Are you currently (or have you been) in a Clinical Trial?
Comments
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I've posted earlier and have learned a lot from everyone. Thank you.
I've now made a decision about my second-line treatment. I started Fulvestrant (everyone's advice on how to stand, etc was very helpful) and I start Everolimus next week. Since my tumor is now ERS1 mutated, this is the treatment supported by my MO and also by the Mayo MO, who I got a second opinion from. Neither my MO nor the Mayo MO thought retrying Verzenio plus Fulvestrant was a good idea, because not it's supported by any studies. My MO would have considered Ribocyclib + Fulvestrant, but she said the study to support this was small, and I read that women with ESR1 mutation in this study didn't do well. The Mayo MO didn't encourage it either.
I'm terrified by Everolimus, especially the interstitial lung disease risk, but I didn't have the courage to insist on retrying Verzenio plus Fulvestrant. After a fairly livable 3 years on CDK4/6 inhibitors and Letrozole, I now have to face declining choices and increased SE risks. It was only after Everolimus became a treatment probability that I became aware my history of Hep B infex and Valley Fever were essentially co-morbidities that present additional risk with Everolimus, and chemo drugs, and who knows what else. I had no idea until the Mayo MO made me aware. I'm having a hard time mentally.
I've read about Lasofoxifene, which is effective against ESR1 mutations. It was used in a phase 2 study (Elaine 1) with Verzenio. It's a repurposed drug with approval for use for osteoporosis and vaginal atrophy, but it's waiting for FDA approval for use in MBC. Not sure why the delay.
I did seek another On-line Second opinion from Dana Farber - cost $2,400. But ran into problems and delays with the company that acts as the go-between with the patient and the institution (the company collect records, etc), so I cancelled and got my money back. I did finally work out the problems and learned that Stanford also has an On-line Second Opinion program for $700. So I'm going to do that. I just want to hear from more than one authority on what my treatment options are. I initially put all my trust in my local cancer institution, in part as a way to not think about it all the time, but that hasn't worked out when faced with the reality of progression and having to make a new treatment decision.
I was offered two clinical studies by my MO, but decided not to participate. I think I made the right decision. I'll keep reading this board as I value all your insights and support. Hope my sharing has been helpful.
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weninwi,
Just my opinion but I'm not a fan of Stanford Hospital's breast oncologists. If Dana Farber didn't work out, I would try UCSF, Sloan Kettering, or MD Anderson.
What were the two clinical trials your MO suggested?
Hugs, Susan
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Susaninsf,
The clinical trials offered me were:
NCT04738292 referred to as the SMILE Study. Small study looking at use of the progesterone blocker Onaprestone and Fulvestrant. Last studied in France several years ago, with limited interest by other researchers since then that I could find. Commenter Cure-ious was skeptical after looking at the study details.....questioned whether progesterone has much of an effect on breast cancer and questioned why the study accepts women with either progesterone Pos or progesterone Neg tumors.
NCT03393845 referred to as the Big Ten Study. Bigger study looking at Pembrolizumab and Fulvestrant. I thought longer about this one, but it would have meant repeating a liver biopsy (just had one mid Aug); lots more blood work; visits to the hospital every 3 weeks for the prembro and then again at the 4 week interval for the fulvestrant. I didn't want to be tied to the hospital for twice a month appts and didn't want to repeat the liver biopsy.
Mayo in Rochester also had a clinical trial, but I was not eligible....I don't remember the reason. I did like the Mayo MO however. I think she was more thorough and answered my questions and responded to my concerns more completely than my MO.
Wendy
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weininwi,
I agree with you about the two trials. Neither sounds promising.
I haven't been on Everolimus (one of the few treatments I haven't been on!). These days they are much more on top of ILD symptoms after seeing it on some of the newer drugs, like Enhertu. Hope it works for you!
Hugs, Susan
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Susan- Have you tried a PARPi yet? Could be great in a combo w/immunotherapy. Has been limited to BRCA1 mutant cancers, but more recently opened up to include other DNA repair genes. However, studies have long indicated that there is a wider swath of cancers that also respond, they just don't have biomarkers to know what those cancers are. I wonder if that is available to you, what Hope thinks, etc...
This site is squashing me! Harder to log on, and now there is no PM? Anybody know how long before they pull the plug on us?!
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Cure-ious- No PM? I sent you one about 6 weeks ago- guess it never arrived .
this is sad
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cure-ious,
I also sent you a PM 9/21. I asked if you'd prefer that I use the regular discussion board instead for my question. I didn't hear back. Maybe you didn't get the message?
Wendy
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Cureious,
Thanks for your thoughts! I did ask Hope about trying a PARP inhibitor. My Caris report said they may work since I have Germline RAD51D and high LOH. She said it wouldn't work. If I run out of other options, I think it would be a good idea to try Lynparza. She has let me try things even if she didn't think they would work. Keytruda+Celebrex added to my Abraxane is the sole example of my failed attempt. The question would be, what immunotherapy to take with a PARP inhibitor? I could try Opdivo but, since it's a biosimilar of Keytruda, it would be unlikely to work.
Treatment histories and now PMs. I wish they would at least let us know they are not working.
Hugs, Susan
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Oh, its so helpful to have her perspective as to things that would or would not be likely to work. The tricky thing about combinations is that getting synergy really depends on the mechanism and why the two treatments would help each other- so, for example, depending on the situation, immunotherapy might not synergize with chemo but could with a PARPi, or vice-versa. Are there other mutations Hope thinks are drivers?
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I have had major progression.... my doctor is looking at these 2 trials I wanted to know what you all think. I have Stage 4 TNBC mets in liver lung and bone... I have 0 HER2....
PARP/ATR inhibitor trial. NCT04972110
- Niraparib/carbo trial. PI Dr. Mike Pishvaian. NCT03209401
(NIH also has my info for the TIL trial)
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Hi Nicole!!! I was wondering how you were doing! So, you know that I would prioritize something with Keytruda for a subtype switch- the NIH trial is the best, and I'd think you'd be the perfect fit, so I'm hoping for that one. PARP inhibitors are good but they also work better in combinations, usually with Keytruda is good, tho also Niraparib with a PARPi is a synergistic combination. I'd stay away from regular chemo, they usually work for just a couple months, if that, in trials.... Did you write to the NIH? What is the procedure to be considered for their trial?
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There are some other trials using the NIH approach, called adoptive T cell therapy, but the difference with the NIH trial is they sequence the entire cancer genome (amazing) and pick up to four different targets that your cancer cells have but are not in expressed in normal cells. The other trials usually have one off-the-shelf pre-determined target, and if you don't have the mutation you aren't eligible for the trial. And the NIH is finding that every cancer has different targets, only a couple were the same among different patients. It's a phenomenally expensive approach they do, I don't think any pharma would pick it up to do a similar trial. So, I wonder what their ( the NIH) criteria are for selecting patients...
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The NIH is VERY VERY VERY picky...they are reviewing my case now...Ill keep you posted.
So Cure...I guess you are saying you like the Study of RP-3500 with Niraparib or Olaparib better than the Study of RP-3500 With Niraparib or Olaparib better than the Niraparib with Carboplatium? Right?
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Nicole, At least they are looking at your case! Do you know what criteria they are considering? And if you are selected, do you need to go to another trial while they do all the sequencing and prep work?
The trials you list are testing a PARP inhibitor either in combination with an ATR inhibitor RP3500, which had good activity in early testing, or with carboplatin, which has worked well in other trials, in one there were three patients who had complete response for three years. So, both look like good options! As you know, a cancer that converted from ER-positive to ER-negative is molecularly different than a triple negative, so there isn't data there. Presumably your cancer has a mutation in a DNA repair gene? Have you had carboplatin in other therapies?
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Dear Nicole, I see in your signature that you never had IO combos... I mean I know... PD-1, PD-L1, etc... but maybe Pembro+Capacitabine or Novilumab+Ipilumab, or durvalumab+olaparib? Why do you not consider it with your MO?
Saulius
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I am PDL1 negative
Also I just got word I was denied for the NIH TIL trial they said I didn't have a resectable tumor. 10 to 15 I'm liver and none are resectable
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Harrumph, what does resectable tumor mean, anyway?! Saulius makes a great point, subtype switching is a much stronger indication of likely response to immunotherapy than PDL1 status, which is a weak indicator at best. Is there a PARPinhibitor with Keytruda trial or can you just get that from your MO?
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Curious...I had PDL1 tested a year ago and went from ER+ PR- HER2- and PDL1 less than 10% to TNBC and PDL1 0% that means that they will give me keytruda or I should say my insurance will not cover it. If in a trial I also do not believe I will qualify if I am showing PDL1 negative. EDIT TO ADD IN UPDATE: the surgeon from NIH called me personally we spoke about it. He wants me to re-scan in a few weeks CT of Lung and MRI of liver (I gave them a PET) ...he said they will re-look at it then and we will talk. The lung ones ARE so TINY ..but they may grow more by then...
You asked about rescetable. That means they have to surgically remove the tumor with surgery not laproscopy not needle biopsy nothing they have to cut you open go into the organ and get the tissue here is there exact words to me While she didn't use the word rescetable here she has many times to me in the past..I am NOT going to portland OR for the trial bc if its like the NIH one you have to be hospitalized for over 6 weeks while they surpress your immune system.. :
Hello Nicole,
Our surgeons reviewed your recent PET scan and unfortunately there is not an easily accessible lesion that we can harvest to make the adoptive cellular product. They note the small lesion in the left liver has been unchanged for over a year. I am sorry that we cannot participate in your care at this time. Please feel free to contact us in the future should scans show progressive disease.
Please consider contacting one of our former surgical oncologists, Dr. Udai Kammula. Dr. Kammula is at the University of Pittsburgh and he has TIL trials for patients with many different kinds of cancer. The contacts are Allyson Welsch (welscha2@upmc.edu) or Heather Jones (joneshl@upmc.edu). I attached some info on their TIL trials. UPCI 19-004: Open Histology: Adoptive Transfer of Tumor Infiltrating Lymphocytes for Advanced Solid Cancers - Full Text View - ClinicalTrials.gov
Another option is a new trial at Providence Cancer Institute in Portland Oregon. Dr. Eric Tran is a scientist who trained at the NCI under Dr. Steven Rosenberg. Dr. Tran leads the Adoptive Cell Therapy Lab at Providence and has an adoptive cell therapy trial https://clinicaltrials.gov/ct2/show/NCT04520711
Wishing you the best with your ongoing treatment,
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Nicole, Thanks for all that info!!! I wonder why would they recommend other adoptive T cell trials if the problem is they can't access a tumor surgically?Or maybe the other trials use an off-the-shelf T cell and so don't need to get their own tumor sample for sequencing. Also, I didn't see that these other trials had an age limit of 70, for whatever reason they put that in the NIH trial. Anyway, it's encouraging they are going to look more carefully at the tumors with MRI, see if they can work with them. And agree, surely insurance wouldn't approve immunotherapy, but I have seen trials where they do not ask about or test PDL1 levels, or tumor mutation burden for that matter...
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Nicole,
Thank you so much for posting your correspondence with the NIH trial. It may help many here who are looking for new trials. The University of Pittsburgh trial looks very similar to the NIH trial, both being TIL based adoptive cell therapy, but the Portland Oregon one looks very different. It looks like a new version of CAR-T therapy and I don’t believe it requires depletion of your lymphocytes prior to the cell transfer, thus no hospitalization required. At least that’s what I get from reading the trial info.
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Thanks Fig tree... Well It looks like the one in Portland would inject every 3 weeks..I don't tbink I could fly from VA to Portland OR every three weeks... but I wonder why theyt wouldn't deplete your lymphoctyes prior to cell transfer?? I mean it does help your T-cells to penetrate the cancer cell better when they do that I believe?
Cure...the way the surgeon explained it is they (NIH) will only take a WHOLE SUGICALLY removed tumor maybe those other trials only need a punch biopsy not resected one?
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I'm wondering if anyone here has knowledge or experience with Imlunestrant or LY3484356, an oral SERD, from Eli Lilly. My MO suggested a Phase 3 clinical trial (randomized to Imlunestrant alone, Imlunestrant with Abemaciblib/Verzenio, or Fulvestrant or Exemestane alone). I had recent progression from bones to liver on Ibrance/Letrozole. I appreciate any insight. Thank you.
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Nicole, The only idea I have is they need a whole tumor in order to get enough material for genomic sequencing. I thought one benefit of depleting the immune cells is you get rid of the Tregs and others that are protecting the tumor, allowing the newly-infused T cells to penetrate the tumor environment and enabling the immunotherapy to work- so if the other trials don't do that, how do they get around that step? The guy in Portland until recently was training at the NIH with Rosenberg, so its interesting if his trial is so different...
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Cure..yes exactly I don't understand either if they dont surpress immun. how the TIL's will penetrate? I am waiting right now to speak to my IR about this new situation in liver...ill keep ya posted. NO Response from Georgetown trial and waiting to hear back from Sibley one....
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Cure..I spoke to the trial TIL in PA they do supress immune system they give chemo for a week (i believe every day) before they infuse the Tcells to you.
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I just found this topic and have tried to read many of the posts. I have no experience yet with clinical trials as I was diagnosed metastatic last week. I was ER+, HER2-, stage 1a, grade3, micromet in 1 of 4 nodes. Despite DMX and AC + T and daily AI, I am metastatic only 1.5 years out from end of chemo. So my MO is proposing a clinical trial. I would get either ibrance and letrozole, or the trial, ibrance plus a newer SERD. I want to ask her if I’d just be better off with ibrance and a known SERD, faslodex. How to decide
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Hi Believe60,
I never had to make a decision about a trial at the beginning of my diagnosis - I'm not sure what I would have done. But I have come to realize that they provide a way to get access to the newest treatments a little earlier.
I've now done 6 trials and turned down one. I literally make a table with 2 columns "Pros" and "Cons" then talk it through with myself
and my husband. If I need more information I return to my oncologist to ask too. I've also never done a Phase 3 or randomized trial (mostly because they aren't offered to the heavily pretreated very often).
Things to think about
- Number of clinic visits for the trial versus standard of care
- Will you like the closer monitoring for a trial? Some find it comforting.
- Faslodex is a shot - you need to go into a clinic which can impact your ability to travel vs oral pills
- relative side effect profile. With a RCT likely the side effect profile of the new SERD should be fairly well known.
Other comments
- You should probably be able to use Faslodex in a later line combo, which could be useful? I've actually had it twice.
- I'd ask questions about if you are randomized to Ibrance and letrozole. You've already had an AI for 2 years - would this be a good combo post progression?
- Have you had genomic testing? Do you know if you have the ESR1 mutation? Therefore you may not want to take the chance of being randomized to Ibrance and letrozole?
Good luck with your decision
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Newgardener, thank you so very much for this info. I was finally able to obtain an appt with my MO for next Monday for my list (it's getting quite long!) of questions. Asking about the ESR1 is on my list but thank you for reinforcing that idea. I worry about getting the letrozole arm of the trial. Arimidex stopped working so fast, maybe it never really worked at all. It is a phase III trial. I've probably had these bone Mets for a while but thought it was aches from the AI. I am perfectly happy with lots of check ins at this point. Still processing the met diagnosis. But digging in and trying to really advocate for myself. Even though I am in the age group to be fully menopausal, my family history is late menopause. So I want to ask how we know my ovaries are fully shut down! I am willing to part with them. I like your pros and cons system. I can do that after my questions answered.
Thank you again. I hope you are doing well. I see from your treatment list you have been through a lot. Hugs to you.
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Believe..this thread is for Stage 4 Metastatic Only.
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nicolerod - I believe she is stage IV, diagnosed last week.
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