Are you currently (or have you been) in a Clinical Trial?
Comments
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Nicole, know that you are in our thoughts and prayers. I believe with the expanded criteria for Gilbert's Syndrome, there is still hope.
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nicolerod- You are still waiting on the Travera results, right? Praying for you. Hugs.
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We are leaving for Florida tomorrow for the trial please please pray that my bilirubin does not go above 3.0 by Monday bc then the trial will send us home..otherwise I start Tueaday (they take my blood on Monday)....
Jsniffs yes!!!! The recieved the sample this morning and they are working on it should have results by Monday I am so nervous that my cancer is so bad it wont respond to anything...
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Nicolerod - praying!!!
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Nicolerod - praying 🙏🏻 for you
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Nicolerod - praying for you that your bilirubin does not rise above 3.0 on your blood test on Monday and you start this trial on Tuesday.
XOXO
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Hello to all. My reason for popping in this morning is to share the following message from the Mods that has been posted on the forum. I want to make sure as many people see it as possible. Please spread the word.
Important update:
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During this migration, which will begin on March 12 and end approximately on March 23, all newly created threads and posts will need to be moved by the mods to the new forum through a manual copy and paste process.
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March 9, 2023
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Dear Nicole, you are in our prayers. Good luck in Florida, and let that clinical trial embrace you!
Saulius
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Nicolerod-Praying that you will be able to do the trial.
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Here is a new phase 1 trial for TILs therapy, similar to the Rosenberg NIH trial that cured Judy Perkins and possibly two other MBC patients. It is short, enrolling just in 2023- hopefully they are successful and move to bigger and better trials. As with the NIH trial, there is an upper age limit of 70. Requires one liver/lung met big enough to measure for shrinkage, and another big enough to cut out in surgery (resectable) to isolate the TILs.
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Cure-ious thank you for posting thi. Feels like we could be on the cusp of something exciting. Some of us may have to make a little change to our birth certificates but I for one would not let that get in the way.
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Cure-ious thank you for posting thi. Feels like we could be on the cusp of something exciting. Some of us may have to make a little change to our birth certificates but I for one would not let that get in the way.
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So true, Chico!!! It's just age discrimination- if they are concerned about some level of fitness or health, then say you have to pass a stress test or whatever, otherwise it sounds like they have concluded that if you're over 70 you aren't worth fixing?!
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Cure-ious
Thanks for voicing what I have been sensing for a while in areas of my treatment, although thankfully not from my MO. I am 72, but have exercised consistently for decades, eaten a healthy diet and never smoked. Unless arthritis counts, I don't have a single co-morbidity. Except for MBC, I'm in perfect health😂 and yet I have had more than one medical professional shrug and mention my age when I talk about fighting for every extra day I can get.
My goal at this point is to live long enough for something else to kill me, but I don't think the medical/political/financial cancer fighting machine is interested in helping me and that has me scared as I move forward.
Finally, I want to thank you for so generously using your time and expertise to educate and assist all of us regarding clinical trials. I am not yet at the point of needing one, but read all of your posts to prepare myself for the inevitable. The area seems very complicated and complex, and your knowledge and guidance are like a beacon of light by which to navigate. I am very grateful for your kindness.
Eleanora
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How discouraging to hear these experiences. We're adding this to content/issues we should address. Keep on advocating, and we will too
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We need to understand that with TIL trials they are very risky bc they are using hard hard core chemos that are not regular chemos we get with SOC. They use them to completely suppress our immune systems when I consulted with the one in Colorado the doctor explained how risky it really is..so the older we are no matter how good of health we are in it's very risky
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Age is interesting- when I mentioned to my MO (at age 69) that I was getting old re some of these treatments - she thought that was ridiculous- I did hear of someone suing to get on a trial who was 75- he did have a personal connection in the trial as well- but, he prevailed.
My mother was 79 when she got major surgery for esophageal cancer- she had to get it cleared by the cardiologist who was obese, sweating, short of breath during the visit. my mother walked 6 miles per day to see birds and had "grit"- she had no problem with the surgery.
In the US if you die before age 75 it is considered a "pre-mature death"
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NKB with all due respect...what is done in these TIL trials to me, is way more risky than surgery...bc you are not only getting these serious chemos to wipe out completely your immunity but you are also getting surgery in difficult areas ie: liver and lung...Noting that these are full RESECTIONS..not a "punch biopsy"
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Hi, I just got my results from Guardant . They list several mutations that have clinical trials in my state. Does anyone know what % of a mutation is needed to be eligible for a clinical trial? Does it have to be over a certain % or just simply have the mutation. It may be a while before i get any response from my onc so I am in research mode until then. Thanks for any info!
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Hi, I just got my results from Guardant . They list several mutations that have clinical trials in my state. Does anyone know what % of a mutation is needed to be eligible for a clinical trial? Does it have to be over a certain % or just simply have the mutation. It may be a while before i get any response from my onc so I am in research mode until then. Thanks for any info!
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Just wanted to let you all know... My bilirubin went down, I also raised my intake of TUDCA... I think that helped but all the Glory goes to GOD!!! I start the trial tomorrow..though I am little nervous bc they asked for a sample from my liver biopsy from last week..I am so nervous that I may not have the mutation this trial requires....
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nicolerod—— prayer
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Nicole, I logged in hoping to see this news. I am so happy your bilirubin went down, will continue to have you in my prayers and thank you for giving us an update
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Continued prayers for you Nicole
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Phew, Nicole, talk about coming in just under the wire!!! So, the B7-H4 protein is expressed on many cancer cells, not just MBCs, and it inhibits T cells, so the antibody you will get serves double duty, inhibiting metastasis and also allowing T cells to infiltrate the tumor... Good luck!!!
Interestingly, it was announced today Pfizer has bought Seagen (Seattle Genetics company) for $43B, and I was wondering where I had been reading about them, and then realized they are the ones running your clinical trial!!! So yeah, there is a boost of confidence, clearly they have high hopes that these folks are really onto something great...
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Thank you all so much for your well wishes and prayers I sure do NEED them!!!!
Cure--- Thank you so so so much... my husband (and I) LOVED the way your explained how my trial drug works he was like "WOW- OK i UNDERSTAND it now"!!! LOL
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Praise God for Nicole getting into the trial. What a relief. Continued prayers for a successful outcome.
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Jsniffs and all... I had the TRAVERA testing done..and the results are little ..well I am stunned about Afinitor. (keep in mind I am TNBC NOW...) the Ixabepilone is IXEMPRA (which I was interested in) I am shocked about Ribociclib??!!!
here is the message from my oncologist ...I am cross posting... I would love all thoughts...
I did look at the Travera results. So they are grading the tumor cells against the different chemotherapies and rating them 0-100. Scores above 50 suggest response, scores below suggest no response.
Everolimus 100
Vinorelbine 100
Ribociclib 100
SN-38 63
Lapatinib 14
Doxorubicin 0
Abemaciclib 0
Carboplatin 0
Gemcitabine 0
Docetaxel 0
They had enough cells to run 10 different drugs (sometimes it is up to 20 but this time they had enough to do 10).
Travera interpretation of the three drugs I had specifically asked for:
- Vinorelbine
- You will see from the formal report that we did see positive response for this
- Ixabepilone
- Unfortunately, we ran into QC issues with our supply of this drug and were unable to include it.
- This was an unusual occurrence; we would typically have this drug available.
- Enhertu
- We have not yet validated the exact load of Enhertu
- We did run SN-38 (the active metabolite of Irinotecan, an alternate topoisomerase I inhibitor)
- You will also see in the report that this drug elicited a positive response
--> Therefore this means that vinorelbine should be a consideration for us. I would also be testing your tumor again for HER status to consider Enhertu. Even if you are HER2 negative (0), I would consider getting Enhertu on right to try as there are reports of activity even in 'negative' cases. So this is just something else for us to consider for the future. I don't know what to make of the docetaxel being 0. We were thinking of using abraxane and I have to say that I can't rule it out just because it's sister medication docetaxel had a 0 response rate. But perhaps we try something else earlier.
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So I asked the Travera guy a few questions..like why would I come up at 100 for Afinitor when I am TNBC and if they have used this test for heavily pre-treated people and TNBC here was his reply:
- Regarding the number of drugs analyzed. Unfortunately, we are always at the mercy of the specimens we receive and this means we sometimes do not have enough cells to adequately run all 20 drugs in the panel. I know this can be disappointing, but our hope is that the insight provided on these 10 drugs is useful to your oncologist decision process. We always run as many drugs as we can, with the volume of cells we can successfully extract.
- I apologize for the challenge with Ixempra. It's important to us that every step of our process meets high quality standards. While we normally would have run Ixempra, there was a QC fail in the pre analytical work for this drug and we could not report on this therapy this time.
- Were there other Stage 4 patients in our data set that were heavily pretreated and used the recommended therapies?
- As previously discussed our data is encouraging, but it is early. We've tested over 200 hundred patients, but only have outcomes on 49 so far. "Outcomes" are defined differently based on the disease state, but it accounts for clinical indicators including, but not limited to, reduced pleural effusions, improved scans, reduced presence of metastatic lesions, etc…
- The vast majority of patients we've tested have advanced stage disease, with heavy pre-treatment, facing 3rd, 4th, or later lines of treatment.
- With all of this in mind our predictive accuracy on the 49 patients we've taken through the full process is 84%, meaning our predictions aligned with clinical response 84% of the time…the number of patients is small, but this means we were "right" in 41/49 patients. Having a clinical response that aligned to our predicted sensitivity.
THIS FINAL QUESTION IS OF A COMPLEX CLINICAL NATURE. TRAVERA CAN SPEAK ONLY TO THE CELLULAR SENSTIVITY OF THESE DRUGS IN OUR HANDS, I.E. "DID THIS DRUG ELICIT A RESPONSE? YES/NO". THE BIOLOGICAL EXPLANATION OF "WHY" IS BEYOND OUR ASSAY'S INHERENT ABILITY…THAT IN MIND, WE HAVE PROVIDED TWO POSSIBLE EXPALANATIONS THAT MAY HELP PROVIDE CLARITY ON WHY THESE SEEMINGLY "OFF TARGET" OBSERVATIONS CAN OCCUR.
- Your assay showed a response to a drug that isn't for my "TYPE" of breast cancer, how can this be?
- While most drugs receive approval for and are "indicated" for a specific diagnosis, hormonal status, mutation burden, etc…it is often true that these drugs hit multiple pathways and can show "off target" effects. There is ample published evidence to show the "off target" effects of many drugs and it is not uncommon that we observe sensitivity to drugs in cells that may not be known to have a certain mutation or hormonal status.
- You noted in your email that your tumor was previously Hormone Positive and has since "switched" to TNBC. One potential explanation is that previous therapies effectively killed off the ER+ cell lines, but after a period of time without those targeted therapies, the respective cell lines had an opportunity to return or grow back-up. This is a phenomenon often referred to as "Re-sensitization"…meaning that drugs which stopped working previously may now begin eliciting a response again after a significant break.
- Neither of these explanations are based on deep understanding of your unique circumstances and/or pathologic findings. I cannot know if either of these explanations make sense for your circumstances or unique disease, but I hope this provides some basic explanation as to why we sometimes see cellular response in therapies that might otherwise be unexpected. I'm sorry we cannot more directly address your questions or the reasons your cells elicited a response to these unexpected therapeutic agents, but I hope that this provides some additional insight for consideration.
I hope that this is helpful.
0 - Regarding the number of drugs analyzed. Unfortunately, we are always at the mercy of the specimens we receive and this means we sometimes do not have enough cells to adequately run all 20 drugs in the panel. I know this can be disappointing, but our hope is that the insight provided on these 10 drugs is useful to your oncologist decision process. We always run as many drugs as we can, with the volume of cells we can successfully extract.
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Wow, Nicole, what an interesting test!!! A couple things occur- first, everolimus is an mTOR inhibitor, no reason why it should not be active in TNBC, and same for Ribociblib, its a CDK4,6 kinase inhibitor, and those enzymes work in many other pathways, not just estrogen signaling. Very interesting it would be positive for Ribo and not for Abemaciclib!!!
Also, remember that ER-positive cells that have lost ER expression are VERY DIFFERENT from TNBC. These are cells that have completely different gene expression pathways either on or off, and losing ER signaling makes them different, but doesn't mean they have much of anything in common with TNBC. Also, you could ask for a FES-PET scan, this will tell you if any tumors light up then they have recovered estrogen receptor signaling, Its a very sensitive way to tell where ER-sensitive cells may be and how many of them there are, obviously a whole-body scan is gonna be way more informative than a biopsy of one met...
The other thought I had about this test, it is telling you what the cancer is sensitive to however there is also the immune system component it does not have a readout about. So maybe the fact that its not 100% predictive is that some drugs may hit the cancer but not help with immune response for example. OTOH, why take a drug that does not even work in this test, no reason at all...
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