Are you currently (or have you been) in a Clinical Trial?
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Lumpie,
Wow, this is the first time I've heard anyone say that you had to "pay" to get into a clinical trial. And it seems like LFF is corroborating that. How the heck does that happen? That automatically excludes people who can't cough up the cash, too. So wrong on so many levels.
Regarding NIH -- I did send an email to them a while back about their CAR-T trials. I can't remember the exact correspondence, but my memory says that when I contacted the "contact" person on that trial, she wrote back to me with info about sending medical records, etc. but said nothing about "we will figure out which trial you qualify for." Maybe it's a distinction without a difference but did you contact the "contact" person? This one was in Dr. Steven Rosenberg's lab - who has been doing the CAR-T research for ever.
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Update: right after I wrote this email, I got a response about a clinical trial being done at Mercy Hospital in Baltimore for one of the oral SERDs (thanks for reminding me about them, Cure-ious!) -- the EMERALD trial.
They sent me the consent letter to look at (although I probably won't do this trial) and in the letter, it says that THEY pay YOU for each "study visit" to defray any expenses that you may have in getting there for the study visit -- $60 per visit. I haven't read many consents, so this, too, was a surprise to me.
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it could also have been an insurance thing snd location thing for me. The trial was out of state and so the insurance coverage changes. I have better insurance now but don’t know what would have been covered initially to get into the trial.,
mince I was in the trial, the trial paid to see the doctors and for the medicine. My insurance paid for screening CT snd for my infusion drug.I was surprised by the way it was broken down. Of course I didn’t really pay attention at first because all I wanted was access to the first drug.
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This is so curious. I thought that everything either fell under usual care, which insurance pays for, or trial stuff, which the sponsor pays for. Lumpie, would you tell me the details about the fee — what trial, where, etc? PM me if you prefer. I’m not saying anyone is wrong, just trying to learn more about this.
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I think the initial visit to the trial site/care team is considered a consult. I am unsure if insurance pays for consults in every case.
I only have one trisl to reference snd the insurance policy I had at the time. There are probably different combinations of coverage depending on those two factors.
I will clarify that I believe ever received some money back from our insurance company after the fact. I had to pay however before. I could even see the trial doctor. I had not officially been accepted into the trial riot to seeing her. I also had to get my echo done in CA snd not at home because I could not get the results in time for my initial visit with the trial team. They needed that information in order to rile me in/out of the trial.,hence me paying out of pocket for the test.
I BBC am unsure what standard practice is. I was just responding to the initial question as to if this process seemed valid.
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I have been on two clinical trials. The first was at NIH for the Car-T trial with Dr Rosenberg. Everything that is done at NIH is at the government expense. You have no medical expenses at all. I did have to send all my records to them. They then said they wanted to meet with me in person. That is the only trip, stay that I had to pay for. Then they had me come again and had many tests done, including a brain MRI. If you have brain Mets they cannot accept you. I then went back and had a liver biopsy and aphaeresis. Unfortunately, they were not able to grow my cells. And then they tried to genetically enhance my cells, but that also was not successful. So that was it. .
In December I did get in to the sacituzumab govitecan-hziy trial, but was randomized to Halaven. In a hospital setting you have to pay for everything except the trial drug. As far as paying $800-1000 in advance, is that the only expense you would have? Does that cover scans, bloodwork? If not, I would be hesitant
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Lumpie,
I can't say how legitimate your situation is but, like the others, I have never had to pay to be in a trial. In fact, I was paid $50 every time I had an Oncology appointment when I was on the BYLieve trial for Piqray (aka Alpelisib). I have been on three trials, Ibrance dosage trial, Piqray and now Sacituzumab Govitecan.
I think you should go with your gut on this one.
Hugs, Susan
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Cure-ious,
Thanks for posting that link to Hope Rugo's discussion of Sacituzumab Govitecan. I was touched when she expressed her gratitude to the trial participants.
I am in the middle of my 4th cycle and have been doing very well, with one exception. My mouth sores started coming back. I will be going back on oral steroids tomorrow. It was the only thing that worked the last time. She thought that maybe I had become neutropenic so I went in for blood work today. My neutrophlls were 3.25! We can't understand why this is happening again on a totally different treatment. The original hypothesis was that the sores were a delayed immune response to Keytruda exacerbated by Abraxane. My neutrophils have been very high and my energy level has been very good. I did lose most of my hair but, so far, have been able to keep my eyebrows and eyelashes thanks to Latisse. Don't have to worry about having Quarantine hair!
Had my first scans and saw some nice shrinkage of my largest lung tumor and general stability everywhere else. Hope I will get at least the 8 months of PFS seen in the trial.
Stay safe!
Hugs, Susan
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awesome, Susan!! So happy that you are contributing to the good stats of SG, and as it is a chemo (but targeted mostly to cancer cells) of course it would come with hair loss. But to have great energy and hopefully good QOL otherwise is wonderful, Good luck and push those response numbers beyond the current averages..
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Ah, I see what you mean about paying for a consult, LFF, and how insurance coverage could vary. As far as tests for determining eligibility, it sure seems like the trial should pay for those.
Susan, congratulations on stability and shrinkage. The steroids ought to help with the mouth sores. So sorry, those are miserable.
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I would like to post a success story! I enrolled in the SUMMIT trial in February. My April scans were fantastic: Shrinkage on CT w Contrast, and no uptake on PET-CT. My tumor markers plummeted as well, to low normal numbers. My onc and I are very happy.
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As are we ! We love success stories!! Thanks for sharing.
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lumpie
The facility for the clinical trial I am looking at took my insurance for the consult and scans, but it is a physician sponsored trial- not a major pharm company or grant. SO I would have to pay up front $12,000 just to order the medication . My insurance may or may not cover it so I am on the hook for 4 treatments if I do and stay on the trial. Right now I am responding to current treatment so I put this trial in my back pocket, but my hubby is all in to pay for it because it is the only trial that will address the Neuroendocrine features that I could find to consider me.
I also contacted NIH. I think it depends on the department/trial coordinator. One area(CarT) just plain turned me down due to my low IGG but another coordinator asked for me to send my records to a researcher that has a special interest in my Neuroendocrine Breast cancer. They said to report my latest scan and that there may be a trial come open in a few months that I would qualify for.
Hope you get through the maze of trial oddities. It is hard to navigate it Neither of my MO’s are willing or able to do the research that I do to find trials that I qualify for outside their own clinic
Dee
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Shetland Pony. So glad for your success story! Dee
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This article really reasonated with me:
https://www.theatlantic.com/magazine/archive/2020/06/surviving-cancer-coronavirus-pandemic/610594/
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ShetlandPony,
Wooza! That is unbelievable and wonderful news. Make sure you celebrate!
SusaninSF,
Thanks for posting that link. That article resonated with me, too.
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Fantastic news, Shetland!!!
Is this the trial? https://clinicaltrials.gov/ct2/show/NCT01953926
This is a big trial in many cities, including Vancover and many european cities. Did your Foundation One indicate that the cancer has a HER2 mutation, or how did you know that? Now I'm hoping my cancer has a her2 mutation...
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“I Thought Stage IV Cancer Was Bad Enough” is the title of the article. I had wrapped my head around dying way too young, and found some comfort in planning to die at home with my loved ones present, when the time comes. But now the specter of dying alone in a hospital terrifies me.
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Way to go Shetland!!! How did they determine you had the mutation?
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Yes, that's the one, Cure-ious. Both Foundation One and Guardant 360 showed an ERBB2 (Her2) mutation and suggested neratinib. ERBB2 mutations are not uncommon in metastatic ILC.
The longer version: When Ibrance + Letrozole eventually failed, and Faslodex + Afinitor did not work, we did a Guardant 360 genomic test (liquid biopsy), and the ERBB2 mutation showed up. It had not been there on my first Foundation One at mets diagnosis in 2014. It developed in response to treatment, presumably. At that point we considered neratinib but my onc recommended we go with the standard Xeloda, which gave me two years. When that failed we once again did genomic testing. That Guardant 360 showed most previously identified mutations as “not detected". I called Guardant and the scientist explained that the reason could be I had only recently stopped treatment and/or there was not enough tumor volume. Several weeks later we did a re-test and we also were able to do a tissue biopsy for Foundation One. There were three actionable mutations and they showed up on both tests: PIK3CA, BRCA (somatic not germline), and ERBB2. My onc believed ERBB2 was the driver. According to my research it was the likely explanation for the cancer being resistant to endocrine therapy. We actually got neratinib approved by insurance, but I liked the idea of using Faslodex with it so the cancer could not switch to being estrogen-driven, and my onc liked how closely they watch you when you are in a trial. There may have been more she wasn't saying, but she was so enthusiastic about the trial, I figured I should go with it. She was so excited to talk about my case at tumor board when we got the scan results.
Thanks, everyone for the congratulations!
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Shetlandpony, so happy for you. I am cut and pasting this info..even thou I am IDC.
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Shetlandpony, your news has made my night. Soo happy for you
Kathy
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Checking on some recent studies, most Her2 mutations are not there in the primary tumor but develop as a mechanism of becoming resistant to endocrine therapy. They are not super-common even in lobular cancers (5%), so Shetland you are one Lucky Pony!!! Also apparently Piqray or mTOR inhibitors would also supposedly be good for blocking these Her2 mutant cancers, however note that Affinitor (mTOR inhibitor) did not work for Shetland, at least not if you don't also block HER2.The data here would say you have to block ER and HER2, and then might see some benefit on top of that by adding in Piqray or Affinitor. However the other approach would be to instead add in more Her2 inhibitors (for example, Shetland is taking both Herceptin and Neratinib)
A 2019 paper (link below) says: "Up to now, the only mechanisms of antiestrogen resistance that are supported in the clinic are HER2 amplification, mutations in the ligand-binding domain (LBD) of ESR1, and dysregulation of the CDK4/6 pathway...ERBB2 missense mutations have been found in approximately 2% to 4% of breast cancers, occurring with higher frequency in metastatic tumors...approximately 70% of these occur in ER+ breast cancers. The paper shows you need to block both ER and HER2 in these cancers ..
https://clincancerres.aacrjournals.org/content/25/...
So bottom line is upon endocrine resistance, be sure to check to see if the tumor acquired HER2 mutation (or of course HER2 amplification to HER2+++)
PS And here is a paper from Feb 2020 about the SUMMIT trial: https://cancerdiscovery.aacrjournals.org/content/1...
They say: "Somatic mutations in HER2 (also known as ERBB2) occur in approximately 3% of breast cancers, predominantly in the hormone receptor–positive (HR+) HER2-negative (HER2−, nonamplified) subtype. These mutations are further enriched in patients with lobular histology, where the rate may be as high as 10%.
They got several complete and partial responses (NED, shrinking) and the majority of patients at the least got stable disease. The paper says the trial is now going to try adding in other Her2 inhibitors into the mix, very exciting!!
Finally, both papers say the cancers that develop the Her2 mutations after endocrine therapy and were not there in the primary (as in Shetand's case) are the best responders to the therapy, and they are researching for biomarkers to understand why
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Thanks, Sandi and Kathy. Yes, a lucky unlucky pony.
Also note that the SUMMIT trial accepts either ERBB2 or a mutation in the related EGFR Exon 18.
Cure-ious, with that link to the Feb 2020 paper, you have provided an answer to the question that has puzzled me since I first considered the trial: Why does it include Herceptin (trastuzumab)?
It says
“ Integrated genomic analysis suggests that concurrent genomic events in HER2 and HER3 at baseline and progression may confer resistance to HER2 kinase inhibition. This finding provides a potential rationale for the combination of multiple HER2 inhibitors in HER2-mutant breast cancer, a therapeutic strategy that has already proved highly effective in HER2-amplified breast cancer (37). To address this strategy, the SUMMIT trial has recently been amended to explore dual HER2 targeting with the combination of neratinib plus trastuzumab (plus fulvestrant in HR+ disease) in patients with HER2-mutant breast cancer.“
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happy dance for Shetland pony, Alabama Dee and Susan SF.
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AlabamaDee, I’m so glad you have found a researcher with an interest in neuroendocrine breast cancer, and a possible trial. It has frustrated me how understudied ILC is (Though it is finally starting to get some attention.) It must be so hard to have a rare type.
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Shetland: I thought "red flag" too. It wasn't on a website. I actually talked with someone - one of the clinical coordinators - on the phone. And she is on-site, not a middleman. And no, not CTCA! They actually have a large and active charitable fundraising arm. She did call me back and that time she said... well, maybe there was a way they could work around that charge. I always heard that they generally had trouble getting enough people for clinical trials so I was kind of surprised.
Leftfoot: yes, I think that this would basically be that... the before admission to the trial stuff. I was talking with a friend in a different field of medicine who said much the same thing: that there can be lots of upfront work to get someone on-boarded and those costs never really get made up. I suppose that is true... and I don't know all the details of clinical trial "economics"... but it still seems pretty brutal to stick up poor patients with the cost.
On situation #2, I guess I will just see if my MO thinks we should pursue that. I worry about washout periods. My tumor has more than doubled in size in the last @ 1 month and I feel like I need to get on something STAT. The bigger it gets, thee harder it is to (hopefully) recover. And with my labs getting worse and worse, I worry that they will not put me on anything. Why do they leave us hanging for weeks??? This seems to be common practice. It's really frustrating.
I just flipped pages.... BevJen... yes, I contacted the point of contact person at NIH for the trial. She is the one who told me that.
Yes, ditto what leftfoot says. It the trial site is out of network but you are not yet in the trial, you are in payment la-la land. So they may tell you you have to pay out of pocket for that consult and certain screening. In general, once you are in the trial, assuming your insurance consents, then insurance pays for routine care and the trial pays for the drugs and certain other trial-specific costs. My impression is that as a practical matter, often there may be a combination of insurance and non-profit funding to cover the cost of the upfront process of getting you screened and admitted to the trial... because they need people. But this is not always the case and you (as the patient) may get stuck with some of those costs.
ShetlandPony: I PM'ed you.
The other trial I was on reimbursed me my co-pay for visits at the trial site, which was nice.
ShetlandPont: Congrats, that is great news.
Dee: True - I pretty much do my own research re trials. My MO has a lot on her plate and my 2nd opinion doc gives me trial suggestions sometimes. Hope you find just the right trial.
Love the article. But it would be much more exciting, not to mention glamorous, to be a war correspondent or a spy. I can't help feeling cheated. I imagine it's apparent to all of us by now that our welfare is for sale. This is just one more instance. (Who, me? Jaded? no!)
The trial is PRS-343 in HER2-Positive Solid Tumors NCT03330561. The question about Foundation One may have been for Shetland, but mine was strongly HER2+ via IHC. I did not have Foundation One, I had Strata. Different brand, similar test. But there was not enough liver so they did the genomic test on the excised breast lesion.
That's interesting. I had ERBB2 amplification and they only recommended pertuzumab. (I am ER/PR-.)
The CAR-T trails looked like they required a 4 week hospital stay. That sounds awful. I should probably search to see how people are doing on those trials.
Shetland, I am going to check out your trial. It did not show up on my search, probably because of location. It sounds promising.
Cure-ious: Thx for your post. I am scratching my head. I have ERBB2 amplification that is not ER+ and not lobular. It sounds like that is rare.
Sorry this is piecemeal. Everyone has offered such great thoughts. Thank you.
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Hi Lumpie, I’ve been following on this thread and while I can’t offer any insights on the clinical trial issues as I haven’t gone that route yet. But I noticed that you and I do have some similar characteristics to our cancers (ER/PR- and strongly HER2+). Given your HER2+ status, I presume you’ve had already Kadcyla? If not, I’d have thought that would be high on your list. If so, what about Enhertu? That’s the DS-8201 name now that it’s approved, right? I know you are aware since you maintain that research thread. Well, just wondered what happened with those drugs for you. I had a pretty good run on Kadcyla - about two years - albeit with some SBRT along the way to deal with minor progressions. I also had a fantastic response to Taxol and Abraxane Early on along with HP of course that stopped things when they were growing quickly. If it’s growing fast, might it be time for chemo? In any case, I hope you find the right treatment be it a trial or otherwise. Would be interested to hear what you decide. All the best! -M.
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Lumpie, the reason my trial did not show up in your research is that it is not for HER2/ERBB2 amplified (HER2 positive, HER2+) but rather for HER2 negative (HER2-) with a mutation in the HER2/ERBB2 gene. That is a very important distinction and not one people are used to making, partly because these mutations are not very common in breast cancer.
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MargaritaMS: Yes, I had Kadcyla. Interestingly, I had it on the Enhertu trial - I was randomized to Kadcyla. Unfortunately, it quit working pretty quickly. They will not let you switch arms in that trial. Not sure what drug I will get next. Might be Enhertu. It did get expedited approval - I believe that happened in Dec 2019. Way back when my Tx for stage 4 got started, it was a bit of a soap opera ... I'll spare you the details, just suffice it to say that it took them a long time to figure out that those tumors in my liver were not benign!... I had an excellent response to taxotere. My MO mumbled something about giving me a chemo drug, not sure whether she meant taxotere or something else. I have a biopsy tomorrow because they are not even sure we are dealing with only MBC anymore. They need to make sure part of it is not cholangiocarcinoma. And I have this one persistent (evidently MBC) lesion they tried to ablate last year, couldn't get to but may try again....if it doesn't get too big.... So once we know for sure what cancer(s) I have and whether or not it can be ablated, then we will figure out the chemotherapeutics. I will keep you posted.
Shetland Pony: OK, interesting. I will have to keep an eye out for results/info and/or do more reading on that study. Thanks for sharing that.
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