Are you currently (or have you been) in a Clinical Trial?

Update on Pelareorep, a vaccine for HR-positive MBC: "encouraging data from 2 [phase 2] randomized studies, [the BRACELET-1 (NCT04215146) and IND-213 (NCT01656538) trials], as well as the [early
phase 1] AWARE-1 study [NCT04102618],"

"pelareorep plus paclitaxel elicited a median progression-free survival (PFS) of 9.6 months (95% CI, 6.5–not reached [NR]) vs 6.4 months (95% CI, 2.0-NR) for paclitaxel alone and 5.8 months (95% CI, 3.5-NR) for pelareorep plus paclitaxel and avelumab. The 6-month PFS rates were 86% (95% CI, 54%-96%), 62% (95% CI, 28%-84%), and 50% (95% CI, 18%-74%), respectively." Note that adding in immunotherapy did not seem to help. talks are underway with FDA to figure out the way forward for this combo.

https://www.onclive.com/view/fda-receives-type-c-meeting-request-for-pelareorep-in-hr-her2-metastatic-breast-cancer

Update: The observed benefit of elacestrant with longer prior CDK4/6 inhibitor exposure was even greater in patients with ESR1-mutated tumors. The median PFS with elacestrant was 8.61 months (95% CI, 5.45-16.89) vs 2.10 months (95% CI, 1.87-3.75) with standard endocrine therapy.

Other updates that came up in Miami: https://www.cancernetwork.com/view/updates-in-breast-cancer-care-from-the-41st-annual-miami-breast-cancer-conference

Cur-ious Thanks for posting this interesting information. Only a couple of weeks on Elecestrant but so far so good. Hopefully my 7.5 years on Ibrance and ESR1 mutations will stand me in good stead. However other things coming down the pipe are good to know about. See my Onc tomorrow for a chat so will run all this by him. Good luck to you kbl for a really good long run.

@chico Thank you. I wish you the same.

@rk2020 Thank you. I don’t comment on the liver thread because I don’t have liver mets, but I do read it. Please know you are in my thoughts. 💕

Hi all! I'm just back from a last-minute quick trip to London which was such a blast, I got to meet Chico's friend and her husband at the Chelsea flower show, she creates beautiful large garden sculptures (waving to you, Chico, they are adorable BTW, and hope to meet you next time!)- he said every year they think it will be their last at the show and then they come back. Also saw Spirited Away at the Coliseum, a Studio Ghibli play, a Japanese fairy tale, lyrical and magical and with all kinds of spirits and gods and amazing puppeteers. Shop and eat till you drop. You can do a helluva lot in a short trip to London!

Still on Enobosarm and Celebrex (and taking Faslodex tho no idea if its even working anymore)-my TMs dropped again this week to CEA of 18.. And stable scans right before the trip. Its a good combination for those with PI3KCA and ESR1 mutations and something to keep in mind in case Elascestrant goes wobbly. Now heading into year 10.

Anything at ASCO?

Hi Chico!! I was surprised to see its still rainy in the UK in May!! So, are you completely off of the CDK4.6 inhibitors now? I am happy to be done with Verzenio, and waiting to see if it improves my hair and nails, but my joint pain is definitely worse, which is consistent with recent reports that the CDK4,6i drugs actually help with joint pain. The Celebrex helps with the arthritis pain, but doesn't cut all of it. I hope you get a long long run on Elascestrant, and have it on my list for whats up next. Enobosarm comes from the Chemyo website, but maybe they don't ship to the UK? Well it could be FDA approved already by the time you would need it!

Any plans for the summer?

Hi CBLaurence

Thanks for bringing up NUV-1511, I'd never heard of it, or of drug-drug conjugates for that matter. What the heck is this drug, I can't seem to find any information about it. I see the company also has a BRD4 inhibitor, and its worth seeing if those are progressing in recent trials as well. Thanks!

Cure-ious I was very surprised about the rain in London in May particularly as it was sunny where I live. Thanks for the ASCO link and yes I am off Ibrance and just doing Elacestrant as a mono.

Luce thank you for the heads up re Enobosarm in the U.K. and it is great to “see” you.

Hi everyone,

Welp, it's official: I progressed on Halaven - the existing liver tumors didn't grow, but slightly more popped up. Next step is a clinical trial.

I am ER+ PR- and HER 2- (0). I have no mutations (dang it). I don't think immunology is an option for me (HR+, low TMB (5) and PD-L1 negative.

I've been down the rabbit hole looking at three different facilities.

NEXT Oncology:

MD Anderson Houston:

Mary Crowley Cancer Research:

I'm very interested in the SON-DP trial because according to the write up, they had a 3-year response with rodents. I don't know exactly what that means, or if it's a good response, but it sure sounds good to me. There are probably a ton at MDA, but I'll just have to do research when they give me something to consider.

I've also had drug-related pneumonitis which disqualifies me for a lot of studies. My cancer is growing fast so I can't be without drugs too much longer, so time is of the essence. Whoever can get me on a good non-immunotherapy trial first will be where I go. My oncologist suggested if it's too long a wait we can do a bridge chemo, but I'd rather not have to mess with it.

If anyone's interested, I uploaded my caris report. It has a crapton of information, but I don't think any of it will really help me. I am curious though why my BRCA 2 is 95% and it's never been mentioned as something to target. I'll ask her on Wednesday.

Anyway, my question is does anyone have an opinion on which way I should go on these trials? I would love to trust the trial doctors to tell me the best one out of all of these, but I'm concerned they're just looking for bodies to put in their studies. Is that too cynical?

If you made it this far, thanks for reading. I'll update when I know more. Hopefully, I'll be on one by next week. My liver is twinge-y and I don't think that I have much time to mess around.

Lauren

Hi @newgardener

Thank you so much for the support and information—the trial successes listed in your signature give me great hope! Seven trials is no joke, so thank you for passing along your experience.

I'm with you on the premise of the trial — I know just enough about cancer to make me dangerous, lol, but I know I don't want immunotherapy. The other drug mechanisms seem to be a crapshoot, but I look for something on Google to support the theory. Time/difficulty is up there for me too - I don't drive on highways (I live in Texas and these people drive fast and armed) so I have to be able to get there on surface streets. Flying isn't an issue, but it would have to be for something good.

I don't know exactly what you mean by "impact on future trial eligibility". I haven't seen anything that would disqualify me from another trial—is there something specific I should be looking for? That would be a huge red flag and I wouldn't accept it. I want to walk in your footsteps and do as many trials as possible!!

Excellent point about the beginning stages - two of the trials I'm looking at are very early - the one at MDA with the 3-year response is one - so maybe I'd keep that one in my back pocket.

I do have a great 'home' oncologist and two of the facilities I'm looking at are part of her same group, Texas Oncology, so she'd be kept somewhat in the loop. The other is MD Anderson, which is less convenient, but they're MD Anderson, haha.

Anyway, thank you so much for responding. I'm flailing a bit but have trial appointments on Friday and Tuesday so will update when I know something.

Lauren

Hi Lauren,

I've had the good fortune of having ER+/anti hormonal drugs continue to work more often than anyone expects so that is the research I've focused on. Also, in general I like the oral drugs and more manageable side effects. I also have two targetable mutations ESR1 & pik3ca.

Maybe this is too much detail, but here's some more info:

1. Palbociclib & bazedoxifene. At the time (2015) palbo wasn't available in Canada so this was a way for me to get access to it thru a trial in Boston. Bazedoxifene is an osteoporosis drug that is also a SERM.
2. Enobosarm. Didn't work for me but it is a drug that targets androgen in the cancer cells.
3. Inasolib & fulvestrant. Inasolib is a pik3ca inhibitor. I couldn't qualify for the Piqray trials at the time.
4. LY3405105 besylate - this was a CDK7 inhibitor. Didn't work at all for me and I landed in the cardiac care unit because the pericardial effusion decided to grow fast:(.
5. CFI-402257 - a TTK inhibitor. This one was at my home hospital. Didn't work for me. Had shown some promise post CDK 4/6 inhibitors.
6. Enfortumab Vedotin - aka Padcev. Also at my home hospital. This is an antibody drug conjugate (like Enhertu and Trodelvy) that is already approved for bladder cancer. It targets Nectin 4. I lasted 6 months on this one.
7. PF 07220060 & PF 07104091 - A combo of new CDK4 and CDK2 inhibitors. I managed 14 months, with actual shrinkage, but eventually all good things come to an end. I travelled from Canada to Boston to go to this one.

Re future eligibility - as you read through eligibility, I suggest just taking note for themes. I got caught by too many lines of chemotherapy for some trials. Also, one tends to only be able to do one of any target - ie if you've had a "ABC" inhibitor, you won't be able to try a second "ABC" inhibitor in a trial.

My mets are in the pleura, liver, pericardium, and peritoneum, but the various liver spots have been indolent to date (they get me kicked out of trials but knock on wood haven't caused health troubles). I can understand how in your situation you'll be looking for drugs that can act fast (which is sometimes the traditional chemos).

If you are low HER2+, I wonder if Enhertu might be a good option for you to try before any of the more novel but not specifically targeted drugs? (I think in past posts you've mentioned you haven't tried it?)

Hi @newgardener

Thank you so much for the response. I saw my regular oncologist today and she wants me on some kind of treatment by June 26 (2 weeks from today). I'm guessing that will be near impossible to get on a trial that fast—I've contacted Mary Crowley and they said not possible, NEXT said probably not possible but I'm keeping my appointment on Friday anyway, sent a message to MDA, but that would be a miracle.

She'll start me on Gemzar if I can't do a trial in time.

So great that you've been able to respond so well to the hormone treatments. I did well for about 4 years, but since then, not much has worked for long. I'm HER 2- (0) so I don't qualify for Enhertu. My oncologist said today after Gemzar I have three lines left. So I realllllly need to get on a trial since the last drug that 'worked' was Trodelvy for 4 months. I failed Xeloda and Halaven immediately. So if each line works less and less time, I've got less than six months unless something great comes along soon.

Thank you for the heads up about the eligibility - I'll be searching for trials even if I fail Gemzar and hopefully be prequalified for something when I need it. I'm not totally giving up on NEXT but it seems unlikely. Yes, with my liver in the shape it's in, I'd need something more akin to traditional chemo.

Thank you for taking the time to respond. I sincerely appreciate the support and information. I'll keep the thread updated if by some freak twist of fate I get into a trial. :)

Lauren

Hi @newgardener

I did ask about the BRCA2 percentile on my Caris report and she said it's not the same as having a mutation, but _________ she said something I can't remember, haha. She did say there was another thing on there that would possibly open up a treatment.

I was not happy with the girl I spoke to at NEXT Dallas, so I called NEXT San Antonio and spoke to a wonderful new patient coordinator. She is getting the ball rolling on both locations and although it's improbable, at least she didn't say no. She pulled up my records from TX ONC chart, looked at my bloodwork…so I know something's happening now instead of waiting until Friday. MDA said the trial process is not quick, so I'm out of luck there.

I haven't specifically looked for NEXT San Antonio trials, but that's my next project. :)

I'll update as I know more (you all will be very tired of me because I'm an overtalker—the hazards of being a writer, haha)

Lauren

Hi Luce, it's a good question and I will add the question to my list. Thank you for the info on repotrectinib.

My original diagnosis with early stage was definitely ductal. The mets biopsy reports mostly don't seem to specify (the 2019 liver one said ductal). But I know breast cancers can be heterogeneous…and I've definitely had a game of whac-a-mole going.

Lauren- How Fantastic!!! I guess sometimes, the news can be unexpectedly wonderful…