear interim results in San Antonio?
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vlnrph, I didn't' realize you were off Piqray. So sorry to hear about the blood sugar and being hospitalized. I hope your glucose stabilizes. And condolences on your mom's passing. It's a lot to go through. I hope you're able to find some peaceful moments.
jsniffs, interesting to hear about using off label bicalutamide. And cure-ious, I'll have to take a closer look at ARTEST and ENABLAR-2.
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I was in Dana Farber yesterday for 2nd opinion. Any one in this Trodelvy+Keytruda trial? I remember @novagirl mentioned before. No sure if she's still in it.
@jsniffs @smallmoments How did you get AR tested? None of my oncologists ever mentioned testing androgen receptor.
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@Nikkiqh - I asked my MO for the AR testing, and I had to push a little for it. It's definitely not tested by default.
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Hi Nikkiqh, it was on the bone biopsy report done when I was first diagnosed under "Addendum Diagnosis" section (along with ER, PR, HER2, PDL1 percentages).
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I got to meet with my clinical trial doc today about my first 8 weeks in the RLY 2608 trial. Looks like so far so good. Re the CT scan, “stable chest without evidence for metastasis”, “bilobular liver metastasis are becoming more necrotic and decreased in size”, “skeletal metastasis not significantly changed but with increasing sclerosis” and “no new site of metastatic disease”! I am happy. Whole fam heads for the beach tomorrow. Grateful to head off with these results!
I am dealing with some elevated blood sugar, but working on that with meds.
Wishing you all the very best.
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Hi Nikkiqh- I am still on Trodelvy and Keytruda but I get it in a private practice. I just had my first scans after 4 infusions. Two spots in my liver that grew but everything else below the neck is stable. We are going to do two more full cycles then scan again. I did have a brain MRI that showed spots on my brain and possible lepto. Because I’m asymptomatic and also the way it looks on the scans-they do not think I have lepto. Three different drs have said that now so that’s what I’m going with. We have no idea if I got the brain lesions on Enhurtu or Trodelvy. I’m having cyberknife in a couple of weeks to the brain.
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nikkiqh,
AR (androgen receptor) was included in my STRATA genomic test from a liver biopsy. My AR is high: 15.0 percentile rank: 95.6%. This is what was written on my report: "Associated Therapies: ADT(i.e. androgen deprivation therapies) +bicalutamide, enzalutamide, apalutamide, darolutamide". These four drugs are referred to small molecule AR (androgen receptor) inhibitors approved for metastatic prostate cancer. The report goes on to say……"Although recent evidence suggests AR may act as a tumor suppressor in ER+ breast cancer, enzalutamide showed an 8% objective response rate and 22% rate of at least stable disease at 24 weeks in patients with triple negative breast cancer expression >10% AR by IHC." My MO has talked very little about any of my test results and not at all about this particular result, so I have very limited understanding of the significance. But thought I would share the info, in case it is useful.
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I really appreciate everyone's share on the AR topic. I rechecked my bone biopsy report it's not included. I guess it's not a default practice at least in MSK. But I send an email asking if they can add that test to my liver biopsy.
@believe60 It's great news that you see solid improvement on the 1st scan especially the liver part. I've been really concerned about my liver progression. The Dana Farber doctor said "liver is big. 1/3 liver is enough to support the whole body".
@novagirl I really hope Trodelvy+Keytruda can get you more time. Your treatment plan is very similar as mine.
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We stayed at NIH for two days. They let me in. and If everything goes right I'll have tumor resection and apheresis in two weeks. Then I'll go back to MSK to start conventional treatment or any other clinical trials preferred. In my case it probably will be Trodelvy for about 3-4 months. Yes they still need that much time to select and manufacturing t-cells. You'll still be eligible even you have progress as long as 1. no brain mets 2.reasonable physical condition. They also mention if you have good response with whatever treatment you have while waiting, they can freeze the T-cell until you are ready. I know I told them I'm willing to do anything to save myself. Yet when I read through all the possible SE pages, my heart is pounding and hands are shaking.
P.S. the newest CT-SCAN shows there are multiple new nodules in my lungs now. maybe because I've been off treatment for 3 weeks? I'm actually much happier in these 3 weeks, travelling with my hubby, kinda like I'm a normal person again. I'll forever remember the moment when the NIH ppl asked "Are you guys in?" My husband grasped my hand gazing at me with tearful eyes ." Yes, no matter what happens we'll in this together."😭
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@nikkiqh - Thanks for the update. It's helpful to hear the next steps. I just submitted my documentation to NIH, just heard from a nurse, and am awaiting their physician review. I'm on Trodelvy now, so we are really doing similar steps.
I can only imagine the possible SE list. Were they able to separate out uncommon side effects from most common?
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Nikkgh- I am thrilled for you! It is great to be off meds however briefly and realize how normal feels!
Jsniffs- congratulations on your progress with this process. I hope Trodelvy is kind and effective while you wait.
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@jsniffs. Yes. they put them as "common,occasional and rare". But the list is very long. You'll start 7 days ahead. First use chemo Cytoxan+Fludara to deplete your immune system. Then followed by Keytruda. Then followed by IL2. Their goal is to make you sick enough, like catching a very very bad cold, but not life threatening. People in bad physical shape has little chance to survive this process and not worth trying. So it's critical for whoever want this trial to pick the right time. You don't want to be in this too early but certainly don't want wait too late.
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