Are you currently (or have you been) in a Clinical Trial?
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BevGen
MDACC told me it will be opening at other locations for phase 2.
I’m going to ask SCRI soon if it is coming there and what she thinks. Don’t want to muddy the waters this week with Dr Hamilton since I am starting the SERD.
Dee
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Hi Dee, Thanks--- yet another ADC in clinical trials! ROR1 is expressed in most cancers (might be why they don't bother testing) its normally on cells only at an early stage of fetal development, but comes back in cancer. This drug has now been tested for immune cancers so you know its safe.
I would consider this in the context of the other ADCs, like Enhertu or Trodelvy, because I think the chemo payloads they use are related so if you pick one you aren't eligible for the other? They are also developing a CAR-T to ROR1, so I would ask if you do ADC-ROR1 would you still be able to take a CAR-T for ROR1? The great news is these ADC drugs are robust, PFS is like 16 months or more. But still, they are chemo, whereas right now you are focused on extending your time on endocrine therapy. Definitely something to research for the future.
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Thanks Cure-ious
I knew you would have some insight. NIH already told me no to Car-T because of IVIG. I asked the MDACC trial coordinator if that would exclude me from their trial. She is checking. The drug uses IgG1 as a carrier from what I read.
Dee
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Might be that Tesetaxel (oral taxane) will be approved soon. A pretty spectacular drug - efficient as Docetaxel/Paclitaxel, oral, but only 2-5 pills once every 21 days. This is a pretty "old" drug, and actually, was forgotten but then rose back from the ashes...
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Just got my scan results and I am still stable! Starting Cycle 15 of the Trodelvy trial tomorrow.
Cure-ious, Sorry to respond so late regarding your questions. I've lost all of my hair including eyelashes, eyebrows, and all my body hair (what a waste of time and money I spent on laser hair removal!). No nausea. Some constipation from the anti-nausea premeds the first day. This eventually went away. Some soft stool from the Trodelvy but only a couple of instances of diarrhea. Increasing fatigue but still able to have a high quality of life and do all of the things I normally do. Still have pre-Trodelvy mouth sores on and off but much less severe than before.
On one of the OncLive videos, I learned that N-28, the toxic chemo payload of Trodelvy, is more potent than its parent compound, Irinotecan. Also, that the payloads of both Trodelvy and Enhertu have twice the toxicity of Kadcyla. Amazing since the SEs are so tolerable on Trodelvy.
These drugs are game changers!
Hugs, Susan
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Susan, so glad to hear about your great scans and that theside effects are so manageable. Hope you get a good long run on this drug!
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Yay Susan! That is fantastic. How often are your infusions- every 3 weeks? Did you get some shrinkage in the beginning? I can’t remember. These new drugs are awesome!
FYI- I just found out that the ADC NCT04504916 trial I was invited to try will allow my IVIG infusions! It is now in my front pocket for next line if the SERD trial fails.
Dee
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Susan in Sf- this is wonderful news! I am glad that it is so tolerable for you as well as long lasting
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Susan - Great news! It's so encouraging to see how well you are doing on the Trodelvy trial.
Dee - I am always impressed with your research and ability to find more trials. It looks like you have a good plan in place.
Tomorrow, I have my first 2 month CT scan of my lungs and liver to see if the AZD9833 (oral SERD) trial with Everolimus is working. My tumor markers have been low/normal. I hope my CT scans will also be stable. ~Kar
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Susan awesome news...
Dee I totally agree with KarPC about you! You really are amazing how you find all this stuff out and you understand it all....and like Cure-ious you are helpful in explaining it to us.
KarPC praying for all good news on those scans!!! Keep us posted!!
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A useful discussion of the AMEERA-1 SERD trial, which sounds promising, and they mention a new type of imaging of the estrogen receptor (FES-PET) that was developed at the Hutch in Seattle and was just recently FDA-approved - this apparently can be used to determine whether or not the cancer remains sensitive to endocrine therapy, and is also a better way to image lobular cancers, some great progress..
https://www.oncnet.com/podcasts/hannah-linden-md-h...
https://www.oncnet.com/interviews/fes-pet-imaging-...
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Cure-ious,
Thanks for posting both, but especially the one about the FES PET imaging, which seems especially promising with lobular cancer patients, as I am. This seems to be very helpful in bone mets, which have been difficult to image in my case.
As for the SERD trials, I just watched a zoom presentation by Dr. Nancy Lin from Dana Farber highlighting potential treatments coming down the pike as presented at SABCS. She indicated that oral SERDS, in her opinion, may make it to the finish line in Phase 3 trials this year or next, and she thought we'd be seeing them soon. BTW, if anyone wants to view her presentation, it will be available at Living Beyond Breast Cancer after January 6 -- they recorded it. The Q & A was extensive and very informative.
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Yes, Bev, this is from the Hutch website:
In late May 2020, the FDA approved the use of FES imaging agent for PET scans in patients with recurrent or metastatic breast cancer as an adjunct to biopsy, thanks in large part to research done by Manohar and her mentor Dr. Hannah Linden of Fred Hutch/UW.
FES stands for fluoroestradiol F 18, a new type of estrogen-analogue tracer (a traceable injected fluid) that's used in PET scans to detect estrogen-receptor binding in tumors. Most breast cancers are estrogen receptor-positive (ER+), particularly the subtype lobular. FES-PET scans pick up the function of estrogen receptors, lighting up the presence of ER+ breast cancer.
"This enables clinicians to help patients select appropriate and effective treatment," she said.Manohar believes FES-PET scans might also be used to great effect in detecting lobular breast cancer, which is notoriously hard to image with current technology like traditional PETs, CTs and mammograms. Lobular is almost always ER+.
Her previous research proved FES-PET can detect lobular bone "mets" and lights up more in bone marrow, a finding that may have an implication for treatment response and prognosis.
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And yep, we need SERDs approved asap, and to figure out which ones are the best for us!
But mostly it does us little good if they approve SERDs for only stand-alone monotherapy, we need them in all combinations, so I hope they can just approve them as an alternative to Faslodex in any use...
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Curious, have you read anywhere if this new estrogen PET tracer could also benefit those of us who might be resistant/refractory to estrogen therapies? Just can't find the data on that.
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Sandi- I'm not clear on your question- I'd never heard of FES-PET before, which I guess is not surprising since it was not FDA-approved until this spring. The video below describes the technique, but its from 2012 so I'm not sure if its still the same- basically rather than looking at the level of ER protein, they are looking at the activity of the ER protein, defined as binding to its ligand, which is labelled in the scan. Then they can follow how the activity of the ER changes as a result of AIs or tamoxifen, and get an immediate or at least fast readout as to whether endocrine therapy is going to work. I read they recently showed that ESR1 mutant also shows up in these scans as it can bind the ligand but since the mutant is constitutively active and does not need to bind ligand I don't get why the scan works in that case? Maybe it would show no change in response to AIs or tamoxifen..Anyway, this is worth talking to imaging people. Also, apparently this technique revealed that lobular cancer that is in the bone marrow is not more aggressive than regular bone mets and has a better PFS- because they can image lobular much better they have been able to learn new things about it using this technique
Some of the papers -
https://pubmed.ncbi.nlm.nih.gov/24079874/
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC38835...
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Here is a very good recent review article on the different causes of endocrine resistance. Lots of transcription factor networks that can affect this, and its a plus that he goes into these signaling pathways as well as metabolic pathways that can affect resistance as well as PDL-1 expression and pro-inflammatory cytokines. But on the downside, in reading the review you can also see the gaps in knowledge, for example the author mentions early on that a CDK7 inhibitor could be useful once resistance develops, but then he never mentions that drug again, and it doesn't appea in the figures where he talks about different drugs that might hit different modes of resistance. So that is because we don't know which modes of resistance CDK7i would work on. But similarly, we don't know exactly which subtypes the other drugs he lists work on, like the BET domain inhibitors or HDACi, and in those cases he is either taking it from studies on mice or cultured cells lines, because there aren't clinical trial data. But anyway it is a fairly comprehensive review of where we stand on this issue. The paper is too big to paste in but hopefully the SciHub link works
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Cure...is this only for Lobular though? I am not lobular but do have lobular features....
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Thank you Curious. I guess I was hoping this scan would be magical and tell me if my antihormonal days are over due to mutations..
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Hi. I got my results from my CT scans yesterday of my liver and lungs. This is the 2 month point since starting the AZD988 trial (oral SERD) with Everolimus. The scans show my cancer as stable, so that's good. I chose participating in the trial over the Everolimus and Aromasin combo. Hopefully this trial will work longer for me than the average PFS time on Everolimus and Aromasin - which I believe is only about 4 months after taking a CDK inhibitor. But for now, I can take a deep breath and relax for the the holidays! I hope we all can! ~Kar
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Sandi- I think that is the point of the scan, to see if your cancer will or will not respond to anti-hormonals. Eventually I will wander over to our radiation center and get a consult to ask about this, because I will want it at some point. they are also using metabolic labelling scans to tell which mets where take up glucose vs. glutamine, there is quite a lot more that could be done with scans. Probably the issue becomes getting insurance to pay for it?
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Follow up on FES PET scan -- I sent my MO information about this, because I have lobular cancer, and she wrote back and told me that it's not widely available. In fact she said that probably the closest one to us (I live in DC suburbs) might be at Penn in Philly. So while this may become a good tool especially for those of us with lobular, again, it's something that we may have to wait for.
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KarPC
That is great news! I can’t remember- do you have esr1 mutation? The new SERDS are trying to overcome that.
My SERD trial starts Monday. I am hoping for at least stable disease. Haven’t achieved that yet.Dee
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Thanks Dee. I do not have the esr1 mutation. I am so glad that you were able to get into your new trial quickly. I will take that as a good sign that this treatment will work for you for a while! ~Kar
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We have it here in L.A. @ USC.. I'm being told to switch to this and I am terrified..
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Hiya,
I know this post of yours was from earlier this year but I was just wondering what the name of the bone biopsy you speak of is called? Thanks hon!
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Hi Ballyhoo. What are you currently taking and what trial are you possibly switching to? Thanks, Kar
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For anyone who might be interested in hearing more about immunotherapy in general for cancer (not just breast cancer) the Moss Reports has just come out with an interesting documentary about how immunotherapy was first developed and its place in cancer treatment today. I'm a bit of a geek on this stuff, so I sat through the entire one hour documentary in one sitting. But for those who aren't as into immunotherapy as I am, you might want to watch this in chunks. I found it fascinating.
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Hi all, I've been lurking here for quite a while, reading through lots of posts about current trials. I was recently diagnosed with secondaries to lungs, two nodules and mediastinal nodes. I was ER+ PR+ in primary (8/8) and they assumed I was endocrine resistant but still hormone positive, so I was initially looking into clinical trials around that. But now after an inconclusive biopsy (long story) they think I'm TNBC. Given this, I'm now particularly keen to look into trials. I'm based in the UK and am looking at TNBC trials with immuno and chemo at Barts hospital, but I'm also Australian with an Italian partner and we're willing to go back to either of our home countries for trials we can't get in the UK. So we can't really access trials in the US (although even that is a vague possibility - my partner is meant to start a 2 year job placement in Boston next September but the complexities of working out the insurance situation there is currently right over our heads).
I've started making a spreadsheet of options in UK, Australia and Italy, with the obvious preference at the moment for UK-based so I can get on a trial/start treatment asap. I know that a lot of TNBC trials are for first-line treatment which is why I'm anxious to make the right decision at the beginning.
At the moment either this: https://clinicaltrials.gov/ct2/show/NCT03424005?te...
Or this: https://clinicaltrials.gov/ct2/show/NCT03742102?te...
Look promising. I'm wondering if anyone has experience with these or similar trials, or thoughts on seeking out a trial for first line therapy.
In Australia there is also this: https://clinicaltrials.gov/ct2/show/NCT03464942?te... which I would be quite keen on as I would really like to have SABR (my hospital told me I wouldn't qualify on the NHS currently because of the mediastinal nodes). But it's the middle of a pandemic and I'd need to transfer my care to Australia asap then quarantine for two weeks before being able to even meet the trial team
As I've only just heard the news I don't know my PDL-1 or AR status yet, but hope those tests will be done soon
I really appreciate the knowledge in this group!
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Phet I am surprised that you were both ER+ and PR+ and now TNBC??? I would have thought you would go to Triple Positive before TNBC.... seems like you got things going in the right direction as far as looking at future treatments keep us posted. Also when you find out about the PDL1 let us know.
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