Are you currently (or have you been) in a Clinical Trial?
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I forget that each "test" has a cost and insurance may or may not pay or only pay for some. With each blood draw, why not test all, I think. Insurance did dawdle for about 10 days on authorizing a Rx change fro Ibrance/Arimidex to Exemestane/Afinitor.
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Dee So happy for you.!!!!
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Hi all!
I guess I'm back here again! I have been on a number of trials including Palbo, Alpelisib & others, but spent the last year on weekly doxirubicin. My MO is concerned that it's losing it's efficacy & could be damaging my heart even though the muga & echo show it's ok. I do get a lot of SOB mid week which I wonder if it's my heart working harder. My CT showed very minor or no growth but a couple of my bone mets are acting up. Going to radiate those suckers on April 9th!
Anyway, next for me is paclitaxol & tesetaxel. Anyone else done this trial? I probably start in about 4 or 5 weeks as I have my last doxil tomorrow. Then a liver biopsy & who knows what other tests the trial will require.
take care all, cheers, dee
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GG, I hope your MO is staying current on the tesetaxel situation because the manufacturer just announced recently they're jettisoning it & moving everyone currently in trials with it to different medications "According to Odonate, all patients currently receiving tesetaxel as part of a clinical trial will transition to an appropriate alternative therapy"
https://www.targetedonc.com/view/fda-feedback-lead...
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Thank you for this information Moth. She said that she was not familiar with the trial but was going to look into it & call me on Tuesday. I think the fall back was Taxol, so that will probably be the new plan going forward.
cheers, dee
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GG27
Hi! Keep us in the loop. Are you willing to go back to hormonal therapy trials? I am on ARV-471 and it is the first drug to really stop the growth of my tumors. There are several out there right now that look promising
I hope you can get a NGS test in your tumor tissue from the biopsy. It would give you more options knowing your mutations.
FYI- I like your name 😉
AlabamaDee
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So it turns out that the resident working with my MO gave me the wrong name of the trial drug, it is Tomivosertib given along with Paclitaxel. I have all 17 pages of trial information to read before Tuesday. Have any of you heard of this one?
Dee, I am willing to try just about anything, but whether some of these trial drugs are available in Canada or not, who knows, ok well I know now because I just looked it up, not available here. My MO is willing to circle back to hormonals that worked for me before, like tamoxifen which worked for about 5 years. She always likes me to try any trials that come along that I qualify for. (yes, good name!! LOL!)
cheers, dee
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https://www.biospace.com/article/releases/effector...
Dee- your trial is run by Dr. Nahum Sonenberg, who is just absolutely brilliant, I've always admired his research so much- the drug is a new MNK1,2 kinase inhibitor that opens up tumors to the immune system for improved killing by the chemo- Good Luck!!
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Just out- a review of the new anti-estrogen drugs in clinical trials:
https://www.onclive.com/view/a-new-crop-of-er-targ...
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Thank you so much Cure-ious, you always have all this information seemingly right at your fingertips.
My only concern at this point is having to travel 6 hours each way every week for the paclitaxol infusion. I am hoping they will allow that part to be done at my local cancer centre.
i will post any new information i get on Tuesday.
cheers, dee
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Hi GG27/Dee, I know a person in the trial you are considering...I suppose the news that she is still in the trial after 4 months is a good sign. You may be already connected on facebook, but I can PM her to ask if she's willing to chat if you are interested. I hope your appointment went well today.
On my side, I'm still on Verzenio/abemaciclib (I started in December). My energy levels (and blood counts) have plummeted, but discussing with my oncologist we've stayed the course at 150 mg/2x day because, well, the last CT suggests that it is working. Starting abema was pretty rough (and we did reduce the dose from 200) because of diarrhea and cramps, but it's stabilized. A plus side of the pandemic is that I'm usually home and not too far from the loo.
I have also been having heart failure trouble, but that might actually be from before starting abema...tumours in the pericardium seem to have made the old ticker a little stiff. Hopefully they'll continue to shrink.
I'm getting used to my couch potato life and the dog loves her new off leash dog walker.
Heather
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Hi Heather,
Yes, I would love if you could ask your friend if she is having any bad SE's. I was on the alpelisib trial & it was brutal for me so I'm a bit gun shy but probably will do it. They will not let me get taxol near my home, I must travel to Vancouver to get it.
I'm glad you are stable, sounds like the energy levels could be due to the heart issues?? I never got to take Verzenio as I was on Palbo for 30 cycles on a trial & they said if Palbo failed then Verzenio would as well.
take care, cheers, dee
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GG27,
Looks like we were diagnosed Stage IV around the same time.
I was on a Palbo trial for 20 months a few years back. I believe there are some thoughts that being on Alpelisib can allow you to take a CDK 4/6 again. I recently started Abemaciclib + Exemestane and hoping that will work. Definitely harder to tolerate than Palbo + Faslodex. Ribociclib is more resemblant of Palbo than Abemaciclib. The approved combo for Abemaciclib is with Tamoxifen but my MO was worried about the blood clot risk and I've already been on Letrozole, Tamoxifen and Faslodex.
Hugs, Susan
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Hi Susan,
Good to see you! I only tolerated alpelisib for 10 days so I'm not sure if I would qualify to go back on a CDK again but my MO is certainly entertaining the idea of putting me back on tamoxifen. I got 30 cycles out of palbo but then blew through a couple of chemos pretty quick. I've been on so many things that I finally deleted them all on my profile as it was so long. So now I've forgotten what I've been on!
I'm going to try this trial even though the travel might kill me. I started a thread for the trial if you eventually end up on it.
take care, cheers, dee
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my bloodwork has been great on my trial since I started in December, but today it came back with low WBC and platelets and raised Mono%. Good news that liver enzymes are perfect and I’m feeling ok. The PA did not seem concerned at all. My nurse said those lab issues weren’t common in this trial. So we will check the numbers again when I have my scan and plan appointment on the 19th.
This is the first time I have felt hope about a drug since it gave me stable disease after 8 weeks. now I am wondering what is going on with bloodwork. 😞
Dee
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So, AACR, the first big cancer meeting of the year, has started.
Of note, Greenwich is reporting very promising data for early stage Her2-positive and Her2-low breast cancers taking their GP2 peptide immunotherapy, which yielded NO recurrences in five years. They are now starting phase 3. Preventing Stage IV may come first, followed by cure for metastatic disease...
https://greenwichlifesciences.com/clinical-trials/
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In a trial adding immunotherapy to I-F, those patients with the bacteria Gemmiger formicillis in their gut microbiota were the best responders
https://www.abstractsonline.com/pp8/#!/9325/presentation/1529
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In pre-clinical work, the combination of a BET inhibitor and PARP inhibitor had strong activity against endocrine-resistant MBC, and did not depend on whether the cancer had a BRCA mutation
https://www.abstractsonline.com/pp8/#!/9325/presentation/2286
Lots of abstracts on PARP inhibitors. A similar result is reported for PARP inhibitor with a PRMT5 inhibitor, and this combination has entered phase 1 trials
https://www.abstractsonline.com/pp8/#!/9325/presentation/2246
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Curious thanks for all the info (even if I don't understand it all) question the Pre-clinical work , combination of BET inhibitor and PARP Inhibitors that is for HER2- ER+ breast cancers right? > I am thinking it is since is says against endocrine-resistant MBC...
Is any of that in trials anywhere?
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yep, that's right- the PARP inhibitors are known to benefit more than BRCA mutant cancers but the search is still on to clarify the biomarkers that better define which cancers are likely to be responders. It's worth to search existing trials on PARP inhibitors in combination with various different drugs, and some of those won't be breast specific but open to other solid tumors as well so it takes time to search
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Cureious...Ok Got it. Thanks.
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AACR reporting not great results from the Neratinib-Faslodex trial; which is for ER-positive cancers that have mutant (active) Her2 (but are not Her2-positive, which requires amplification of the gene), not enough people responded... Interestingly, the lobular cancers did better, plus they also got a response when trying herceptin on these patients once they had progression, so perhaps this trial will continue in a different way, either including herceptin from the start? and/or limiting it to the lobular cancers?
https://www.onclive.com/view/neratinib-plus-fulves...
But, I think Shetland was one of the winners in this trial, is that right?
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A new driver of endocrine-resistant MBC was recently identified, this happens in about 10% of MBCs overall. The gene, called AAMDC, is part of a region on chromosome 11 that is amplified in the ER-positive IntClust2 subtype. The study found that many of the ER-positive cancers in IntClust2 over-express the AAMDC protein. The IntClust2 subtype is the most aggressive MBC subtype except for the HER2-positive cancers, which top the list. Where there are good treatments for HER2+, there are no specific treatments or even tests for AAMDC cancers- the AAMDC amplification would probably not show up on a Foundation One report because it is not mutated, just expressed more highly.
The AAMDC protein is used by cells to survive under stress, including conditions of low estrogen. Therefore, traditional treaments with anti-estrogen therapy can actually make these tumors grow more.
The study shows that the AAMDC gene turns on PI3K pathway including genes like mTOR, cMyc, CCND1, CCNE, indicating that inhibiting the PI3K and mTOR pathways might restore the cancer to estrogen-dependence. They show these cancers can be inhibited by everolimus-AI or better with a pan-PI3K inhibitor called dactolisib in combination with AI or Faslodex; presumably Piqray would work as well. Therefore Piqray might benefit a larger group that it is currently used for, because now it is just given to treat cancers that have activating PI3K mutations; whereas those cancers that turned on AAMDC have activated PI3K without mutating the gene. But they think there may be better ways to inhibit it, which are just now being studied- clearly they need to develop ways to test for it and to best treat it.
https://www.salon.com/2021/03/31/scientists-have-i...
https://www.scimex.org/newsfeed/gene-found-for-dea...
https://www.euroweeklynews.com/2021/03/30/major-br...
Here is the paper:
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Cure-ious, that AACR report is on the 2 MutHER study (NCT03289039) in which only 40 patients were enrolled. The report has the headline "Neratinib plus fulvestrant fails to meet efficacy threshold in ER+ Metastatic breast cancer". Sounds disappointing, right? But when they only looked at lobular the results look good!
"The anticipated CBR for the FUL-treated group was 55%, with a null hypothesis of 35%. The anticipated CBR for the FUL-naïve cohort was 65% with a null hypothesis of 40%...Results from the trial showed that the FUL-treated population had....a CBR of 38%....Patients in the FUL-naïve cohort had a CBR of 30%...Additionally, lobular histology was associated with an increased CBR. The CBR of 13 patients with lobular histology was 61.5%."
So the ILC patients DID meet the efficacy threshold for clinical benefit, right?
Second, as you point out, this trial did not employ a dual blockade from the beginning, only adding herceptin at disease progression, where it benefited 80% of the patients.
I am in the SUMMIT trial (NCT01953926) which does employ, from the beginning, herceptin along with the neratinib and faslodex for the ER+ Her2 mutated (not amplified) breast cancer cohort. It has been successful for me since I began in February 2020.
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Shetland- so glad your trial is working!!! We have talked that since I have ERBB4 on my RNA I may be able to put neratinib my bucket.I find out Monday if my trial is continuing to work- hoping for a loooong run.
Cure-ious Thanks for the updates on AAMDC protein. Interesting-most of my findings are on chromosome 11. I will read those links and discuss with Dr Hamilton what she says.
DEE
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Shetland, Oh, thank you for clarifying all of that!! The story absolutely should have mentioned the bigger follow-up trial and the fact that it included herceptin from the start, all of which makes a lot more sense than how they covered it, plus it is a dis-service to cancer patients who read this and conclude, oh, never mind this is going nowhere, when in fact it is continuing very promising-ly. AACR should give some editing or messaging help, they are very disappointing- they've had virtually no headlines on MBC this time and you would think they'd put some effort into it. (IMHO they are too busy giving each other awards to bother with actual cancer patients, but then I'm not a fan with how they operate). Or even if the reporters would just send their articles to the relevant pharma hosting the trial, to get the bottom line correct and just some more background info to add to their story. And this is published on onclive; this is what they ostensibly do for a living!! From the storyline you'd never know that they are making big headways treating HER2-low and HER2-mutant ER+ cancers with drugs used for HER2-positive patients, there's no consistency in the reporting. I know you've done spectacularly in your trial, but how are the side effects, not too bad, is that right?
AlabamaDee- In your pocket for Monday's scan!!!!
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Well, the side effects were pretty bad for a while, but I am doing well now and feel good (considering). These drugs have been more of a challenge to me than to the typical patient. Neratinib is known to cause diarrhea so they have you take loperamide/Immodium from start and then taper off of it. For many people this works fine, though they may have to be a little careful with their diet. Me, I had a lot of vomiting and diarrhea when I started, and had to use loperamide, lomotil, budesonide (months), scopolamine, and zofran. I also had to use dose escalation on my third try (at my insistence and with my onc telling them they must not kick me off the trial), reducing from 240 mg (six pills) to 120 mg (three pills) and then up to 160 mg (four pills) of neratinib, which is where I stay. I still take at least one daily loperamide and have to pay attention and "manage" bowel issues. I also got hypertrichosis, and had to get a diagnosis and help from the dermatology department. Fatigue is just normal fatigue on days I do not have a lot of diarrhea. The Faslodex component has also been unusually challenging for me, with three episodes of pain that lasted weeks, but I think I have figured out some solutions, as summarized on the Faslodex thread. Herceptin has been ok except for weak, breaking nails. Even there I have to get my infusion over 90 minutes instead of 30 to avoid headache and nausea. BUT it is worth it to get this great remission, and I do feel pretty good now.
I agree that the reporting needs a lot of improvement. We really do need to read the details and the actual results, and not rely on a reporter's take on things.
Awaiting your report on Monday, Dee! Things look hopeful for you.
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Cure-ious ~ thanks for all the helpful info on trials.
I am ending my AZD9833 trial (Oral Serd). I was on the trial for 6 months. I was on the trial with everolimus and that drug was giving me a problem with my lungs. I ended up having Covid lungs and possibly pneumonitis from the everolimus. My scan last Thursday showed the covid 'fog' is clearing up from 3.5 months ago but there is a new infection in my lower lungs which looks like pneumonitis from the everolimus. My progression is minimal and I could have remained on the trial if it were not for the covid lungs and pneumonitis. I took the last few weeks off from the everolimus and I can tell I am starting to heal, but I do not want to continue with that drug. My next treatment is Verzenio.
I would recommend the AZD9833 trial. I had complications from Covid for the most part, but otherwise it was a fairly easy treatment. The AZD (Oral Serd) can be taken alone, with Ibrance, or with Everolimus. I am happy I got the extra 6 months and consider it a bonus. ~Kar
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KarPC
- Sorry the covid and envirolimus gave you lung issues. prayers for healing. 6 months bonus is good. It's nice to have a plan for next steps. Hoping this one works wonderfully.
Will you take Faslodex with verzenio?
Dee
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Thanks Dee. My plan with my onc changed today. We had talked about starting Verzenio over the phone a few days ago. Today was my appointment, and I was surprised to find out I could stay on the trial and take the AZD9833 Oral SERD without the Everolimus. My progression was very minimal (my largest tumor grows 2 mm every 2 month scan). I decided to stay on the trial for a bit longer. I expect some progression and doubt the SERD is strong enough on its own, but hoping my lung mets stay slow growing. I will get a CT scan in 6 weeks. The trial drug is so easy on me and will hopefully allow my lungs to heal from Covid and pneumonitis. Ugh, the decisions we all have to make are so tough. ~Kar
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