Are you currently (or have you been) in a Clinical Trial?
Comments
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Here is a recent report from Susan's MO, discussing SERMs and SERDs and trials exploring what is the best way to treat ESR1 mutations. Unfortunately it sounds like these trials might not include a +Ibrance arm, as EV11's does...
https://www.onclive.com/web-exclusives/er-modulati...
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Hello, all...Well, for me at least, the SERD plus palbo trial was a bust.
I had my 2 month CT scan yesterday, and despite the fact that SCCA won't release the scan before your appointment with the onc (scheduled for this Monday), I got the results last night.
My local onc scrounged around in her patient portal for me and sent me the report last night. Unfortunately, it shows that there is more ascites, thicker stranding in the omentum, slight growth in the bladder lesion and two new lesions in my lung...I've not had lung mets before, so that is a bit of a shock. They are 1.2 cm and 6mm in the longest diameter, but appeared in two months, so are significant. I have not been sick, and unlike a few years ago when I had two odd-shaped lung lesions appear, these are ovoid and look like metastases....the ones in January and April 2018 were very oddly-shaped and the radiologist noted "not typical in appearance." Those disappeared over 6 weeks when I was off drugs waiting to get onto a trial. One of the lung lesions was going to be my "measurable disease" for the trial, so when my start of trial scan showed them resolved, the trial was off. But I was never so happy to fail to meet inclusion criteria! These look more like cancer...I'm going to see about a biopsy (I'm wondering if my HER2 equivocal disease--2+ on IHC but ISH negative-- might be driving this more than the ESR1 mutation) but they might not be in an easy to access place, and even at 1.2 cm, might be too small. I know the 6mm one is.
So I imagine I am off the trial. I will learn my fate officially Monday morning. I am so thankful that my onc understands my preference to know the scan results prior to our appointment so that I don't feel blindsided and can come to an appointment with some well-though-out questions rather than spend our appointment time digesting the news. She worked behind the scenes late on a Friday afternoon to find the results for me. The trial is at a different cancer center, in a different state, and they are not on the same EHR system that her clinic uses, so it took a bit of work. She's caring and thoughtful like that, and I am so grateful to have her as my usual doctor. Se will be at SABCS next week (I won't--ugh) and says she will be on the lookout for some new ideas for me.
I'm sad. I'm scared. I don't know how to tell my 16 year old daughter that yet another treatment was ineffective. But it won't be tonight-- tonight she and her best friend of 10 years and I are going for our annual outing to have a nice dinner and see the Nutcracker. This is our 8th year in a row for that. So this morning the three of us will decorate our tree, do a little Christmas shopping this afternoon and then enjoy our annual outing.
I might just try for one of the HER2 low drugs next. My local cancer center is just starting a phase 1 trial for HER2 expressing solid tumors using A166...I'd really like to get into the DESTINY trial, but that's phase 3 and I could be randomized to the "standard of care" chemo only arm. There's no crossover to DS-8201 if there's progression on chemo, so it's not quite as appealing. I'm open to thoughts and suggestions from any of you smart, innovative thinkers!
I hope you all are feeling well, and finding happiness and joy in this holiday season.
Peace...
Elizabeth
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I am so sorry Ev11. You are in my prayers that the next treatment is effective.
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I'm so sorry, Elizabeth.
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Elizabeth,
Sad to hear this as well. Do you have the ERBB2 mutation? I don't see it in your listing, but I see that you've got something going on with HER2. If so, what about neratinib? Also, what about a liquid biopsy if you can't get at the new stuff to get answers?
In the meantime, I hope you, your daughter, and your daughter's friend have a lovely evening at dinner and at The Nutcracker. My daughter (now 32) was a dancer when she was younger, so she started dancing in The Nutcracker with a semi professional troupe from grade 3 on as one of the children in the opening scene. In her last year of dancing, she finally made it to the Snow Queen's scenes, and she was thrilled. I can hum every bar in every song of that ballet! I hope you enjoy it!
Bev
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Elizabeth, I am very sorry to hear about your results, and know that you and your MO are thinking things through carefully.
I realize that this is a bit of a paradigm shift: perhaps you might consider adding a Naturopathic Oncologist (NO) to your medical team? I work with mine remotely, and he is excellent. His protocol is designed to complement one's standard therapy, and both my MO and NO know about each other. The issue is that neither the consultation nor the protocol is covered by insurance. If you want further information, please PM me.
Another outside the box thought might be to consider chemo sensitivity testing, which either Nagourney or the Weisenthal Cancer Group (my preference) can do.
Hoping that your next treatment works long and well.
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((((((((EV1)))))))) We're here for you
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EV11- I don’t know if your treatment data in your signature is up to date. But, wondering if you have a PI3K mutation and alpelosib ( piqray) would be an option or an mTor like Afinitor if you haven’t had the test or don’t have the mutation.
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EV11, You are so brave!! We don't get special evenings back, no matter what, so its great that you can put it out of your mind and truly enjoy the mom-daughter-friends evening. There are a ton of powerful drugs out there and new info will come thru SABCS, deal with it in a few days is fine.
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Also, your instincts may be correct. A Nature 2005 paper identifies several genes responsible for MBC metastasis to lung, including: "the epidermal-growth-factor family member epiregulin (EREG), which is a broad-specificity ligand for the HER/ErbB family of receptors, the chemokine GRO1/CXCL1, the matrix metalloproteinases MMP1 (collagenase 1) and MMP2 (gelatinase A), the cell adhesion molecule SPARC, the interleukin-13 decoy receptor IL13Rα2 and the cell adhesion receptor VCAM1. In addition to these genes, we included the transcriptional inhibitor of cell differentiation and senescence ID1 and COX2.
As BevJen suggested, studies are focusing on drugs that may target HER/ErbB mutant proteins and lowHER2 expressors. One positive preliminary phase 1 trial tested Trastuzumab deruxtecan, which FDA just fast-tracked this October for HER2 cancers in general, but it was also looking good for HER2-low cancers, and is going to be discussed at SABCS
https://www.astrazeneca.com/media-centre/press-rel...
https://cancerres.aacrjournals.org/content/79/4_Su...
And don;t forget the COX2, which can be inhibited with celebrex or other NSAIDs.
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Here is recent review of anti-HER and combination therapies, and mentions also HER2-low ER-positive cancers
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC64255...
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Sorry to hear about your trial, Elizabeth. I was really hoping this would be effective. The low Her2 drugs sound promising, Im waiting to see what we uncover at SABCS. Fingers crossed.
Hugs,
Ann
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Elizabeth -
I am new to the group and very sorry to hear the trial did not work for you. As you know, once a new plan is in place, it is a bit easier to deal with...
Best Wishes for a great new plan in the near future.
Gumdoctor
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Hello All -
I am brand new to the group. I cannot sleep so thought I would post some notes here. I just started the IMMU -132 clinical trial today. I am randomized into the study drug group and very grateful.
After 5 pre-meds (Tylenol, Pepcid, Aloxi, dexamethasone and Benedryl), the drug infusion was 3 hrs total then a 3 hr break with an EKG before going home. We were in the clinic for 11 hrs including our long lunch break.
Husband packed a fabulous lunch box for us both and we had fun eating out of it all day.
Known side effects are similar to the Abraxane I just stopped so hoping they will be similar for me. Even if hard, there is some small comfort in the familiar...
Heading for bed to attempt some sleep again...
Warm wishes to all,
Gumdoctor
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gum doctor - sounds like a long and exhausting day! hope you feel OK on IMMU-132. I've heard it can really work great for people. I am currently considering that trial too, so I may be following in your footsteps
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Hello, all, and welcome, Gumdoctor....
Thank you for the kind and heartfelt words of support. We had a lovely evening out at the Nutcracker, and I was able to really enjoy myself. I am grateful for that, and so many things.
My wonderful oncologist has been emailing me from SABCS (I din't get to attend this year.) She also spoke with a few of her colleagues who are PIs for a few different trials and has three for me to consider. We will discuss at my appointment next week:
DESTINY 04 (HER2 Low ) with DS8201a--it's phase 3, so I have a chance of getting randomized into the SoC arm, which for me would be Taxol or Abraxane
A166- (HER2 low) phase 1/2-- so I would be in a dose-finding arm, guaranteed to get the drug, but at a yet-unorven dose, and for a drug without out much known about it's likely efficacy
SG LIV-1A (an ADC)...I would be in newly-opened weekly-dosing arm, designed to hopefully minimize the significant neuropathy that is very common with this drug.
I am leaning towards the DESTINY trial, although if do enroll on it it would make me ineligible for the LIV-1A trial in the future; if I started with LIV-1A I would still be eligible for DESTINY. I just have a hunch that my EGFR mutation and my HER2 2+/ISH- status (but not mutated)I would be best treated by the HER2 drugs; although lobular tends to respond well to anti-tubule drugs, and that's the payload in the LIV trial. UGH...
It looks like I would be eligible for A166 regardless of being on one of both of those trials, so I am thinking of saving that for later, hoping it will be in phase 2 when I would be needing to try it.
My signature is up-to-date...I have no PI3K mutation. So no Piqray for me. Everolimus was not effective (per BOLERO analysis) for the small cohort that had the ESR1 Y537S mutation that I have, so no need to try that. It's either IV chemo or one of these trials.
I'd appreciate (as always) any thoughts from you kind and smart people.
Elizabeth
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Elizabeth, thanks for posting. I am also HER2-low and hoping to some day get on an HER2 or HER2-low drug. I also have the ERS1 Y537S mutation and Afinitor didn't work for me. I think one needs to have the PI3CK mutation to qualify for Afinitor anyway. I am not familiar with A166 or SG LIV1-A. Do you need to have LIV-1 protein expression to qualify for the SG LIV1-A trial?
It is a tough call - nice with the Phase 1/Phase 2 trials that one is guaranteed to receive the trial medication. However, there are risks of it not working or the dose not yet being calibrated for safety and efficacy. I have heard that DS8201 is having good results in HER2 low. Not sure if results are being posted at SABCS but I believe a small bit of results was released in Japan a year or two back on DS8201. However, it is unfortunate that in a Phase 3 trial, one cannot guarantee to receive the trial drug. My sense is that you should go for the one you feel is best for you at this moment (and don't worry too much about eligibility/ineligibility for future trials).
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Hi All - Need a little vent...
Was all set for my 8 hr chemo day in the IMMU - 132 study. WBCs too low at .5. No tx today. Come back next week and we will try again...
So incredibly disappointed.
Gumdoctor
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Darn it, Gumdoctor...that is so frustrating. I hope that your counts rebound for next week...and that your entire body takes advantage of this extra delay to recover in lots of other ways, as well.
Treat yourself well in the meantime.
Elizabeth
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EV11 - thank you for the encouragement. Struggling tonight. Waiting for my protective numb mode to kick in.
Gumdoctor
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Gumdoctor,
Oh, I can feel your frustration in this process. I've yet to go into a clinical trial, but having hope that you will start on a new treatment and then having to wait another week -- that is difficult. I also admire your strength, as others have said, as you make your way through this journey. Prayers and good thoughts coming your way.
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EV11 - have you made a decision re: trials yet? I met with a doctor today who suggested DESTINY for me, since my most recent biopsy shows me HER2 low. I am going to start looking into the options... She did say that the DESTINY results are impressive thus far.
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thrivingmama-- I am sitting in my oncologist's office after just having left my appointment with her, scrolling through posts--
We decided on the DESTINY trial...there's a 2:1 chance I'll get the trial drug, but if not, we decided that weekly taxol would be my SoC chemo.
The trial is at a different cancer center in town- I have an appointment at noon on Christmas Eve to sign the consent and schedule the labs, scans, and other hoo-ha that needs to happen before I officially get randomized into an arm. so much for a calm and restful few days over the holidays! Plus....I am back in my onc's waiting room to meet with a local trial coordinator to volunteer for a bone marrow biopsy (!!) before the DESTINY trial...It's for an unrelated 'proof-of-concept' experiment to see if bone-marrow-derived lymphocytes can be used (in a process kind of similar to CAR-T therapy) in ER+ MBC.
It's a very intriguing concept...it's been successful in a few other cancer types--there is a brilliant researcher at my cancer center who is collaborating on the MBC side of this... (Check out the sponsor's site, WindMIL Therapeutics, for a description of what they are trying to do.) There's no immediate clinical trial that it is linked to, but if it proves to be viable for MBC, then my cancer center will open up a phase 1 trial. There's no guarantee that I would be eligible at that point to participate in the phase 1 portion, but it takes people willing to undergo inconvenience and discomfort in order to propel new therapies into existence, so I hope that it ends up being do-able.
I hope you get into the DESTINY trial-- it really does seem to been of the most promising drugs in trial right now... Are you IHC 1+ or 2+?
It seems to be most efficacious in the 2+ subgroups, although even some 1+ are having good, long responses.
Let us know how it goes.
Elizabeth
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Well...
WBCs did not rebound and were worse last Monday. So again no tx. They did prescribe filgrastim (Neupogen) for 4 days so we are more hopeful for next Monday.
If tx is delayed again next Monday, I will likely exit the study. It is not benefitting me in any way. I am in my 3rd week of no tx now.
Gumdoctor
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I'm so sorry for all of this frustration and delay. My heart goes out to you and may your WBC soar this coming week.
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Kattysmith - Thank you for your sweet concern.
Now I am dealing with insurance too. For the 2nd time in 2 months, I am told I have no insurance.
I am an active duty Army Colonel. These things should not be happening.
This is how the Army treats its Soldiers. Venting.
Gumdoctor
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Gumdoctor,
I am so sorry to hear of your troubles with your clinical trial. I hope that your numbers are up on Monday.
But that pales in comparison to your insurance issues. What the heck is that all about??? As you said, you are an Army Colonel. No one should be treated this way, but least of all, someone who is in the armed services. I saw that Grannax posted on another thread about sending letters or emails. I would be happy to do that as well. I think this is outrageous, also because you are in a health situation where you should be avoiding stress. Does the Army not understand what kind of stress this can cause?
Thinking of you and hoping that all works out on Monday with your trial, and with your insurance.
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FYI, an experimental cancer-specific virus is being tested with checkpoint inhibitors (immunotherapy) for MBC and other solid tumors. The idea is that the virus will selectively infect and kill cancer cells, providing cancer-specific antigens that trigger the immune system to go kill more cancer cells throughout the body.
https://ir.oncolyticsbiotech.com/press-releases/de...
The BRACELET-1 trial (phase 2 with 48 patients) will test combinations of the virus (called pelareorep) with Avelumab and/or paclitaxel and is planned to start in first quarter of 2020.
Obviously there are various combination immunotherapy trials out there, hopefully some hope for immunotherapy in MBC will emerge in 2020..
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Cure-ious,
This looks very interesting. Thanks much for posting.
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BevJen - thank you for your concern. Yes the Army situation is draining me and my husband of precious energy in already-short supply. They "fixed" it, again. I am not hopeful it will stay fixed given their track record.
After no tx twice in a row, I was able to receive study tx (IMMU - 132) yesterday.
WBCs were through the roof (21 vs 0.4 last week) due to 4 filgrastim injections in the past wk. Phophorus levels were in normal range due to KPhos supplementation.
I will continue with both filgrastim injections after each chemo and KPhos daily.
Thank you for all your encouragement everyone. Feeling a bit more upbeat for now.
Gumdoctor
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