Are you currently (or have you been) in a Clinical Trial?
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@cure-ious Oh gosh I'm sorry to be a pita, but the link expired before I had a chance to read it. Could you please repost it??? Thank you, Irishlove aka Laurel
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I'm finally feeling better after the harvesting procedure at NIH. The surgery went well and they were very generous to let me stay in-patient for additional days before apheresis. It has been 52 days since I'm off treatment. I had bloodwork done today. My liver enzymes and tumor markers are all very high but white cell and pallets are back to normal which means tomorrow will be my Trodelvy day.
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It's typical 30 days off before surgery. But I think they only do surgery on Tuesday. I was told it takes up to 3-4 months to grow the TILs. But they'll know for sure if it will grow in 2 months. They'll try all possible ways available to grow them. Like my case if they couldn't find good TILs directly from my liver tumor, they 'll use TCR-T technology. That's also the reason why everyone needs Apheresis. Dr.Rosenberg is looking at each case. I met him several times during my stay. He works very diligently .
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How wonderful that Dr Rosenberg checks in on each patient!! And that they are so good at communicating all the different things they are trying, maybe that makes it easier as you wait, knowing they are trying hard and there are a lot of variables. In terms of prior treatments, you were diagnosed with MBC in 2021, and have had three prior treatments, 2 endocrine therapy and one chemo? And did Xeloda fail, or you just dropped it to start this NIH trial? Beyond PI3KCA mutation, are there other meaningful mutations in your cancer? For example, RLY-2608 did not work for very long, and I've been reading that this is a problem for PI3KCA drugs, that they don't last long. Or if the cancer has ESR1m, then it wouldn't respond well to Faslodex… And now you will be moving to a second chemo while you wait? It seems that you have really timed this trial very well, ie, still early in your treatments, and I wonder if the trial people suggest what treatments they think would be helpful as you wait?
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no recommendations on treatment plans. Though they did mention if whatever is working well they can freeze my cell until I"m ready to move on. Yes after Xeloda failed me I jumped right into this TIL trial. I didn’t waste any time thinking too much. Besides PI3K mutation I also have TP53 and ESR1. My MO is not excited on any endocrine therapy for my liver Mets. Maybe she hasn’t seen enough successes in Elacestrant. Right now besides Trodelvy I‘m only getting Lupron and Xegva. Anybody is receiving ADC+ endocrine therapy + keytruda？
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I started Trodelvy on 8/29 so far hasn't felt any SE. Isn't that strange? My 2nd infusion will be on 9/7 which is the 10th day of the cycle. Do you all stick to the 1th and 8th day routine strictly?
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PI3KCA mutations are among the most common to arise after CDK4,6i-Endocrine therapy.
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The new therapies, like RLY-2608 and LOXO-783, are specific for mutant forms of PI3KCA, and do not inhibit the normal PI3KCA in healthy cells. They do not have the horrible side effects of Piqray, and they are also stronger than Piqray. RLY-2608 and others will inhibit multiple PI3KCA mutations, whereas LOXO-783 is specific for the most common PI3KCA mutation, H1047R.
One problem mentioned for PI3KCA drugs historically is that they tend not to last a very long time, and it remains to be seen how long RLY-2608 and LOXO-783 last. However, one important limiting factor is the combination of these drugs with Faslodex. Many clinical trials have shown that the activity of Faslodex drops dramatically after progression on CDK4,6i therapies. Whereas Faslodex as monotherapy usually works 4-5 months on patients who have not seen CDK4,6i, it drops to 1.5-2 months after CDK4,6i treatments. And of course, if testing reveals an ESR1 mutation, then Faslodex will certainly be sub-optimal, if not completely ineffective.
So, at a minimum, one would want to look for a trial with an oral SERD in combination with a mutant-specific PI3KCA inhibitor.
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The link below is to the trial for LOXO-783, which is what I wanted to highlight in these posts. This trial (PIKASSO-1) is exceptionally large (400 patients) for phase one, and is available at many sites, including many of the big cancer centers, UCSF, UCLA, Stanford, MD Anderson, Memorial Sloan Kettering, Sarah Cannon, Mayo Clinic, etc. As mentioned above, LOXO-783 is designed to treat the most common mutation of PI3KCA (H1047R).
Importantly, in this trial, LOXO-783 is being paired with an oral SERD, Imlunestrant, so it is a good option for those who progressed after Faslodex with a CDK4,6i, or for those whose cancers also include an ESR1 mutation. For those who only have had an AI, the LOXO-783 drug can also be taken with Faslodex, and in other arms it is also offered in a 3-way combination with a CDK4,6i and either Imlunestrant or Faslodex. The trial allows for those with up to five prior treatments, and does accept patients with bone-only mets. In addition, and very unusual for phase one, it is also available in Australia, Belgium, Canada, China, France, Germany, Japan, Korea, Singapore and Spain.
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Lastly, there are three supplements that might help PI3KCA treatments last longer:
The first is a statin, many statins are known to inhibit the AKT kinase, which is a critical part of the PI3KCA pathway. Pitavastatin (Livalo) has particularly good anti-cancer activity, and does not use the Cyp3A degradation pathway, so would not interfere with drug metabolism or have muscle pain side-effects, and is in clinical trials for lung cancer. The second supplement is Celecoxib (Celebrex), which is a prescription NSAID that inhibits Cox2, which is turned on by the PI3KCA pathway. In addition, Celecoxib is also a strong inhibitor of PDK-1 kinase, which is a common route by which resistance to PI3KCA inhibitors develops. The third is the DIM/i3c supplement, so-called broccoli extract, which stabilizes the PTEN tumor suppressor protein, which plays a critical role in cells to counteract the PI3KCA pathway.
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Cure-ious
Thanks once again for your expertise and time. Nice to finally see a trial that accepts bone only. The LOXO-783 sounds very promising. Have not gotten to the stage where I would need it, as I am still bone only, stable for 13 months so far on Kisquali and fulvestrant. I also take celebrex (100 mg 2x/day). MO prescribed it last year at my request to treat my arthritis pain. Would be great if it was also working against recurrence!
I am currently having palliative radiation to sclerotic rib mets which are causing pain to muscles and nerves in my back. Thought I saw a comment somewhere that researchers are looking at the benefit of radiating even sclerotic bone mets with the intent of extending life. Have you heard anything about that?
Hope springs eternal!
Eleanora
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Reading through these latest entries, I see a lot of references to RLY2608 and other PIK3 drugs. I spent eight weeks on RLY. 1,000 mg dosage. In the last part of that 8 weeks, I was starting to swell everywhere with edema, my fasting blood glucose would not go below 460, and I could feel my heart race. Also red blood cells really dropping. This all led to a critical event that landed me in ICU for 5 days (while on our beach vacation. Ugh). I had ketoacidosis (blood sugar at 695), severe edema, and tachycardia. Chemo was better than this. I am still having trouble recovering from that episode which left me feeling very weak. I’m now not on the trial drug, or any other drug for that matter. Had to have heart tests as they think I had some heart failure during the ICU stay, so I take metoprolol now. My MO said no cancer treatment until I’m stronger. It’s going to be at least 50 days off treatment. That scares me.
I really hope that my experience is a total outlier and that others do very well. Interestingly enough, scans taken right before this episode showed good results. But my MO says no way I try it again. And the clinical trial doc indicated this hadn’t happened before. I really don’t mean to discourage anyone else. This is just how my body reacted.3 -
believe60- What is with these doctors over-dosing patients in trials? Do they really think its safe taking such a high amount? Don't they want us to stay on the drugs? Don't they imagine that there is no-one anywhere who is going to take a freaking GRAM of drug?! Like a gram EVERY DAY?! Don't they want any level of trust in clinical trials?! It sounds like a truck-load, are there other targeted drugs that are routinely prescribed at that level? What level are they dosing other patients? Several people on these threads have had to drop trials due to side effects, why aren't they more careful when trying high doses like that? I mean, what do they tell you now?!
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unfortunately, at this moment in time I would not be willing to be in a clinical trial. They did joke about all the paperwork I have created for them. But they were very apologetic about what happened. I think that’s because they overlooked some warning signs. They offered the 600 mg dose to me, but my MO said no way after being so sick. I know to question dosages moving forward!
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Believe60, Its a great warning for everybody- there have been several on these threads who were creamed after being given way too high a dose on one trial or another. For sure that CDK2,4,6i combo Pfizer has been working on comes to mind, I think we had two people here who were given way too high a dose in that same trial, even though they were treated quite a long time apart, and the drug is still in trials. For me, I couldn't even take the highest dose of Ibrance or Verzenio, and that's what they decided on after phase 3… And my pharmacist keeps calling the high dose the "therapeutic dose", as if the others aren't….
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"Therapeutic dose" really bothers me. Isnt that just the dose they tested the drug at?. Every body is different and some may very well need less for desired effect. Discussing chemo with 3 Dr's, all acknowledged that chemo has killed. My neighbor/Dr said to do my research but didn't suggest how to do that. I poke around on Pub Med a bit but much is a foreign language. Lately it sounds like it's from a different planet.
A special thank you to all those willing to participate in a clinical trial.
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Believe: you could take enobosarm aka ostarine while off other cancer drugs, if being off therapy concerns you. It is negative- side-effect free.my blood glucose went down on it, Chemyo is said to be a reliable source. I’d buy the powder and eyeball the dose but they also sell a liquid that’s easy to dose. I’m on it right now and it’s been keeping my tumor markers fairly stable.
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Dosing is a hot button topic for me. We know my body is sensitive to drugs, so why do we always start at the highest dose? My current MO is good about reducing the dose based on my reaction but yet we always start at the highest dose. Sigh. When I was on the CDK2 trial, I was given the highest dose yet and although I didn’t land in the hospital, they stopped that dose after just a few days and then a few days after that, they reduced it from 800 mg to 400 mg. But that is what phase 1 is all about - seeing how much they can give a human and is that dose effective. What I went through was difficult enough. I can’t imagine what Believe60 went through. But I can’t blame the scientists completely because they can’t possibly predict how each body, each cancer will react. I’m currently on Enhertu and it amazes me that some women live a normal life on the full dose - only feeling side effects 1 or 2 days out of the 21 day cycle- and yet I’m on the lowest dose, get only 1 acceptable week out of 3 and my side effects only reduce. They never go away. How crazy is it to have such a wide range of reactions?
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well, we also are very different sizes and these drug doses are not based on body mass- so for things like side effects, do smaller people suffer more? Surely how efficiently one metabolizes a drug must make a big difference as well.
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luce,
I know nothing about enobosarm aka ostarine. Wikipedia says it's a SARM Selective Androgen Receptor Modulator. Went to the Chemyo website and found the product(s) you mention. My liver tumor genomic test showed I have a High AR (Androgen Receptor) level at 15.0. This test result goes into details, that I don't claim to understand, about Androgen deprivation therapy and AR being a tumor suppressor. I may MyChart my oncology pharmacist with a question about Enobosarm. Anyway, what is your understanding of how enobosarm/ostarine might work in someone with MBC? Thank you.
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Enobosarm is in phase 3 studies (one of them finished; results expected in San Antonio) for breast cancer right now.
Here is one of many articles about that.
Your pharmacist won’t be any help; this is DIY until it becomes approved.
o
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luce,
Thank you for the study links. I've listened to Dr. Lee Schwartzberg on other MBC topics and really like him. Enobarsam sounds very interesting, but I'm not near any of the current study sites that are recruiting. I probably would not consider DIY use because I'd feel obligated to inform my MO, and she would not be receptive. Fast Track status gives some hope.
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weninWI, it used to be thought that for MBC you would want to inhibit AR activity, and then a paper came out showing we have it wrong, the AR is a natural suppressor of the ER in breast tissue, so Enobosarm is a booster of AR activity in ER-positive MBC. Everyone gets confused, because for triple negative MBC, where there is no point to suppress ER, they still advocate for taking an AR inhibitor. What's wonderous about Enobosarm is its an old-time bodybuilder drug, strengthens muscle and bones, probably good for hair(?). So the company has rushed to get it into trials, including firstline rather than AIs. The trials use (I think) 9mgs per day, or maybe its even less? Luce would know how much..
Here is a link to the 2021 Nature Medicine paper that describes AR as a tumor suppressor for breast cancers:
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Yes, 9 mg of enobosarm is the dose they used in trials. It seemed to work a tad better than the higher dose, 18mg, they trialed. But since there was no real toxicity at either dose and the substance had long illegal /underground use in bodybuilding and doping and appears safe, I just eyeball it, so am probably getting anywhere from about 5mg to 30 mg a day. (I do measure with a kilogram scale but nothing short of a lab scale is accurate at such a light weight, so I call my measuring eyeballing. I also have a tiny measuring spoon that works just as well. It’s the bigger side of the yellow plastic spoon that’s for sale for bodybuilders on Amazon that measures approximately 10mg of enobosarm powder, in my experience.
I’d suggested it for Believe, since she expressed concern at not being on any medication while recovering from the trial drug’s SEs. I’m taking it. My oncologist knows but is not putting it into my chart. I strongly feel oncologists need to at least tolerate if not support our choices. If not, get another one. This is my body and my shit cancer so I have to do whatever I have to do. My SOC options suck at this point. Also, I generally don’t qualify for studies since my tumors aren’t measurable by their standards. I have tumors all over—entire skeleton, nerves, lymph, pleura, lung, omentum, pericardium—but it appears to be lobular (I was mixed at initial diagnosis), so isn’t growing in the shape they like for measuring.
weninwi: enobosarm seems to work in ESR1m tumors. (Who knows if durable, but it seems to elicit a response in that population. I acquired a polyclonal ESR1m on letrozole.) As does high-dose estradiol, by the way. Just letting you know since that information might become relevant to you.
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Just an update on my NIH TIL trial status. I am now waiting for them to review all of my previous biopsy slides because they need to determine if my trip neg lesions evolved from my original ER+ breast cancer or are from a new primary. Fingers crossed for the former, as that will keep me eligible!
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My wife has used enobosarm from time to time. It really boosts her stamina. 9 mg/ day.
Be very cautious about the source you obtain it from. There is a high percentage of counterfit, underdosed ostarine (enobosarm) being sold. Chemyo has a good reputation.
Way back, they used to treat breast cancer with the androgen masteron (drostanolone). So the connection between androgen treatment and estrogen receptor positive breast cancer isn't that recent. But the understanding of how it works, is. They believed drostanolone was interfering with aromatase, and that was its mode of action, but it may not have been that simple, as is now known that stimulating AR receptors may be suppressive of breast cancer.
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Jsniffs, Good luck, also good luck to have switched receptor subtypes, makes the cancer more responsive to the immunotherapy!! How do they determine if it is a switch or a new primary?
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Husband, I was just wondering if it would help w/stamina- does it help w/hair loss too? And how did you determine dose (powder or liquid)?
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