Are you currently (or have you been) in a Clinical Trial?
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cure-ious thank you for your response. JFYI the Guardant test in the U.K. shows mutations and what meds are recommended eg ESR1= Elacestrant. It also shows other things such as MSI but not MTB. I had a long chat with one of their reps and he said the USA test is different. It is a price thing and we could order the more expensive USA test but he suggested the U.K. version again for me next time I need one.
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It would be helpful if the mods could bring in a guest breast oncologist from time to time, so we could ask a few questions, after the first couple of lines of endocrine therapy, the best steps forward and sequence of events can be far less obvious
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Thank you everybody to keep this thread so packed in info!
@cblaurenceauthor I think OS it is very important as weel as PFS, because as Cure-ious said a therapy can work also after it is discontinued. Also certain therapies may turn cancer more aggressive after they stop working, other weakened it. And again, some therapies may make working better or not working at all the lines of treatments that are use afterwards, by enancing or eliminating some tumor caracteristics.
So keep track of it (if for example a drug keep people PFS 8 months but after that they immidiately decline and have a very short OS) is import. All though the study may not understand all the causes involved in the process, but it is sure an important number number to keep in account!
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Excellent point about PFS and OS. My cancer exploded after Trodelvy stopped working—like in a month my liver was 60% tumor. Fortunately, the Halaven seems to be working somewhat to keep it under control. I don't think I'll have much of a choice but to go on the vaccine and hope it keeps going.
Thanks for the info and I'll keep everyone posted!
CBL
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Amel, I feel the same way about Orserdu, e.g., it may not work for long if monotherapy is insufficient to hold back the cancer, but at least it is quickly clearing out the reservoir of ESR1m cells, and these might not return if we don't select for them with AIs, so overall its making forward progress.
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SPECULATION AHEAD:
Okay, so get this sh*t…
I just received the results from my Signatera test: it went from 129 to 3.5. That's a like 96% drop. The last drop was from 1529 to 129. This is all on Halaven. So my tumor markers went down 50 (25%), then Signatera goes down 96%, but my scans supposedly show slight progression. However, my last set of scans were misread, so I'm guessing this round has also been misread. Jesus.
I have an appointment with my regular oncologist in 90 minutes. The Signatera report was published yesterday so she probably hasn't even looked at it yet, but I'm guessing she'll either reorder scans, a re-read of the scans, or a repeat test of something. With any luck, I'll stay on Halaven and skip the trial for now.
If it turns out a change of treatment is not necessary, I'll be grateful, don't get me wrong… but WTF? I sure the hell don't need to be on this kind of emotional rollercoaster AGAIN and freaking out my family and friends, and wasting my time and trial people's time, etc. etc. Get it together, radiologists!
It's possible my liver is so covered in cancer, it's hard to decipher, but @#$TT$RW!!!
Anyway, I'll post what she says as soon as I know. Ugh. Stupid cancer.
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what is the signatera measuring? Meaning which value went down?
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This was for circulating tumor dna - similar to tumor markers, but more precise.
At least that's my understanding.
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Okay, so she wasn't as impressed with the Signatera results…not the news I was hoping for, but at least all my worry and stress wasn't for nothing. :)
Considering the mixed response indicated on the MRI, she still considers it progression and a change in treatment is necessary.
She doesn't consider a vaccine to be immunotherapy (which I was concerned with since I don't have the PD-L1 or anything else to say I'd be a good candidate).
She will run weekly labs until I start the trial in case my cancer explodes like it did last time we can back out of the trial and start Gemzar right away.
Sorry for the freakout. Will let you know what the trial coordinator says about my questions.
CBL
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CBL, Sounds like Halaven did a lot, and maybe its better to leave a bit early & give time for the vaccine to work? Good luck!
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Updates stats on RLY-2608+Fulvestrant for PI3KCA mutants
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Cure-ious very intrresting what you wtote about Elacestrant and clearing esr1.
I wish there were more studies about all this, the right meds sequencing, the effect on meds on cancer cells genetic...i think is so important.
CBL good luck. Let us know about the vaccine!
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ESMO update: A phase Ib/II study in patients with metastatic breast cancer (mBC, n=26) and other solid tumours (n=7) demonstrated that a combination of selective inhibitors of CDK4 (PF-07220060) and CDK2 (PF-07104091) was generally well-tolerated with promising antitumour activity. For patients with mBC, median progression-free survival was 8.3 months and the clinical benefit response rate was 50.0%. Of the patients with mBC and measurable disease (n=18), 5 had partial responses (all with known ESR1 mutations) and 5 had stable disease. Commenting on the results, Siu says, “This is a clinically relevant strategy as all patients with mBC in the study had previously received CDK4/6 inhibitors. Resistance to these agents occurs and such patients will require new treatments. It is also noteworthy that patients with ESR1 mutations appear to be particularly responsive to the combination used in this study and may serve as a selective biomarker for future evaluations.”
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Background. We present dose escalation multicenter data of PF-07220060 (PF-60, CDK4-selective inhibitor) plus PF-07104091 (PF-91, CDK2-selective inhibitor) in patients (pts) with HR+ HER2- metastatic breast cancer (mBC) and advanced solid tumors (NCT05262400).
Methods PF-60/PF-91 (100/225, 200/75, 200/150, 300/75, 300/150 mg) was given orally twice daily (BID) in 28-day cycles. BC pts could start fulvestrant at Cycle 3. Primary objective: safety and tolerability; secondary objectives: pharmacokinetics and anti-tumor activity. Efficacy data reported for mBC pts.
Results
At data cutoff 9 of Oct 23, 33 pts median age 56y, median 3 prior lines of systemic therapy (range 1–14) were enrolled. 26 (78.8%) had mBC (all prior CDK4/6i, 80.8% fulvestrant, 50.0% chemotherapy); 7 pts had other solid tumors. Treatment-emergent adverse events (AEs) occurred in 32 pts (97.0%; 21 [63.6%] grade [G] ≥ 3). Most common were nausea (66.7%; 3.0% G3), neutropenia (66.7%; 33.3% ≥ G3) and diarrhea (63.6%; 3.0% G3).One pt discontinued due to treatment related AEs. Dose-limiting toxicity occurred in 2/6 pts at 200/150 mg [1 G3 nausea; 1 G2-3 hematological AEs], and 3/8 pts at 300/150 mg [1 G4 thrombocytopenia; 1 G3 fatigue; 1 G2-3 fatigue and gastrointestinal AEs]. Steady state exposures were comparable to monotherapy. Early (cycle 1 day 15) decreases in circulating tumor DNA were seen. Based on safety, 2 recommended doses for expansion (BID: 100 mg PF-60/225 mg PF-91; 300 mg PF-60/75 mg PF-91) were chosen in combination with endocrine therapy. Of 18 mBC pts with measurable disease, 5 (27.8%, all with known ESR1 mutations) had RECIST v1.1 partial responses (PR) with duration of response up to 12.1 months (mo), 5 pts (27.8%) had stable disease. For mBC pts (n=26) median progression free survival (mPFS) was 8.3 months, disease control rate was 69.2%; 6 pts are ongoing at data cutoff.
Conclusions
PF-60/PF-91 combination was generally well tolerated with promising antitumor activity in heavily pretreated post-CDK4/6i mBC pts, including 5 PRs in mBC pts with ESR1 mutations and mPFS 8.3 months. Dose expansions are enrolling CDK4/6i-treated and naïve mBC pts.
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Has anyone been involved in any clinical trials targeting B7-H4? Any success? Trying to decide what my next steps should be. Progressed on Trodelvy and Enhertu.
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Thank you cure-ious for posting the presentation from the NCT05262400 trial at ESMO (for the CDK2 and CDK4 combo). That was the trial I was in from late February 2023 until April of this year - so I was one of the heavily pretreated patients who had a good response. I'm now on Enhertu - and to my surprise and my home oncologist I'm having a good response too. So one upside of having done the trial was that in the meantime Enhertu became funded here in Canada for people with low HER2+.
Good luck to the others looking at trials, I'm sorry to have no advice other than to keeping trying and to commiserate that finding and participating in trials is a lot of effort.
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Hi NewGardner!!! So great to hear from you, you rock!!! Girl are you serious that you are now 15 years metastatic?! Damn!!!! You also should be proud to have contributed to that CDK2-4 trial, they have since discovered that if you hit CDK2, then CDK4 takes over, and vice versa, so you gotta hit both. But that CDK2 drug has been really hard to take, esp as combo, and has taken a long time to even get this far, so hopefully they are pushing it hard across the finish line now…
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MLane,
For AZD8205, 9/44 got tumor shrinkage, however it does have the same chemo payload (Topo I inhibitor) as Trodelvy and Enhertu, and there is some speculation that you get diminishing returns by hitting the cancer with the same chemo and just a different targeting antibody, so you might ask the trial people about that?
There is good pre-clinical data for SGN-B7H4V (see below), which has a chemo payload is different from Trodelvy and Enhertu, maybe this could also be a good choice
https://www.researchgate.net/publication/374464094_SGN-B7H4V_an_investigational_vedotin_ADC_directed_to_the_immune_checkpoint_ligand_B7-H4_shows_promising_activity_in_preclinical_models
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MLane- Don't know if its an option for you, but eIF4A is looking like a good target too
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