Are you currently (or have you been) in a Clinical Trial?
Comments
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Nicolerod Thank you for sharing the Travera information. I tried to talk to my Oncologist but she was not interested. That is great that your onc is willing to look at all avenues, and takes the time to explain her decisions with you. That sounds like a great doctor.
Were you able to choose which drugs they tested? Or did you get a panel? Once you have digested the Travera results, would you consider doing the test again? Please keep us updated.
Prayers for you and your clinical trial or whatever treatment is your next step.
Cure-ious That is a very informative response! It makes so much sense. This test does not consider the immune system response to the drug nor does it show how a person will metabolize the drug which will in turn determine how effective the treatment will be. It is nice to have some data to back up treatment decisions though. It really feels like many oncologists have the Standard of Care "see which drug sticks" approach to treatment which I find nerve racking.
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bookgal - Personally, the "see which drug sticks and cross your fingers that the side effects don’t suck the life out of her" approach is what I find most frustrating. I think the Travera test is a big step forward in the right direction and will become even more meaningful and accessible as the technology is refined.
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For people in the Bay Area with plural effusions or ascites due to any type of cancer, there is a clinical trial that is using the TRAVERA test (that Nicole described above) on malignant fluids, to assess which drugs would be most effective. Available in Oakland CA only:
https://clinicaltrials.gov/ct2/show/NCT05461430
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A phase I study evaluated abemaciclib in 47 patients with different subtypes of breast cancer: HR-positive (36), HR negative (9); HR-positive/HER2-positive. The clinical benefit rate was higher in HR-positive subgroup compared to the HR-negative subgroup. The PFS was 8.8 months in HR positive patients compared to 1.1 months in HR negative subgroup...
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Bookgal...I can tell you that choosing what they test for was discussed between my MO and them. I do know that she did ask specificially for Ixempra, Vinorlbine and Enhuertu.
Thanks for the info Cure!
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Update on BLU-222 CDK2 inhibitor trial:
Last October, while on Xeloda, I had a PET scan. It showed some new bone mets with low SUV and new liver lesions. To start the trial, I had to stop Xeloda and have a baseline CT just 4 weeks after my PET. I expected the baseline CT to show the bone mets, but it did not. It only showed the liver lesions. So that says to me that a CT isn't as sensitive to my bone mets as a PET. I started the trial and 7 weeks later in January, I had a CT and the report mentions nothing about new bone mets, a reduction in 1 liver met and yet my typically accurate tumor markers went up a bit. In February, my TMs were close to doubling in 1 month. I don't yet have my March TMs but I just met with my trial doc about my March CT scan. The scan shows some progression in my liver and NOTHING new in my bones. I definitely expected bone findings given increased pain and rising tumor markers but the CT showed nothing. I wonder what a PET would have shown? Anyway, stopping this trial has been weighing on me lately. Although my diarrhea is off the charts, my colon is literally screaming (it even showed up on the CT) and the nausea sucks, I am not looking forward to IV chemo. Moving off the trial would also mean making a decision on keeping my convenient local yet mediocre oncologist or traveling to an area of the state I'm not fond of to see a new doctor. Anyway, my doctor asked me if I wanted to stop the trial. She said that although the liver growth isn't technically enough to get me kicked off, she doesn't think I will get more then 1, maybe 2 more months. I completely agree with her but I still hemmed and hawed so she said she was going to make the decision for me. She recommended stopping the trial. Her reasons being that I am miserable, I've put up with the SE longer then any other patient and that the benefit of the drug no longer out weighed the QOL loss. And she is right. This is the first time I needed a nudge to make a decision but I'm grateful she pushed me. My husband told me weeks ago that I should quit this trial so he's in total agreement. But wait, there's more!
To give me options beyond chemo, we spoke at length about 2 more trials with openings. One was an immunotherapy trial. Intriguing and I liked this particular trial over the PY159 offered in the past but I wasn't sold. Then she offered a PROTAC trial - an oral estrogen receptor degrader. Bingo! That's the one I want. It's another Phase 1 -AC699 is the drug. 60 participants across the US. I don't know how many are already enrolled. My facility was only given 2 spots. During my 2 week wash out, I'm scheduled to get my other baseline tests done. My start date hasn't yet been scheduled but it will be between 4/5 and 4/12. I don't know if this one will work, but I'm willing to try. I feel strongly that even if this doesn't make a difference for me, it will be meaningful to researchers.
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Hi rk2020, I've had a couple of trials like that - a nudge of progression and I think, phew, I can get away from the side effects! I'm sorry that the Blu222 trial drug was hard on your quality of life. So far on my combined CDK2 and CDK4 trial I'm a little more regular than I'd like to be, but not quite at diarrhea. Day 1 I had nausea, but since then I've done much better. I'm still crazy fatigued and short of breath, but that might be the travel, January's bout with covid, or the mets still. We're all happy that the icky skin lesion I have is shrinking. It's nice to have a visible sign to keep going. My trouble is the travel required to get to the trial - I'll be happy when the weekly visits stop for the Phase 1 trial. I'm just at week 3 of my first cycle.
That's great news that you can try a new trial that speaks to you right away. Good luck.
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rk2020- sorry to hear that the trial drug didn't work well, but, it sounds miserable! Diarrhea is so difficult- I've rarely had it- but, it is awful. I am very excited to hear about your protac experience- it's a category of drug I hope to try one day. enjoy the wash out period!
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rk2020- I was interested to learn that the ER degrader you will be testing is called by the company one of the very first drugs created by artificial intelligence (AI)-enabled drug discovery! Good luck and hopefully very little in the way of SEs- a fast 2 week washout is very smart too!
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NewGardener- can you post a link to your trial or the name of the CDK2 inhibitor you are trying?! Maybe this is will be a good one!!!
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wow newgardner, you've got some extensive trial experience under your belt. Go girl go! My husband watched his mom die of mbc and now me. I'm joining trials so hopefully my son never has to watch his wife go through this.
I've typically got a strong stomach. I had a bit of diarrhea on Verzenio but it was the cramping that was my biggest complaint. I've never been nauseous on any drug -even chemo - much less thrown up. But I am very sensitive to any drugs, even over the counter drugs will make me feel odd. I'm glad to hear that your SE aren't too bad so far. I threw up on day 1 and had diarrhea within 18 hours so I was off to a rough start. Since you are taking a combination, your cdk2 dose is probably lower than what I took. I started at 800 mg and quickly had to reduce to 400 mg. After my bad experience on 800, no other patients were put on that dose. Others were on 600 and the starting dose of the trial was 200 mg.My only apprehension is that AC699 is another Phase 1 trial. I don't know how many participants have joined already or where they are in the dose escalation process. Will I be started on too low a dose to be effective? Will I be given a dose that is too high for humans (like my last drug)? I'll talk to my doctor about these concerns but the answers won't stop me from signing the consent.
Thanks for all the support! I'm in it to win it.0 -
RK2020, thanks for the update. It sounds like you really gave it your all in that trial. I wish you success in the latest trial, and that you pave the way for others to benefit from a new, sucessful treatment.
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Cure-ious - here's the link to my trial. I'm in Part 1, but the doses have been established.
https://clinicaltrials.gov/ct2/show/NCT05262400
rk2020 - I agree about the concern with the dose escalation aspect of Phase 1 trials - will the doses be high enough to be effective? That's when one really feels more like a lab rat than a person. I hope they can give you some satisfactory answers.
Nicolerod - how are you doing with the FL trial? I think that in the end you were able to get in after some not so pleasant uncertainty.
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Newgard... I am in the trial...they put me in the 1 week on 1 week off arm..as oppsoed to the 2 week on 1 week off..either way you only get 4 doses then they scan. I had 1 and still have all my liver pain so its not working yet. This Tuesday March 28th is my next infusion I am praying my liver pain starts receding... as you probably know I have never had a treatment work more than 3 months... aside from Y90... which I have had 2 times and Microwave Ablation once and Cryoblation once...my IR will not treat with cruative intent anymore and I understand why there are just too many tumors now and they are in so many organs now...anyway I have no side effects...but at this point I would take side effects just to have something work...even for some time..
. Ill keep ya posted my scans are gonna be the last week of April.0 -
Nicole, I am so happy you passed all the criteria to get into the trial. Praying for results!
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Nicole, good that it's all going forward now. I hope infusion #2 goes well and your pain starts to abate.
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Nicole, I hope you get some relief soon!!! And just wanted to point out that the ADC-chemo part of the drug should work relatively quickly, like chemo, whereas the immunotherapy component may take longer, as in weeks longer, as the immune systems gets better access to the tumor and destroyed cancer cells and imprints so it knows how to go hunt more cancer. So if scans show progress, that could further improve with time, based on how this drug is hoped to work...
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Cure...I am not getting immunotherapy only the ADC drug... ???? Also yes, the doctor said when this drug (ADC) works, it works fast that is why they scan after only 4 treatments..unfortunately today i found out my bilirubin is now higher than ever which for me, is like TM's.... and its now 2.0..so the first treatment did nothing... my 2nd is tomorrow... I have decided that if after the 3rd treatment in 2 weeks , my bilirubin is still going up and still have my liver pain ..I am leaving and not waiting for the last treatment...there is no reason to at that point.
Also please pray for me..i got ANOTHER UTI...I had one back in Jan now I have one again we spent yesterday morning in the ER....
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Nicolerod - You are not just in my thoughts but my prayers as well. Please keep us updated. I hope treatment #2 lands a good solid punch, sends your cancer reeling and your bilirubin plummeting. Hugs.
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Continued prayers for you Nicole. I hope this treatment kicks in and starts working for you!
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Nicole, I agree, its very scary!!! I don't know how we are supposed to be "tough enough" to handle the news coming at us so fast from the constant scans and bloodwork in this disease, when its all out of our control so completely.. What I meant in the previous comment is that the drug you are taking is hoped to do two things: 1) B7H4 antibody-directed chemo at the tumor, which should work fast; and 2) the drug also targets B7H4 on the surface of macrophages that are protecting the tumor, and in so doing may open up the tumor to the immune system. This part takes longer to work, and they say on the order of weeks to months. So there could be a late benefit to taking this drug...
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Thank you Cure for explaining that but 1. they unfortunately do not give "months" to see if it will work...and 2. my immune system (neutrophils) have already dropped after only 1 treatment from 4500 to 2500...and now I have treatment tomorrow they are going to tank even more.. they will not allow Neulasta shot until you hit 1500...so at 2500 my immune system isn't great. He did say he didn't have a problem if I took Papaya Leaf Extract which works really well platelets and neutrophils. Im in a bad position bc if I wait TOO long for this trial and my bilirubin keeps rising i wont even be able to do Vinelorbine and /or Enhertu....
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Nicole, I agree completely with all your points!!!
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I was on the SERD Camizestrant (AstraZeneca) trial during phase 1/2 a few years ago. I took it after progressing on several treatments: Ibrance / letrozole followed by Ibrance / faslodex followed by xeloda. I went 10 months on the oral Serd before progression. They started me out in a very small arm with affinitor and the oral Serd. We dropped the affinitor because it caused pneumonitis after 3 months but they let me stay on the trial just taking the oral SERD. It was the easiestdrug ever.
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karpc,
Thank you for sharing. Your experience with the oral SERD Camizestrant is encouraging. Do you know if you have the ESR1 mutation? My MO has mentioned Elacestrant (Orserdu) as a possibility in the future, but not Camizestrant. I will bring it up for discussion at some point.
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Weninwi - I did not have the ESR1 mutation.
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Ok ladies and Gents... this was my off week after 2nd treatment and my bilirubin went from 2.0 to 1.7!!!!! Praise GOD He is so merciful!!!!! I am praying this means the treatment is starting to work!!!!
I have other news... I spoke to my oncologist about what treatment would be next based on the Travera results AND based on the regular testing they did from the biopsy.... GUESS WHAT..... look at this:
The receptor testing came back on the liver biopsy and it is ER and PR negative but HER2 1+ - which means HER2 LOW.
Therefore I would like to consider doing Enhertu BEFORE doing vinorelbine - but happy to discuss with you. And that is clearly standard of care so no isssue getting it approved.
Bili levels can also be high for all of those:
------ Vinorelbine can be given full dose if Tbili is 2 or less. 50% dose if bili is 2.1 - 3. 25% dose if bili is > 3. Advised if extensive liver mets to always give 50% of dose regardless of bili. Dosing is weekly --- super annoying.
----- Enhertu can be given full dose up to 3 x ULN of bili (3.6 or less). Dosing if every 21 days.
----- Abraxane can be given up to 3.6 bili as well but dose reduced. Dosing is 3 weeks on, 1 week off or 2 weeks on, 1 week off.
Waiting on Tempus still but the results won't change our plan for next line of therapy.
Can you guys believe it I am HER2 1+ !!!!!!!!!!!!!!!!! I am writing her back to ask why she would pick Enhertu over the Vineorlibine bc according to the Travera I came up 100% to the Vine... and even though they didn't have Enhertu to test against they had something similar and that showed a 68% response....
Anyway thoughts?
*cross posting in Liver Mets
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Nicole, That's a no-brainer, Vinorelbine PFS= 2 months, Enhertu=17.8 months. One cannot directly compare trials with different populations, etc, but this one is easy. You may lose your coveted Her2+1 status upon treatment, but Enhertu works almost as well on Her2-zero cancers anyway.
But hopefully this treatment is working!!! Give it time, and remember the immune benefits kick in later...
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karpc- Thanks for weighing in on Camizestrant, now I'm even more excited to try it once it gets FDA approved or they open up a relevant trial...
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nicolerod- I have no advice but am hoping and praying to hear continued good news. Hugs.
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