Are you currently (or have you been) in a Clinical Trial?
Comments
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Dear Susan, I was just checking in and sorry to hear about the troubles you are having lately! Indeed, PY-159 is a sister drug to PY-314. PY159 is going to bind to TREM1 on the myeloid (immune) cells that are protecting the tumor from attack by the immune system. Once bound, the myeloid cells flip a switch and become anti-tumor, and pre-clinical studies showed it can work alone as well as in combination with drugs like Keytruda. "PY159 is designed to "reprogramme" immunosuppressive myeloid cells such as macrophages, neutrophils and myeloid-derived suppressor cells, causing them to stimulate a pro-inflammatory, anti-tumour immune response." So, hopefully the presence of this antibody is going to allow the immune cells to get at the cancer, and also allow Keytruda to do its immune-boosting thing!!!
This listing is for a brand-new trial of Y159, is large for phase one but they are testing different cancers, designed to be quick too, plan to stop taking new patients next April: https://www.curetoday.com/view/early-phase-trial-t...
Good luck, hopefully this works!!
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Susan,
Here are the details I follow for the alcohol free dexamethasone mouth swish. Based on the Swish Study by Dr Hope Rugo.
Dexamethasone 5mg/5 ml oral solution. Use 10 ml and swish for 2 minutes. Don't swallow. I used a sand one minute timer. Most of the women in the study did the swish 3-4 times/day for 8 weeks, then as needed. I've been doing it 3x/day. I'm coming up on 8 weeks and plan to stop. I have not had any mouth sores. One women who responded to me about taking Everolimus said she did the swish twice a day and had no mouth sores.
Hoping the best for you on your next study....that the drug works and no mouth sores.
Wendy
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Thanks, Saulius! I try my best to help those in my support group, MetsintheCity, and on this board but I have received much more from others than I can possibly give with my homeschooled understanding of cancers.
Hugs, Susan
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Didn't know where to post this but I thought I should spread the word. This study shows that having a pre-menopausal oophorectomy increases your risk of Parkinson's Disease.
Parkinsonism, Parkinson Disease Risk Up With Bilateral Oophorectomy Before 43
I just finished a Resiliency workshop for those with serious illnesses and about half the people in the workshop had PD.
Hugs, Susan
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WOW Susan, I had no idea! that is astounding.
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In my Mom's generation and earlier, it seemed like most women were given hysterectomies when they were still pre-menopausal. My Mom, my mother-in-law, my grandmother, all had hysterectomies in their early thirties. Luckily, knock on wood, none of them had/have Parkinsons.
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I found this publication interesting but have never heard of APOBEC before. Does anyone know how it is determined if you are APOBEC+?
I was recently offered a trial for immunotherapy for HR+ but decided to join a different study instead. I can still join the immunotherapy study at a later date if I want.
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rk2020,
I saw that publication also, and checked my recent STRATA genomic profile test results. There are 7 pages of details in the STRATA result, but I don't see APOBEC listed anywhere.
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Does anyone know anything about "THe Right to Try" for trials? If so can you tell me how it works?
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Not great news about ARV-471, the PROTAC ER degrader, when the company accidentally posted (then quickly removed) more info than they had intended in their abstract for the upcoming SABCS 2022 meeting. As with other SERDs and drugs hoping to replace Faslodex, the leaked data show a higher response rates for cancers with ESR1 mutations, which are not effectively targeted by Faslodex, than for non-mutant ER+ cancers. Phase 3 data will enrich for ESR1 mutant cancers, as is the case for many SERD trials, starting w/Elascestrant, which hopes for FDA approval in Feb. The real question is how good are these drugs when taken with CDK4,6i or in other combinations following progression on I-F,and for that we still have to wait...
https://www.evaluate.com/vantage/articles/events/c...
The poster is here, clinical benefit rate (six months stable for those who do respond) for non-mutant cancers is 37%, for ESR1 mutations is 47%.
https://www.sec.gov/Archives/edgar/data/1655759/00...
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Cure-ious,
I have the ESR1 mutation so I'm watching the developments for Elacestrant. The Menarini-Stemline website says they offer Expanded Access in USA for this drug. I have no idea how easy/hard it is to qualify.
I'm currently on Everolimus and Fulvestrant and have scans this week, so will know soon if I'm responding. My MO has mentioned Elacestrant, but has said she is not overly impressed with the PFS time. But I've watched/read comments by Dr. Aditya Bardia about Elacestrant and the Emerald Trial and to me his opinion seems favorable. He talks about median PSF survival analysis as compared to landmark PFS analysis. What is a "landmark analysis"?
Dr Bardia: "In patients with mutant ESR1 breast cancer, you could see improvement in progression-free survival hazard ratio of 0.54 with Elacestrant median PFS 5.3 months versus 1.9 months with standard endocrine therapy. Finally, if you look at the landmark 12-month PFS analysis, it was 31% with Elacestrant so one in three patients being without disease progression at 12 months with Elacestrant versus 12% with standard endocrine therapy."
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Weninwi, do you mind me asking when you were tested for the ESR1 mutation? My MO won’t test even though I lasted on arimidex for less than 18 months before going metastatic. She says “that will come later.”
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WeninWi- Fulvestrant is suboptimal for ESR1 mutations, esp the Y537S mutation, and so going onto a SERD tends to revert the cancer to estrogen-dependence, which would seem an important next step, preferably in combination w/CDK4,6inhibitor to increase the response of the SERD...
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Believe60,
When I asked my MO why I progressed from Stage 1 to Stage 4, after lumpectomy and radiation and 2+ years on tamoxifen, I was told it was probably due to microscopic cells that had escaped my initial treatments.
I think my ESR1 mutation developed later.....sometime during my treatment for MBC, which spanned about 38 months and included two CDK4/6 inhibitors and one AI drug (Letrozole). Very early signs of progression in my liver developed in the 30th month but I continued on the same treatment. The solid tissue liver biopsy itself was not done until the 38th month, when the tumor reached 1.0 cm and was big enough to biopsy.
The PADA1 Study interests me because to my reading (and I could be wrong) it raises the possibility that if the ESR1 mutation had been identified earlier, by monitoring with liquid biopsies during treatment and before clinical signs of progression developed, then a treatment change could have been made from the AI drug to Fulvestrant, resulting in longer PFS.
Might the benefit of monitoring for mutations apply to treatment during Stage1 disease??? From my further digging and reading, I get the impression that liquid biopsies are not widely used in breast cancer and I do not understand why not.
My opinion......I'd ask for a more complete explanation so you're not left wondering, guessing...trying to fill in the blanks. I find myself in a similar situation, far too often, with my MO.
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cure-ious,
I see my MO this Fri, a couple of days after my scans. I plan to go with my STRATA results in hand (from Aug) as she has yet to explain the results to me. I will also ask about Elacestrant. I do have a follow-up appointment about a week later with the Mayo doctor who gave me a second opinion after the Aug liver biopsy. I'm having trust issues with my MO, but I like the Mayo doctor. I sent you a PM about a week ago. I don't know if you saw it? If it's too much information, I understand.
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Seeking the Canadians among this group!
I am not doing much advocacy these days (treatment is draining), but I am still part of Clinical Trials Ontario's College of Lived Experience.They are conducting a survey right now of Canadians on the issue of decentralized clinical trials. CT Ontario is a government, health care, industry partnership aiming to increase clinical trial activity in Ontario but the survey results will hopefully help those all across Canada.
https://queensu.qualtrics.com/jfe/form/SV_064sQQGS...
I know this group appreciates the importance of clinical trials. But there can be barriers to doing trials, especially if you have to travel a great distance. Some of these barriers might be addressable by decentralized clinical trials.
CT Ontario is hoping to hear from Canadian patients, caregivers and the general public to learn about people's thoughts and concerns on the topic.Their survey applies to all diseases, not just cancer. You don't have to provide contact information and other demographic information is also optional.
I hope you'll consider completing the survey (and passing on to your friends too if you like)
Thank you!
Heather
PS I ran this post by the moderators ahead of time to make sure it was okay to post the survey link.
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Part 2
I just posted the survey link for Canadians on decentralized trials, but I realize that one of the Canadians here, GG27, hasn't posted since August when she told us of her rapid liver progression. I'm quite sad thinking about this.
I'm actually doing a little better than I expected after "being lefted" from my last clinical trial in August. I turned down a first in human immunotherapy trial - it just didn't seem right for me and I was already nervous about the 6 weeks I'd had without treatment. I started eribulin in September. No scan yet, but an xray showed that the pleural effusion is now small - confirming that the decision to ditch the Pleurx catheter was the right one. Other than usual crap chemo side effects and the drag of 2 weeks out of 3 at the cancer centre, things are about the same.
I had a second FoundationOne analysis done. I'm not HER2+ low so those exciting drug developments are not in my future. I appreciate the links to the new CDK 2,4,6 inhibitors trials that rk2020 and cure-ious posted. I'm wondering if cross-border trial participation is something I can consider again. The new things that showed up were CDND1 and also FGF3,4,19 (all equivocal). I still have ESR1 and pik3ca overexpression so maybe I can consider one of the new SERDS etc.. if any get approved (those trials all exclude me these days it seems). I'm looking forward to hearing more via SABCS next week.I wish everyone well as they navigate progression and new trials.
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I hope that GG27 is just too busy having fun to post. It's so hard to have no closure with people we feel so close to. Does anyone know how AlabamaDee is doing?
Had my first dosages of PY-159 and Pembro yesterday. Last night, I was up for 2 hours coughing continuously and violently. Today, I'm not coughing as much but my SOB is definitely worse. My MO sent me to acute care and they did bloodwork and ordered a CT chest scan. They also tested me for COVID which came out negative. Didn't seem to be any progression and my bloodwork was pretty good. So we don't know what is causing my worsening lung situation.
Really hoping this trial works!
Hugs, Susan
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I hope that GG27 is just too busy having fun to post. It's so hard to have no closure with people we feel so close to. Does anyone know how AlabamaDee is doing?
Had my first dosages of PY-159 and Pembro yesterday. Last night, I was up for 2 hours coughing continuously and violently. Today, I'm not coughing as much but my SOB is definitely worse. My MO sent me to acute care and they did bloodwork and ordered a CT chest scan. They also tested me for COVID which came out negative. Didn't seem to be any progression and my bloodwork was pretty good. So we don't know what is causing my worsening lung situation.
Really hoping this trial works!
Hugs, Susan
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Weninwi, I asked that very same question about how I had gone from stage 1a to stage 4 so quickly despite faithfully taking the arimidex. She said that’s something that they just don’t know yet. I am going to look at that PADA1 study. At my appt last week to check my blood after 1st cycle of ibrance, I asked the nurse about whether the ESR1 mutation might cause a lesser response to fulvestrant, not just the AI. She said that was a good question! Ha. Not reassuring. My MO looked at two clinical trials for me involving oral SERDs. I qualified for neither as you had to have lasted at least 24 months on an AI before going metastatic. Ah well. I have a second opinion appt coming up. So many questions. Take care
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Weninwi, I asked that very same question about how I had gone from stage 1a to stage 4 so quickly despite faithfully taking the arimidex. She said that’s something that they just don’t know yet. I am going to look at that PADA1 study. At my appt last week to check my blood after 1st cycle of ibrance, I asked the nurse about whether the ESR1 mutation might cause a lesser response to fulvestrant, not just the AI. She said that was a good question! Ha. Not reassuring. My MO looked at two clinical trials for me involving oral SERDs. I qualified for neither as you had to have lasted at least 24 months on an AI before going metastatic. Ah well. I have a second opinion appt coming up. So many questions. Take care
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I've been thinking about dendritic cell vaccines ever since Saulius mentioned it years ago. I just saw this paper that piqued my interest even more: Dendritic Cell Vaccine and this trial for Glioblastoma Dendritic Cell Vaccine for Glioblastoma
Saulius, How did your wife get access to a dendritic cell vaccine?
Hugs, Susan
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I've been thinking about dendritic cell vaccines ever since Saulius mentioned it years ago. I just saw this paper that piqued my interest even more: Dendritic Cell Vaccine and this trial for Glioblastoma Dendritic Cell Vaccine for Glioblastoma
Saulius, How did your wife get access to a dendritic cell vaccine?
Hugs, Susan
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susansf,
Good thoughts and prayers that the PY-159 and Pembro trial works for you....and hope the SOB improves too. You seem to have top notch medical care which is reassuring. I'll follow with interest any discussion re Dendritic Cell Vaccine in breast cancer care.
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susansf,
Good thoughts and prayers that the PY-159 and Pembro trial works for you....and hope the SOB improves too. You seem to have top notch medical care which is reassuring. I'll follow with interest any discussion re Dendritic Cell Vaccine in breast cancer care.
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Thanks for the link Newgardener. I completed the survey. Let’s hope it has a positive impact as I feel that access to trials is very limited in Canada unless you live near a big centre. Even then, it seems to take forever for trials to make their way north. As my list of potential treatments grows ever shorter I keep looking…
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Thanks for the link Newgardener. I completed the survey. Let’s hope it has a positive impact as I feel that access to trials is very limited in Canada unless you live near a big centre. Even then, it seems to take forever for trials to make their way north. As my list of potential treatments grows ever shorter I keep looking…
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Thanks Sadiesservant. Changes are never fast enough in health care but I hope decentralized trials can become a reality so more can participate.
SusaninSF - I'm sorry to hear of the rough start with the new combination - hopefully it will resolve quickly.
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Thanks Sadiesservant. Changes are never fast enough in health care but I hope decentralized trials can become a reality so more can participate.
SusaninSF - I'm sorry to hear of the rough start with the new combination - hopefully it will resolve quickly.
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Dear Susan, it is pretty simple to get DC vaccine here, as there is one company that produces them under state license for "investigative cell therapies", so you go through their doctor multidisciplinary board (can also be your board at NCI), make 1000 blood tests, sign an agreement and they draw your blood - 150-400 ml. Then there's a process how they separate these immature cells from blood, charge them with either your tumor antigens or general cancer cell line antigens, grow them till they mature, and re-infuse them into you. My Sandra got 8 doses trained with HER2+ BC cell lines, that were administered during 2 years, 5 million cells each. We also had CIKs (cytokine induced killers) made along and got 4 doses that were administered, 1 billion cells each. CIKs work as a passive immunity, i.e. they are "angry" cells, go and kill c-cells, live not long in your body, while DCs play part in your active immunity - travel to your LNs and are maternal cells to transfer information onto your newly produced WBCs. DCs live in your LNs for many years (5-10) and do their job but it takes time (6-9 months) until that immunity starts to work. Main question that remains: DCs are additionally trained with antigens might be not that effective when C mutates, and it does mutate:/ I was always told by our doctors that DCs work in cooperation with other therapies and complement them. There's a very nice and simple book about those things. It is in Lithuanian but could easily be translated into English online. The link is this one: https://www.google.com/url?sa=t&rct=j&q=&esrc=s&so... If someone needs a translation which I have in PDF, just PM me with your e-mail address, and I can send it to you.
Your Saulius
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