Are you currently (or have you been) in a Clinical Trial?
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dee, glad you're still in the trials; I'm hoping things start kicking in and working. Abaraxane is supposed to be the same but it actually has a slightly diff effectiveness from taxol so fingers crossed for it to work and synergize with the trial med.
The waiting for abraxane is a pita. it's always at least 30 min for me but 90 is ridiculous. Pharmacy must have been swamped
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Moth, the 90 mins was because the intake person didn't write down my weight the day before. Pharmacy didn't let my chemo RN know, she kept phoning them to find out where the Abraxane was, they said they were working on it, in reality they couldn't mix it because they didn't have my weight. I wish I could have this treatment in Nanaimo, it's a small centre and seem to have it together, where as Vancouver is so big & busy things get shoved aside. I will keep in mind that the wait time should be added on. Thanks for that info. cheers, dee
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Very impressive early results (1 year interim report) coming in from a phase 2 FDA fast-track trial of 30 TNBC patients: Leronlimab added to Carboplatin led to a decrease in cancer-associated macrophage cells (these are immune cells the cancer uses to hide from immune system surveillance), resulting in a 3-fold increase in PFS (ie, 6 mos compared to 2 mos) and 4.5-fold increase in overall survival; with a 70% response rate).
Leronlimab is a monoclonal antibody treatment that binds to the CCR5 surface protein on T cells. It has been used medically previously to block HIV-1 infections (the virus infects T cells by binding to the CCR5 receptor); and those studies showed it has very few side effects. In pre-clinical studies, Leronlimab reduced breast cancer metastasis by more than 97% in a murine xenograft model, and the drug may be working through effects on the cancer (blocking metastasis) as well as its ability to get rid of the immune cells that are shielding the cancer.
In principle, this drug should also work on ER-positive MBC and many other kinds of cancers, depending on how they are shielded, and there is a phase 2 trial that is testing 22 different cancers. It is not a major pharma handling this new drug, and hopefully something changes so they can move faster to get this drug on the market.
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what is the trial number ??
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Nicole, the leronlimab+carboplatin trial is NCT03838367
here's another write up of it https://www.cancernetwork.com/view/leronlimab-plus...
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For those following the SERDs, here is a write-up that summarizes the current trials. They discuss the recent $1B payment PFIZER (maker of IBRANCE) made to partner with the maker of ARV-471, an oral ER-degrader in Dee's trial that looks really promising.Interestingly, they note that Pfizer last fall made some similar investments in this area, including OP-1250 (combined degrader and inhibitor of ER), which is also in trials. One view of this is Pfizer is trying to cover the market for what will be combined with Ibrance in future secondline or firstline treatments- another view is that maybe OP-1250 is not looking as good as ARV-471 in the internal data, because otherwise why would Pfizer bother adding that drug now? Regardless, it sounds like we may not get much more information/updates on these trials until San Antonio, but we can hope for ESMO2021 in mid-Sept.
https://www.evaluate.com/vantage/articles/news/dea...
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For those of you who have done clinical trials, how much notice are you given for appointments, scans, biopsies, etc? I have been frustrated with my clinical trial that I am not given much notice. For example, my last biopsy was on a Monday and I was told on the previous Wednesday. I understand scrambling in the beginning to get all the tests done on time but this is not the beginning? It’s my first trial and possibly my last. The scheduling has been hard on my husband and me.
Thanks,
Libby
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Libby, I didn't get tons of notice but it did settle into patterns for all the 'regular' things. That said, it was very time intensive, tons of extra appointments, and yes, lots was sort of last minute. One reason my MO advised me to quit school was that it would be impossible to do the trial while in school. Regular treatment maybe, but not the trial...
It was totally worth it to me for access to possibly life extending therapy. Covid struck right after I was dx'd so only dh could drive me (I was quite weak and not up to driving myself for a few months) so yeah, big headache. He worked from the car in the parking lot, zoom meetings etc.
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wanderingneedle
Sorry you are struggling with trial surprises. I don't have anything like that and it does not seem right if they want you to participate-they should take better care if scheduling.
My trial (actually both of my trials) was up front and listed in the papers I signed- biopsy before the trial and again at 6 weeks. Appointments every other week after week 4. I also knew the schedule before I signed. I get actual appointment times every 8 weeks out, including my scan date and time. I think this is due to my clinic being so helpful. They are great to schedule me out.
But the required regimen for the trial should be published in your paperwork. I would push your team to schedule you out. You can always change if needed. Mine is pills so I don’t know what infusions would be and how poor blood work could affect the schedule.
One trial was Pfizer and the other is Arvinas.
Dee0 -
Thank you, moth and Dee. After the first week they’ve been better about scheduling blood draws and doctor appointments. It’s the other things that are in the paperwork like scans and biopsies. They know when they’re supposed to be done but wait for? I’m having a scan Monday morning that could have been scheduled weeks ago but they call me at 4:30 on Friday afternoon telling me I need a scan on a certain date and to schedule it. There were no times for the next three weeks so I’m getting squeezed in after a call from the clinical trial. I’m not understanding why they do that so I thought I would stick my head out and ask if it was normal. Drive time is an hour minimum, my husband takes a day off work to take me (so sometimes 3days in a row) and they know this is an issue for us. We keep showing up! So far I’m not showing any progress (only the cancer is) but maybe that will change with the next treatment.
Libby
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Libby - It's so overwhelming the amount of appointments needed when starting a trial and during the first few months. My trial was at my normal cancer center which was helpful. I don't see how I could ever travel to a trial (more than a few hours) now that I know what is involved. I had an adorable trial coordinator. She was very responsive to calls and texts, so she worked really hard to schedule my appointments ahead of time when it was easiest for me. I still had to miss some work tho and that was frustrating. Maybe bake your trial coordinator brownies and send flowers - lol.
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Hi all,
ARV471 Trial scan and plan on Monday. If all is good we move scan to every 12 weeks. Still going every other week for bloodwork. I am hopeful for a good report on the cancer, but dealing with UTI, migraines, vertigo and random pains. My step mom moved to a hospice house for her pancreatic cancer. It was hard to deal with my emotions for her and my thoughts of an eminent future for me. Needless to say I am dealing with the usual scanxiety. Will let you all know the results. 🙏🏻
cure-ious I talked to Dr Hamilton about Arvinas partnering with Pfizer. She was somewhat involved in that process and said Pfizer is looking for a good hormonal backbone to go with Ibrance. Hopefully ARV 471 continues to work well. But it won't make the process to get to market any faster- trial protocols are lengthy.Dee 🦋
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Praying for good scan results for you Dee. That is very sad about your step mom.
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Continued stable disease🎉🎉🎉 Breathing a sigh of relief! I started this trial in Dec 2020 so this is the longest I have been on any MBC drug. The shrinkage went from 11% to 9% from start of study, but they considerate that still stable. And for my history that really is great.
Hope this trial drug has great success and becomes a new alternative to faslodex. Pills are better than shots.
Dee
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Fantastic news Dee!
cheers, dee
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Fantastic Dee! So happy for you.
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Great news Dee!
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Fantastic news Alabama, hopefully it shrinks to oblivion and never comes back. I will have to ask my DR about clinical trials. I wonder if I would be disqualified, because I am on everlimus. Why can't they just have someone stop for period of time before starting trial? With MBC it seems like a person is likely to have thrown every gun they can find at it.
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BGRS- Some trials like mine allow many previous lines. I tried envirolimus. If you are interested in a trial- you can get in their system nowbut, most need you to be failing your current treatment to get started.
Dee
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Dee
I saw a trial at Seattle cancer care alliance that I think is similar to yours? But it is only a 1/2 trial.
https://www.seattlecca.org/research/clinical-trial...
Julie
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jjzn- yes that is my trial butat SCCA
A Phase 1/2 Trial of ARV-471 Alone and in Combination With Palbociclib (IBRANCE®) in Patients With ER+/HER2- Locally Advanced or Metastatic Breast Cancer (mBC)
It has reached expansion cohort for max dose single agent, plus has the Ibrance cohort. I am in the escalation cohort at the max dose.
It is at a great time to join.
Dee
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Wanderingneedle, re your question about scheduling on a trial, my experience has been similar to AlabamaDee's and Kar's. My big packet of informed consent papers included a chart saying how often everything was to be done, enabling me to know what is happening each week. The sponsor is strict about it. This includes the infusions, injections, doctor visits, PET and CT scans, Echocardiograms, and blood tests. Since my doctor always has clinic on the same day of the week, my trial nurse just makes that my day and schedules everything for that day of the week (even weeks without a doctor visit). So I can mark my planner months ahead and just fill in time of day as the nurse orders the appointments. She knows I prefer after 9:30 AM. So while there are a lot of appointments, I feel I they are under control. My DH, like moth's, drives me and stays in the parking lot, mostly working on his laptop and phone. The vehicle is equipped with bedding for naps, a cooler with food, and a big battery for running air conditioner and laptop. What if you look at the trial schedule and prompt your nurse ahead of time? "I believe I have a scan in four weeks. Can we please schedule it now? And let's get my biopsy scheduled, too. You know my husband has to take off work to bring me. I really appreciate this..." I always check my portal to see what is scheduled, and once in a great while I send my nurse an email if something seems to be missing.
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AlabamaDee, it's so great to hear your scan shows stable! And thank you for helping patients eventually get access to that oral SERD. I know the nurses will be happy, too, when they don't have to give those faslodex shots.
Can anybody tell me how to find out about news of ongoing trials? For example, I was looking at this one, the ROLO trial in the UK. It is looking at using crizotinib specifically for metastatic ILC. I want to know if there is any info so far that I can share with my oncologist. I think this drug, crizotinib, should be on my list, but not sure when or how. What does "Last Update Posted" mean?
ClinicalTrials.gov Identifier: NCT03620643
Recruitment Status : RecruitingFirst Posted : August 8, 2018
Last Update Posted : May 19, 2021.
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SP,
Usually there is a point person listed on trials. I've communicated with the ROLO people before, and they will write back to you. Unfortunately, when I last checked, they had no info to share and that trial is limited to people in the UK, as you know.
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SP-Here is a really excellent review on the unique features of lobular MBCs:
https://theoncologist.onlinelibrary.wiley.com/doi/...
Most have mutant or truncated CHD1 gene, which leads to a loss of E-cadherin (a cell surface protein that controls cell adhesion/ metastasis), and causes p120 cadherins to move from the cell surface into the nucleus where they turn on a pathway needed for the cancer cells to survive.
As you know, Her2 mutations are more common and can be treated with a Tyrosine Kinase inhibitor and Trastuzumab. This and/or high levels of FOXA1 and/or FGFR amplifications can give endocrine resistance. These cancers also have higher levels of PTEN and PI3KCA mutations.
They mention the ROLO study (NCT03620643) "a phase II trial, is investigating the role of ROS1 inhibition with crizotinib in advanced E-cadherin–negative, ER-positive lobular breast cancer and diffuse gastric cancer. E-cadherin defective cells rely on ROS1 for proper function, and ROS1 inhibition demonstrates a synthetic lethality in in vitro and in vivo studies"
And they are waiting on the results of a nearly-completed trial of the FGFR2 inhibitor Pemigatinib:
https://clinicaltrials.gov/ct2/show/NCT03822117
And they mention that a "phase II clinical trial is assessing the efficacy of carboplatin and atezolizumab in metastatic lobular breast cancer (the GELATO study, NCT03147040)."
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Hmm, I wonder if I should ask my onc to touch base with the ROLO trial person. Is that a better idea? The drug is approved in the USA for lung cancer (?) so I was thinking of looking into off-label use or something.
>>> I would very much appreciate any input from you guys on what drugs or trials to consider. Here is my current status:
My scans from last week still show NEAD, but I am getting concerned with what looks like a trend upward in both CA 27.29 breast cancer marker and CA 19.9 Gastro cancer marker, which we monitor because it appeared to reflect the rise and fall of the un-seeable breast cancer mets in or near the bile duct. Until the bile duct stuff, we though this ILC was very apparent on scans, but now we feel we need to be more suspicious. Also alkaline phosphatase has been a bit higher lately, and I am experiencing more burping, which seems to go along with progression for me. My onc and I agree that there is nothing alarming enough to make us change treatments right now, but we did have a discussion about what to do next. She said PARP inhibitor because of my last Guardant report showing mutations in ARID1A and CDK12, as well as some VUS in BRCA2 and ATM. I countered with how about PARP and stay on Falslodex, too. She did not say no. The other targetable mutation is PIK3CA, but she thinks that would be more difficult and not necessarily better. Of course when the time is right we will try for a new biopsy and genomic test.) I also want to ask her what role enobosarm could play for me. And maybe down the road they will figure out how to make immunotherapy work better with ER+. A taxane is an option if something happens fast and I need a big gun.
My other treatments that worked lasted two years each, and I will be very disappointed if my current drugs don't get me at least that and more. I thought that addressing the Her2 pathway might give me longer-term results. We wait and watch.
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Oh, now I see your post, Cure-ious. I will read what you linked to...
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Thanks for those links, which I have bookmarked.
So my report shows the CDH1 mutation, hallmark of ILC. I believe this is only actionable with the crizotinib being tested in the ROLO trial (Untied Kingdom), or the entrectinib being tested in the ROSALINE trial (France and Belgium). These target ROS1 and use synthetic lethality.
It shows ERBB2 mutation, which we are currently addressing through the SUMMIT trial with neratinib, herceptin, and fulvestrant. (This mutation is suspected of causing the endocrine resistance.)
There is a PIK3CA mutation, so alpelisib is an option.
There are the mutations in ARID1A and CDK12, as well as VUS in BRCA2 and ATM, for which my onc recommends a PARP inhibitor.
There is no mutation detected in PTEN, FOXA1 or FGFR1.
Also, Foundation One shows mutations in KEAP1, SMAD2, and TBX3.
And the germline mutation in MSH6, a mismatch repair gene. But no microsatellite instability. Tmb 30, which is not low.
GELATO is looking into immunotherapy with atezolizumab along with carboplatin. Seems like I should put this near the bottom of my list until we learn more.
So what do you say, Cure-ious?
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SP- My lab studied CDK12, so that is something I know about- a mutation in CDK12 can be a strong indication for responsiveness to immunotherapy. CDK12 mutations create many cancer neoantigens and the cancer stands out as odd to the immune system- there is a clinical trial where they give immunotherapy for any type of cancer containing a CDK12 mutation. It should be better still in combination, for example with a PARP inhibitor, or the carboplatin-Atezo combination they are using in the GELATO trial. But I would try to move immunotherapy up in line because it is more effective when given earlier in the sequence of treatments, before the immune system gets weakened by too many chemos.
Perhaps you could do that and then re-try endocrine therapy in the form of the SERDs or ER-degraders, being on these alternate treatments could re-sensitize estrogen signaling, after all, you did get two years from AI-Ibrance. And then they should know if the ROLO trial was worthwhile, or by then its time for ADCs or CAR-Ts...
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These pics show T cells (brown spots) infiltrating prostate cancer- the upper two pics on the left are in cancer with CDK12 mutation, where you see lots and lots of TILS- the upper right is where the cancer has a DNA repair defect but otherwise CDK12 is normal, and the bottom ones are controls where the CDK12 gene is not mutated and DNA repair is normal- these are the "cold" tumors.You need two things to respond to immunotherapy: 1) T cells have to infiltrate the tumor and recognize it as weird,and 2) you need to get rid of tumor-shielding immune cells. So with a CDK12 mutation, you have taken care of thing one. Other drugs, even celebrex, can help with thing two.
So perhaps one reason you have already done so well is because your immune system is able to better get at the cancer, Just would help to give it a big boost with immunotherapy.
https://cdmrp.army.mil/pcrp/research_highlights/18...0
