Are you currently (or have you been) in a Clinical Trial?
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chasing on the heels of trodelvy, another TROP2 candidate is currently enrolling met tnbc pts in a phase 1 trial. U.S. and Japan.
Drug is called DS-1062
https://www.daiichisankyo.com/media_investors/medi...
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https://clinicaltrials.gov/ct2/show/NCT04505826
Dee, Is this your trial? It just started and is offered only where you are and two sites in FLA- how lucky is that?!
It seems like they are saying you have to both inhibit the two transactivation domains of ER and cause it to get degraded, and maybe this is why so many of the earlier SERDs failed? A very exciting drug...
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Just checking in here because I received a newsletter today from the Cancer Research Institute, which promotes immunotherapy treatment for cancer.
Is there anyone reading this who has used immunotherapy successfully AND is not TNBC, either as a single agent, or with chemo, or with cryotherapy to a tumor? Keytruda is on my doc's list for possible use after Piqray and Ibrance, because I have tumor mutation high and the FDA has approved for all solid cancers with that finding in genomic testing.
Thanks for any replies. Just trying to gauge if folks are dipping their toes in this yet.
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cure-ious
Yes that is the trial. I just got the call that I have a secured spot!!! but I must wait to sign consent on Sept 28 because it is a dose escalation study and Sept 25 is the phone call day to proceed to next dose.
There are only 6-12 patients in front of me. So it is very new but SE are similar to other SERDs- Potential SE are hot flashes, vag dryness, Nausea, D, some liver enzyme issues, etc.
I will have start up scans and a newbiopsy. My first dose is Oct 7. That is a 6 week washout 😳 Weekly visits for 2 months then scan again. I stay on it as long as it is working and I tolerate the SE.
No more Faslodex shots🙌🏻
Dee
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Bev.... How different is Keytruda than Tecentriq?? I can tell you that in the thread on here August Chemo...that Mel is on Abraxane + Tecentriq and she is ER+ Her2-... She just started though.
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Nicole, keytruda targets programmed cell death receptor PD-1 whereas Tecentriq targets programmed cell death ligand PD-L1. I have to look up my bio texts for more details but I THINK PD-1 is the whole protein where as the ligands are signalling molecules that get others to bind to the protein. science direct said: "Programmed cell death protein 1 (PD-1) is a cell surface receptor that regulates T cell activation through binding to soluble ligands PD-L1 and PD-L2"
So anyway.... my understanding is that these 2 drugs are targetting a slightly different aspect of the cell signalling process so might have slightly different outcomes
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Nicole, thanks for posing the question (my F1 report said that tecentriq was also a good match for me) but the molecular tumor board at Hopkins suggested Keytruda as a single agent.
Moth, thanks for that great information. A bit over my head, though I read stuff every day, but interesting nevertheless.
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Thank you for that explanation Moth! My F1 says PD-L1 so me wanting Abraxane with Tecentriq next would be good for me.
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There's a good explanation of PD-1 and PD-L1 on bco's article about kaytruda research
https://www.breastcancer.org/research-news/keytrud...
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Dee,
I've been looking at the DS-1062 trial too. I am currently on the ADC, Trodelvy, from Immunomedics. Because of the similar payload to Enhertu, I cannot get on to Enhertu after I progress on Trodelvy. The payload for DS-1062, patritumab deruxtecan, however, targets HER3. I have 2 ERBB3 somatic variants. Will talk to my MO next Thursday.
I am not TN but Trodelvy is also supposed to be for TN and I have been on it for 10 cycles so far as part of the TROPICS 2 trial.
Looks like the closest site for me would be UCLA. Hopefully, UCSF will join the trial too.
Hugs, Susan
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According to this there was supposed to be a trial of Trodelvy PLUS Tecentriq together - this really interested me as a possible next step if my taxol + tecentriq stopped working. https://www.pharmaceutical-technology.com/features...
But now that Gilead bought Immunomedics I wonder if Roche is still interested in pursuing this... I sort of wonder if Gilead swiped Immunomedics from under Roche's nose.0 -
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For those researching clinical trials, here is one that started in 2020. and combines a CDK7 inhibitor with fulvestrant, designed for use after progression on I/F. The pre-clinical data for this drug look good, The drug hits MYC pathway genes, among others. let's see what it does in people!
https://clinicaltrials.gov/ct2/show/NCT04247126
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I am amazed at how many breast trials are at Sarah Cannon in Nashville. Why didn’t my old MO get me in their system long ago? Why am I the one to find the trials and get myself in? Grrr
cure-ious- I looked at this one since it is at Sarah Cannon
SY 5609, a Selective CDK7 Inhibitor, but it says no one who is Immunocompromised. Hope it is a good one.Susan- I‘M not triple negative or ERBB3 so I don’t know much about the trial you are looking at, DS-1062. But it looks like AstraZenica just put billions of dollars behind it!
I did find out that once the OP-1250 trial reaches Best dosing, they are expanding the trial sights. Hopefully that may happen for the DS-1062 and will include UCSF for you. FYI-My daughter is moving to the SF Valley in Feb for her husbands job- he is Air Force.Dee
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Cure-ious,
Thanks for sharing info about the CDK7 inhibitor + Fulvestrant trial. Sounds promising. Unfortunately, patients with brain mets are excluded. Lately, most trial exclusions are "No active, uncontrolled brain mets". No brain mets at all doesn't make sense. I've had brain mets for at least 6.5 years and doing fine.
Hugs, Susan
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Dee, I thought of you, because there are (right now) only a handful of sites for this trial and you are one of them! Their contact is Erika Hamilton, maybe she would be good to go consult about it sometime? I don't know what they mean by being "immunocompromised"
Susan, Maybe the brain mets are something that can be argued? This trial otherwise seems pretty open, no restriction on prior chemos, most restrictions seem to be to wash everything out before you get started. Perhaps they know it cannot cross the blood brain barrier and so brain mets would be untreated? But if they were already treated it seems this could be worth arguing to open up on this issue, like the other trials do
If anyone has tried a CDK7 inhibitor in trials please weigh in! Would love to know if this works, and what the side effects might be..
Hope this trial is successful and moves to other sites. An oral CDK7 inhibitor and Faslodex would in principle be a welcome new option
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Susan- you doing a headstand In your photo is amazing. Sorry about the brain mets issue with trials
Cure-ious- Erika Hamilton is my trial MD!! She is over many trials. my history of being immune depressed with hypogammaglobulenemia and taking IVIG almost kept me out of any Sarah Cannon trials. Long story there. IVIG has the potential of keeping me out of most immunotherapy trials or drugs like yervoy, opdivo, keytrudabecause they bind to Ig to carry the drug. I am testing weekly to see if I can wean off IVIG But each week it is dropping lower! Still in the normal range but close to low normal.
NIH said they have a breast trial (CV301 vaccine with M7824 and an anti-IL8 receptor drug) coming out in November that I can potentially enroll. but I need something now and the NIH doctor said that being on an experimental drug won't disqualify me but I will need a wash out from it. Keeping it in my bucket.
If you have some questions for Dr Hamilton about SC trials please send me a private message. I will do my best to bring them to her at the right time.
Dee0 -
BevJen, I am successfully using Keytruda and I'm not TNBC. I am HER2+ so I am receiving Keytruda along with Herceptin. My MO suggested it due to the fact that I also have high tumor mutational burden. I've been on it for about 15 months and have been NEAD since the first scan after starting on it. I've previously had 4 lines of treatment as well as SBRT (twice). It's been a great drug for me with very manageable side effects though I know that's not the case for everyone. What else can I tell you about it? Whatever you want to know, feel free to ask.
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Hi, Margarita,
Thanks so much for responding. I'm guessing there may be others out there but you are the first to respond.
I may be at a treatment change point. I've been on Ibrance/Faslodex since August 2019. My MO talked with the molecular tumor board at my cancer center, and as of now, there recs for next drugs and order is this: piqray (I have been tested for PIK3CA); then keytruda (based upon my high tumor mutational burden); then neratinib (based upon my ERRB2 mutation). I am a fan of immunotherapy and would like to move that one up. My MO is not as high on it as I am, and consistently talks about the rare side effects. But your story is heartening.
Two questions: 1) do you use a port to have this drug delivered? If you've been on it that long, you must be getting it every 3 weeks (the FDA just approved treatment every 6 weeks, which is what I would push for).2) what side effects do you have?
Thanks so much.
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Always so much to gain on this thread! Feels like home😊. I’m interested in the CDK7, Keytruda for HR positive And SBRT. Thankful for all the sharing Here and potential Treatment options. I continue to pray for healing Treatment for all of us!
Nicolerod you look simply beautiful! Thanks for sharing. My son will get married this coming June and I’m with you about Mother of the bride issues.
It looks like my original biopsy(1/18) came back positive for Pi3k mutation. I will go over Piqray and Faslodex with my MO on Wednesday. Have my first Faslodex shots. I’m sad to move on. Really Scared about SE and my liver not responding. I’m going to bring in treatment options and local options for him to look at.0 -
MargaritaMS,
So wonderful to hear a success story on Keytruda! Keytruda did nothing to my tumors but instead gave me what seems to be chronic oral mucositis. I was only on Keytruda for two months. My TMB=5 so not high and I'm not TN. I requested the treatment despite these indications that it wouldn't work. I do think it kept my immunity high for the first eight cycles of Trodelvy. Only recently had to start taking Nivestym because my Neutrophils were too low.
Dee,
What is the trial for CV301? I looked it up and on one site it said it had been discontinued for breast cancer. Since you spoke to the NIH they must know best.
Hugs, Susan
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I posted this on the stage 4 triple neg thread also; trial for metastatic triple neg but PD-L1 negative
Trodelvy versus Trodelvy+ Kaytruda https://clinicaltrials.gov/ct2/show/NCT044680610 -
Susan
I don’t know much about the NIH breast trial triplet (CV301 vaccine with M7824 and an anti-IL8 receptor drug) coming out in November other than it was something NIH said I could consider since they said no to carT.
FYI- it does not have an NCT number yet. When it does I will post it since I am in contact with the research doctor.
Dee
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Dee --
Was the no to carT by NIH because of your immune-depressed status? Did you send your records through to them? I've got three different carT trials sitting on my desk that I think look very interesting, but they each require some period of time in the hospital. Normally that wouldn't be SO awful bc I live maybe 15-20 minutes from NIH and my DH and family members would be able to visit presumably. But I am guessing that's not so in Covid times. One of the trials requires a month long stay at NIH...
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bevgen- yes my hypogammaglobulenemia is too risky to try carT. I have not put my paperwork in yet at NIH. Have you? I hope you get some clear direction about which way to go. Sometimes one door closes- even temporarily and another opens.
Dee
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Hi BevJen, to answer your questions, I do use a port for Keytruda but every treatment I've had for the last 5 years of this fun and games has been via infusion (Taxol, Herceptin, Perjeta, Kadcyla, Zometa, Abraxane) and now Keytruda. Funny enough, since Covid, I've been switched to injections for Herceptin in order to reduce my time in the med center. And yes, I'm on a three week cycle. To be honest, I'm not sure if that's because of the Herceptin schedule or what. There was never a discussion with me about it.
As for side effects, for me (so far) they've been minimal. I get a headache on around the third day after infusion that is bad enough to wake me up and a bit of the D that I can only describe as intermittent but frankly these could be due to either of the drugs. I'm fortunate to have these mild side-effects - I know - because many people, like our own Susan in SF have much worse effects. Feel free to PM if you want to discuss further. It's a tough choice. I also have the PIK3A mutation but since there are other lines of standard treatment for HER2+, I wasn't offered Piqray.
SusaninSF, I’m really sorry to hear that you now have chronic mucositis - it sounds terribly uncomfortable. I followed your treatment updates while you were on Keytruda. It seems like there have been scant few to have benefited without significant side effects.
-M.
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ESMO2020 is finally underway. New data were released regarding Trodelvy, the drug that induced Gilead to buy Immunomedics for 21B. Trodelvy is the ADC Trop-2 antibody w/chemo payload.
Great data for TNBC in the update, explaining Gilead's decision to go with this drug, it not only improved outcome over standard chemo but increased overall survival by half, and this is just as monotherapy. They are now starting two phase 2 trials combining Trodelvy with Keytruda, moving to firstline TNBC as well as to ER+ HER2- cancers, where there obviously is a lot of room for improvement over chemo alone .
https://www.fiercepharma.com/marketing/esmo-new-tr...
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oh man, I'm so excited about trodelvy!
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Looking for that trial of keytruda and trodelvy for hormone positive cancers!
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More data out from ESMO2020 about the Piqray trials: Piqray is for ER-positive patients with a PI3KCA mutation
Piqray was already known to extend PFS to 11 mos compared to 5-6 mos with Faslodex alone.However, new data now show that overall survival also increased by eight months- which was just short of being considered clinically significant.
However those with liver or lung mets got a bigger 14 mo boost in overall survival, to 37.2 mos- definitely significant and big progress! They now want to move Piqray to TNBC and HER2 patients with PI3KCA mutation
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