Are you currently (or have you been) in a Clinical Trial?
Comments
-
Elizabeth- Hoping all your tests are favorable for trial qualification. Hope your travel goes smoothly! Thanks for all the great info you share
0 -
Elizabeth, Good luck qualifying for the trial!!! Does the trial require biopsy showing that the cancer remains sensitive to ibrance? I like this approach and wonder if this trial is open to secondline, right after I-F? And is this a phase 2 or phase 3 trial?
0 -
Elizabeth, best of luck! I'm very excited for you!
0 -
Elizabeth, I'm just seeing this. You have been such a positive supporter for all of us. Wishing you the very, very best!
--Lynn
0 -
Elizabeth,
Good thoughts coming your way!
0 -
Hello, all...
First, WOW...thank you all so much for your kind thoughts and support. I'm sitting in the Clinical Trial Unit at the Seattle Cancer Care Alliance having just taken the first doses of SAR438959 and getting re-acquainted with my old friend, palbo. I'm a tad bit frustrated because the protocol requires starting palbo at 125 mg, which did a number on my ANC and WBC last time...I didn't tolerate 100 mg, ether. 75 mg was the charm and worked well for 39 cycles...thankfully the protocol allows for dose reductions if needed. I get blood drawn every week for the first two moths, so hopefully there is early dose reduction options.
Cure-ious- there was no biopsy required for this arm of the trial. There is one arm that does have a pre-trial and on-trial biopsy requirement. Since my tumor is only accessible during laparoscopic surgery I don't qualify for the biopsy arm. But they are doing liquid biopsies periodically on my arm,looking at all sorts of things, I imagine. There are no exclusions for pre-existing CCND1 or Rb or ESR1 mutations. In fact they are specifically looking at the efficacy of re-visiting palbo with the SERD in light of ESR1 mutations. I'm the first enrollee on the SERD/palbo arm. The trial coordinator told me that they have been having good results on the monotherapy arm in general, but she is not aware of which participants have an ESR1 mutation and who doesn't ...most of the dozen or so patients have had a 12-16 month responses on monotherapy. I'd be thrilled to have a year or more of positive results!
I'll keep everyone update as the trial goes on...
I do hope you all are doing well, and are happy, and find a moment of joy in each day.
Elizabeth
0 -
If those responses hold up, that would seem to be a big improvement for the SERD-alone arm, given that Faslodex gives a pretty consistent 4-5 month PFS when tested as monotherapy in secondline; 12-16 months with the possibility of moving that further out by adding Ibrance starts sounding pretty good!!- good luck!!
0 -
Elizabeth, Did you ever get anywhere with trying to source crizotinib off-label when you weren't sure if you'd be admitted into the SERM trial? (Glad you WERE admitted and wishing you much success with it!)
0 -
Had gamma knife on Wednesday to zap four brain tumors. Went in for my Abraxane infusion this afternoon and they walked in with Keytruda. Looks like I have started the add on of Keytruda to Abraxane. I'm not on a trial. Is anyone else on this combo?
Hugs, Susan
0 -
Hey, Susan- How interesting! Were you not expecting to get Keytruda? It's approved for TNBC with chemo, but you are ER-positive, right? And do you know if you have high PD1/PDL1 expression?
Remember that adding an NSAID COX-2 inhibitor can make immunotherapy work better- is that allowed in the trial? In short, tumors that express IDO1 turn on COX-2, and are sensitive to COX-2 inhibitors, which promote T cell infiltration into the tumor- in turn, this makes those tumors more accessible and readily killed by immunotherapy. Good luck, and thanks for all the great info!!
https://immuno-oncologynews.com/2017/07/22/cox-2-i...
"Our studies provide a clear rationale to test, in the clinics, combinations of anti-PD1 immunotherapy and COX-2 inhibitors,"
https://stm.sciencemag.org/content/11/497/eaax9566
https://www.aacr.org/Newsroom/Pages/News-Release-Detail.aspx?ItemID=1070
https://www.oncologynurseadvisor.com/home/cancer-t...
0 -
Susan Sf- wow! What a surprise! I hope it works really well for you. I didn’t know that you were getting gamma knife- I was hoping that you were on a beach in Hawaii.
0 -
Susan I’m really surprised that you would be given Keytruda without your explicit knowledge and consent because the potential side effects and adverse effects are no joke. I’m on Keytruda but with Herceptin rather than Abraxane and I had to go through special medical counseling on the risks vs benefits. That said, I’ve been on it for about 4 months and I’m doing well: feeling great, tumors receding and none of the scary side effects (so far!) From what I’ve read, they have seen some amazingly great responses in brain tumor primaries and mets especially when Keytruda is administered along with radiation and/or chemo. Hoping you get a great response!
0 -
Posting here plus on the Ringworm, etc. thread --
I just listened to a fascinating interview with James Allison, Ph.D, from MD Anderson, who was the winner of a 2018 Nobel Prize for his work in immunotherapy and cancer. I won't pretend to understand the entire interview, which was quite technical at times, but I thought the interview was really, really interesting, especially in Dr. Allison's views about T cells and immunotherapy.
The interview is a full hour long, so buckle up if you are going to listen to it.
0 -
I had asked a couple of times about adding Keytruda to my Abraxane. As I remember it, MO didn't seem enthused but said she would test my last biopsy sample for PD-L1 expression. So, it's not like I didn't ask for it. Just no one told me I was going to start it before I went in for the infusion yesterday. Haven't heard anything about the biopsy result. I'm happy that I got it, just surprised.
Cure-ious, Yes. I'm ER+/HER2-. Will definitely ask about adding a COX-2 inhibitor.
It's only been one day but I feel good.
Hugs, Susan
0 -
Cure-ious,
Doing some research on COX-2 inhibitors. The latest study summarizes with "Use NSAIDs at the lowest effective dose for the shortest time possible."
https://www.medsafe.govt.nz/profs/PUArticles/June2019/NSAIDs-and-cardiovascular-risk.htm
Two earlier COX-2 inhibitors were taken off the market because of adverse cardiovascular effects.
Hugs, Susan
0 -
Susan- I read an older large clinical trial where they tested Celecoxib in combination with something else (chemo?) for breast cancer, and it did not help, but they had zero heart problems arise, and another study concluded the heart risk is no greater than for ibuprofen. My MO was very supportive about taking it, as she said my potential benefit far greater than the risk. In my case, the "potential benefit" we were talking about was having the drug inhibit the PI3K/IPO1 pathway, and delaying progression.
There are other newer-gen COX-2 inhibitors, like the EP4 drug that Kattysmith took with her checkpoint inhibitor in a trial, and for that drug it does not intersect with the cardiac pathway. Main thing is that its good to inhibit COX-2 to get a better response to immunotherapy, anyway, as you say, its something to discuss with your MO...
PS, well you need to see if the treatment combo is working first off, of course- but its something you might want to add-on later
0 -
Further progress towards immunotherapy treatments that could benefit most of us, just published in Nature:
https://www.sciencedaily.com/releases/2019/10/1910...
0 -
Cure-ious,
This article and information ties in well with the interview of James Allison by Ralph Moss, posted above. In fact, Allison mentions Schreiber, the subject of your linked article, and his work.
0 -
Luce-
So far, I have not been successful in sourcing crizotinib for off-label use. I earn too much money to qualify for Pfizer's PAF (although even if I qualified there is no assurance they would have been willing to provide it to me for MBC...) Without financial assistance I could not afford to have my onc write a prescription for it.
The Pfizer consultant for compassionate use said I have too many treatment options remaining to qualify for compassionate use at this time. Apparently you do not ned to be completely out of options, but the choices need to be slim and unlikely to work. Since I have only been on one line of anti-hormonal tx, one targeted therapy (with the anti-hormonal), one chemo, and one IO trial, I don't meet their threshold for "limited treatment options." Perhaps in the future I will be able to qualify for that. Or perhaps in the future the ROLO trial will have been successful and crizotinib will have gained another indication and insurance will pay for it...
For now it is something for me to consider only in the future. There is also entrectinib that was approved this summer that I may try to request PAF and/or compassionate use as well when it looks like I need to figure out a new treatment. But for now I am hoping for months on this SERD/palbo trial. I'm only two weeks in, so who knows how it is going!
I am occasionally in contact with the PI for the ROLO trial, and as of this summer there were only three patients enrolled (I think the Brexit fiasco muddled the initial negotiations between Pfizer and the NHS-- they were delayed by more than a year in opening the trial.) But it opened last April and so they are on their way. She expects to possibly have sufficient enrollment (10 patients) with enough time on trial so that in late 2020 there may be some early report of efficacy...she didn't say at 2020 ESMO or SABCS, but that would be my guess for any news. If the news is good, then there needs to be a larger trial, and then fast-track approval-- so 2024 may be the soonest we could expect it on the market for lobular MBC. Seems forever away. But we should know much sooner than that if it is even promising. I am willing to travel across the continent if ever there is a US trial for it.
If you are willing, would you tell me what approaches have you tried for your lobular disease? Anything unusual or with an exceptionally long response? Where in Portland are you receiving your care? Is your disease more IDC-like or ILC-like (mets in the 'usual' places for IDC, or in the typical ILC places-- like abdomen/peritoneum/GI tract)?
If you happen to find a way to get one of the ROS-1i drugs off-label, please do share your approach!
Elizabeth
0 -
BevJen- I enjoyed the Allison clip, very uplifting!!
0 -
Me too! Loved what he said at the end that we are wasting a lot of important information by just measuring end point data in these trials. Biopsies should be done one those who succeeded and those who failed so we can better understand why.
Thanks BevJen!
Hugs, Susan
0 -
A new documentary about my fellow Texan Dr. Jim Allison was released this September. I can't wait to see it, even though I'm no longer on immunotherapy. I used to plant a kiss on the life-size image of him in the lobby of MD Anderson every time I passed it! He's an amazing scientist and a real character.
https://www.cancerresearch.org/blog/september-2019/jim-allison-breakthrough-documentary
0 -
It's showing in Berkeley! Bought my tickets.
Thanks Kattysmith for the heads up.
0 -
Here is a summary of the Nature paper that came out a few days ago- its complicated (!!) but basically shows that combining immunotherapy with a cancer vaccine can give a much larger response than the immunotherapy alone, however the cancer vaccine has to include cancer-specific proteins (neoantigens) that will attract both CD8 and CD4 positive T cells...
https://www.nature.com/articles/d41586-019-03106-1
0 -
Rotavirus vaccine also combines well with immunotherapy. Aspirin also, but best if started 6 months prior. Frankly, the repurposed drugs that can enhance response to immunotherapy (while adding no or minor risk themselves) are legion; I don't have time to go into them here but I would NEVER just start keytruda without researching them in detail first, and deciding on a protocol. SOC is NOT going to be very useful for add-ons at this time, although they haven't solved the problem of how few people respond to their approach, and many studies show the benefit of combos.
0 -
Elizabeth: Thanks for your detailed reply. I hope the new oral SERD will buy you much time. I am both ductal and lobular. my mets are in places like pleura and omentum and pericardium. i don't get imaging so don't keep track. i have no good ideas currently. bcl-2 inhibitors and pi3k inhibitors both need to be combined with a strict ketogenic diet, in my educated opinion, to avoid the insulin feeback-loop that just leads to progression and failure, fast. but after five years of very low carb, i am done with that, so consequently will not use the above drugs even though i have those mutations. so i guess it's xeloda next, although chemo is a road of no return.
i sent you a PM a while ago with details about where iam treated and such. feel free to contact me if you'd like to meet up sometime.
0 -
luce- I’m on afinitor for 8 months and my blood sugar remains normal. I’m not on a ketogenic diet- love sweets and carbs - eat healthy but lots of fruit and daily whole grain bread and oatmeal, some sweets. Hope you find the winning treatment. Diabetics seem to have big problems with afinitor and piqray I’ve noticed ( anecdotally)
0 -
A trial for an ADC, Sacituzumab Govitecan, was recently opened. Anyone on this trial or taken Sacituzumab Govitecan in another trial?
"This is an open-label, randomized, multicenter Phase 3 study to compare the efficacy and safety of Sacituzumab Govitecan versus TPC in subjects with metastatic or locally recurrent inoperable HR+/HER2- MBC, after failure of at least 2, and no more than 4, prior chemotherapy regimens for metastatic disease."
https://clinicaltrials.ucsf.edu/trial/NCT03901339
Sounds promising!
0 -
Started taking COX-2 inhibitor, Celebrex (celecoxib). 200mg twice a day.
So now I'm on Keytruda + Abraxane + Celebrex. Crossing my fingers!
0 -
Interesting combo. Good luck, Susan!
0
