Are you currently (or have you been) in a Clinical Trial?
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I wrote to NIH/NCI about my brain mets and this is what I got back: "Our investigators would like to look at the images. As they have been treated and stable for a length of time it may not be an issue." So I need to fill out some forms and send them images and reports.
There is also the CAR-M trial at City of Hope which is near LA so much more convenient. Any thoughts from anyone about which might be better?
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Susan,
Good for you for pursuing things with NIH. I also wrote to them -- to Dr. Stephanie Goff, who is the no 2 person on all of these trials -- and they sent me a series of questions. I sent my responses in to them, and then strangely, they asked me about my current treatment and whether it was a placeholder to keep things stable while we look around for another treatment or trial. I thought that was a weird question. Isn't every treatment that we are on a "placeholder" of sorts, where we hope that that things don't get worse? I must be missing something. So I wrote them a long explanation of how I came about to be on my current treatment. Let's see what else they come back with. They have not asked me for any imaging or records or anything, other than the responses to their questions
As for which trial, my gut would tell me to go with NIH since they've been at this for so long. I'm not familiar with the CAR-M trials and the only thing I know about it is what Cure-ious posted on here. It would be a massive pain for you since you are on the West Coast, but really, it sounds like you'd have to be here a few times at the start -- mostly for the 3-4 week hospital stay that they talked about in the information -- and then not that much later on. So I think you need to dig deep and think about what you want to do and how much travel you want to do for trials. Sorry for not being more helpful in that regard.
Bev
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They told me they wont do anything until a person has clear progression...if a person is on a treatment and it is keeping them stable or working they wont get in the trial...they must have progression on current treatment. Susan I thought you were on a trial and having success did something happen?
I sent NIH my TEMPUS and will be sending them all my images discs records etc on Tuesday.
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That explains it, Nicole. Did they ask you if you were definitely progressing, or are you just sending them your info to move the process along? I assume that they can look at your next scan and say yes or no based upon that, right?
B
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yes they will hold my stuff but will not do anything without progression...They told me to let them know after I scan March 15th.
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BevJen, Thanks for sharing your thoughts.
Nicole, I think my current treatment is working. I have scans next week. I hope that I can stay on ARX-788 for a long time but I have been on treatments like Tamoxifen and Piqray that worked great at shrinking my tumors but only lasted a short time, 7 and 8 months. Getting on a new trial can take months so I want to get the next treatment lined up. If on review, I won't be accepted into the NIH/NCI trial, it's best to know that now, not after ARX-788 stops working. If I have any progression in my brain, I will be disqualified from joining. Nerve-wracking!
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Susan..ok ...gotcha
. Yea..you say something working for short time 7-8 months...that would be long for me... I have never gotten more than 4 months... its to the point now that if I found out at 3 month scan something is working I can't even be excited bc I just feel like "ok big deal its just gonna stop working 4 week from now"... ya know what I mean? Its almost like PTSD..seriously...
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Nicole,
There have been several women in my MBC support group who also went from treatment to treatment with nothing working. I would hope that these days, now that they seem to be working harder to develop treatments for TNBC, you will be able to find something. Perhaps they are not looking enough at the specifics of ER+ BC that has become TNBC. I hope you can get on the NIH trial.
Hugs, Susan
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Hi everyone,
I've been happy to read of some positive results (SusaninSF and GG27) though it seems a shame that the tomivosertib trial is now closed at the three sites.
I managed to squeak out 12 months on abemaciclib (MBC line of treatment #11) and was sliding sideways for a bit hoping for a clinical trial to pop up.
Well, my oncologist did come up with an open trial once we ascertained that yes, I've only had two cytoxic chemotherapies as an MBC patient (I worked hard at dodging them). The drug is enfortumab vedotin. It's an ADC (like Trodelvy or Dato-Dxd) and is already approved for use in urothelial cancer. The target is Nectin-4 and drug MMAE. It seems that 80% of bladder cancers express Nectin-4 and 53% breast cancer.
There's a HR+ arm. I've been washing out and getting all the tests, and in theory I start next Monday. Sadly during this washout period my QOL plummeted. I grew a "massive" left side pleural effusion (CT radiologist used caps in his report, of course I knew since I was having trouble walking and talking). I had a pleuroscopy to drain it and get some new biopsy tissue. I'm now living with a pleurx and still draining tons. Home care nurses have been nice:)
What's strange is that I haven't encountered any news on it. I thought I'd ask here and see if anyone has run across it.
https://clinicaltrials.gov/ct2/show/NCT04225117
The news today re Enhertu and HR+ today seemed very exciting (except of course they don't say WHAT the PFS/OS is) but I'm excluded from Destiny 6 trial and can't afford to try U.S. off label. My ability to access Trodelvy is similarly constrained.
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NewGardener,
I hadn't run across that trial before but it looks very promising. Phase 2 trials are the best because you will definitely get the trial drug. It's also great that it is already approved for urothelial cancer.
Sorry to hear about your pleural effusion. I went through all of that, thoracentesis, pleurx, and pleurodesis. It was a long road for me though many do the drains for a few months and dry up. I hope you are one of those people.
Congratulations on getting 12 months out of Verzenio! I progressed after six months but I'll take whatever I can get these days.
Hugs, Susan
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A CAR-T clinical trial targeting a cancer-specific form of Muc1 (in 93% of breast cancers) is now open at City of Hope:
https://clinicaltrials.gov/ct2/show/NCT04020575#co...
They are taking 15 patients each with ER-positive, TNBC, or Her2-positive MBC. Phase One, first in human, open till Jan 2023.
No maximum number of prior systemic treatment regimens.
- Patients with hormone receptor positive disease must have received at least 3 prior endocrine therapies and at least 2 prior lines of chemotherapy in the metastatic setting.
- Patients with HER2 positive breast cancer must have received at least 3 prior HER2-directed therapies (trastuzumab, pertuzumab, TDM-1 or others) in the metastatic setting.
- Patients with triple negative disease must have received at least 2 prior lines of chemotherapy in the metastatic setting.
CNS mets must be treated and remained stable for at least 4 weeks prior to starting the trial.
https://www.businesswire.com/news/home/20220201005...*-Targeting-CAR-T-for-Metastatic-Breast-Cancers-at-City-of-Hope
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Recent CAR-T success in CLL is discussed in the latest Nature: https://www.nature.com/articles/d41586-022-00241-0
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Posted this on the Liver Mets thread but copying it here. Lots of overlap of members between the two groups.
Just got my scan results yesterday. Everything is shrinking or disappearing! Haven't had a scan this good since I was on Alpelisib (Piqray) almost four years ago. Usually, the best I could hope for was small progression or stability.
No noticeable side effects so far. Will get my 3rd infusion next Thursday.
If anyone wants to give ARX-788 a try, they are still accepting new patients.
https://clinicaltrials.gov/ct2/show/NCT04829604
Cheers, Susan
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Congratulations, Susan!!! And thanks to you for helping get this drug to market quickly!
It's amazing how quickly the body heals once the cancer burden is lowered, hope you aren't having bad side effects and get a long long run!!!
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Wow Susan, that is fantastic news!! I checked the link you posted, not available in Canada yet, fingers crossed that it will be soon.
cheers, dee
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That is fantastic, Susan! We're so happy for you!
Cheers, the Mods
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great news Susan!
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Thanks to everyone for always being so supportive!
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SusaninSF - such wonderful news! Maybe I'm missing something in your signature -- are you HER2+ now or is there a cohort of HER2-low or negative enrolled in the trial?
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I posted to you in liver but YES!!!!!! SUPER DUPER HAPPY FOR YOU!!! If only my scan in 3 weeks would say that....
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Thanks, Nicole. Hoping for a great scan!
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Interesting new model to grow and model MBC developed at Huntsman (Salt Lake City) described in the latest Nature Cancer- they have a small clinical trial (called FORSEE) that is ongoing
In this trial they take a biopsy and grow the patients tumor cells in their mouse metastatic model, then test FDA approved as well as experimental drugs and suggest best combination therapies and sequencing of therapy to suppress cancer growth and ideally prolong patient survival. This is for both TNBC and ER-positive cancers, however the latter patients do need to have progressed past endocrine therapies in order to be eligible.
https://clinicaltrials.gov/ct2/show/NCT04450706
https://healthcare.utah.edu/huntsmancancerinstitut...
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Cure-ious,
Isn't this similar to what the Nagourney Institute in California does?
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It sounds like the same thing. When I first became metastatic eight years ago, the woman who did my intake to the MetsintheCity support group was doing something similar. She hadn't found a treatment that worked so she was doing something where they took some of her tumor and put them in mice, then tested various therapies on the mice. Sadly, she died soon after. Not sure if she was able to get the mouse info in time to try a treatment indicated from the results. Must have been the Nagourney Institute since it was in California. Checked out the site and they don't mention mice anywhere so maybe they moved on to a synthetic environment.
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In the past, I used CEA as my tumor market but my MO stopped it because it didn't seem to be working. Recently started using CA 15-2 and CA 27-29. Received my CA 27-29 result yesterday and I was pleasantly surprised. Tracks my progression on Gem/Carbo and my mixed but overall positive response to Eribulin. The last two points are since I started ARX-788. Green lines are "normal".
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Wow, Susan, that's fantastic. Pretty dramatic -- something must be going right!
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wow susan awesome!!!
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that’s great Susan. I might get in touch. We will see what Wednesday brings.
I sm having brain surgery Wednesday to remove a cyst they have been watching for a year. It continues to grow and they can’t really treat it with radiation as it’s in sm area that has been treated twice. It could becradiation damage but my RO doesn’t think so. Guess I’ll find out.
I haven’t met with oncologist yet. Haven’t heard from them in fact. My RO was the one who looked at my zpET scan from Wednesday to see if there was any other cancer causing any problems. I was stable from head down.
So I’m off for surgery on Wednesday. I’m told it’s a simple surgery and I might be home on Thursday.
Here is hoping to get good results. It’s been 7 years since my last brain surgery and that showed necrosis not new cancer. I eoiuld love to hear that again.
Take care everyone. I might scan things in the days to come but likely won’t respond.
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Good luck, Left Foot Forward. Here's praying that this is necrosis or some sort of an artifact and that you will be in and out of the hospital quickly.
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Wiyou all the best , LFF. Hope you will be in your own comfy bed quickly!
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