Are you currently (or have you been) in a Clinical Trial?
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Thanks Cure..so there are no trials for it right now recruiting in the USA correct??
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This is a screenshot from an account I follow on Instagram - @north.star.cancer.advocacy. It is from a story titled “TNBC trials". Which is saved as a highlight on their profile. There is also one titled “TIL Trials". This is a link to the TNBC reel. -
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Hate to be a naysayer but PACT Pharmacy doesn't have a good reputation. Theresa45 who was connected to the industry said she was seeing a lot of resumes from PACT. The trial started in 2019 but now says Recruitment Status : Suspended (Business decision).
Hope I'm getting it wrong. It's being run by a guy named David Oh at UCSF,
Hugs, Susan
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Susan, I think you are totally correct!!! Right after the trial concluded, PACT moved a bunch of their workforce onto other projects. I read that someone connected with PACT (advisor?, co-founder? don't recall who) told a reporter, "Well, we didn't cure anybody, but on the other hand, we didn't kill anybody, either!" I think he was talking to someone looking at the financial investment side of things, not the cancer... To the cancer press, its a bunch of PR, talking about how they have developed all these cool assays to measure every little thing and are working on the next breakthrough. Does not inspire any confidence...
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More importantly, how are YOU doing?!
PS I could not get through to your husband's blog from the link you provided, just to the Stanford Alumni site- is there a better link?
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Same question Susan- how are you?
I also could not get to your husband's blog from the link- only went to a generic Stanford Alumni site.
Hugs
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Interesting discussion, the SERDs are coming, we could get Elascestrant approved in a month or so, the numbers for this SERD were stronger for those with ESR1 mutations, so its not clear if its much stronger than fulvestrant alone if the cancer does not have an ESR1 mutation. By contrast, a second SERD, Camizestrant, gave a 8 month or so PFS as monotherapy, much better than Fulvestrant alone, independently of ESR1 mutation, but its not as far along in the approval process. Will be interesting to see how quickly MOs ditch fulvestrant... Also there seems to be significant excitement about combining these SERDs with the new AKT inhibitor, Capivasertib
https://www.onclive.com/view/clinical-implications...
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Dear Members,
For your interest, we have posted information on Dana Farber's Embrace MBC virtual forum series for 2022-2023.
The Mods
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Maybe there was a small misspelling? csh@stanfordalumni or chuck.han@gmail.com. Will try from my side.
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Testing. csh@stanfordalumni.org, chuck.han@gmail.com,
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Cure-ious: What do you think of results coming out of the Briacell immunotherapy trial? They hope to move from their Briacell IMT trials to their Briacell OTS trial which will target mostbreast cancer patients HLA.
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Hi Elenas,
I had not heard of BriaCell before, and am no immunologist so I don't have an opinion- hopefully others with more expertise in this area will weigh in!
In small trials they have had success combining Keytruda-type immunotherapy with a cell line that expresses MHC molecules that match the patient and a variety of neoantigens that might overlap with the cancer of the patients. They have only had a couple small trials but FDA is fast-tracking the treatment based on some good results thus far. What do you think about it?
https://www.einnews.com/pr_news/613076767/briacell...
https://www.globenewswire.com/en/news-release/2022...
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Not sure what to think but my oncologist is talking about immunotherapy to me so it sounded interesting. I’ll try to see what she thinks after my CT and follow up next week, Thanks for the info you posted
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Circling back to the PACT pharma trial, although they had modest results the infused T cells were limiting and overall the approach is considered very strong, as discussed in these reviews of the Nature paper published last Nov:
https://www.nature.com/articles/d41586-022-03676-7
https://www.bbc.com/news/health-63584355
So, let's see if new trials are set up quickly.
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Cure for the PACT they do not take Stage 4 cancer patients is that correct? Thats what I saw when I looked it up and it was ONLY at MDAnderson..correct?
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Nicole- The PACT trial I was referring to was only in CA, at like nine UC campuses and a couple other CA sites, and as I recall they were funded by the state via CIRM (CA Stem Cell funding). They took advanced cancers of several different types (two known to be responsive to immunotherapy, like melanoma & lung, two that were middle, like colon, and two that were low-response and MBC was one of those). We discussed it a lot when it first came out, they would sequence the cancer with their own platform technique and pick up to 3 different neoantigens to target- now they are saying the trial was promising but they think they should have infused more of the engineered T cells.
Post a link to what MD Anderson trial you are looking at...
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Oh, interesting, the FDA approved the oral SERD Elascestrant (now re-named Orserdu) but only for cancers with ESR1 mutations (cancers may acquire this mutation as one of several different ways they escape AIs). The study showed a clear advantage for ESR1 mutant cancers, but never reported what the benefit was for cancers without the mutation and clearly it wasn't sufficient for FDA to approve it for all MBC.
So that leaves Camizestrant, which showed a clear benefit over Faslodex, regardless of ESR1 mutation; the other SERDs that have been in contention failed their trials, or dropped out along the way. Testing as monotherapy, Camizestrant had a PFS of 7.7 months, compared to Fas at only 3.6 months,and in the trial for ESR1 mutant cancers Camizestrant PFS was 9.2 months with Fas at 2.2 months. Patients could have no more than one endocrine therapy and one chemotherapy to be eligible for this trial (SERENA-2), but numbers in the trial were small. And beyond that, the only current trials ongoing are Cami plus CDK4,6i for early breast cancer, and for ESR1 mutant MBC, so no idea when it might get to phase 3 and from there to FDA approval.
Looks like we won't be leaving Faslodex anytime soon...
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Cure-ious,
Your news about the FDA's qualified approval of elecestrant has pulled me into this thread.I haven't posted about my latest CTs because I was reluctant to rain on the Faslodex parade after so many successful years of treatment and without yet having a new plan. My lung mets showed progression that my oncologist said required a new treatment. I can't take PDK4-6 inhibitors because I had pneumonitis from Ibrance. My doctor spoke of Verzenio, which I nixed because of my reaction to Ibrance. (I think he had forgotten.) Apparently two possibilities remain before I go on chemo: elacestrant and Piqray. I knew the latter required a gene mutation, but not the former. He sent my blood off for a liquid biopsy two weeks ago. I should learn the outcome Wednesday.
I am a bit shocked that my treatment options before chemo have dwindled so rapidly, but I suppose everyone's learned much more in the 11+ years I've lived with MBC.
Tina
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I'm encouraged to learn of the FDA approval for Elacestrant. My main question is whether the ESR1 mutant cancer may regain estrogen sensitivity after Elacestrant exposure - that would be a second benefit based on my understanding. I have the ESR1 mutation so should be eligible for it when the time comes. I'm on Xeloda right now (after everolimus (Afinitor) and fulvestrant failed). My MO expressed a qualified opinion of Elacestrant last fall....something about a small number in the study who had been on fulvestrant?? I really did not understand her explanation. I see her next week so will bring up the topic again. I'm under the impression that Lasofoxifene is another oral SERM in clinical study. Not sure how far along it is for FDA approval.
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tina2- have you tried Xeloda yet?
Curious - I heard that it was approved, but, not about the restrictions to ESR1 mutations- last time I was checked I did not have one. I have hopes for Camizestrant, but, realize it is probably a long way off. I have been off anti-estrogens for many years-
any news on the Protacs? PACE results? at a summary of San Antonio they seemed to suggest that if you have indolent cancer you could try switching CDK4/6 i after progression.
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I did not see anything posted so copied this info about Susan from her husband...
This is Chuck Han, husband of Susan Kobayashi. I'm sorry if I am breaking etiquette by using her account, but one of her wishes was to notify the breastcancer.org boards of her passing.
Susan passed away peacefully this morning with her family at her side. She was grateful for the support of this community.
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Mara,
Thank you for letting us know. Susan was an extraordinary person. I will miss her.
Tina
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Nkb, Yes, they approved for ESR1 mutants only and also the Guardant test to check for ESR1 mutations. In the link below they explain the analysis of the non-ESR1 mutant cancers showed hazard ratio 0.86, and that most all of the benefit they got was in the ESR1 mutant group, for which Faslodex is not very effective. Good question about the PROTACs and others, will keep an eye out. And yes, I think for those who did well on firstline CDK4,6i, they are now saying the numbers look good for those who got another CDK4,6i in secondline. We need more options, tho!!!
https://www.fda.gov/drugs/resources-information-ap...
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New legislation to allow MBC patients immediate access to healthcare benefits has just been re-introduced in the house, hope it fares better than last time!
"This legislation would provide immediate access to support and medical care for individuals with metastatic breast cancer (MBC) who already qualify for Social Security Disability Insurance (SSDI) and are therefore eligible for Medicare. Under current law, these individuals must wait five months for SSDI and 24 months for Medicare benefits to take effect. This bill would waive both waiting periods, helping individuals with late-stage cancer get the benefits they are eligible to receive."
https://castor.house.gov/news/documentsingle.aspx?...
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Unfortunately, Pfizer announced today they will be dropping the CDK2/4/6 inhibitor they have been developing for endocrine-resistant ER-positive MBC.
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Wow Susan went quick she just posted the other day
CURE... here it is : NCT02593175 can you please post the ones in CA??
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Cureious- For the. CDK2,4,6 I was it too toxic or the efficacy wasn't great? Did they have an arm with an AI or SERD?
I remember Dr Melisko (UCSF) not being very excited about it a year ago.
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nkb, Well they never say, just put it on a list of drugs they are announcing they are dropping, they want to do that as quietly as possible, no details ever...
Nicole, These are apples to oranges trials, anyway, here is the now abandoned PACT trial that was written up in Nature.
https://clinicaltrials.gov/ct2/show/NCT03970382
The only way to get a good adoptive T cell trial is with Rosenberg/NIH, and I wonder if you aren't now eligible, having done the brain rads?
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Here is the obituary for SusaninSF, please share it in the various threads... We were lucky to have her here!!!
https://www.legacy.com/us/obituaries/sfgate/name/s...
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