Are you currently (or have you been) in a Clinical Trial?
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Thanks Susan! Much appreciated!
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Hi, Margarita,
Glad that you are still doing well. Good to hear from you.
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Margarita..I am happy for you that you have had such a good experience and I appreciate your post. I do have to say though HER2+ people that respond to Herceptin are in a whole different world (to me anyway) they can live 20 years..easily 5-10...we don't have those chances. I wonder if it was the herceptin really working so well after some time rather than the Keytruda. You said H+ P were not working but if they werent why are you still on H?
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Nicole, thanks for your response. You’re right that Herceptin responders generally have longer response timelines and a number of good treatment options available to try. It is also true that HER2+ cancers tend to be fairly aggressive and for many of us, Herceptin alone (or with Perjeta) just doesn’t work for long. In my case, I first responded to Taxol with HP but when we dropped the T, I immediately progressed. Added back Abraxane and responded again but when Abraxane was dropped due to neuropathy and other side effects we knew HP on its own wasn’t enough so I had SBRT and started Kadcyla which also worked for awhile but then progression again. Had more SBRT and then went on to Keytruda (with H) thanks to results of genomic testing. It is possible that my response to Keytruda was also boosted by having had SBRT not long before.
Your question about why be on Herceptin if I have progressed on it previously is a very good one! I asked my MO the same and she said that it is standard of care for HER2+ patients to remain on Herceptin even when NEAD is achieved so she didn’t want to take me off it (there is likely a more scientific answer but I don’t know it) and also, I guess the hope is that it would, at the very least, act to slow the progression when it occurs. I realize my experience is unusual (ie: I have yet to find anyone else on the Keytruda + Herceptin combo!) but that’s partly why I wanted to share it. And, for those who are considering Keytruda but are nervous or scared of the possible severe side-effects, that sometimes it works without causing them. I truly wish we better understood why and for which cancer profiles so it wouldn’t be such a crap shoot.0 -
I have a question about clinical trials and other people's experiences.
So I have been seeing my MO since spring of 2019. My age at that time was 67. One time she mentioned a clinical trial at her institution, but didn't provide much information. By the time we got around to talking about it again, they were all filled up.
So we are trying to find the best drug for me right now and I've bounced around a bit over the last year and a half. Started out with I/F, got about 14 months out of it, I think. Then went on keytruda -- a monumental disaster for me which caused a speed up of my cancer. Then nothing, while I had a hip replacement and a pin in the other hip, and radiation, followed by PT. Then went on neratinib (been on that since last June) with xeloda added in. Having issues now on those two drugs in combination. Asked my doc about clinical trials, and she has said to me that she doesn't think anyone will take me. I've yet to probe this further with her, but I wondered if others had similar experiences.
I can't figure out if it's my age (70 on March 1) or my hip replacement (she talked about ECOG status, but most say 0-1, and I can't see how I don't fit that) or if she thinks I'm circling the drain or what. She told me I could look into trials at MSK or Dana Farber, but she thought it unlikely that they would take me.
Does anyone have any insight, or has anyone experienced this?
Thanks.
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BevJen, I read through a lot of trials and go through their exclusion criteria. I don't see top age mentioned much. ECOG yes, brain mets - yes, expected survival >3 mos or sometimes >6 mos - not infrequently. I would honestly suggest trying to find trials yourself & if you find something, just trying. Sometimes you go through your dr & sometimes you can reach out directly to the enrolling oncologist's office. Perhaps it is the last issue in her mind & she didn't want to say?
have you ever tried one of those trial finding registries? I did trialjectory. It didn't come up with tons but I check it regularly
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Thanks, moth, I have tried some of those registries. I will look some more. I was just wondering if anyone else had a similar experience. 70 is the new 50, right?
I don't think that she's thinking that I'm circling the drain -- the other day we were talking about different drug choices that I still can try, even going back to the CDK 4,6 drugs. Why would she talk about those if she thought I was on my last legs? At my last appointment, when I was still using a walker, she talked about ECOG status, but only briefly. I am retired so I don't work outside of the home any more, but I also don't just sit around except when I am having a drug reaction (like I have been having) and I'm too nauseous to function very well.
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For everyone who progressed on I/F and/or subsequent chemos or targeted drugs and are considering one of the newer SERDs/ SERCAs/ARV-471, it could be very helpful to get a FES-PET. This is a newer imaging scan that measures the activity of the estrogen receptor directly, and so can indicate whether the cancer is still estrogen-dependent. We discussed it awhile ago when it got FDA approved, and at that time not a lot of places had it available beyond Fred Hutch in Seattle, but now its more widespread use. No idea also about insurance approvals and would love to hear from people who had this done. Its also the most sensitive method for detecting lobular cancers.
https://www.onclive.com/view/overview-of-estrogen-...
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BevJen, Sorry I forget, why are you on neratinib? Is it for mutant HER2 or low HER2?
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Dear Nicole - your link is about TILs, just remember Jusy Perkins story. So they are in clinical trials.
Dear BevJen, knowing you, your knowledge, attitude, general health and energy, I don't know how on earth a clinical investigator would not want you on his clinical trial? If I was one, you'd be first on my list. As Cureious asked, depending on HER2 mutation/expression, you could have many other options. Also... what about different CDK4/6 inhibitor or some immune-therapy combo (I know your experience with pembro but maybe others)?
Saulius
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I am on neratinib because I have two ERBB2 mutations. That was the drug of choice once I went back on treatment after all of my issues with Pembro and my hip replacements. I've been taking it coupled with xeloda.
We did discuss several possibilities once we get this liver/ pseudocirrhosis issue figured out. One would be neratinib coupled with fulvestrant. (In today's Practice Update, it says that this can be effective in at least 1/3 of patients previously treated with fulvestrant.) Another would be one of the other CDK 4,6 inhibitors -- the one suggested was Verzenio. I'm not sure if that would also be coupled with fulvestrant.
Saulius, thanks for the vote of confidence. We'll see how this goes.
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What is ECOG???
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ECOG is generally mentioned in trial requirements. It's a way of measuring how "active" you are -- we had a little bit of a discussion of this on another thread (can't remember which one) not too long ago. Most trials list an acceptable ECOG score for someone to participate in the particular trial. I think most of the ones I've seen say 1-2 or some with 0-3. From the Palliative Care Dictionary online, it's described this way:
"The ECOG score describes a patient's level of functioning in terms of their ability to care for themself, daily activity, and physical ability (walking, working, etc.).
The scale was developed by the Eastern Cooperative Oncology Group (ECOG) and published in 1982; it is also called the WHO or Zubrod score and runs from 0 to 5, with 0 denoting perfect health and 5 death.
0 – Asymptomatic. Fully active, able to carry on all predisease activities without restriction
1 – Symptomatic but completely ambulatory. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (e.g., light housework, office work).
2 – Symptomatic, <50% in bed during the day. Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours.
3 – Symptomatic, >50% in bed, but not bedbound. Capable of only limited self-care, confined to bed or chair 50% or more of waking hours.
4 – Bed bound. Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.
5 – Death. "0 -
Thanks for explaining Bev!
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Wouldn't it be helpful if oncologists and clinics had an ECOG rating. Something like: 0- Fully engaged goes beyond standard of care..., 5- Well if you can't say something nice...
Maybe there is a rating system and I just haven't heard about it. Please tell me if there is one.
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Coco...lol.... my MO would get a 0 she goes beyond for sure...but I know what you mean
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BevJen,
It is not true that no trials will take those of us who are heavily pretreated. I'm surprised your MO would say that. Phase I trials will often be open to us. Of course, Phase I trials are riskier. I am on a Phase Ib trial for ARX-788. My TMs have gone down, my cough is gone and my SOB is slowly getting better. No SEs. If not for this trial, I didn't have any great options left. I've been on 11 different treatments, 5 of them chemos. I've never seen an age limit on these Phase I trials. I wish Phase II trials accepted us. Maybe someday the FDA will force them to. How good is the data if it only includes those who have only been on a few treatments? These trials are biased to make their results look good. As more and more treatments are developed, limitations on the number of treatments make less and less sense.
When I spoke to my MO about a trial I was interested in at Stanford, she instead suggested the ARX-788 trial at USC. She also did the leg work necessary to get me in the trial. There was a lot involved particularly because USC isn't on EPIC so my digital files couldn't be directly shared with them. There is no billing code for all of this extra work but she did it because of her sheer dedication for me to access the best drug.
Hoping your MO will step up to help you with finding a good trial.
Hugs, Susan
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Susan - your MO is a gem!
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Saulius I can be accepted to that trial I spoke to them and they want me...however its been going on since 2017 and I don't see any real progress...
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Susan, That is so great that you seem to be responding to ARX-788 already!!! And there are plenty other Her2-directed strategies out there that could work also on the Her2-low tumors, up to and including HER2-directed CAR-T!!! The Her2 pathway is a strong one and a lot of tumors get addicted to that, even if they started out using estrogen for growth...
BevJen, I did also see that Practice Update recommending Neratinib (+Faslodex) for Her2 mutant cancers. I don't understand how, but the Her2-mutant and Her2-low cancers have differences, and the the Her2-low usually does not respond to Neratinib, and that was the drug that got blown away recently by Enhertu for secondline of Her2-positive tumors. So perhaps the Her2-mutant cancers should also respond well or even better to the newer Her2 drugs, like Enhertu or ARX-788, it seems that Her2-mutant is a bit rarer situation? there's not as much discussion about it...
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Cure-ious,
Can you send me a link to the HER2-directed CAR-T trial? Always trying to plan ahead for the next treatment.
What do you think about the current state of CAR-T therapy. There was a trial at UCSF with PACT Pharma but I heard it wasn't going well. Before she died, Theresa45 told me that a lot of PACT Pharma resumes were being circulated so it sounded like people were jumping ship.
Thanks, Susan
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Susan. From my past inquiries, CaR-T therapy was not working on many people. Maybe things have changed. That would be great. I haven’t looked it up in awhile as it wasn’t a good option for me with the results. So far I’m holding steady on kadcyla and tucatinib.
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LFF,
So happy to hear that Kadcyla and Tucatinib are working for you!
Hugs, Susan
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susan, you're right, its not ready yet, first we will have the drugs that get rid of immunosuppressive immune cells in the tumor microenvironment, but after that, a Her-2 CAR-T/CAR-M will be coming along..
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Cure-ious,
I am definitely in the HER2 mutant cancer club. I have two ERBB2 mutations that have shown up on my testing. My doc is big on enhertu, and we were going to go that way until she suggested upping the neratinib and continuing on xeloda. Xeloda and I do NOT get along, and so when I saw that Practice Update abstract, I was so excited. Of course, it may not work, but then we may add something else to it. We have also discussed Verzenio. She's had some luck putting people on that after Ibrance has crapped out and it's been a period of time. I've been off Ibrance for over a year now.
So I will probably get to Enhertu or the drug that Susan is now trialing at some point, but for now, I'm happy to try this and see what happens. From where I sit, a lot of this is just a crap shoot anyway, because, as someone has said in one of these threads, no one ever really knows how a person will react to a particular treatment. That's the real issue. But at least there are possibilities.
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Nicole,
I think the trial that you're talking about at UVA had a very slow ramp up. And even if you look at the trial design, they started with very few people. Sp I'm not sure I'd discard it for that reason. Also, from what I've observed by looking at start up dates, they often bear no resemblance to when a trial actually gets into operation. If I would still qualify for that trial (I don't, because I've had keytruda) I would make an appointment to talk with the doc in person and get a feel for what's going on. It's worth a day trip for you, I think.
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Bev thanks for your input I actually have the appt set up...its in mid March...I wanted to have my scans first to be sure the Trodelvy is not working...thanks for the info about start up dates..I didn't realize or know any of that...however now after reading this article https://medicalxpress.com/news/2022-01-tumors-approach-cell-therapy.html. its seems like they have figured out why they cannot get more success on CAR-T trials.... so I am thinking is that just gonna happen to me to ref:
This is the case in cell therapies used in clinics today, where a mixture of "exhausted" and "naïve" cells is used to treat tumors. After they are extracted from tissue, cells are grown in labs far away from the patients they were harvested from. By the time they've multiplied and are ready to be placed back in the body, many of the cells are exhausted and unable to fight, having been in the tumor for too long.
CURE....any thoughts to add?
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BevJen, Here is discussion of the Neratinib-Faslodex-Herceptin combo for those with Her2 mutant(s)- I have read that the more mutants the better, in terms of response..
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Nicole, Whether Keytruda or CAR-T or any other immune approach, there is the problem of getting high levels of activated and not exhausted T cells, macrophages, NK cells, etc into the tumor and to overcome the immunosuppressive cells that are sitting there protecting the tumor from attack. There are a bunch of different ways people are trying to overcome the problem, including the cutting-edge TREM-2 monoclonal that is in the trial mentioned earlier here, as well as the EP4 drug that kattysmith took with Keytruda (discussed at the very top of this thread) which gave her nine months with a (normally unresponsive) ER-positive tumor...
Speaking of which, KattySmith, how are YOU doing?!!
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