Are you currently (or have you been) in a Clinical Trial?
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HIGH FIVES, Katty! 🍾🥂
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Ann273, thanks for the info on Alisertib and FGFR status/FGFR inhibitors. Cure-ious, good question you had about the interplay between these two. I don't know the answer but Ann posted an interesting point on this. I will now be looking into this further! It is frustrating to see drugs out there that appear likely to help us but to which we have no ability to access.
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Gran - Yes, I'm at MDA and I'm the only patient there who is on this trial. https://clinicaltrials.gov/ct2/show/study/NCT03661...
I am in a Phase 1/2 study of BMS-986310 administered alone and in combination with Nivolumab in participants with advanced solid tumors.
I take 2mgs of BMS-986310 per day and a 30 minute infusion of Nivolumab (Opdivo) on the first day of each 28 day cycle.There are only two other patients at other sites in it, and at as a month ago, neither was responding as well as I have. My doctor was teasing me yesterday about how leery I had been about consenting to the trial. They won me over and I'm glad they did. I told them it was like jumping off of a cliff that had a beautiful view, but no parachute!
Cure-ious - I have felt well all along - lucky lucky lucky me - so there hasn't really been a noticeable change. I think I have more energy, but that's hard to say since baseline I'm lazy and out of shape. I'm more of a "reading on the couch while sipping a gin and tonic" gal than a marathoner! (Aaanndd, I have a bad knee which sometimes limits my walking.) As far as side effects, I've had patches of rash here and there since the git-go, but they have never been bad. I have some cream to use if there's a bothersome spot. I don't have any outbreaks right now. For a couple of weeks in late February, I had minor acid stomach; it felt like when you've very nervous - no pain or nausea, but just sour, so I started taking Nexium and that cleared it up. There was no evidence of bleeding, so I didn't have to get scoped. I have some minor inflammation in one of my lungs, but am totally asymptomatic (no dry cough or breathing issues), so no treatment for that. I live in Houston and our air quality is no bueno at any time, plus we've had a massive amount of smoke and toxins in our air since one of the petrochemical plants exploded almost three weeks ago. I think environmental factors are at play here, too.
I'm heading over to MDA in a few hours for my Nivolumab infusion - which always makes me sound like an Earl Grey tea bag - and should be home by mid-afternoon, I hope.
I hope you are all feeling well and have a good week!
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Katty. That sounds like a good trial for me, too. But, it's not at UTSW n Dallas. Bummer. Sounds like it's an immunotherapy drug combo? Phase 1/2, you are brave and your bravery has paid off. It's shrinking your liver mets, Hallelujah.
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katty- Given how great you have responded, its disappointing that there are so few who have signed up for the trial- we can't really tell much about the two other non-responders they have had, because they might not have been breast cancer patients.
Hopefully more people will take that leap off the cliff and join this trial, because you have landed in such a sweet spot!
I love that your doctors are now teasing you for being unsure of the trial, they must be pleased as punch, this is what they go into the profession hoping for...
PS Also, this trial does offer a big potential benefit with small relative risk (in terms of side effects) compared to chemo!
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The big news out of AACR continues to be the CAR-T story, the first demonstration that it works in solid tumors. The test is done for mesothelin-expressing cancer, 72% response rate across different cancer types, boosting with immunotherapy drugs like Keytruda to keep the cells in an active state. The hunt will go on to identify other proteins that are over-expressed in cancer cells that can be targeted by this method , the key being that the proteins have to not be over-expressed in normal cells (lest all of those cells be killed as well). And we can count one metastatic breast cancer patient among the responders. Huge implications, really, this story will dominate headlines for quite awhile...
https://www.medscape.com/viewarticle/911137
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Cure-ious, I think I am the only breast cancer patient in the trial.
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Kattysmith,
I thought Cure-ious was referring to Judy Perkins, who was in the phase 1 of CAR-T for solid tumors for the NIH - I think. She achieved a durable remission in 2014, and is still in remission.
I've been trying to slog through the articles about that trial, and its approach. From the looks of it, they weren't even aiming at mesothelin, just some proteins.
Here is the article I can't really understand:
https://www.nature.com/articles/s41591-018-0040-8....
This is the first trial I tried for, but didn't produce the right protein
https://www.roswellpark.org/media/news/super-t-cel...
Article focusing on somatic mutations in TNBC, and a lot of other stuff that I can't quite ingest yet
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC54809...
CAR-T and solid tumors
https://www.cancercommons.org/knowledge-blog/the-c...
If anyone can help me slog through some of this stuff, I'd be grateful.
Jennifer
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Thanks Cure-ious for the link on Aurora-A kinase inhibitors potentially being effective in cancers with RB loss!! You really do have a gift for sniffing out relevant research! I appreciate your willingness to share your gift!
Kattysmith, CONGRATULATIONS on your excellent response to treatment! I'm absolutely thrilled for you! I love your analogy of jumping off a cliff with a beautiful view, but no parachute. That's exactly how I felt when I entered the talazoparib trial, although that trial had a fair amount of data from the BRACA1/2+ trials. Thank you so much for sharing your experiencing. I'm praying for you and cheering you on!
Hugs! Theresa
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Kattysmith- we have to get some more breast cancer patients to join you! But for now, just relax and enjoy the healing and getting your health back!!
BlaineJenner- I will dig into those papers right now, see if I can tell anything from them. You mostly want to see what fraction of MBC patients express mesothelin? I found some reports and can dig them up if that helps. They will re-test you this week to see the levels expressed? Its wonderful they are so careful, it would be awful to go through the trial and then realize your cancer wasn't really making enough mesothelin..
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OK, BJ, the first paper is obviously the one describing Judy Perkins, and she had the CAR-T done at the NIH (so not in your trial, but they used a similar approach), and they looked at her cancer and identified four different mutants they could target (SLC3A2, KIAA0368, CADPS2, and CTSB). BTW, none of these are mesothelin, which is called the MSLN gene. It is incredible the amount of work they describe doing to characterize her cancer. She did not have PDL1 expression but they added Keytruda to the CAR-T in hopes of making the T cells work for longer. As they say, this worked great, whereas Keytruda alone would be unlikely to have done anything much against her cancer .
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BJ- Your cancer is a rarity for sure, the attached paper says mesothelin expression on Er-positive MBC is quite low, 0.31% for luminal A cancers, 5.5% for luminal B cancers, 6% for HER2-positive cancers, and 30+% for triple-negative cancers..
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC46950...
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Cure-ious,
My brothers would agree that I am weird as heck, so this wouldn't surprise them a bit.
I have my first appointment with MSK on April 18th. I'll report back.
It's funny - I am prepping for this like it is some sort of audition. I've got a new frock to wear, and I'm trying to get fit so that I don't puff or wheeze in front of them. I've even got some new specs to wear that are very funky. All these are talismans to ensure that I pass their mesothelin testing, and fit all the inclusion criteria.
All digits crossed.
Jennifer
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good luck!! A new start!! like the funky specs
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LOL! Love the picture!
Just got back my latest scan results and I have more progression in my lungs. My scan two months ago showed some progression there but it was overall so small, my MO decided to keep me on Alpelisib+Letrozole. I see her next Tuesday but I'm guessing I will have to switch treatments. Too bad because I have been feeling so good and hoped for at least the median PFS of 11+ months.
- Susan
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On Monday I will finally have my PET. I'm spending way too much time wondering what/how much is growing inside me. Only my friends here understand how that feels. I'm having more pain more often in my right shoulder blade area. That worries me. I have enjoyed my five weeks with no TX. My wash out in case my new MO decides on a clinical trial for me. I don't see her until Thursday, more waiting, unless it shows up on my Portal.
I am so ready to have a plan, I don't like being in limbo land. Six more days until I know the plan of action.💞
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I'm sorry Susan, but grateful for all the info you provided about this drug. Among some trial options you can ask her about are Alisertib trial that Anne (and Anne) are on, the immunotherapy-EP4 inhibitor trial kattysmith is on, apparently anti-VEGF plus immunotherapy combinations are looking really really good. Look for some mesothelin expression so you could join the CAR-T trial BJ is on, and any other immunotherapy given that it would be a really different approach to all the targeted drugs. Hopefully none of these would have particularly bad SEs.. Will be very interested to hear what Hope suggests..
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Thanks Cure-ious!
Posted on the Alpelisib thread the following list of trials I perused. Reposting it here so others will see it:
Looked at the qualification for entering these trials and this is what I found:
1) EMERALD Phase 3 Trial of RAD1901: Must have an ESR1 mutation, which I don't have.
2) Morpheus Trials: Must be TN, which I am not.
3) Erdafitinib: Must have FGFR amplification, which I don't have.
4) Avelumab: Seems to work best for TN. Also, two patients died of treatment-related causes.
5) Mesothelin-specific CART T Trial: Only 0.13% of ER+/HER2- patients express mesothelin so it's unlikely that I do.
6) Alisertib: Couldn't find a trial where I would be sure to receive the drug.
I'm no medical researcher so I could be wrong. Let me know if anyone has thoughts on this list or other recommendations!
Hugs, Susan
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Kattysmith,
In looking at the qualifications for your trial it said you needed to have "metastatic disease where no other standard of care treatment option is possible" or be TN. Since you are ER+/HER2-, your doctors put in for the former?
Hugs, Susan
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SusaninSF, my erdafitinib trial required the "no other treatment option" scenario too. For the most part, that is in a doctor's discretion and can be based on the patient's decision that she/he doesn't want to try any other option at the time of the trial. For anyone who has been through a few treatment lines, that qualification should not be a problem. I think the trials do that for liability reasons and MOs are usually very flexible on making that determination for purposes of trial qualification.
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Thanks JFL! Good to know.
Also, I found a great link about PARP inhibitors that lists all of the trials by category, i.e., monotherapy, PARP+immune checkpoint inhibitors, etc.: PARP Inhibitors
Looked through the list and, from the very short description, narrowed it down to these since I am not BRCA1/2 or TN:
Monotherapies
NCT0077758228: Olaparib,
w/ angiogenesis inhibitors
NCT0307546284: Fluzoparib + VEGFR inhibitor apatinib
NCT0248440486: • Olaparib + PDL1 inhibitor durvalumab; VEGFR inhibitor cediranib + durvalumab; Olaparib + durvalumab + cediranib
NCT0249861387: Olaparib + cediranib maleatew/ Immune Checkpoint Inhibitors
NCT03330405: Talazoparib + PD-L1 inhibitor avelumab
NCT02657889(KEYNOTE-162)89: Niraparib, 200 mg po bid + PD1 inhibitor pembrolizumab, 200 mg IV on day 1 of a 21-day cycle
Did not look at the individual trials yet so don't know if they are still recruiting.
Hugs, Susan
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Susan alisertib trial with/without faslodex
https://clinicaltrials.gov/ct2/show/NCT02860000
and there has been a bit about oral taxanes
http://www.ascopost.com/issues/july-25-2018/oral-t...
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Hi Susan,
Yes, I'm in the former category. My MO and I had previously discussed Xeloda as a possible next step, but he was concerned that I needed something more aggressive because my liver mets were really multiplying and researched some trials with his colleague in the clinical trial dept. Ironically, the trial he thought would be best (Taxol + ???) got bumped (with my consent of course) in favor of this immunotherapy trial, which has turned out to be a good choice. Who knew??? The winds were at my back for a change!
Best,
Katty
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Does anyone know more about the Emerald phase 3 trial? I wonder how well it's working. I do have ESR1. Maybe this could be an option for me. How did all of you get so savvy about these trials? I would like to be able to speak your language. Ha
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Susan in SF-- There are two separate MORPHEUS trials--one for TN, and one for ER+/HER2 (https://clinicaltrials.gov/ct2/show/NCT03280563)
....however, the ER+ trial at this point in time excludes people with even one line of prior chemo (It looks like you have been on Xeloda in the metastatic setting, so no go for -- or me....that trial is open here at my cancer in POrtland (my one is the PI for it here) ... she says that she heard their MAY be an arm opening for one prior chemo late summer (if the trial sponsors approve it, which has not happened yet.)
Just want you and others who may be interested in it to know that there is one for ER+/Her2- and that there may be an option for those of us with 1 prior chemo....Stay tuned.Hope you find a good next treatment....it's very unsettling to "be on the hunt."
Elizabeth
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Elizabeth has it right, there is a separate MORPHEUS trial for ER-positive, and Hope runs it out of UCSF
https://clinicaltrials.ucsf.edu/trial/NCT03280563
The unique thing about the trial is that when patients do get progression, they have the option of taking Faslodex with immunotherapy plus anti-VEGF inhibitor
I saw a tweet from an oncologist attending AACR2019, who said that the anti-VEGF combo was looking like the "treatment to beat" in terms of immunotherapy effectiveness. So, I would ask her how you can get that combination?
Also for Alisertib, it is in phase 2, so you would know what treatment you are getting in advance.
UCSF also has an NKTR-102 trial, but you would have had to gone through chemos in metastatic setting:
https://clinicaltrials.ucsf.edu/trial/NCT02915744
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Thanks wildplaces,Katty, Elizabeth and Cure-ious!
Will read up on the oral taxanes and anti-VEGF treatments. One of the PARP trials is combined with Apatinib, an anti-VEGF.
NKTR-102 and Gedatolisib were the other two options we discussed when I switched to Alpelisib.
The more I research, the more I get excited about the massive amount of new treatments being developed! Like i always say, "Just have to stay alive long enough to get the next new treatment!"
Hugs, Susan
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SusanSF - another option is to consider seeing Dr. Kurzrock at UCSD. Her Predict trial essentially allows her to match you to whatever set of FDA available drugs she thinks is the best combo for you (even if they are not BC drugs). But, be aware, that the drug manufacturers are not sponsoring the drugs, so that means they try to push them through your insurance for approval and if that fails, they help you make a case with the manufacturer for compassionate or discounted use. So, that can take some lead time to set up. Something to have on your radar though.
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Thanks ThrivingMama! Have never heard of her work. That would be "Hail Mary" time but good to know.
Read your profile under your message and was surprised that you went off of treatment while metastatic. Was that your choice or was it recommended by your MO?
Hugs, Susan
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Susan - recommended by a number of doctors. I had 3 PET/CTs that were all NED.
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