Are you currently (or have you been) in a Clinical Trial?
Comments
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Thanks, Susan, that is so exciting to see them moving it along- this looks like they are trying to vie for second or thirdline treatment. Lots of sites in the US, and then a bunch in Poland, Ukraine, and Spain, plus one in Puerto Rico!
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I just found a new drug, OP-1250 in phase 2 trials. Looks like a great ER+ drug when it finally comes out.
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I thought that there was some new rule or law that said that drug trials had to take more high risk people, not have so Many exclusions- has that not started or did I get that wrong?
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NinaCA, OP-1250 does look promising and the company developing it, Olema Pharmaceutical, is in Emeryville, CA. Not sure why they don't have UCSF as a site. A friend of mine knows the people at Olema. I'll ask him.
Nkb, I haven't heard of this law but it should be passed. We are the ones who need it the most and we can't get into any trials because they want their numbers to look good by excluding us.
Hugs, Susan
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https://www.annalsofoncology.org/article/S0923-7534(21)04498-7/fulltext#fig1
this very detailed ESMO article gives recommendations for lines of therapyIn ER+ notice that targeted therapies are preferred to chemo for the first 2 lines in most cases. This should help more patients who don’t respond and are interested in clinical trials be eligible due to the rigid restrictions of lines of chemo.
ER positive Second-line treatment after CDK 4/6 +ET
- o Selection of second-line therapy (ChT versus further ET-based therapy) should be based on disease aggressiveness, extent and organ function, and consider the associated toxicity profile.
- o Alpelisib/fulvestrant is a treatment option for patients with PIK3CA-mutant tumours (in exons 7, 9 or 20), prior exposure to an AI (± CDK4/6 inhibitors) and appropriate HbA1c levels [I, B; ESMO-MCBS v1.1 score: 2; ESCAT score: I-A].
- o Everolimus/exemestane is an option since it significantly prolongs PFS [I, B; ESMO-MCBS v1.1 score: 2]. Tamoxifen or fulvestrant can also be combined with everolimus [II, B]. If everolimus is used, stomatitis prophylaxis must be used.
- o PARP inhibitor monotherapy (olaparib or talazoparib) should be considered for patients with germline pathogenic BRCA1/2 mutations [I, A; ESMO-MCBS v1.1 score: 4; ESCAT score: I-A] and as an option for those with somatic pathogenic or likely pathogenic BRCA1/2 or germline PALB2 mutations.
- o At least two lines of endocrine-based therapy are preferred before moving to ChT
Dee
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Susan- it's interesting in trying to google it- there does seem like many institutions are ready to revamp criteria - essentially the way things are now very few lobular patients can get into studies, bone met only patients can't (no measurable disease), most hx of brain mets are excluded- possibly if they are"stable" brain mets you will get in or else they couldn't do many trials for Her2+, most elderly and people with heart disease and diabetes often excluded- they basically want healthy patients- doesn't reflect who needs treatment.
Hope for changes soon-
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Thanks Susan for asking about OP 1250. And while you are asking around, is there anyone at UCSF that specializes in ILC for a second opinion?. I'm taking Xeloda and have high tumor markers above 1500 but nothing on scans at the moment. I'm thinking maybe I should add an AI. They discounted taking Tamoxifen and Chemo a long time ago, but I've been looking at research and there were trials that showed adding an AI was helpful to chemo. Maybe with ILC it will be very helpful.
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Nina,
I don't know much about ILC but I did a quick search and found this BC surgeon who is leading research/treatment for ILC at UCSF: https://breastcaresurgery.ucsf.edu/faculty/breast-care-surgeons/rita-mukhtar,-md.aspx
You should contact UCSF and see if you can get an appointment with her.
Turned out that my high school friend, who talked big about his connections with Olema, came back to me and said that his friend is not in trials so wouldn't be able to help me. He didn't even offer to try contacting his friend. The company is pretty small so I'm sure his friend there would know who to contact. I asked him to try.
Instead I started off by writing to the contact listed on the trial site. It's a long shot but worth the small amount of effort.Hugs, Susan
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Some good news! An oral SERD, Elascestrant, reached its primary endpoints in a Phase III trial. Hopefully, it will be approved early next year.
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For those with triple-negative cancer, the FDA just approved a clinical CAR-T trial- the cancer will be targeted to ROR1+ -expressing tumors, as ROR1 is not in normal tissues- the CAR-T design includes a built-in immunotherapy component, so the immunotherapy only acts in the cancer cell and thereby avoids some of the systemic side effects/risks.. Requires at least one prior chemo and no limit on number of previous treatment, needs at least 20% ROR1 expression in the cancer
https://www.wwnytv.com/prnewswire/2021/10/26/preci...
A similar trial is already operating at the Fred Hutchison Cancer Center in Seattle. "Genetically modified therapies, such as ROR1 specific chimeric antigen receptor (CAR) T-cells, are taken from a patient's blood, modified in the laboratory so they specifically may kill cancer cells with a protein called ROR1 on their surfaces, and safely given back to the patient after conventional therapy. The "genetically modified" T-cells have genes added in the laboratory to make them recognize ROR1"
https://clinicaltrials.gov/ct2/show/NCT02706392
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Drug under clinical trials- OP-1250 - a CERAN drug- a Complete Estrogen Receptor Antagonist. This drug is in phase 1/2 stages at the moment, developed by Olema Pharma. They say "Our goal was to develop a next generation antiestrogen that is both orally available and potently blocks all agonist signaling mediated by ERalpha by targeting both activation functions of the ER (AF1 and AF2) " They finished animal studies and are now gathering volunteers for dosage levels in many different states. It looks like a promising new anti-estrogen drug, but we have heard that before. At least looking forward to the future.
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Curious would the ROR1 be something that shows on the TEMPUS???
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Nicole, I don't know about TEMPUS, some of the genetic tests only look for mutations, and TEMPUS has one test that looks just for DNA repair mutations so that one would presumably not pick it up- reportedly, more than half of TNBCs express high ROR1. There are also reports in the literature of CAR-Ts directed towards other cancer-specific proteins and are intended for TNBC, but I don't know if any have yet made it to clinical trials. I just saw a report using newer more sensitive antibodies that finds some ROR1 can be detected in certain organs, but they have yet to see whether that creates a problem or not
The California Stem Cell initiative is sponsoring a trial looking at monoclonal antibodies to ROR1, in combination with paclitaxel
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Does anyone know of a clinical trial that accepts "free fluid surrounding the live and pelvis with increased FDG uptake" or "Nodularity of omentum with mild increased FDG uptake concerning for metastatic disease." as a way to measure results? My MO doesn't know of any so I am just switching from Xeloda to Taxol for my next move. Thanks,
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A new phase 2 trial has started up looking at an ADC that is directed towards Her3 (ERBB3) protein in MBC. It allows three prior chemos for TNBC, 2 prior chemos for ER-positive cancers...
https://clinicaltrials.gov/ct2/show/NCT04699630#co...
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Cure ious, I had an appointment at Mary Crowley Research Department in Dallas last week. They don’t have any trials open for me right nowbut are still checking.
The Dr did tell me about a trial they had
that just closed. She said it did really well and should be FDA approved soon. It is a SERD type drug especially for my type of ESR1 mutation. D538G.
I wonder if you can find out what the name and or number of the study drug is. And who the Pharmaceutical company is. If it’s fast tracked and coming out soon, I may just wait for it.
Thanks, Vicki.
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crossposted to liver mets
I'm off the Arv-471 trial due to progression in the liver- "several new hepatic lesions". But no location or size on the report !!! 😤 stupid radiologist. SCRI PA let this slip too. 😡.
I was able to get in to see my home MO today (I know I am so blessed) and he actually looked at the images and had trouble finding the lesions on my latest scan, so they are small. I am asking for Sarah Cannon to get an addendum with the missing specifics.
It was a good 11 month ride with manageable SE so I recommend it to anyone with strong er+ that can qualify. I was on single agent.
SCRI wants to get me in the OP-1250 CERAN trial next. That is a great next step. However, since the original tumors were still mostly stable, and new lesions showed up, they want a biopsy and TEMPUS to make sure I am still er+ and look for any new mutations to target. Scheduling is an issue because I am driving to Iowa for my step moms funeral this weekend. I want to have the biopsy at home. I'm on a blood thinner so i am stopping that in hopes for a biopsy on Wednesday or Thursday this week or it will have to wait until middle of next week.
Ugh! The new trial is a 4 week wash, Tempus takes at least 3 weeks, we don't have the complete scan data for IR, will the new lesions even big enough to biopsy, my BP was 168/92 from the frustration and anxiety, etc etc etc. 😵💫
The good news is my wonderful home MO 😇 was so compassionate. He asked about me and how I was doing before the report today. He wants a follow up in 2 weeks just to check on me while I wait. He said my liver does not look much different from the June scan. We want to get on top of this progression, but my liver enzymes are perfect so it is not emergency level, but he understands and supports the urgency.
I am resisting researching other next steps in case I don't get in the OP-1250. 🙏🏻 for everything to work out and I don't have to be off treatment too long. I'm thankful for trials that give us access to new drugs.
Dee 🦋
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Vicki- I will guess that they are referring to the Lasofoxifene trial (link below), which is active but no longer taking patients, as they were are a small phase 2 trial that filled up quickly. And they do have the trial going on at Mary Crowley, you can see there on the Contacts & Locations.
Lasofoxifene is a tamoxifen-like drug which binds and inhibits the estrogen receptor, even if it has various mutations, and unlike the AIs, it is bone-strengthening (has anti-estrogen activity in tumors but some pro-estrogen effects in other tissues, like tamoxifen does). It is stronger than Faslodex and works even better when combined with a CDK4,6 inhibitor (Ibrance or Verzenio have been tested)
https://www.uchicagomedicine.org/forefront/cancer-...
Here is the trial: https://clinicaltrials.gov/ct2/show/NCT04432454
the question is whether to wait for it- is it really going to FDA for approval? It must need to do phase three, but with Ibrance, they did not wait for the phase three trial to be completed, once it was fully enrolled, the FDA went ahead and approved it for everybody with the proviso that the trial would be completed and had to show the anticipated good results.
Here is an announcement that the trial filled up last August, and expect to start reporting results early in 2022, along with a "plan for clinical development". It is fast-tracked by the FDA due to the unmet need in treating ESR1 mutations. But its not quick, you will probably need to pick something else to try if you have to change treatments soon, as this will still take a bit of time
https://www.globenewswire.com/news-release/2021/08...
However, with the ESR1 mutation, you could join a trial for ARV-471, as Dee did, or another SERD, they all seem to work on the ESR1 mutations
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Dee: I'm sorry to learn of your progression. Just want to thank you for letting us know about your future treatment plan. You're willingness to share gives us hope and a pathway for us to follow when needed.
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Dee I am soooooo sorry to hear about your progression but very glad your liver numbers are good and they are very small keep us posted on what is going on.
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Dee, we were cross-posting and I just now saw your note- I'm sorry to hear about the progression, but wonderful that they caught it early, and yeah its all OK except for the extreme anxiety it produces!
It's really interesting how the clinical trials world work, and these days it means moving patients around on different SERD trials, there is no reason to leave that realm, since these drugs work by different mechanisms and they are very interested to know what they can eke out in different sequences.
Presumably they will also look at the ESR1 mutation status, apparently it can disappear once you are on treatment for awhile, so would be helpful to know that is maybe one less thing to worry about. If you go onto OP-1250, is there a chance you can also get Ibrance? (it seems you haven't had Ibrance thus far?)
And any change (increase) in Her2 levels would also be action-able nowadays, at least in trials. One would think the trials would be very interested to know what resistance to their drugs looks like in the real world, in terms of molecular changes in the cancer, so it makes sense they want all the biopsies and tests they can get.
Happy to hear your MO is going to keep a close eye on you as you go through the waiting and washing out and testing period!!!
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Here is an update of the HorseRace that the SERD trials have become, now that there we have a race to the finish line...
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Gosh Dee I’m so sorry. Those liver monsters are so stubborn for both of us. Grrrrr. I’m glad yours are still small and I’m praying they can get a good BX quickly so they can get it to Tempus, etc. I’m glad you have another trial available. Especially thankful that your home oncologist is so caring, too.
Cute ious. Thank you thank you for all the information you posted for me. I’m going to devour it.
Thank God for BCO friends.
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(((((Dee))))) We're here for you All
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thanks everyone!
Biopsy on Thursday (7 th one since MBC)
Only 3 spots open on CERAN and they don’t hold spots so I am hoping I qualify and get one 🙏🏻
Dee
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Dee, Sorry to hear of your progression. Hoping you can get one of those spots on the CERAN trial.
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After reading all the details about the trials MC thought were open, I don’t think I am going to be able to do what it takes to be in a ct. Even a local one would mean going everyday in some cases. Of course MC is now saying they don’t have ANY trials open that I would qualify for.
I’ve read all the links you posted Cure ious and understand more about the time it takes for approval, etc.
I am talking to my onc about circling back to one or two of the drugs I’ve taken before. It’s been five years since I took Ibrance. Plus we could try Faslodex again. If either or both of those would just keep me stable until a new SERD or SERM is approved, that would be great.
Quality of life is my most important pri right now.
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Dee, so sorry to hear about your progression, it's always tough to hear. Fingers crossed for the new trial.
Grannax, i'm sorry that it will be too much for you to handle with the beginnings of a trial. it is very wearing. My MO is firmly in the camp of revisiting old drugs that worked well in the past. I hope one of those will give some relief.
I'm off my trial for a couple of weeks as my port blew up at my CT scan yesterday. Tracer blew out of it, all down the back of my shirt but apparently enough actually went into me that they could read the scan. MO says she's not a radiologist but it did look better to her. I'm hoping that once they get a new port installed they will do another CT as I would like to really know if being on 1/2 the trial drug & 90% one week on/ one week off nab-paclitaxol is doing the trick on these liver mets.
take care all, cheers, dee
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dee, wth about your port?!!? I've never heard of that happening. How old was your port?
Fingers crossed for good scans.
grannax2, definitely important to figure out whether a trial is a help or whether it just sucks up way too much time. Early on after I got dx'd with mbc I read something where the author was suggesting to consider how much time we wanted to sit around in doctor's offices & trials definitely take their toll with appointments.... Hope your oncologist comes up with an excellent plan.
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moth, my port is 7 years old. I hadn't had any trouble to speak of previously. The radiologist looked at the scan & could clearly see where two sections of tubing had exploded and he waited in the dept til my MO came to look at it. I'm a bit scared to not get chemo yesterday but OTOH I'm excited to feel better & get some painting done and the kitchen reno finished off.
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