Are you currently (or have you been) in a Clinical Trial?
Comments
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To All,
I'd be interested in any comments on this study listed on ClinicalTrials.gov - Identifier: NCT05346484
A Study of CF33-hNIS (VAXINIA), an Oncolytic Virus, as Monotherapy or in Combination With Pembrolizumab in Adults With Metastatic or Advanced Solid Tumors (MAST)
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WeninWI, My first thoughts are this is a brand-new phase 1 trial, with the first patient was just dosed in May this year, so this trial is in its earliest stages and there will be no reports of efficacy for quite awhile. Phase 1 trials are useful because they normally have fewer exclusions, and so this might be better for later line of therapy when there are fewer options for drugs with known efficacy, especially when there is more info about the results they are getting with actual patients (tho its open to all cancers so they won't have a lot of breast-cancer specific data in the near-term anyway). Oncolytic viruses have been around for quite awhile but haven't broken through (yet) to established MBC treatments. The preclinical (mouse) data were collected on triple-negative breast cancer, which they indicate is their initial target population ( though its not clear it wouldn't work for ER-positive MBC). The virus is engineered to express an antibody to PDL1, so its meant to provide its own immunostimulatory effect in addition to virus-caused cancer cell-killing activity, they are hoping to leave out the Keytruda, so are checking it whether it works better with Keytruda or not. They require at least two prior treatments, which to me suggests they are wanting this more as an early line treatment, or expect to see better results if used in an early line. However for MBC, there are quite a few established therapies I'd want to try before going to something more risky like this. For those interested, here is the trial and some papers..
https://clinicaltrials.gov/ct2/show/NCT05346484?le...
https://www.cityofhope.org/first-patient-dosed-tri...
https://www.cell.com/molecular-therapy-family/meth...(21)00188-1
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Cure-ious,
Thank you for all your comments, insight, knowledge. I'm keeping your responses so I can reread and hopefully absorb the info.
I informed my MO that I am not interested in the SMILE study of the PR blocker Onapristone. My husband read over the multi-page handout we were given and he was concerned by the following....."participants will not receive results of research tests such as F-FFNP PET/CT scans and such scans will not be reviewed by the physician who is involved with your care. As a result, you will not be informed of any unexpected findings." How common is this for clinical studies? To me it would mean the participants would be exposed to an increase number of scans - those for the study and those needed for their regular care. I also asked the study coordinator for confirmation that they are accepting PR-Neg patients - answer "yes".
Another question for you: My MO mentioned another immunotherapy using Nivolumab or DF 1001 (my notes are unclear), but she added that it's new and insurance would probably not authorize? Is this common - that insurance will refuse to authorize if a drug is used in a study or is new?
My next request of my MO will be to ask when I can start Fulvestrant. I'm starting to have bone pain (shoulder, clavicle, iliac crest). I had NO bone pain before the now confirmed progression in the liver, which started in January with vague indications on scan. Can't help but wonder why meaningful action was not taken sooner.
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Hi WeninWI,
Sorry if you went over this earlier but have you gotten a new biopsy of the liver tumor and genetic testing? Normally this is where you would start to see if there are new genetic changes or mutations the cancer made to escape the Ibrance-Femara, and give you some clue how the cancer has acquired resistance to the first line treatment. For example, being on Femara or an AI can often push the cancer to generate an ESR1 mutation, which would indicate you go for a trial with a SERD, or take elascestrant when it gets FDA-approved, or a trial with lasofoxifene. Other ways to get endocrine resistance are to develop Her2 expression (not full blown HER2-positive but what is called HER2-low, which also comes with certain suggestions for drugs to add to the Fulvestrant. Also mTOR inhibitor (everolimus) or Piqray or an AKT inhibitor can be indicated if that pathway is turned on. Fulvestrant alone in second line has a very short PFS, so you would want to combine it with something else. If the genetic tests don't show anything, you can just continue on with the Ibrance or Ribocyclib, they make a big difference. Also, if the cancer has BRCA mutation, or mutation in any of quite a few genes that affect DNA repair, you can look for a trial that includes a PARPinhibitor, they are very powerful and can be combined with immunotherapy or other drugs. The MAYO clinic people should be able to direct all this
I was very interested to read about DF1001, because it is one of the new agents that are being tested to see if they can remodel the tumor microenvironment to remove or inactive or switch the immune cells that are protecting and hiding the tumor into cells that are actively fighting the cancer. In this respect, DF1001 is being tested together with immunotherapy in the same way that PY314 is being tested with immunotherapy, to see if it can make MBC respond a lot better to drugs like Keytruda that can be (but so far aren't) game-changers for us. Below is an review article that states: "Two cell types of the innate immune system that shape the tumor microenvironment (TME) and can initiate anti-tumor immune responses are natural killer (NK) cells and cells of the myeloid lineage" where they say NK cells are good and myeloid cells are bad. They also say: "The most advanced therapies are those that modulate myeloid cells, depleting or inhibiting recruitment or promoting reprogramming to activate or de-repress tumoricidal mechanisms (9), but these modalities have been disappointing in the clinic"; well PY314 is an antibody directed at myeloid cells, so it is trying (like those drugs that came before) to get rid of the bad players. DF1001 is a drug that binds to NK cells and links them to the tumor directly, hoping to counteract the negative interactions of NK with myeloid cells. This issue here, however, is that DF1001 is binding to tumor cells through the HER2 cell surface receptor, and I have only seen trials where it is being used for HER2-positive cancer. Link below is to one clinical trial with DF1001 and Nivolumab where you see the Her2+ requirement (under Eligibility it says "Primary tumor must have documented HER2 expression by immunohistochemistry."- they do not say whether it has to be HER2-positive or at least HER2-low, but you would want some significant HER2 expression on the cancer cells to expect it to work.
https://clinicaltrials.gov/ct2/show/NCT04143711
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC80921...
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SusaninSF: A new clinical trial opening for HER2-positive or Her2-low MBC in San Francisco: https://clinicaltrials.gov/ct2/show/NCT04257110
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Cure-ious,
I have the liver biopsy done tomorrow Monday Aug 15. I'm anxious of course. Have been told I'll be given "moderate" sedation, so I can follow instructions, and pain is "mild". The specimen gets sent to Strata for genomic testing. It will take 2 weeks for results. I have my next bone scan Aug 24. I see my MO Sept 1.
This is going off topic of Clinical Studies, so if I need to take this discussion to another board, please just say so.
I just listened to a discussion on OncLive, Aug 5, 2022, between Dr Mark Pelgram and Dr. Lee S. Schwartzberg on "Measuring Ki-67 Levels To Inform HR+ Breast Cancer Treatment". Abemaciclib (Verzenio) has been shown to be particularly effective for high Ki67. A High Ki-67 and Grade 3 correlates with poor prognosis.
This caught my attention because that is what the biopsy showed on my original tumor from the lumpectomy when I was Stage 1a. My tumor was Ki67 60% and Grade 3. I asked about this when I was first diagnosed because I knew it was not good, but I got next to no response and no one since has ever mentioned this as a factor in treatment consideration and no one has had a conversation with me about how it factors into prognosis.
I was started on Abemaciclib (Verzenio) and Letrozol after the MBC Dx, but I was told Abemaciclib was chosen for me because I had been infected with Valley Fever (turned out to be a mild infection). No one ever said anything about high Ki67 or Grade 3 as a reason for the choice. I started at 150mg but quickly dropped to 100mg. Thankfully the tumors in my liver shrank and the tumors in my bones remained stable. I stayed on the Verzenio in spite of low protein, low albumin, swollen lower legs, clay colored stools that floated, and low B12, low Vit D (which I corrected with SL supplements). But finally thickening of the bowel wall showed up on scans and the radiologist suspected it was d/t "drug toxicity" so I finally agreed to switch to Ibrance. Two months after starting Ibrance, my liver scan showed an early suspicious area - that was January of this year and by Aug 1 the lesion was 1.0 cm.
I've started to think about contacting Dr Lee Schwartzberg for a second opinion of my situation. He's either in Memphis or Reno, I'm not sure which, but I would go to either location.
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Oh, great to see you have everything in place for the biopsy and testing! In the couple of weeks you have to look around, try to find a physician who specializes in MBC and who is at an institution that has a robust clinical trials program, so that they may be able to direct you in future to some promising trials. They probably gave you Verzenio because you were fighting an infection and they did not want your white cells (neutrophils) to go down (which is something Ibrance and Ribocyclib does that Verzenio does not). V is also somewhat stronger and has the ability to inhibit cancer by itself, whereas the others can make AI or Faslodex last about 2-3 x longer but do not have activity on their own. It could be the cancer was becoming endocrine resistant such that V helped more than the others, but it also might have failed soon regardless. However, Verzenio and Faslodex could well be your next treatment, right? Because you switched to Ibrance there is no reason to think the cancer became resistant to V
Anyway, I don't know the physicians you mention, but AlabamaDee here was happy to have connected with Erika P Hamilton of Sarah Cannon in Nashville, who you can follow on Youtube and is on a lot of the onclive discussions etc, quite connected to the clinical trials world, so you might look there too. There must also be big clinical centers in Chicago? - Good Luck with the Biopsy!!!
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Wenn, I can't remember, are you being treated at Medical College of Wisconsin or at UW Carbone? You may want to reach out to ddil - I think shes being treated at Northwestern.
Ive been poking around in both Northwestern and UW sites to find a new MBC doc if we come home next year and its been impossible to sort through doctors for MBC specialisation. That is how I found my current MO because it clearly stated she does HR+ MBC as a research focus. I thought for sure there would be something like that in the US too!
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cure-ious, sondraf, susaninsf, ddil, el-tigre,
If I've missed someone my apologies. All your advice has helped me tremendously to move the ball forward. I've requested an appointment at Mayo in Rochester. I started this process by filling out the Clinical Trials form on their website. Got a call back within about 30 minutes by a woman who works in Clinical Trials. She walked me through the next steps on how to get an appointment and what to ask for....."I'm interested in a fresh set of eyes (second opinion).....and a discussion of any and all treatment options including Clinical Trials". Mayo uses Epic medical records so they can easily access my Carbon Cancer Center records. A MO will review my records and I was told to expect a response in about 3 days. If I don't hear back by Friday, then I should call. I hope and pray they will agree to see me.
I also may seek an appt with Dr. Lee S. Schwartzberg. He's Chief of Oncology at Renown Regional Medical Center in Reno, NV and he sees their breast patients. He wants a formal referral from my MO. I learned about him from a discussion on OncLive with Dr Mark Pegram about tumors with a high Ki67 percentage and grade 3 (like my tumor) that have poor prognosis. Apparently Abemaciclib has been shown to be particularly effective with this type of tumor. No one at Carbon Cancer Center has ever had a conversation about this with me. Thankfully, I did not progressed on Abemaciclib and only switched to Ibrance because of an accumulation of side effects. I'm going to ask if I can go back on Abemaciclib, plus switch to Fulvestrant, even though my MO did not mention this as a possible option.
I'm now off all treatment for the next two weeks.....makes me very nervous, but I'm so thankful for all your help.
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I've been off the trial chemo for 6 weeks due to serious neuropathy & the trial drug for 10 days. My liver has grown hugely & I am so uncomfortable, along with edema in my feel & legs. I had an US over a week ago & there is no fluid at all. I have been waiting to start new treatments, MTX & Cytoxane.
Anyone have any words of wisdom? I am dealing with a Vancouver MO who is on vacation at the moment & a GPO in Nanaimo who needs to run things past my MO. I feel like I'm floating between systems.
I am having another blood transfusion, my third in 2 weeks. While it makes me feel a little bit better for a couple of days but the swelling of the liver is causing so much SOB. I am hoping to get some answers this week but hoping that maybe some of you have been here & can give me a bit hope.
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Hi GG27,
I'm sorry to hear about the rapid change in how you are feeling. I thought I'd partly reply your query about MTX & Cytoxane. My oncologist here in Ottawa also suggested similar variation - IV CMF - back in Nov 2020 (other choices were erubilin and abemaciclib, I chose the latter). The CMF choice made me laugh because I've actually been at this long enough to know that CMF was still somewhat in use when I was first diagnosed in 2004. His thinking at that point was emphasizing QOL and that CMF can work. I like the idea of the low dose oral metronomic treatment that you may get (I think) - fewerswings in side effects.
I'm also up in the air right now. My oncologist is on vacation and I got bumped from the enfortumab vedotin trial today:( New spot and progression in many of the pericardium and pleural lesions. Plan is to wash out and see him in 2 weeks. I'm hoping he might have some new trials, otherwise most recently we've discussed erubilin. Nonetheless I'm happy to have squeezed out 6 months. I'm hoping to get my last biopsy tested for lowHER2+, though I'm not sure how I'd manage to ever pay for Enhertu and I'm not holding my breath for funding here.
I don't know much about liver mets (I have them, but my other mets are the troublesome ones). If it's ascites in your liver, can it be drained?
Hoping you can get some relief soon.
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thank you Newgardener for your reply. I would be getting the oral version so the QOL part is very important to me ATM. As it is, this isn't living. I had an US 10 days ago & it didn't show much ascites at all, in fact the radiologist wouldn't touch it because there isn't much there. For some reason I don't trust his judgement & will be talking to my MO next week when I see her. Maybe I can get another one in Vancouver. My feet & legs are so swollen but they don't want to give me a Diuretic because my BP is quite low, always has been.
Is there a dept at your Cancer clinic which looks into funding for things like Enhertu? I suppose you've already looked into it.
thanks again for the info, makes me feel a little bit better. GG
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gg, I am sorry that you are feeling so unwell and that you had to leave the clinical trial due to neuropathy. I was on Methotrexate and Cytoxin a while ago. I felt pretty good while I was on the treatment. Unfortunately, I had progression after 5 months and had to change. The only SEs I had were some fatigue and minor nausea. I hope you find a treatment that relieves your symptoms and brings things back under control. Please keep us informed about what you decide to do as well as how you are feeling.
Hugs from, lyn
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Cure-ious, Thanks for pointing out the BB-1701 trial. Will ask Hope about it.
I'm interested in the MTX,CTX combo. I don't have it on my list.
Got the bad news yesterday that I had progression in my lungs and liver. This was my first scan since getting on Enhertu so it either didn't work at all or it worked for a very short period. I was very surprised because, until a week ago, I was feeling great. My TMs were low, my oxygen saturation was 100%. I was sure the Enhertu was working. Then about a week ago I started feeling an increase in SOB. Then a couple of days ago I was coughing occasionally. Could it really turn around that quickly?
Seeing Stanford Early Drug Development team tomorrow. Spoke to my MO last night and we decided to go on Epirubicin if nothing pans out tomorrow. Also waiting for PY-314 trial to start at UCSF. Should be soon.
I'm not too worried since I still feel good and have been able to keep up my activities (yoga, dance, walking the dog). Ultimately, that's going to be my barometer of health, not the scan results.
Hugs, Susan
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cure-ious,
I read about "first-line setting" or "second-line setting". What does this mean? I was started in Verzenio and Letrozol and remained "Stable" for 2 yrs 3 mo. Then switched to Ibrance plus Letrozol (because of side effects, not because of Progression) and now 3 months later I have "Progressed", so next treatment options being considered. Which setting am I in?
susaninsf,
You mention that you spoke to your MO last night. Your MO seems very accessible to you. How accessible is your MO? Accessibility is one of my issues with my MO.
Thank you for all your help.
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I saw this news today about Sanofi discontinuing the development of amcenestrant and I'm quite disappointed. I haven't been eligible for any of the new SERD trials for years because of my prior treatments, but I guess I also hoped that one day I might be able to just be prescribed one. I'm managed to have a good run at times with fulvestrant and bazedoxifene in combination, and my tumours have the ESR1 mutation.
https://www.sanofi.com/en/media-room/press-release...
WeinWi - hope you don't mind me jumping in...generally "first line setting" ends with progression, "second line setting" starts at that point. Your situation is trickier as you note because of the change due to toxicity, but I think they would consider you now entering second line setting. Usually for clinical trial eligibility, the distinction is first line (ie treatment naive) versus not first line, but the key restrictions will otherwise be related to # of prior chemotherapies, # of hormonal treatments...there's lots of fine print to read.
GG27 - I haven't been in touch yet with the drug navigators re Enhertu - I'm a little ahead of myself since I don't even know if the cancer will be lowHEr2+ or not. I believe it's possible to apply for compassionate access, but Canada and the provinces still haven't decided on funding for HER2+ folks yet so the line must be long.
SusanifSF - I'm sorry to read about your progression so soon on Enhertu. I hope your meetings about next steps go well. Isn't Epirubicin the cousin of the Red Devil? Hopefully that can be avoided a bit longer.
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WeninWI- firstline is what you start with after the mets diagnosis, then second and further lines. So you did firstline Letrozole with Verzenio/Ibrance (i would say this is all first line because you did not progress till now). The standard would be a move to Fulvestrant (Faslodex) with Verzenio or Letrozole. For me it was Femara-Ibrance then Faslodex-Ibrance, currently at 7.5 years; clearly the progression I had was not due to Ibrance. You only move lines with progression as determined by scans.Your progression may not have anything to do with Ibrance, it has no activity without Femara, and its more likely Femara failed. Because you had good results with Verzenio it would make sense to continue with that along with the Faslodex, if you find a dose where side effects aren't too challenging.
BTW, for those whose TMs might be going up but you want to try to eke out more time, Luce suggested supplementing with i3c (also called DIM) a broccoli extract. A Science paper in 2019 reported that the top molecular target for i3c is an enzyme that degrades the PTEN tumor suppressor, which a key regulator of endocrine-resistant breast cancer and levels often go down or the gene goes off causing resistance. The i3c supplement inhibits that enzyme, which causes PTEN levels to go up. PTEN is critical for CDK4,6 inhibitors like Ibrance to work, so it may synergize and induce the mets to go back to sleep. The recent study showing that mets are only active at night indicates just take a supplement at night,so yeah it might help!
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Considering that it can be so hard to find good breast-specific oncologists in some parts of the county, here is a YouTube clip of a discussion by Dr. Jane Meisel from Emory Univ (Atlanta). It covers the basics most of us well know, but I thought she brought in quite a few interesting side notes and is clearly connected to the trials world, a good example of an MO in this field.
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cure-ious
I had a phone discussion today with my MO. I asked which drug she thought had failed - the Fermara or the Ibrance? She said she thought "both".
I told her I was interested in staying on the CDK4/6 inhibitor and just changing the hormonal therapy to Fulvestrant. I explained that I've read/heard this referred to as "circling back" - staying on CDK4/6 inhibitor and just changing the hormonal choice. She said there are no studies to support this option and her treatment decisions are based on studies.
I mentioned the interview between Dr Mark Pegram and Dr. Lee S. Schwartzberg on OncLive Aug 5 where they talk about the effectiveness of Verzenio with high Ki67 % and grade 3 tumors (true of my tumor). I said I was interested in restarting the Verzenio, since I did not progress on that. She did not like the idea, and said it was not supported by studies. She said she thought the doctors were probably referring to a "first-line setting", or maybe I misunderstood her. I listened to their discussion again, maybe they are referring to pre-metastatic setting?
Both you and rk2020 have said staying on CDK4/6 inhibitor and changing the hormonal choice is not uncommon. Wonder if my MO is under tight institutional practice guidelines?
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WeninWI, Standard practice varies a lot by doctors, and what they think insurance will cover is sometimes a big part of that. When I first started with my MO, she said secondline for her would be fulvestrant, however by the time I progressed she had figured out that adding a CDK4,6i was OK. One early trial showed about 1/3 of people who progressed on I-F had good results with fulvestrant plus a CDK4,6 inhibitor (ie stable or better for at least six months), another 1/3 responded but then had progression by 6 months, and the other 1/3 were fully endocrine-resistant and the treatment didn't work. Another study said for bone-only mets the average time of response to secondline Ibrance-Fulvestrant was about 18 months, which is quite good. If you look at doctors who specialize in MBC I doubt you would have trouble finding someone who would agree that Fulvestrant with Verzenio is a perfectly reasonable choice, but of course you'd want to also see the results of the biopsy and genetic testing, which may indicate if a different targeted drug would be appropriate. Has your MO said what she would do? Surely its not time for chemo, and Fulvestrant alone in secondline has a PFS in all the trials of only a couple months, not worth it, so what does she think is good?
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https://clinicaltrials.gov/ct2/show/NCT03412877
I thought it was time to update the Rosenberg trial at NIH. As most of you know, they have thus far treated six late-stage MBC patients in phase one, three died of their advanced disease, one is thought to be cured, now beyond five years without any treatment for her cancer, and two others had to have minor spots radiated again after treatment but are a couple years out, again taking nothing, and may be cured. The new trial above is phase two, they have removed the requirement for chemo in the metastatic setting and are accepting MBC patients after progression on the first two lines of therapy. Presumably there are strict requirements for large accessible tumors (probably liver or lung mets) because this is a highly personalized trial where the cancer is fully sequenced and they identify and isolate tumor infiltrating lymphocytes (TILs) that can home in on and target your cancer specifically. during this reseach, they discovered that only 1:1000 T cells in the tumor are capable of doing the targeting, and those are the ones they grow up then in the lab and infuse in large numbers to the patients. This is preceeded in the hospital by chemo-induced depletion of the immune system, which strips away all the immune cells, including the bad ones that are coating and protecting the tumor. This allows the good T cells they put back in to hit the mets hard, and it is amazing the success they are seeing. I wrote to him to ask more about the requirements and procedure and will post again if I learn anything new.
Here is a press release from Feb 2022:
https://www.nih.gov/news-events/news-releases/nih-...
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cure-ious,
I have Tri-Care for Life and so far no denials of treatment.
Fulvestrant alone was one of my MO's options for me. This option added to my doubts/lack of trust because I had read Fulvestrant alone has a short PFS.
Her last option for me is Ribociclib + Fulvestrant; but only as a last option, because of lack of studies - I think that's her reason.
Her other options depend on Genomic test results:
1.) Alpelisleb if PI3 kinase mutation seen 2.) Everolimus if PI3 kinase not seen 3.) Onapristone - the SMILE Clinical Trial - I told I'm not interested 4.) Immune therapy + Keytruda - Clinical Trial at UW Madison - I'm waiting for more information to be sent to me so don't know very much.
My MO said being off treatment until I see her Sept 1 is OK, but not safe to go much longer.
After looking over my records, Mayo has given me an appt for Sept 6, and I'm on their cancelation list. I can do the visit either in-person or video. I've asked my MO if waiting until Sept 6 is still safe. I'm hoping for a cancelation.
I'm also going to ask my MO to send a referral to Dr. Lee Schwartzberg at Renown Regional Medical Center in Reno, NV. He's Chief of Oncology and sees all their breast cancer patients. He requires an in-person appt for the first visit. I'm willing to fly to Reno. I think a consult visit would be helpful even if it occurs after I start second-line treatment. I'm impressed by this doctor based on his video discussions and practice updates that he's written.
When I look at Clinical Trials do I need to pay attention to "second-line treatment" being listed as a qualifier or disqualifier or does eligible vs ineligible criteria have more to do with a history of specific treatments (drugs) regardless if first-line, second-line, etc?
Thank you for all your help
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cure-ious,
I found a phase 2 interventional clinical trial that is looking at Palbocilcib with Fulvestrant after Treatment with Palbociclib with AI.
So contrary to what my MO told me there is a study. It started Oct 2016 and is due to be completed Jan 2023.
Might those MO who have followed this treatment option have done so with this study in mind even though the findings are still outstanding?
Is it permissible for someone like me to contact the researchers and ask about their findings to date? If yes, what specifically should I ask?
I've learned about the other Clinical Trail that I've been offered by my MO:
Phase 2 study of Pembrolizumab Plus Fulvestrant .....clinicaltrials.gov: BTCRC-BRE16-042
Thank you for all your help.
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Hi WeninWI, you are coming along fast!! So, I like the phase two trial of fulvestrant and Keytruda, however if I were in that trial I would ask my primary to prescribe Celecoxib (Celebrex), a prescription NSAID for arthritis pain. If you read Kattysmith's entrys from the very start of this thread, she took a trial that had Keytruda with EP-4, which is basically a nex-gen Celebrex that inhibits the same pathway but at a different point. The data on combining an NSAID with immunotherapy is quite good, otherwise I'd worry that the Keytruda won't do much to help fulvestrant because there is nothing there to get rid of the negative immune cells that are shielding the tumor in the microenvironment. In particular, the tumors express high levels of an enzyme called COX-2, and this produces prostaglandin E2- the Celebrex is a COX-2 inhibitor, and it acts in synergy with Checkpoint inhibitors (like Keytruda) to promote anti-tumor T cell activity. In clinical trials for melanoma and lung it roughly doubled the response to the Keytruda.In pre-clinical work it was also reported that Keytruda helped anti-estrogen treatments, rather a strong effect, but it hasn't seemed to made much difference in clinical trials, but maybe with the Celebrex in there to dampen the inhibitory immune cells this would be good?!
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WeninWI, I see that older trial, but I think it may be irrelevant. Below is a link to a review of the CDK4,6i: "Palbociclib and abemaciclib are both approved in combination with fulvestrant for second- or later-line treatment of HR+/HER2− advanced breast cancer, and either combination is an appropriate choice in this setting. There are no direct comparisons of these two agents and they are likely equivalent in efficacy. Of note, the patients who received abemaciclib-fulvestrant in MONARCH-2 had a much longer PFS (16.4 months) than did patients who received palbociclib-fulvestrant in PALOMA-3 (9.5 months). This likely reflects differences in the characteristics of the patient populations enrolled...Ribociclib with fulvestrant will likely have activity similar to that of the palbociclib-fulvestrant and abemaciclib-fulvestrant combinations."
I sounds like your MO is kinda out-of-date and it makes no sense that she would only let you use Ribociclib if any of them are FDA-approved, although all three CDK4,6i have very similar efficacies in clinical trials and in real-world studies of patients outcomes that many hospitals keep track of. Probably your second opinion MO can clarify it to her. And it seems you ought to be able to get V if you want it...
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Cure-ious- interesting videos. Dr Jane Meisel is very articulate and organized, good review.
the NIH study re TILs has a cut off age of 70.
Have you seen any new data re cycling back to a different CDK4/6 Inhibitor after failing one in the past? Abema alone for example. I have seen many MOs doing this, wonder about the data. Esp if it is just as good as going on IV chemo as the next line. The last article said they looked at the effect of having a biomarker of CCND1, but, was from 2018.
Hope you are doing well!
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Met with the Early Drug Development team at Stanford today. I had previously spoken to them virtually. They showed me the extensive document that UCSF sent to them regarding my lengthy cancer history. This must have been created by my UCSF team for my ARX-788 trial at USC. They were so impressed by it! They want me to join the BDC-1001 trial and we are planning to start on 8/29! I'm a bit nervous since it is still in the dose escalation phase AND it is immunotherapy. I had such a bad reaction to Keytruda. But I feel lucky to have another cliff edge to jump to.
weninwi, I agree with you that access to your MO is paramount. However, when you are still on early treatments you probably won't get that kind of access since the path is following protocol. This will be my 13th treatment so we need to make quick decisions that can't wait for my next appointment. I do think I am very lucky to have my "Best Breast Oncologist on the Planet" (quote from Cure-ious) MO!
Hugs, Susan
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I have been off nab-paclitaxol for 6 weeks now & the trial drug Tomiversertib for 2 weeks & have seen a rapid increase in liver problems. Luckily I start a new regime tomorrow, Cytoxane & MTX, fingers crossed that these help reduce the liver problems such as the edema in my lower body & the distended belly. I am going to call the US dept again tomorrow to book another appt. The last time, the radiologist said there was no fluid, but the RN today looked at me & said there is no way that only gas can cause a 20# increase in weight in only 2 weeks.
I had another blood transfusion today, the fifth pint in as many weeks. My hemoglobin is coming up slowly.
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gg,
So sorry you are going through all of this. I hope the Cytoxane & MTX kick back your liver problems. I don't understand why they couldn't get you on this treatment six weeks ago. I believe they are both approved drugs.
Looks like you were diagnosed Stage IV just two months after me with basically the same oncotype. Gets tougher and tougher to hang in there but we're still alive!
Hugs, Susan
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Cure-ious,
I'm in awe of the fact that you have been on Ibrance for 7.5 years. Where did you have mets at first diagnosis? Are you NED now?
Hugs, Susan
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