Are you currently (or have you been) in a Clinical Trial?
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@Susaninsf - my doc is suggesting immunotherapy for me as well. I just have one site anterior to my sternum. When it was biopsied my NGS resport showed high tumor burden - as I understand high tumor burden in a HER2- ER+ patient makes them a good candidate. This article was very reassuring - 67% had good response!
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I am heartbroken to pass on the news that Shetland Pony passed away July 16.. Very heard to bear.
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Oh, not our sister Pony.
She is another one who made me feel so welcomed to the group with my diagnosis and being so uncertain about everything. I loved her posts and her treatment story was always one to bring hope. She can rest well now.0 -
So sorry to hear about Shetland Pony. Thank you nkb for posting.
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So heartbroken. Shetland Pony was so kind and generous. Hope she went peacefully.
Hugs, Susan
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Several new trials are testing monoclonal antibodies directed against different proteins in the tumor microenvironment that protect the tumor from immune attack. These are being tested together with checkpoint inhibitors, in the hopes that they will greatly increase the response of MBC and other solid tumors to immunotherapy.
The link below is to one of these new trials, phase 1: this one uses an antibody to the LAIR-1 receptor, in combination with Keytruda. At present, this trial is offered at MD Anderson, Mt Sinai, and in MI, and is open to many solid tumor types:
https://clinicaltrials.gov/ct2/show/NCT05311618v
https://www.jci.org/articles/view/155148
Another one we discussed before has anti-TREM2 (PYR314) in combination with Keytruda: https://clinicaltrials.gov/ct2/show/NCT04691375?te...
This combo has found its desired dose and is going forward in 5 different cancer types, including metastatic HR-positive/HER2-negative and triple-negative breast cancers
https://www.businesswire.com/news/home/20220526005...
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Jensgotthis, How are you doing?!
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sad news about Shetland pony , big loss for this community. Condolences to her family and friends. May she RIP
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Enhertu for HER2-low ( and it even worked fairly well for HER2-no) was given priority tracking today by the FDA, with a decision expected towards the end of this year. It was the big story as ASCO2022, with clinicians giving the presenters a standing ovation, good progress!!
A good discussion here: https://www.medscape.com/viewarticle/975138
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Cure-ious,
Thanks for the updates on PYT-314 and NGM-438. How do you find out about the latest trials? I use a few of these search sites but I haven't found one that I can use to filter out by date.
Hugs, Susan
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Wait...so are you saying that Enhertu may be approved for those that are HER2 0%???? or should I say those that either receptor flipped ER+ HER2- and TN????
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Hi Nicole- Nope, it will be approved for HER2-low and probably have to come to some agreement about the exact assay used to measure that. One of the summaries I read showed that the response rate for HER2-zero wasn't far below that of HER2-low, so they are studying whether that means whether those have "some" HER2 expression and/or whether the ADC is targeted to additional protein(s) on the cancer cell surface. They are looking at how the data in detail to see if they can tell how low qualifies as HER2-low. The TNBC group responded as well to Enhertu, slightly less robustly however that was only 10% of the total trial population so I don't know if that is sufficient for FDA to approve those cancers, or whether they need another trial (hopefully not)?! For most the control group was taking Halaven/Eribulin; so Enhertu did better and also gave a 6.6 month overall survival advantage on top of that
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I'm HER2 2+. The trial results were enough to convince my insurance company, after a ridiculous battle over dosage frequency, to approve Enhertu on a monthly basis. Cigna insisted the dosage frequency is every 4 weeks though you can just google it to see that the approved dosage is every 3 weeks.
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Susan, Is that new? I thought you had some +1 or +2 HER2 that developed over time (upon resistance), but now the cells have amplified the HER2 gene? If so, WOW, fabulous news!!!
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Cure-ious,
Actually, my first FISH test back in 2014 said I was positive. I don't think my MO ever believed that since I wasn't put on any HER2 treatments. Every test since then has said I'm 2+, equivocal. Since I responded well to ARX-788 (accepts 2+ or 3+), I may be able to qualify for HER2+ trials. Stanford is talking to Bolt Biotherapeutics to see if I can get on the BDC-1001 trial.
Hugs, Susan
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Wow, Susan, this is an exciting trial (if I am looking at the right one?), and altho quite new, its large for a phase one. Anti-HER2 monoclonal that has been linked to a TLR 7/8 agonist component and given together with checkpoint immunotherapy! And the trial is open for any and all cancers that either ampliify or over-express HER2 . And look at the abstract below, they are seeing results with just the monotherapy on patients who progressed on previous anti-HER2 regimens, and the whole design is this should get much stronger when immunotherapy is layered on, since the TLR7/8 agonist remodels the tumor microenvironment to let the T cells get in and attack the tumor.
https://ascopubs.org/doi/abs/10.1200/JCO.2021.39.1...
https://clinicaltrials.gov/ct2/show/NCT04278144
So, does Hope Rugo suggest all these trials for you? Or is there someone who helps navigate clinical trials? It seems that you go in and out of these so much faster than anybody else on this site, and have really top-notch options?
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I'm new to this board. Lots of information to absorb. My starting questions are very basic. Do I wait until my MO brings up the possibility of participating in a clinical trial? What if the MO has expressed limited or narrow interest? Am I on my own to find a Clinical Trial that is appropriate and available for me? I assume the feasibility of travel is a major consideration, correct? How do you work with your current MO and also take part in a Clinical Trial at a different facility? Some general guidance on this aspect of the MBC journey would be appreciated. Thank you.
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I just read about the MAINTAIN clinical trial that showed the benefit of ribociclib and switching endocrine therapy after progression on a CDK4/6 inhibitor. Lead author is Kevin Kalinsky, MD, of the Winship Cancer Institute in Atlanta. Palbociclib (Ibrance) was the prior CDK4/6 inhibitor in the majority of participants.
I've recently progressed on Ibrance and my MO has laid out a plan with several treatment options, but ribociclib is her "last option". I just don't know what to think or how to evaluate the quality of advice I'm getting.
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Cure-ious,
I comb through the clinical trials myself and pay careful attention to anything you bring up here. Hope suggested the ARX-788 trial. She is also very supportive of my efforts to contact the trial sites I have found. She had a colleague at USC to help me get on the ARX-788 and also worked with the sponsoring company. Most of the sites don't want to talk to you without a referral. I found the BDC-1001 trial but Stanford didn't get back to me until she asked a colleague to help. Stanford has an Early Drug Development group that contacted me. These extra efforts don't have a billing code so Hope basically does it for free. When I thanked her for all of the extra effort she said, "This is what doctors are supposed to do!".
As you once described her, "Best breast oncologist on the planet!" Combined with all of the information you share with us, I'm so lucky.
Hugs, Susan
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Susan, it sounds like you make a lot of your own luck!!!! ;-)
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weninwi- Generally one would keep on with endocrine therapy in some combination until the cancer is truly endocrine resistant, and at that point try (by genetic testing) to identify which signaling pathway the cancer is using to grow- get a drug to hit that pathway and then most often the cancer reverts to estrogen-dependence and you can get back on endocrine therapy. Or like Susan, the cancer may develop HER2 expression or amplification and then there are a series of HER2 drugs that can be used. I went from Ibrance-Femara to Ibrance-Faslodex, and next would maybe be some other CDK4,6 inhibitor with a SERD or ARV-471 in a clinical trial. The clinical trials have many great options but its hard to know how trials work, one has to consult a doctor at a site where it is offered. They can have a lot of restrictions, such as no more than one or two chemos in the metastatic setting, so best not to leave it for last, when all of the other options have run out. Trials often expand the number of places where they are offered, so if not convenient at first, might become an option later.
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weninwi,
I suspect that Ribociclib is at the end of your list since you have already been on Verzenio. They are both CDK 4/6 inhibitors and Verzenio is newer and stronger.
You can see from my posting above some of what's involved with getting on a clinical trial. I should clarify that when I still qualified for Phase II or III trials, my MO found them for me. Now that I'm so heavily, pretreated, I can only get onto Phase I trials so I have been researching them myself. My last trial was in LA, but I don't want to travel beyond that. This limits my choices since MD Anderson and others have some interesting trials too. If I run out of choices, I will consider travel. I just need to stay alive long enough for more drugs to come out, trial or FDA approved. I was on trials for Ibrance, Piqray, Taxol, Trodelvy and ARX-788. All have bought me more time. The introduction of ADCs, for example, opened up a whole new class of drugs. There are a lot of new ADCs in the pipeline right now with innumerable combinations of antigen targets and toxic payloads.
You may not have to look at trials for a long time since there are so many approved drugs you haven't yet tried. In a big hospital like UCSF, it's beneficial to be on a trial because you are assigned a trial coordinator who makes sure everything gets scheduled on time. Don't what it's like where you are.
Hugs, Susan
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Cure-ious,
I think you missed my post to you about my HER2 status. I didn't develop it. My first FISH test back in 2014 actually said I was HER2-positive though I wasn't put on Herceptin. Subsequent tests have said I was HER2 2+ equivocal.
Hugs, Susan
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Cure-ious and Susaninsf,
Thank you both!...gives me some real-life context to better understand the world of clinical trials. I found and sign up at breastcancertrials.com which gets me on the path to learning about studies. Cure-ious I sent you a private message to ask your opinion about the particular study my MO is pushing me towards.
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FDA Approves Enhertu for HER2-low!!!
Faster than I expected!
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Wonderful news!!! I guess this was an easy one, since its already approved for HER2-positive cancers, so just an additional application...
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https://www.sciencealert.com/breast-cancer-spreads...
"Our research shows that the escape of circulating cancer cells from the original tumor is controlled by hormones such as melatonin, which determine our rhythms of day and night," says Zoi Diamantopoulou, the study's first author and a molecular oncology researcher at ETH Zurich.
This finding suggests to me that taking a melatonin supplement at night might not be a good idea. And yet some integrative medical oncologists and naturopaths use high dose melatonin as a treatment.
And then there is this that was recently posted on the Ibrance discussion board:
Melatonin in Cancer Treatment: Current Knowledge and Future Opportunities - PMC (nih.gov)
I recently developed progression after I started taking low dose melatonin 1.5 mg. I sleep better, but did the melatonin trigger the progression?
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Now that my cancer has progressed and my treatment is in flux, I applied for a second opinion appt from Mayo Clinic, Rochester, MN. I also indicated my interest in applying for a Clinical Trial of PY314 (a monoclonal antibody) at their facility. I was told that my "self-referral" would be reviewed by a Medical Oncologist and after reviewing my latest scans, biopsy, etc and my current MO's treatment plan, they would decide whether or not to offer an appt for a second opinion and whether or not I'd be eligible to apply for or join the study.
Adds to my feelings and the reality that the walls are closing in.
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WeninWI Some here have had good results just sending an email to the contact person listed on the trial, have you tried that? for PY314+Keytruda, the trial lists two contacts who are at the company sponsoring the trial.
Contact: Akin Akinsola 217-637-1792 aakinsola@pionrytx.com Contact: Lynnae Jackson 805-750-0553 ljackson@pionyrtx.com 0 -
weninwi,
I communicated directly with the team at Pionyr who then forwarded my request to Grace Park at OHSU. My email to Akin Akinsola bounced back so it must have been Lynnae Jackson who passed on my request. OHSU then requested a formal referral from my MO. In the end, we decided to give Enhertu a try first. Next up will hopefully be PYT-314 or BDC-1001.
Good luck with your search! You are lucky to be near the Mayo Clinic.
Hugs, Susan
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