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Are you currently (or have you been) in a Clinical Trial?

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  • sadiesservant
    sadiesservant Member Posts: 1,875

    Fabulous news! If I can just hang on with my slow moving beast…. 😊 Wonder if trials will make their way here.

  • sondraf
    sondraf Member Posts: 1,665

    That ARX-788 announcement said there are 175 treatments in trial for HER2+ - yeah, that sounds pretty crowded. Let's hope some of those turn out to be evolutionary and work for HEr2 low as well.

    From the Spain news report, there is a linked article on AZ releasing data today on two trials with two drugs showing promising results over Faslodex + placebo, for post endocrine treatment patients, especially for ladies with common mutations in PTEN and PI3K:

    https://www.biospace.com/article/astrazeneca-hits-the-mark-in-two-breast-cancer-studies-/

    Any thoughts Cure?

  • susaninsf
    susaninsf Member Posts: 1,099

    Yay! Thanks for sharing, Cure-ious.

  • cure-ious
    cure-ious Member Posts: 2,854

    Thanks Susan, We all need that list of good options to keep growing!!!!

    Today's exciting entry comes from Luce, who really keeps on top of things, and its actually from a phase III trial, no less!!!

    The new drug is Capivasertib, which is an AKT-specific (ATPase enzyme) inhibitor. In this trial of endocrine resistant ER+ cancers, the drug worked on both cancers with an PIK3CA, AKT1 or PTEN mutation, but also on cancers that did not have those biomarkers. Capivasertib was combined with Fulvestrant in this trial, and they are saying it met their PFS endpoint goals, but specific details not yet provided, surely we will hear about it at San Antonio in Dec. Overall survival also look "encouraging", but data not yet mature, so something to keep a lookout for....

    https://www.astrazeneca.com/media-centre/press-rel...


  • nicolerod
    nicolerod Member Posts: 2,877

    I am meeting next week with the TIL trial at NIH (providing I have a clean brain Scan on Tuesday....so please pray my scan is clean...Thanks.

  • bsandra
    bsandra Member Posts: 1,023

    Dear Nicole, I pray that your brain scan is clean, that you are a perfect candidate for the trial, and that everything goes smoothly and TILs will do their job! With all my heart, Saulius

  • cure-ious
    cure-ious Member Posts: 2,854

    Sondra, Oops I missed your earlier post here, but yes, we are both posting the same trial, and the results sound so encouraging for endocrine-resistant cancers with or without PI3K mutations- waiting to hear the response rates and PFS numbers, but this was a big trial with almost 700 patients so the numbers should be at least accurate and hopefully hold up...Hoping that the data are strong enough that they decide to go ahead and file for FDA approval and get it into the clinic ASAP, we need more targeted therapy options, alternatives to chemos!!!

  • cure-ious
    cure-ious Member Posts: 2,854

    Nicole, Wow that is great news that the NIH team will meet with you now, maybe your new scans show a resectable tumor they can sequence? If you have to go onto another med while waiting for them to sequence can it at least have some immunotherapy, since ER+ tumors that lose ER expression are the most responsive of all MBC to IO? Also, if you do have brain mets, can't you have radiation and verzenio to kill them while you are waiting for them to get the T cells ready for you? Remember Perkins was in bad shape when she took this trial, and it worked so completely... But also if this doesn't go thru some kind of IO option could be a gamechanger for you... best of luck, you are showing us what real bravery and perserverence looks like!!!

  • sondraf
    sondraf Member Posts: 1,665

    Amen cure - Id love for a new treatment to be available to slot in when Lynparza goes, hopefully it won't be for a while yet!

  • myshadow
    myshadow Member Posts: 40

    Nicole - wishing the best for you regarding the NIH trial. Hoping you get clean brain scan results.

    I am also waiting for more data on Capivasertib. Wondering if it shows activity in the brain. It would be nice to have more options for brain Mets. I haven’t had much luck in the past with endocrine therapies despite having high ER+. Hoping this is the game changer.

    BriaCell is another trial I’m interested in.

    https://clinicaltrials.gov/ct2/show/NCT03328026


  • susaninsf
    susaninsf Member Posts: 1,099

    Nicole,

    So exciting that you are meeting the NIH team! Keep us up on how the process works.

    Hugs, Susan

  • nicolerod
    nicolerod Member Posts: 2,877

    Thank you all.

    Cure...I do have a tumor that is resectable in my liver now near the capsule the surgeon from NIH already reviewed my scan from last week thats why they are having me now come in. I cannot get Immunotherapy while I wait bc my insurance will not cover it since I am not PDL1 positive. We will most likely be going to gemzar and carbo...When you say "IO" do you mean immunotherapy? What scares me about this trial is I believe I read a while ago that if you are accepted that when they suppress your immune system you need to be admitted to the hospital for 6 WEEKS!!!! I just don't know how I will handle that especially if I cannot see my husband..etc...I will of course find out more once and IF I can meet with them. There are NO exceptions for the brain mets...if you have brain mets you are out that is what they told me.

    I also feel worried whether or not I am picking a good trial... :(

  • cure-ious
    cure-ious Member Posts: 2,854

    Oh, Nicole, I'm so happy to hear you now qualify!!! I am sure its intensely nerve-wracking, however this trial is in the highest-possible-reward category, and can at least have the potential to work for a very long while, as it is capable of getting the most durable responses. If you have to go into hospital for so long, well, at least we are all here 24/7?!

    PS Yes, IO is shorthand for immunotherapy...

  • susaninsf
    susaninsf Member Posts: 1,099

    Nicole,

    That long hospital stay also scares me. Three days in the hospital is torture enough. I mainly worry that I will be so weak after that long a stay. But my husband pointed out that, if I can be cured, it will be well worth it. True dat.

    Regarding the CNS issue, they told me that they would review my records. If I had been stable for several years, they would consider me for the trial.

    You are brave and deserve this kind of specialized treatment. We are all hoping you will be cured!

    Hugs, Susan

  • nicolerod
    nicolerod Member Posts: 2,877

    I will only qualify if brain scan is clear....Brain Scan Tomorrow Tuesday 6pm please PRAY NO METS!!!

  • nkb
    nkb Member Posts: 1,561

    So excited for you Nicole! Hoping that your brain scan is clear!

  • husband11
    husband11 Member Posts: 1,287

    Praying for a clear brain scan for Nicole, and for sucessful treatments for all those looking at trials.

  • nicolerod
    nicolerod Member Posts: 2,877

    Trial is out I have brain mets


  • candy-678
    candy-678 Member Posts: 4,166

    So sorry Nicole. So what is next?

    Did you have any symptoms of brain mets, I didn't think so. They just did the brain scan due to the trial, right? That is what I don't understand. Why not brain scans routinely for us MBC'ers. They wait until symptoms to occur. I don't understand.

  • susaninsf
    susaninsf Member Posts: 1,099

    Oh Nicole, I'm so sorry. How many brain tumors do you have? Hopefully, they can be quickly zapped. Other trials usually just require that any brain mets are treated.

    Hugs, Susan

  • moissy
    moissy Member Posts: 371

    Nicole - I'm sorry that things are changing up. I hope the mets can be treated and then back on to other possible trials.

  • myshadow
    myshadow Member Posts: 40

    Nicole, I’m so sorry about the brain mets diagnosis. After you take time to process this news, please let us know what your MO suggests for treatment. I’m hoping cyber knife or similar therapy can be used to zap them.

    There is a trial of erx-41 that is supposed to open up in the first quarter of 2023. If you can get things somewhat stabilized, I wonder if this could be an option.

    https://www.utsouthwestern.edu/newsroom/articles/year-2022/hard-to-treat-cancers.html

    Keeping you in my thoughts.


  • nkb
    nkb Member Posts: 1,561

    So sorry Nicole

  • tinkerbell107
    tinkerbell107 Member Posts: 292

    I'm sorry Nicole.

  • nicolerod
    nicolerod Member Posts: 2,877

    There are 2 brain mets.. My oncologist spoke to the RO and they can do cyber knife I am waiting for them to call me to set up appt to meet with them.

    Trial said if I go 6 months with clean brain scans I can apply again.

    This is TNBCnow ( has been for the past almost year) and that is why it is now been extra aggressive and I feel..unfortunately ...coming to the end. We are going to GEM/Carbo I start Nov 15th. I am not hopeful at all at this point ...I know carbo can be very effective but I also know its not tolerated well .

    Candy, no symptoms except my husband says possibly short term memory stuff....I will ask the RO about that.

  • dodgersgirl
    dodgersgirl Member Posts: 1,902

    Nicolerod— sorry for the new progression.

    Will keep you in my prayers.

    Hope RO knocks them dow

  • eleanora
    eleanora Member Posts: 299

    nicole

    Just logged on and saw your update. Sorry for the repeated gut punches. Sending you as much positive energy as I can muster. The good news is that you can re-apply for the trial in 6 months. Although you may not feel like it right now, you are strong - you can do 6 months of treatment in order to get into that trial. Fingers crossed for you.

    Eleanora

  • bsandra
    bsandra Member Posts: 1,023

    Dear Nicole, I am so sorry the scan is not clean. Is this your first brain-scan? If so, this sucks... they cannot compare it with something previous, which might be stable or not mets at all:/ Really... why these brain scans are not routine... HER2 and TNBC BCs are known to go to brain, so rationale for not scanning is really hard to understand, although most leading scientists still hold on to this approach "not to scan until symptoms". This all comes from supposed incurability of mbc, which is bs in the middle of 21st century.

    Saulius

  • nicolerod
    nicolerod Member Posts: 2,877

    Thank you all... Saulius this is not my first brain scan I had one about a year ago (maybe a little bit over a year ago) it was clean then.

  • cure-ious
    cure-ious Member Posts: 2,854

    Agree w/Saulius, its ridiculous the brain is ignored in scans. Apparently the NIH group agrees, so in this case they are in essence ensuring that you are as healthy as possible before beginning the procedures in their trial. Treat, six months recover, then onward. I guess there will need to be yet another treatment after they do the liver resection while waiting for the T cells to be prepared.