Are you currently (or have you been) in a Clinical Trial?
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Wow, wow, wow. Ok I will look into this carefully, Cure-ious, and discuss it with my onc. Thank you so much.
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Does that "MMRD" for case 222 in the upper right stand for mismatch repair deficiency? Because I have a mismatch repair deficiency in the germline MSH6 mutation...
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Yes, and normally that alone would be considered an indication to try immunotherapy and PARPi, but you can see how much stronger the case is if you also have a CDK12 mutation. In addition, CDK12 is needed for BRCA1 expression, so your cancer may also be BRCA-deficient, but we and others showed these cancer cells are much more defective than BRCA cells for mitosis. That's why I think you may be more interested to try PARP-IO before drugs like crizotinib that we don't know much about
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ShetlandPony, I too have a CDK12 loss of function per Guardant360 in December 2020, as well as in my tumor tissue DNA sequencing at diagnosis in 2019. I noticed the Guardant360 report says “the CDK12 mutation detected in all Guardant360 test is of germline”. Did your report say that? Look for it on the very last page of the entire report. I thought it’s interesting because does it mean I have both somatic and germline CDK12 loss of function??
Here is a Olaparib and Pembrolizumab trial. I’m interested but couldn’t find an opening at a location that’s near me. Don’t know where you are located but I think it’s a strong trial. https://clinicaltrials.gov/ct2/show/NCT04123366
This trial is Olaparib with or without atezolizumab, and it’s ending this month. It’s not limited to patient with HRR pathway mutations. https://clinicaltrials.gov/ct2/show/NCT02849496
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Cure-ious, I have a question for you if you don’t mind. How do you measure TILs in tumors? I have read in many papers that agree the level of TILs is a better indicator for immunotherapy but I wonder why it’s not done in our biopsy tests? Do you count these TILs under a microscope in tumor tissues? Or can you see and count them in CT films? I want to know my TIL level but where can I have it done?
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Hi all!
I'm on a trial with Tomivosertib & Abraxane (weekly for 3 weeks, then a week off) I am having terrible SOB on exertion of any kind and just don't feel well at all. MO doesn't seem terribly concerned about it and the chemo RN last week kind of indicated that this is how it is.
I changed taking tomivosertib from lunchtime to after dinner to see if that helped, but I think it's probably the Abraxane. I know the RN said my platelets were somewhat low (100) so not low enough for a transfusion & I have had anemia my whole life.
I can't just sit around all day, feeling like crap, maybe a couple of days but this is ridiculous. Any thoughts? tricks? tips?
thanks! cheers, dee
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GG27, that sounds horrrible. Sorry you're feeling so crappy. how is your SPO2? When I had SOB on exertion and then eventually a bit at rest, it was due to pneumonitis and a tiny effusion. I'd think if it doesn't improve, maybe consider a repeat CT or at least a quick chest xray?
Air here is horrible the last couple days & now today with the frigging smoke, it's insane. Could it be that?
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Hi Moth,
The air quality here on the island isn't too bad yet today but the heat is certainly making it worse as I have never been good in the heat, give me a nice 21C & I'm a happy girl.
MO gave me a chest xray a couple of weeks ago because I had severe chest pains but turned out to be nothing, probably caused by extreme coughing due to acid reflux caused by trial drug. A SE of a SE if you will.
This SOB has only cropped up in the last 10 days or so. Someone else suggested i ask to get my iron checked which I will do. cheers, dee
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Dee - I have been on Abraxane for 21 months. I’ve had two dose reductions primarily due to neuropathy. Noticed after the reductions I felt better in all ways. Not sure what the trial protocol for dose reduction might be, but if you think the SOB is due to Abraxane, perhaps dose reduction might help your blood counts stay a bit higher.
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Moissy,
Are you on weekly Abraxane or every 3 weeks? I didn't know they could dose reduce, that's good to know!! Who knows what the trial protocols are, they seem to change their minds with the wind. They wouldn't let me take an acid reducer even tho I had esophagus damage from the drug, but then they relented and said, yes. All these tips are great. I need to get to the bottom of this. cheer, dee
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Dee - I'm on weekly Abraxane, 3 weeks on and one week off. When I was on a previous trial of another drug, it seemed that the trial onc had some discretion to dose reduce or pause meds if deemed necessary even if it did not exactly follow the trial protocol. I'm sure the trials are all handled differently, but you should not have to just endure feeling badly if it's not necessary. Good luck!
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Figtree, That is a great idea- I would love to know my TILs status as well... I have no idea how those are assessed, would love to hear from anyone who has some insight!! It must not be simple or they would use this instead of biomarkers to decide who should get immunotherapy
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I asked my MO if we go to Abraxane can we do 2 weeks on 1 off..she said yes.
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Cure-ious, and others who are interested in TILs, I got a PM from someone (a husband of an earlier stage BC patient who doesn’t post here) who shared some great info about TILs with me. I’m passing these along. Apparently any pathology labs should be able to assess TILs. https://www.annalsofoncology.org/article/S0923-7534(21)02185-2/fulltext
https://www.tilsinbreastcancer.org/
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TILs are one of those things I'm not rushing out to test because it doesn't open anything new to me (in the mTNBC setting) and might just tell me that what I'm on isn't going to work anyway - eeek, I don't want to hear that. I can't change my TILs and so then the information for me would not be clinically actionable. Is it clinically actionable for ER+ pts?
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Moth, My cancer has an SF3B1 mutation, indicating there should be high TILs despite low TMB and agnostic about PDL1 levels. It would be nice to be able to confirm the TILs are high, but then I guess one would be left trying to petition a clinical trial designed for mTNBC patients. There is a trial that would approve IO for me after progression, but I wouldn't want to take it as monotherapy...
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Hello fonts of research wisdom. Does anyone know much about the Tapistry Trial (https://clinicaltrials.gov/ct2/show/NCT04589845) - it seems one of these new-style, massive basket trials aimed at mutations and not tumour type. I have a friend who is Stage 4 ER+ BC, and has had aggressive progression on every treatment - hormone therapy, CDK4/6, and three types of chemo. She is really despairing - but NGS says she has a high TMB (I think about 15!) and a PI3Kca mutation. She is in the UK so cannot access Piqray.
Tapistry has an arm with an experimental PI3KCA treatment (inavolisib) and a separate arm with Atezo for high TMB. So it could allow her to try these different approaches to the cancer. But I wonder if there would be better options? Any thoughts appreciated!
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Phet, I don't know what else is available in the UK- there is the MORPHEUS trial where she could get the PI3K inhibitor Ipatasertib together with Atezo, but the only sites outside the US are in Israel and South Korea:
https://clinicaltrials.gov/ct2/show/NCT03280563
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Hello Phet,
Your friend can ask for a second opinion from the first cancer center in Europe (according to me, it’s free of charge contrary to the request of an appointment).
https://www.gustaveroussy.fr/en/international-patients
I am surely wrong but I thought that with the Pi3k mutation, faslodex/fulvestrant could still work, did she tried?
Pikray is available in France.
Keep us informed.
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Hey Cure, I keep seeing quite a bit pop up regarding treatments for BRCA+ cancers - from an older article about an old antibiotic that was shown to have benefits and now POLQ inhibitors?
https://www.icr.ac.uk/news-features/news-archive/n...
Scientists have identified a new class of targeted cancer drugs that offer the potential to treat patients whose tumours have faulty copies of the BRCA cancer genes.
The drugs, known as POLQ inhibitors, specifically kill cancer cells with mutations in the BRCA genes while leaving healthy cells unharmed.
And crucially, they can kill cancer cells that have become resistant to PARP inhibitors – an existing treatment for patients with BRCA mutations.
Researchers are already planning to test the new drug class in upcoming clinical trials. If the trials are successful, POLQ inhibitors could enter the clinic as a new approach to treating a range of cancers with BRCA mutations, such as breast, ovarian, pancreatic and prostate cancer.
I only read this as I was checking something for phet - (phet - maybe worth your friend calling Cancer Research UK to see if they can provide some guidance? I know someone on the ward with me in 2019 was on Piqray in a study, but that was some time ago)
ICR has quite a bit of research/big name firepower behind it, so I would definitely expect to see this in trials by end of the year.
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Sondra, I saw that report too, and I agree it sounds so promising!!!
And, I know some of the ICR researchers, best of the best... Everybody knows the PARPi are great drugs, and that they work on many more patients than just those with a BRCA mutantion or even a DNA repair defect, it's just that they don't yet have good biomarkers to indicate who should get them. At this point we all should probably keep this drug on our list until it is clearer who can benefit. Do we even have a thread for PARPi?
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Well, I am off the trial. All my infected lymph nodes have about doubled in size and added a few. At least I didn’t have to do the second dose and today started Gemzar/Carboplatin so I’m hoping it works as we’re starting to scrape the bottom of the barrel of available treatments. I know my doctor has a few things in mind based on mutations but I’d like a good run on this. If anyone is interested this is the trial - it was for skin mets, not a breast cancer trial. https://clinicaltrials.gov/ct2/show/NCT03946800
Libby0 -
Libby
I’m so sorry your trial did not work. I know the feeling. My first trial was a bust for me. Hoping your new treatment knocks the cancer down fir the count. And minimal side effects.
Dee
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I got kicked out of my first snd only trisl as well after 3 months.
Hoping there are options out there for everyone.
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Hi all...I forgot to tell you all ...I found out that not only have I receptor flipped to TNBC but I now know I am AR- Androgen receptor... if anyone has any thoughts let me know..
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What questions should I be asking when considering a clinical trail. In mid-Sept I will meet a DR at a new clinic about 5 hours away. Reviewed history with schedular so she could contact where I have been treated in the past, get biopsy samples, copies of scans etc. There may or may not be any trials for me.
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Nicole- have you talked to your MO and see what drugs are now available and trials you qualify for? I hope the flip opens up more treatment options
BGRS- For me, it was important to be in a phase 2 where you get the drug, not phase 3 where it is random- trial drug vs standard of care or doctors choice. There are other options in phase 3 depending on the trial.
I wanted to know where I would be in the phase 1/2 trials. I did not want to be early in the process of dose escalation, but preferred dose expansion. I asked how many months the longest patient is on the trial.
Actually, I wasn't given many choices. Exclusions and timing of openings are big factors. I did ask how long I had to flush out of current treatment- 4 weeks is common, but some are 2 weeks.
My questions:
- what is the flush out period from current treatment?
- How long will I be completely off treatment before I get the new treatment?
- What is the schedule? Every week, every 2 weeks… long days of bloodwork. Can I get my schedule well in advance to plan transportation?
- Does this trial require a new biopsy, second biopsy during trial?
- How far away is the trialcenter? Will I get reimbursed for hotel, gas, food?
- What is covered by my insurance or the trial(most all routine testing is billed to my insurance so I have to pay deductibles and copays- the drug and certain procedures like the 2nd biopsy are covered by the trial)
- What are the side effects and how are they treated.
- Has anyone died as a direct result of this treatment? How many?
- What are the extra requirements like diaries, food timing (take pills with a meal vs 2 hours after/before), fasting before bloodwork.
- Can you share how others are doing on the trial so far- partial response, stable disease, complete response? What percentage of trial participants are still on the trial?
- (Added) Can I continue to take my current medications for other conditions besides cancer? For example I had to switch my statin for my current trial. What's the procedure for changing medication including OTC during the trial?
hope this helps. I believe that knowing in advance gave me a better picture of what I was signing up to do
Dee
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Dee - what a helpful list of questions! Thanks
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Hi Dee thanks for asking. I have not...I believe we decided we are going to go back to Halaven/Eribulin...since I did very well on it back in OCT- Dec....If it doesn't work we will either go to Trodvely or Abraxane..and also look at trials... the other reason not looking at trial right now...is bc the Tempus FULL testing is not back.. my liver tumor sample was re-tested and supposably was now negative for PDL1 but we are not counting that...since it was positive back in 2019 and after the literature that Moth showed me about liver tumors not showing PDL1 well...we aren't trusting that 100%.
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Well, this is not about breast cancer, but may portend some good news for all of us- a phase 1 trial in lung cancer reporting 2 of 16 patients at FHCRC who got adoptive T-cell therapy using tumor-infiltrating lymphocytes (TILs) remain disease-free 1.5 years later... And these were cancers that had progressed on immunotherapy, lacking PDL1 and with a low TMB, very impressive to get such durable results for lung CA, these may be cures. Reported in Nature Communications....
https://www.medscape.com/viewarticle/957143#vp_2
What about MBC? We haven't really heard much beyond the original write-up in 2018 of Judy Perkins, who had four neoantigens in her cancer be targeted specifically by TILs, at that time she was not quite two years out from treatment:
https://pubmed.ncbi.nlm.nih.gov/29867227/
The current protocols are improved, but it would nice to have some MBC-specific numbers as to success rates
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