Are you currently (or have you been) in a Clinical Trial?
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OK, I think this is at least related to your trial, they do use the FES-PET to monitor your response to therapy. This is a 2021 report, they got good results!!! For those with high levels of ER, and they got 5 out of 30 patients had partial responses (ie tumors shrinking) along with a 6 mos PFS, I will look for more recent findings:
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Here is a good recent review of this area, the counterintuitive idea that one can inhibit tumor growth with estrogen if the cancer has been exposed for a long time in estrogen-depleted environment. They describe some of the pathways involved, and newer data that alternating PARP inhibitors with estrogen also works, even in cancers that do not have BRCA mutations, because the estrogen creates DNA damage that make the cancer unable to grow if they do not have the PARP system to fix it. They also mention an approach using fetal estrogen (E4): "A more favorable side-effect profile was achieved with estetrol (E4) in the treatment of 12 patients with advanced breast cancer, with five of nine patients showing objective response (ie tumors shrinking) after completing 12 weeks of treatment. This is an encouraging result, and larger future studies with estetrol are anticipated
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This approach was largely ignored when newer endocrine therapies showed up, but it can be really effective in cancers that have lived in an estrogen desert, and we know Luce has used it successfully, your MO may have seen people have good success, its well worth a try and side effects surely will be easier than a lot of treatments we get…
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Hi all,
I received the consent packet and tentative calendar yesterday for TTX-MC138.
It's a busy schedule: pretreat bloods, then Day 1-TTX+ 6 hours, then Day 2,3,8,15 for labs for cycle 1, then pretreat bloods, Days 1-TTX+2 hours, then Day 2,8,15 for the next 3 cycles. A lot of visits, but fortunately I'm only 45 minutes away—for someone who lives far, it would be a hassle.
There is an optional tissue biopsy after cycle 3, and scans are at 12-weeks unless clinically necessary (blood numbers I'm assuming). I'll definitely do the biopsy—the more info the better.
According to the packet, the major side effect possibilities are low platelets and iron overload since the drug contains iron. My iron test came back on the low end of high, and the other was normal, so I'm good to go.
CBL
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cure-ious,
Thank you so much for the additional information. One eligibility criteria I don't fit is Her2Negative. I'm now Her2 low. My last labs were still pretty good on Jan 7, but based on increasing pain which I assume is my liver, my labs may change rapidly. Perhaps chemo is the only thing left for me or else hospice. Thanks again.
Wendy
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Wendy: you don’t need a trial to try high/dose tamoxifen or high-dose estrogen, you just do it by yourself. I posted about that a few days ago after you last bemoaned that your only option might be hospice but then deleted my reply due to the deafening silence to it on this thread. And in the Chinese tamoxifen study they allows her2-targeted drugs. You could do that yourself too, with the help of your oncologist. It’s salvage therapy and insurance will likely pay for it. Or you can just buy tamoxifen yourself, it’s presumably cheap at places like Cost Plus or Good Rx. Same for estradiol; very DIY. And I’d know cos I’ve done it.
PS it might help if you posted a link to the trial. All I found when googling was the 2021 write up of a trial in China thar Curious is referencing above. Here is the detailed write up of the results. It also mentions endoxifen (one of tamoxifen’s active metabolites) as salvage therapy that works for some patients tamoxifen did not.https://journals.sagepub.com/doi/full/10.1177/1758835921993436The original way the study was written it’d, it mentions chemo being added, but not which chemo.
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luce,
Thank you for reposting your comments. I don't have your same daring boldness, but appreciate you sharing.
Here's the link to the trial as posted on ClinicalTrials.gov:
It's ID #: NCT0414352 - "Fes Imaging to Optimize Tamoxifen for Metastatic Breast Cancer".
Wendy
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With “by yourself”, I mean with the help of your oncologist, just not in a trial. Much easier path. And any reasonable oncologist would help you utilize cheap, available medications if based on some science (current trials, for example) and your only other option was hospice (as you keep repeating) or much more aggressive chemo (it’s reasonable to try an unconventional hormone-therapy that has some rationale behind it before moving on to chemo).
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Wendy, The paper cites a trial that is no longer listed at the NIH site, altho there is the listing you posted where they are still doing the trial to use FES-PET to determine that cancer is still endocrine-sensitive and how much tamoxifen the person should use. Apparently the issue with tamoxifen levels is that higher amounts are needed for cancers with ESR1 mutations. So because there is no list of the protocol for the trial other than how they image, can you let us know what the procedure is that you will be following? I wonder if it is just straight high-dose tamoxifen or whether it is alternated with anything else?
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So, I'm trying to guess what is going on with the phase 3 trial of Pfizer's new CDK4 inhibitor, which is being tested both on those who have progressed on ET+CDK4,6i and as first and secondline therapy. Its a large international trial at 241 sites, and at least one record indicated its for 333 patients, how can that be, they only need one person per location? Anyway, the trial looked very good at earlier stages, and worked on cancers that had progressed on the standard CDK4,6i, and on those with ESR1 and Pi3KCA mutations:
It started Jan 2024 and is estimated to finish Dec 2025, however it is currently being listed as "Active, Not Recruiting". So they are full and won't need more people. Will it take the whole rest of the year to generate the data they need to submit for FDA approval? I have no idea but am hoping it means Pfizer is rushing this ahead of schedule, and might be able to submit sooner than later. It would still take FDA some months to evaluate and decide, but hey, wouldn't it be sweet? We all need some hope…
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Here is a link to the trial, for those who want to check out a trial with an unbelievable number of sites. I am hoping they were flooding the zone with sites in order to fill up as quickly as possible, and then move earlier than expected to the FDA. They still need to monitor those patients who signed up recently, but their control arm is fulvestrant alone, or fulvestrant with everolimus, which doesn't work for very long (like 2-3 months) in those who progressed on fulvestrant with CDK4,6i. And because their earlier trials suggested the new CDK4i has a PFS of around 8 months, I guess it shouldn't take too long for them to be able to show superiority?
Regardless, their initial estimate for study completion was Dec this year, and instead it just happened this month…
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Sounds promising! Thanks for the update!
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Thanks @cure-ious . I myself have been curious about these new CDK4 inhibitors. Go, scientists, go!
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The last couple of studies mentioned are for HR positive, Her2 negative tumors. Why are these new promising treatments not applicable for HR positive, Her2 positive (low, 1+, 2+. 3+)?
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Hi WeninWI
The paper that cure-ious posted about high dose tamoxifen was the reason I have it on my radar. I'm also going to read the estrogen one too. And Luce's comments about SERMs/SERDs have also had me put my thinking cap back on. Hopefully at your appointment your oncologist can tell you why she thinks why the taxmofixen trial might be good for you right now versus other options because I do wonder if it's "too soon" from when you last had it. I put high dose tamoxifen on my list because I'm much further in (15 lines and counting up..).
You asked about the issue of being HER2+ low. When that tamoxifen trial started, HER2+ low wasn't really a thing yet. HER2+ low was essentially HER2- because it meant you couldn't get Herceptin, Perjeta etc. I doubt it will exclude you from the trial.
You wrote "If nothing looks even a little promising, I'll start Hospice." Choosing to end treatments takes a lot of courage (I've been doing this a long time so sadly many of my friends have needed to make this decision). But really there's still a lot for you to try. I hate IV chemo, especially paclitaxel, but I was lucky they worked (had real regression with paclitaxel) and then I could try something else that had come along in the meantime (like the new CDK4 inhibitor for you?).
And in my experience the oncologists are very good these days with managing side effects/reducing dose for the conventional treatments. And chemo nurses are really nice (which you've likely found as you've had Enhertu).
Good luck at your appointment.
Cblaurenauthor - I am so happy for you that the trial came thru.
Cure-ious - (answering your question from a page back) yes, I think I'll ask again for another biopsy & genomic testing post Enhertu, if only because I am also curious for what it looks like versus 2017 and 2022. Also it really seems like the outputs are getting amazing. Your points about liquid biopsies were interesting.
Take care all
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