Are you currently (or have you been) in a Clinical Trial?
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Dee,
It sounds like you have a great advocate in your Dr. Hamilton who is looking out for you. Your reasoning behind the second SERD seems very sound. Fingers crossed that you get into that trial and that it works for you.
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Awesome, Dee. Keep us posted.
I just found out that none of my labs will disqualify me. Yay. Also the scheduler for BX should call today. They don’t have my CTs back yet, though.
One step closer.
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Grannax,
Fingers crossed for you, too, that this works out.
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dee, great news!
grannax2, fingers crossed for the scans!
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Grannax- Wishing you well on all the qualifications
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Dee, How exciting! Your MO probably figures that the cancer found a way to prevent the ARV-471 from degrading ER, we have another drug does the same thing by a different mechanism, you probably can go a long time on that as well!!! Plus, its really helpful for all of us to know that you can be resistant to one but still respond to the other
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great news Dee..really happy for you! I really wish I had such a clear leading....
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AlabamaDee,
As always, I so appreciate the details you provide about the process you are going through to choose a trial. You are definitely a trailblazer!
I finally got a call from USC. My MO thought they were going to call on Friday so I was a little worried. They scheduled a telemedicine visit for Thursday. So grateful I can do it remotely.
Hugs, Susan
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Good luck Dee, your success is also our success, so... thank you for fighting and helping to push mbc research forward! Saulius
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Thanks BevJen, moth and Moissy.
I did get my liver BX scheduled for Monday, November 22. One more step in the right direction. Ya
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Grannax, Dee, and Susan. I'm glad to hear you found some trials. I hope the drugs get you to stable. I look up to all of you in these trials. You're paving the way for others.
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Anyone see this..especially UK people.... I mean unfortunately we here in the USA probably wont see it to even go to trial for years...let alone be approved..but looks pretty promising...
https://www.express.co.uk/life-style/health/1521058/Cancer-vaccine-latest-NHS-trial
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The producers of Leronlimab (CCR5 monoclonal) have filed with FDA for breakthrough designation, having already received a fastrack, based on a small (28 patients) phase one study and some compasionate use patients, all with TNBC- they find longer PFS and OS for leronlimab and chemo compared to chemo or Trodelvy alone. It would be nice to see leronlimab combined with immunotherapy and tested on additional MBC subtypes.
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Cureious is there a link about that being fastracked?
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So if its fast tracked..(Saulius talked about this too in the liver thread).... what does that mean how soon would it be approved none of the articles i read about it say it?
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Nicole, If FDA approves it as breakthrough for TNBC, it means that they agree the data show that the drug is significantly better than standard-of-care, and then the FDA would work closely with the company to get it through the clinical trials as fast as possible. With it being already "fast-tracked", it just gets an even bigger push. Bestbird said this was one of the top "hot topics" for TNBC at the last San Antonio meeting, so there is a lot of excitment for this drug.
It is known from HIV-1 infection trials (CCR5 is a receptor for HIV-1 entry into cells) that leronlimab is effective and safe. In the literature it has been reported that CCR5 inhibition also boosts the immune response, so it may work even better when combined with checkpoint inhibitor immunotherapy.
With all that said, there is a way you may be able to get it - the link below describes an Expanded Access Compassionate Use Trial, designed for 30 patients. It would be given (by your MO?) in combination with physician choice chemo (eg, eribulin, gemcitabine, capecitabine, paclitaxel, nab-paclitaxel, vinorelbine, ixabepilone, or carboplatin). This trial is sponsored by the company that makes Leronlimab, and they just reported it doubles the response time to Trodelvy, so presumably they also support using that as physician's choice.
Here is the link to the trial:
https://clinicaltrials.gov/ct2/show/NCT04313075
And here is the link discussing the data that led them to file for Breakthrough Designation:
https://www.targetedonc.com/view/leronlimab-applic...
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Nicole- I don't know if my experience with Leronlimab will help at all, since I'm using it under the “Right to Try" act. I'm ER+ not TNBC. I contacted Cytodyn hoping to get into the solid tumor trial. They requested a tissue sample from my cancer center. They tested it for CCR5 and also PDL1. I was CCR5 positive. At that point, the trial was put on hold due to Covid (October, 2020). I contacted Cytodyn again in April 2021 and was told they were only doing the TNBC trial at that time. They said I could get it faster by using Right to Try. My MO took over at that point and filled out the paperwork, which I had to sign. They send the drug to my cancer center - no charge to me. I administer two shots in my abdomen once a week.
I started it as mono therapy in June and added Faslodex in July (my MO likes to introduce one drug at a time to monitor side effects). I added Verzenio in October. I honestly do not know if it is working, but I can tell you I felt fantastic all summer. My blood counts and metabolic panel finally returned to normal range for the first time since MBC diagnosis. Unfortunately, my CEA marker keeps going up. It has always been a good indicator of progression so that is troubling. My MO wanted me to stop Leronlimab temporarily when I started Verzenio - again to track side effects. My blood counts tanked after two weeks and I feel horrible. Emotionally, it's tough since I felt so good before Verzenio. I'm adding the Leronlimab back in next week.
As far as side effects, I experienced a bit of constipation and temporary increase in bone met pain. Unfortunately I get no guidance or testing from Cytodyn since I'm not in a trial. I did speak with a doctor at Huntsman Cancer Institute as they did a small TNBC trial there. He did mention there is a tumor flare phenomenon associated with this drug since it is changing the tumor micro environment. That could explain the CEA increase and also more FDG uptake on my recent PET scan. The problem is I don't really know for sure if it's progression or flare and I hate not knowing. I wish I could say definitively whether or not it is working, so I could wholeheartedly recommend it. We could all use a better treatment with minimal side effects. I believe it can be combined with most chemos and even immunotherapies if you are PDL1. I will try to update when I know more. Sorry for the long post. 🤪
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MyShadow...does one have to be PDL1 positive? Bc I am showing negative now.... also would I be eligible for Right To try??
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Nicole,
Google federal right to try. There's lots of info there about eligibility.
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I am PDL1 negative. I’m not sure why they tested me for that. Maybe just to see if they can combine with immunotherapy drugs? It didn’t prevent me from getting access to Leronlimab.
As far as Right to Try - I wasn’t completely out of other options yet. I had to sign a consent form that stated I was using an experimental drug under Utah’s Right to Try Act.It basically states I have a terminal illness and I’m aware that I could have a negative outcome and it could even hasten death. 😬 It lists possible side effects and outcomes. It also protects them and my doctor from being sued. You would need to check the laws in your state to determine if you could get access. Your MO might know. They did tell me it is fairly easy to get access in Utah. I feel lucky that they are providing the drug at no cost. Sometimes the patient has to cover the cost of the drug. Insurance definitely would not cover it!
I did check with my insurance company to verify it wouldn’t prevent me from being approved for other SOC treatments if/when this one fails.
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https://friendsofcancerresearch.org/clinical-trial-eligibility-criteria
I found this article on modernizing CT eligibility. Maybe with some pressure there will be changes.Dee
FYI- here is a link for expanded access info I read somewhere t try that path first before right to try(insurance doesn’t have to pay for RTT)https://www.fda.gov/news-events/expanded-access/expanded-access-how-submit-request-forms
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Thanks Cure...but wouldn't it have shown on my Tempus if I had CCR5???
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CCR5 is expressed in more than half of all breast cancers, and >95% of TNBC. The trial confirms the minimal level expression they need for response, this is not a mutant gene they are talking about .
The trial inclusion list says no/low PDL1, presumably because high PDL1 should be on checkpoint inhibitors
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The federal right to try act now supersedes any state laws, so you should check that and not state of Virginia laws. It used to be state by state, but no more.
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Dee- thanks for those links. I always thought expanded access only applied to FDA approved drugs.
I'm glad they are finally recognizing the need to broaden trial eligibility requirements. It frustrates me that they are allowed to “cherry pick" the patients they have pre-determined will have the best outcomes. How will they know if a drug will be effective for brain mets if those patients are excluded. They could even separate the patients into different categories when they are gathering data to show how well the drug works on different metastatic sites.
I'm super frustrated to learn that Bayer is not moving forward with ErSO. I was hoping that it might be the golden ticket to making MBC an actual “chronic disease". I guess my expectations are too high 🤦🏻♀️.
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Im sorry Cure.....I don't know that I am understanding you...are saying "not a mutant gene" meaning it wouldn't be on my TEMPUS? I am confused..I just know I do not see that on my report....
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I have no idea if Tempus would note relative expression levels of CCR5 mRNA, but it doesn't matter, the clinical trial says you have to have it tested by immunohistochemistry (protein staining). They do the test, and the vast majority of TNBCs have it...
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Nicole, ccr5 is a gene that codes for a protein. This drug targets that protein & they're looking for expression of the protein, not gene mutations.
Similarly the gene cd274 codes for pd-l1 but we test for the protein, not the gene.
Does that help?
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Yeah, what Moth said!!
Basically, the treatment is a monoclonal antibody, and they stain the cancer with the monoclonal to see if the protein is expressed and lights up the cell- they want at least 10% of the cells to show CCR5 expression. This is how they test for Her2-positive MBC, by staining cells with the her2 monoclonal antibody.
Because you are a converter (ER-positive to ER-negative) it would be of particular interest to know if your cancer responds well to Leronlimab, potentially even better than classical TNBC. These converter cancers tend to respond exceptionally well to checkpoint inhibitors, and Leronlimab not only has anti-cancer activity but also boosts the immune system, by inhibiting CCR5 in tumor-protecting immune cells. So would MBC converters also be exceptional responders to this drug? nobody knows...
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Well I get it....but..here is what my MO said :
I would prefer doing more standard therapy prior to trying a 'right to try drug'. Taxanes and trodelvy first would be my bet. We can start with one and then do the other. I don't think there is a right or a wrong. I won't feel comfortable giving you this at this point off of clinical trial as I have standard options for you
I don't know what to say to that..... I did say well why cant we "Right to Try" the Keytruda + Trodlevy...??? But no response yet...but personally how well will I actually even do on Keytruda when I am not PDL1 anymore...
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