Are you currently (or have you been) in a Clinical Trial?
Comments
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Cure-ious: I just had FoundationOne test done after progression in my right primary tumor. My tumor markers are jumping. It came back with not alot of options and I was disappointed that nothing was indicated for immunotherapy that I could see. Amplification of CCND1(which doesn't sound good) recommended trying Verzenio. My insusrance co. denied coverage since I had been on Ibrance previously which failed after two years. MY onc. pushed to get Lily to cover it anyway and they're sending it out tommorrow. So I'll try that and if doesn't do anything she's talked about Halaven. My cancer changed from ER+PR+ HER- to ER+PR-HER-. I noticed that your cancer also changed to PR-. Was that a big worry for you and how did you feel it affected what treatments were good for you? It worried me in my case since my cancer now seems to be more aggressive and tumor markers are higher than ever. Appreciate your insight.
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Hi Elenas,
What mutants did the Foundation One report find? I only got four, and none were associated with any actionable treatment. That the SF3B1 mutation would make me a possible candidate for immunotherapy was just something that I bumped into, when searching for clinical trials.
I like Verzenio and am glad they are shipping it! Will you take it as monotherapy? Luce did that, and I think she got two years or so, it was a long time. It also gives you some time to research clinical trials before moving to chemo (unless the situation is urgent on progression). The real question of course is why the cancer is able to escape the endocrine therapy, but most of the time the tests just don't pick up the reason. What I really dislike are all these insurance "rules", compounded with the fact that some doctors (including mine) base their decisions on what they THINK the insurance will approve, which can mess with what we want to do. We all have thought long and hard about what to try after the next progression, and then doctors, insurance, or clinical trial rules throw us some roadblocks, its really not OK. Some trials exclude patients who have had chemo, or more than two chemos, so you want to have your next steps in mind in advance.
PS I did worry when my primary tumor switched from the PR+ to PR- in the metastatic setting, because the PR gene can be turned on by ER, so when PR goes low, it is sometimes due to low activity of the ER. However, I've had a long time on endocrine therapy, coming up on six years, so clearly it worked despite the PR-negative status- I since read that other types of signaling can shut off the PR gene, so it does not necessarily mean anything about ER activity or aggressiveness. Originally HER2-positive cancers were one of the scariest, until they came up with potent treatments and now its got the best survival, and all of our cancers are that way, not really a question of how intrinsically aggressive are they as much as do we have the right therapy for them and the right biomarkers to tell us what to try.
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Just checked my FoundationOne report, and sadly I don't have the SF3B1 mutation either!
It's been a point of frustration of mine that I don't really have many (or any) good "actionable" mutations. I know that's not uncommon. In my case I have some of FGFR stuff that is somewhat actionable, but there's not a whole lot of good stuff going on in the FGFR area, in my opinion. Those trials are still very early phase and have questionable effectiveness, safety, and tolerability. I just don't think my cancer will wait around while I try something like that.
Sigh. I want that magic bullet already. For all of us!0 -
Several points in this discussion are resonating with me at the moment. I’m coming off six cycles of Xeloda and while it was very effective (complete reversal of one lesion and second lesion greatly reduced) my MO does not want me to continue. Still trying to understand the rationale and will be reaching out to him with questions. I really like my MO but one area of friction is the issue of genomic testing. He did recently jump at the chance to get a ctDNA test but is very resistant to biopsies. He doesn’t feel these tests show actionable mutations the majority of the time and his experience is that they point to treatments he would try regardless. I know he is concerned about the risks with biopsies and, until recently, there was nothing easily biopsied anyway. Unfortunately the ctDNA test came up empty but, in my mind, that does not preclude us from looking at tissue as it’s my understanding the ctDNA can be hit or miss. It’s frustrating.
The other issue that I am grappling with is the barriers to treatment related to approvals. My MO believes I am now endocrine resistant and doesn’t feel I will benefit from additional hormone treatment. He has prescribed Aromasin, which he wants me to take in a few weeks when I have recovered from Xeloda. I wanted to add Afinitor but he said he didn’t think we would get approval as I have been on Ibrance and Verzenio. Say what? I’m positive it’s a cost thing as I haven’t seen any clinical guidelines indicating that we should not have more than one targeted therapy. I’m going to push as neither of the CDK inhibitors were funded by the agency but we shouldn’t have to fight for treatments.
Sorry this is a bit off topic. I watch this thread but clinical trials are few and far between in Canada.
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Saddieservant, if he thinks you are endocrine resistant, why is he prescribing aromasin?
There was an Italian study that suggested that melatonin could reverse endocrine resistance.
We face a similar situation in Manitoba, in that the province won't permit more than one targeted therapy for a patient's lifetime. It has to be cost related. Our argument would be similar to yours, in that my wife's insurance company plus the drug maker paid for the drug, not the public dime.
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Thanks Husband. I think he was humouring me with the Aromasin to be honest. When he said “no treatment” following my six cycles of Xeloda I mentioned that he previously thought we would try Aromasin. I suspect he thinks it won’t hurt to try but I don’t want to throw it away if it’s my only shot at Afinitor. Who knows if I would even tolerate it though. Ibrance totally wiped out my red blood cells.
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Sadie..my MO allowed me to go back to endocrine therapy after I failed Ibrance/Let/Faslodex after 4 months..worked for 3 months failed month 4...we circled back bc there are studies showing if you go to chemo sometimes after that if you circle back...endocrine therapy can work... While I do not believe it is working for me (my spine mets still hurt) we are trying it anyway..to be fair...I was on the 2.5mg for 2 weeks..then 5.mg for a month and now the 7.5 for almost a month...or 3 weeks...
Husband ...well thanks for that...you just made me decide to restart the melatonin
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interesting trial in Maryland and D.C. for those who progressed on CDK4/6 inhibitors
https://clinicaltrials.gov/ct2/show/NCT04720664
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Saddieservant - I don't see why your doctor wants you off of Xeloda if it’s still working for you. It worked 9 months for me and my onc and I were both bummed it did not work longer. If you may face insurance issues in the future, more the reason to stay on Xeloda as long as possible. Maybe consider reducing dosage if you are having bad side effects until you see progression. Also, as mentioned, the break from a hormonal while on Xeloda may allow a future hormonal blocker to work for you again - it did for me. Can you get a second opinion? ~Kar
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Hi Luce- Great to "see" you, how is it going?!!
Interesting find!! They are looking to bring in a cancer-killing metabolic drug that could be used before chemo. The phase 2 OASIS trial will examine the effects of a tyrosine (amino acid) derivative that cannot be metabolized in the cancer cells, and therefore blocks protein translation as well as autophagy, killing cancer cells - normal cells do not take up the drug, so there are far fewer side effects than chemos. They say that in the initial studies of SM-88, there were encouraging tumor responses in HR+/HER2- patients, including complete responses or complete resolution of the tumor. The trial is not yet recruiting but will open up in the fall...
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sadiesservant- I don't see Faslodex in your list of meds. If you are endocrine resistant (esr1 on the NGS) then aromasin won't be much help but Faslodex may a little.
Afinitor and Aromasin or Faslodex (with esr1) combo is recommended after progressing on a cdk 4/6 plus AI many prominent oncologists including my clinical trial doc who is a research rockstar but most say test for the PIK3CA first!
FYI- I have had 6 liver biopsies in 2 years- they are not fun but quite manageable. Can you push for a tissue biopsy for an NGS? I had 2 liquid biopsies with no results. I hope you get some peace about moving forward. You don't seem to be NED so staying on a systemic seems like s good idea. Maybe just a short break to give your body a break. Get answers and get peace.
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Hi Dee.
Thanks for this. I was on Faslodex for three years. I layered on Verzenio once it became available in Canada. At this point, no, not NED but, to cut my MO some slack, I THINK that he is trying to buy me time by hitting it hard and then backing off. I suspect his experience is telling him that if I stay on chemo I will become resistant that much faster. But I’m guessing and that’s why a follow up conversation is in order. I was hoping the ctDNA test would point me to Alpelisib but not sure what they would do given that I was on Faslodex for such a long time.
Biopsies are trickier to get her, particularly during COVID. This may be where a second opinion comes, as my MO is going on a research sabbatical for six months as of August. But in the mean time, based on what you have provided, it looks like A/A might be the way to go, although Afinitor scares me a bit!
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Sadie..I am hearing good things about rotating...in other words..hit hard with a chemo and then stop (before it stops working) circle back to endocrine therapy ...then back to chemo...etc...
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Sadie, That's an interesting idea, to drop chemo before the cancer has a chance to mutate and become resistant...
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Sadie- Afinitor is really expensive ( was much more than ibrance) but, I heard that there is a generic now. Supposedly afinitor makes you sensitive to AIs again. I took it with few side effects- but, that may not be the norm.
Hi Luce- I second cure-ious in saying nice to see you
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Thx Nkb,
Yes, I looked it up and was shocked at the price in the US but they do have a generic that they use here. Novartis’ Afinitor is not covered. It was also my understanding that it could resensitize the cancer to endocrine treatments which is why I will push. Having said that, my MO may prefer me to wait until I have been of hormone treatments for a while longer.
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Trial update cross posting from liver mets thread.
Still stable disease! 8 weeks until next scan and plan. 🙌🏻🎉🎀 I'm so grateful for a drug that is halting progression.
One tumor in left lobe is 5mm smaller. The oblong tumor in the right lobe is 3 mm larger in the smaller dimension. So great news considering before this drug they were both growing fairly fast.
Blood work is pretty good. Mag is finally staying in the normal range. Slightly low wbc, RBC, platelets and ANC but liver enzymes are absolutely normal on the drug. Whooohooo!
The PA said I need to enjoy the good report!
Dee
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Dee,
This is such wonderful news! So happy for you!
Hugs, Susan
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Fabulous news Dee!! yes, enjoy the moment indeed!
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Dee - Yay! Stable is always good news but to have a reduction in tumor size is amazing.
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Fabulous news, Dee!
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Cure...and all...I am so disappointed.... Cure you said :
"Interesting find!! They are looking to bring in a cancer-killing metabolic drug that could be used before chemo. The phase 2 OASIS trial will examine the effects of a tyrosine (amino acid) derivative that cannot be metabolized in the cancer cells, and therefore blocks protein translation as well as autophagy, killing cancer cells - normal cells do not take up the drug, so there are far fewer side effects than chemos. They say that in the initial studies of SM-88, there were encouraging tumor responses in HR+/HER2- patients, including complete responses or complete resolution of the tumor. The trial is not yet recruiting but will open up in the fall...Interesting find!! They are looking to bring in a cancer-killing metabolic drug that could be used before chemo. The phase 2 OASIS trial will examine the effects of a tyrosine (amino acid) derivative that cannot be metabolized in the cancer cells, and therefore blocks protein translation as well as autophagy, killing cancer cells - normal cells do not take up the drug, so there are far fewer side effects than chemos. They say that in the initial studies of SM-88, there were encouraging tumor responses in HR+/HER2- patients, including complete responses or complete resolution of the tumor. The trial is not yet recruiting but will open up in the fall..."
My MO looked at this for me and today we discussed...I wont qualify (and she said it would have been a great fit for me) bc I have had 5 lines of treatment...you can only have had...4
I am really so sad.
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Cure...and all...I am so disappointed.... Cure you said :
"Interesting find!! They are looking to bring in a cancer-killing metabolic drug that could be used before chemo. The phase 2 OASIS trial will examine the effects of a tyrosine (amino acid) derivative that cannot be metabolized in the cancer cells, and therefore blocks protein translation as well as autophagy, killing cancer cells - normal cells do not take up the drug, so there are far fewer side effects than chemos. They say that in the initial studies of SM-88, there were encouraging tumor responses in HR+/HER2- patients, including complete responses or complete resolution of the tumor. The trial is not yet recruiting but will open up in the fall...Interesting find!! They are looking to bring in a cancer-killing metabolic drug that could be used before chemo. The phase 2 OASIS trial will examine the effects of a tyrosine (amino acid) derivative that cannot be metabolized in the cancer cells, and therefore blocks protein translation as well as autophagy, killing cancer cells - normal cells do not take up the drug, so there are far fewer side effects than chemos. They say that in the initial studies of SM-88, there were encouraging tumor responses in HR+/HER2- patients, including complete responses or complete resolution of the tumor. The trial is not yet recruiting but will open up in the fall..."
My MO looked at this for me and today we discussed...I wont qualify (and she said it would have been a great fit for me) bc I have had 5 lines of treatment...you can only have had...4
I am really so sad.
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Nicole, I assume most of us can only have a few trials, at most, because of all the time they take and all of their exclusions. But can you get this at some point as compassionate use? When they are successful they usually move to earlier stage where their numbers will look better, but there must be a strategy in place for everyone else who has not tried it to have access to the drug? Once FDA approved, everybody has access, so compassionate use must be for this type of situation?
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Nicole, when the trial opens, contact the investigator.
From what I remember of other studies, the line of failed treatments are those that mets were proven to grow.
Didn't you have at least one treatment that the side effects were too harsh and you had to move on?
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How to keep the Natural Killer Cells active and suppressing mets?
Apparently these cells, like T cells, are boosted by TIGIT antibodies..
https://www.curetoday.com/view/immunotherapy-optio...
Below is a detailed review showing how the anti-TIGIT antibodies make checkpoint inhibitors work better..
https://www.targetedonc.com/view/anti-tigit-and-ic...
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A recent paper in Nature Comm, researchers at McGill (Canada) found that most TNBC is driven by a combination of two pathways: 1) activated mTOR signaling, and 2) loss of the HIPPO tumor suppressor pathway. So they tried combining two existing drugs, an mTOR inhibitor called TORIN1 and an inducer of HIPPO signaling called verteporfin. Surprisingly the combination was way better than either drug alone- it turns out that both drugs induce cell death, but by different means- plus the TORIN1 caused the cells to take up a lot more of the verteporfin drug. The results look so good they hope to start clinical trials for firstline treatment for TNBC. Could work well on other breast cancer subtypes too..
https://www.futurity.org/triple-negative-breast-ca...
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Hi, I saw the following today.
The FDA issued a draft guidance encouraging industry to allow more patients with incurable cancers to participate in oncology trials, regardless of their past treatment history.
"The FDA believes patients with incurable cancers, if provided adequate information to make an informed decision, should be eligible to participate in oncology clinical trials," said Richard Pazdur, MD, director of the FDA's Oncology Center of Excellence, in a statement. "If there is no scientific rationale for excluding these patients, then clinical trial eligibility criteria should be broadened to include these patients, with appropriate informed consent."
Pazdur pointed out that many clinical trials have required participating patients to have previously received multiple therapies. This draft guidance encourages the clinical trials industry to include patients with incurable cancers "regardless of whether they have received existing alternative treatment options," he explained.
"When planning cancer clinical trials in the non-curative setting, sponsors should consider eligibility criteria as it pertains to available therapy. FDA encourages sponsors to discuss their drug development plan with FDA early in development, including their approach to available therapy when developing eligibility criteria," the draft guidance noted.
The draft guidance suggests that patients be allowed into trials of investigational drugs -- including first-in-human trials -- regardless of whether they have received available therapy in the non-curative setting, with appropriate informed consent clearly stating "that other treatment options known to confer clinical benefit exist, and should include discussion of possible benefits, risks, and uncertainties associated with the drug."
The FDA also recommended that patients who have received available therapies be evaluated in separate cohorts from those who have not, "particularly if interpretation of efficacy results requires a homogenous patient population." Sponsors can also conduct efficacy analyses using prespecified subgroup analyses "defined by prior receipt of available therapy(ies)."
This draft guidance is part of the FDA's broader initiative to encourage rational expanded patient eligibility for oncology clinical trials.
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So what exactly is a "DRAFT GUIDANCE".???? Is this something we can do now...or its just something they are suggestion we should be allowed to do ....bc if it's the latter that could take YEARS....
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Kar-PC that sounds like it could be a major fix to stupid trial exclusions and take some of the stress out of getting into a trial- if only now they could allow us to get the drugs from our own MOs and participate in trials virtually, to the extent possible
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