Are you currently (or have you been) in a Clinical Trial?
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Hi everyone,
Thank you cure-ious for keeping us up to date on upcoming/promising trials. I believe it was a link from you that led me to the trial I started yesterday for a CDK2 and CDK4 inhibitors. (PF-07220060 and PF-07104091) https://clinicaltrials.gov/ct2/show/NCT05262400
It's treatment try #14 for me so I'm quite nervous about all the travel (I'm in Part 1 though I believe Part 2 is about to open) and my health is more precarious than for previous trials I've traveled to. But the next conventional treatment proposed was gemcitabine, so I thought I would try to return to the hormonal treatment trough one more time.
MissMonty - you'll see from my treatments that I have been lucky to have been able to return to hormonal treatments after chemotherapy several times. Navigating the Canadian treatment schedule is a challenge because of funding, as you note. I've tried to increase my options with timely clinical trials - some in Canada and some in the U.S. I've used my retirement savings (that I'm unlikely to need to be honest) to pay for the U.S. trials. I've known some people in Canada to get abemaciclib via compassionate access as a later treatment line - I believe you have to had a taxane to qualify but best to ask your oncologist.
Rk2020, I hope you can keep going on the BLU trial for the CDK2 inhibitor. I was sorry to see the FDA announcement, but I'm glad that your eyesight is unaffected.
I am thinking about and missing our former clinical trial discussants, like SusaninSF and GG27, as I start this latest trial.
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NewGardener- How great to hear from you!!! You have a really promising trial, test a CDK2 inhibitor that was developed for CDK4,6i-resistant cancers with Cyclin E:CDK2 amplification together with a new CDK4-specific inhibitor, hope it works and there's not a lot of SEs!!! Pfizer is pushing hard as Ibrance sales are dropping a bit and they've been trying for awhile to come up with the next best thing for cancers that have become resistant to CDK4,6i. Please keep us posted, and Good Luck!!!
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Here is a trial for metastatic TNBC- it is using a new monoclonal antibody directed against CCR8, which is on the surface of inhibitor Tregs (a type of T cell found in the tumor microenvironment that prevents a good response to checkpoint inhibitor immunotherapies). It will be tested in combination with either Opodivo (a checkpoint inhibitor immunotherapy) or the chemo Docetaxel.
Its a large phase 1/2 trial covering multiple cancers, with sites in the US, Canada, Australia & europe
https://clinicaltrials.gov/ct2/show/NCT04895709
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Pfizer is setting up multiple clinical trials of ARV-471, a PROTAC that effectively degrades the estrogen receptor.
Here is a new phase III trial (560 participants), started two weeks ago, testing ARV-471 alone against Faslodex. It is for those who progressed from firstline AI+CDK4,6 inhibitor, and also allows treatment with a single-agent AI (but not Faslodex), however no Faslodex or chemo treatments allowed. A handful of sites in the US, and also in Japan and Puerto Rico.
https://clinicaltrials.gov/ct2/show/NCT05654623
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Dear nkb, hmm... might it be DB-08? They say you have to be at least IHC1+ but who knows how exactly her2 zero is identified?
https://clinicaltrials.gov/ct2/show/NCT04556773
Saulius
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Saulius, not sure which Destiny it is- yes, who knows what Her 2 zero is! I have heard they are trying to come up with a new test to standardize or quantify it.
Cure-ious- thanks for the study data- I am glad that they are expanding ARV-471- when these studies have exclusions like must have one chemo treatment, or no faslodex or chemo or must be PR+, are those criteria to get a better outcome or those are the folks that they want to target if approved for these drugs? Lots of jostling for a step 2 drug? seems like we really need drugs for "heavily pre-treated". so many work well enough as a step 2 drug.
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Nkb- In the case of that one ARV-471 trial, they were testing it as monotherapy directly against Fulvestrant alone (the control group), so of course you could not have taken Fulvestrant already, because it was a phase 3 trial and for that you might end up in the control group.
My MO was talking up a phase 3 trial they were participating in (rare because they almost never do trials) and I told her I'd likely only be interested in a phase one or two trial because I'd want to know that I am getting the study drug and not whatever standard of care drug in the control group. However, looking over the requirements, I realized this trial, and probably other phase 3 trials (?) do accept bone-only mets, so long as one is at least big enough to be considered "evaluable" (as opposed to "measurable"). So phase 3 trials may be where one has to look for options for bone-only disease?
It was interesting that this trial was testing a SERD (giredestrant) together with everolimus, and comparing that to the control which was everolimus and exemestane (aka, the old affinitor-aromasin combination). Participants were limited to not more than two prior lines of treatment in metastatic setting. But think about that, if you progressed after firstline AI+CDK4,6i and secondline Fulvestrant+CDK4,6i, it seems like a step back in potency to go onto A-A (ie, if you ended up in the control group). But maybe some would risk that if you had bone-only mets and this was the only available trial option? Anyway, I thought of you and wondered if you had looked at phase 3 trials?
Another thing I thought was interesting- giredestrant has a huge phase 2 trial where it is paired with like 5 or 6 other targeted drugs, including Ibrance, Ribociclib, Verzenio, everolimus, as well as some drugs only available in trials, including a CDK7 inhibitor, etc. It is a long trial, called MORPHEUS, that will go on for several more years still. Yet here comes a new phase 3 trial for giredestrant, before phase 2 has ended, and tho its a big trial of 650 people its quite short, having started last summer and ending next summer. And is only offered in combination with everolimus, none of the other options. So you wonder if the rush is on for the company to get something to the FDA for approval, given the competition in the SERD field? And perhaps they have enough data from MORPHEUS trial to see that the everolimus arm, at least, seems to be working? Anyway, it's odd that there would be a short & sweet phase 3 paired with a long phase 2 trial that is still ongoing...
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Cure-ious- this is interesting. The phase III trial at your hospital is for Giredestrant? I have heard from researchers that a SERD alone as a second line (or 3rd line) hasn't been as successful as they had hoped.
I was told by dr Melisko that if I had a 2 cm "hole" in one of my bones, I might qualify for a trial. I do have a large met in my sacrum, but, it is fairly quiet now on the Enhertu. I did do A/A and it worked for 10 months and was very tolerable for me- but, my MO said I was the only patient she has had who found it tolerable- not a good sign for others. It is generic now, so less expensive at least.
I am hoping (perhaps ignorantly) that Td XD will work long enough for some other oral combo to be available that works better than standard chemo - which I have heard is about 15% efficacy and I am thinking that even worse for "indolent" bone only mets. I would love perhaps Abemaciclib or a CDK 7 or 2 with a protac or oral SERD that works in people who do not have an ESR1 mutation. Still wondering if I am resistant to anti- estrogens or not or if I regain that pathway after being off of them for 3 years.
I do think that trying to get drugs FDA approved before the first one in their class gets too huge of a following is on the drug companies agenda, it is good for us also- I did read that 1/3 of fast tracked meds (not all for cancer) get unapproved due to efficacy or other issues over time.
Thanks for thinking of me, in the back of my mind I do worry about the next drug at the same time as hoping for a long run on this one. I do miss Susan telling me what UCSF and USC are up to with trials.
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So, Nkb, its fairly straightforward to do a FES-PET scan, which will tell you whether the cancer remains estrogen-dependent. The "dye" is a kind of labelled estrogen, if the cancer is endocrine-resistant, it will ignore the dye. The only caveat is that one cannot take this test if they are already taking some kind of anti-estrogen. Not only do they scan to determine that the cancer is still estrogen-driven or not, but if it is, then they can repeat the scan after starting some endocrine therapy, to see if it is working.
Also, I think its interesting you got fairly reasonable time out of the AA, even after CDK4,6 inhibitor and faslodex. Now that you've been off endocrine therapy for awhile, the estrogen pathways may well be back and running the show.
I think the best of the SERDs so far sounds like Camizestrant, and ARV-471 (a PROTAC, ER degrader) and enobosarm are also interesting. Will go look around to see if anything else is in phase 3 by now...
If and when the cancer moves to organs, then obviously the phase 2 trials open up, until then you are doing a great job keeping it to the bones. I keep remembering Jimmy Carter had melanoma mets to liver and brain, and took Keytruda at age 90 and it cleared them out so he could keep trucking on! We just need some special sauce to make immunotherapy work as well for MBC...
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Captivasertib is an AKT inhibitor that did very well in a phase 3 trial with Faslodex, as announced last Dec, and SEs do not sound so bad either. AKT is upregulated in cancers with PI3K or mTOR mutations, but also in response to multiple other pathways, and the data showed one did not need high AKT to have a good response to this drug. And unlike Piqray, the high sugar problems and stomatitis aren't seen with this drug. No news about any submission to FDA so far.
https://www.medscape.com/viewarticle/985402
Also Camizestrant SERD looked good in phase 2, and some phase 3 trials have opened but again these are for first or secondline. Maybe the pharmas move to early lines of treatment because they have an easier time filling up the trial, so they can get the data sooner? It is also discussed in the link above...
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Are the FES-PET scans widely available?
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Thanks NewGardner and Curious for your input. Most of the time I do appreciate our health care system in Canada (I have been lucky and have always felt that I am treated as a priority patient with a sense of urgency) the longer I live with MBC, some flaws are become more evident. I sometimes do feel that the sentiment is “just be thankful you’ve lived almost 6 years”. I am grateful for the time, but come on?? Hopefully more clinical trials open up in Canada and I am still eligible to participate. I’m definitely going to keep pushing for more hormone targeted therapies as an option. An FES-PET scan has never been mentioned to me so I don’t think it’s standard protocol in Canada.(not 100% sure though) Perhaps with more private options becoming available here, it can be requested. I really pushed to stay on Ribociclib and just change out Letrozole to Fulvestrant, and was told no at every turn, because of funding. Insurance would no longer pay for Ribociclib, and it’s expensive. Frustrating.
I will also be researching clinical trials and hopefully, in time I will be able to contribute meaningfully to this Topic.
Thanks again all
Anna
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From what I understand, FES-PET would work fine while on an AI as those don’t modify the ER. But correct me if I’m wrong.
The issue with FES-PET that I have encountered when I requested it is that Medicaid (I’m 51) only pays for it ONCE in my lifetime. So thereforeI haven’t used it yet.
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Does Medicare pay for an FES-PET scan? what do they cost?
I have never been offered one, I may bring it up to my MO next visit- can it be done on the same machine just a different contrast?
Would be great to find out if I am still estrogen sensitive esp with the new treatments on the horizon.
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Salius- Hope Rugo mentioned this new trial at the Miami Breast cancer conference for Her 2 ultralow (IHC0-1) in Destiny 06 that will have patients who are HR+ and no prior chemo.
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I got accepted to my first trial... We will be leaving to go back to Florida this weekend and start trial next week. https://clinicaltrials.gov/ct2/show/NCT05194072#co...
Also...this week (Wednsday) I have my biopsy. I am having the Travera testing done..wish me luck please!!!!
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Much luck, positive thoughts and prayers coming your way.
Eleanora
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Nicolerod - Best wishes! I'm so interested in hearing about both the trial and how Travera works out for you! Sending you lots of positive thoughts!
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Praying that this trial is a success for you Nicolerod
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Good luck, Nicole!!!
B7H4 blocks T cells from infiltrating the cancer, and by targeting an ADC to this antigen it is hoped not only that it will get in and kill the tumor cell, but also allow for a greater infiltration of T cells which can then further attack the tumor. Any previous exposure to a Keytruda-type checkpoint inhibitor could also help to get a robust response.
I thought it was interesting that although this trial is just in phase 1, it is rather large (375 participant slots!) and is also being offered in Canada (Ottawa), London and Madrid...
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Dear Nicole, best of luck!
Dear nkb - I suspected this was DB-06!
Hugs,
Saulius
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Sorry it took so long to reply on my BLU-222 CDK2 inhibitor trial. My tumor markers have always been reliable in the past but maybe this drug has them reacting different. 🤞🏻Shortly after I was taken off 800 mg, I was told that largely due to my reaction, that no other patients were being put on 800 mg. At that time I was told there were some that had started at 600 mg and were still on that dose. This was back in December. I’m usually not one to put my doctor’s comments under a microscope but because this is a phase 1 trial, I find myself scrutinizing every word and innuendo. I need to get a grip and stop with that nonsense. Until my March 20 CT, I’m just trying to find the good in everyday but it’s difficult when I’m so weary from the constant nausea and diarrhea. I never thought I’d long for a solid poop. It’s been 3 long months. Lol.
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Well cancel all that.... turns out my bilirubin today was 1.7 from 1.2 just last week..and the trial limit is 1.0... they want me to re-check it Thursday...but its not gonna go down bc its up from progression this always happens when I progress and right now there are over 20 tumors in my liver and it hurts...so I will probably be eliminated from trial... I just literally CANNOT get a break... to say I am upset would be an understatement. I only have abraxane left so I am thinking about just giving up especially since no trial will let you in with raised bilirubin. I did mention to the trial guy that many years ago I was told that i have Gilberts syndrome (raised bilirubin) bc all my life I would always test a tiny bit high...but there is no way for me to prove it... so yea thats that.
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I am so sorry to hear that Nicole. You are in my thoughts and prayers.
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abraxane now and then once bilirubin goes down trial?
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Another one the trial was not effective for those TNBC that had abraxane
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nicolerod - praying for your disappointment and that something will give for a trial, and/or relief for your liver pain.
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Nicole, Could you get some Keytruda to see if the bilirubin might go down enough to get into the trial? With your subtype switch you might have a strong response to checkpoint inhibitors, and Keytruda is approved for TNBC?
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My heart just breaks for you NicoleRod. I'm so sorry the trial didn't work but it sounds like others have some good ideas. I don't know enough about all this to have suggestions I'm just here rooting for you.
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I cannot get keytruda its too late I have to be there tuesday plus they wouldnt approve it unless my MO did right to try and it would have taken to long... I had my blood work done today it went even higher to 1.9 yesterday I had my biopsy. They said because I had gilberts syndrome I can still get in the trial but we are worried now that from today to when they take my labs there Monday it will be even higher and the threshold for trial with gilberts is 3.0 ... I mean i went in 6 days from 1.2 to 1.7 then in 2 days to 1.9.... I looked back at my bilirubin and in 2020 it was 2.4....once and that was with only 4 liver tumors I now have over 20...
I cannot stop crying... I think this is the end for me.
. We are gonna go but I don't feel hopeful at all..I actually am feeling dispair...
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