Are you currently (or have you been) in a Clinical Trial?
Comments
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FYI-
NCT03616587 the AZD9833Serena-1 trial-is at Sarah Cannon in Nashville. I considered this one but could not go on it because According to SCRI the Trialrequired a Faslodex wash out of 6 months, which I was on it at the time. If I fail on the CDK 2/4/6, I may consider this one if I qualify before I go to gem/carb.
Dee0 -
MOTH congrats on signing for your trial. Keep us informed.
Dee
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I am on the Serena-1 trial taking the AZD9833 with everolimus. It is offered at my cancer center in SLC, Utah. I am only 3 weeks into the trial. I took Faslodex with Ibrance last year. When I first expressed interest in the trial, there was only 1 spot available in the AZD9833/everolimus arm at the Utah location. Having been on Ibrance for 2 years and also concerned that taking a SERD as a monotherapy may not be the best choice of treatment on my grade 3 visceral mets, I asked to be in the everolimus arm. So far I have experienced several side effects but nothing serious. I suspect some of the side effects are from everolimus.
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Glad you got in that trial KarPC. When are your Trial scans? Would you consider Xeloda or Envirolimus more difficult? I had an awful time with hand and foot on , but really good QOL on Envirolimus.
Best wishes on your trial. Let us know how it goes. our “bums” thank you for trying out a new Serd that is a pill. 😉If it works we can get rid of the monthly shots!
Dee
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Thanks Dee. My scans are December 17th. It's too early for me to compare Xeloda and Everolimus. I always get nervous the first few weeks of starting a new drug with each new side effect. So, I am still in the nervous stage. I was lucky with Xeloda and barely experienced the horrible hand/foot syndrome.
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Hi KarPC..you had no issues with HF on Xeloda? Wow. Any secret to that? Were you on 2000mg/day?
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Hi SandiBeach. Yes. I got lucky. I was on 2500mg/day for 8 months. My hands and feet turned red right away but were never sensitive. I was even able to hike or ski for an hour or two everyday. I put aquaphor on my feet every chance I could. At home, I put on thick aloe vera infused socks which helped seal in the aquaphor. I used disposable gloves on my hands for everything. I wore comfortable cushioned shoes at work. So maybe the lower dosage, strict adherence to preventive measures along with some luck all played a role. ~Kar
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Thank you KarPC. Please keep us posted on your trial.
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disappointing news for me as I got randomized to standard radiation and will not be in the SABR arm
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Moth, so sorry... standard radiation is also a beast, a beast with its disadvantages... Saulius
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MOTH
I’m so sorry that you did not get SABR. I imagine you can drop out if you don’t want standard radiation. It is your body.
Dee
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Hi Dee, oh for sure I can quit but the thing is, this met is aggressive & already causing me problems. The MO is worried that even if we switched to a new chemo, it might not respond in time.
& she really doesn't want to switch to new chemo because she's reluctant to take me off the immunotherapy combo while the liver mets are responding.
Everyone is saying my best bet right now is some sort of localized control, otherwise this thing will put me into that 'visceral crisis' which generally leads to rapid decline.
If we weren't in the middle of a pandemic I might have thought about going to Seattle but the way it is, I just can't justify it. I just don't think the risk is worth it & getting covid.
I'm all verklempt. I honestly cannot even believe this tumor that was all necrotic and was slowly being re-absorbed, has come roaring back to life so quickly and aggressively. WHY is it not responding to immunotherapy?
I'm having the realization that running ahead of this monster is just going to get less and less likely 0 -
. moth....0
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((((((((moth))))))) What does your treatment team recommend as "localized control"? We're so routing for you !
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hey mods, thank you 🤗
15 days of standard radiation. Don't know how many Greys yet but max or close to it
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Moth - So sorry that you were not randomized to SABR! Your oncologist makes a strong argument for going ahead with regular radiation. I'm ER+/PR+/HER2- and my cancer has been very sensitive to radiation, so I'm biased toward local treatment. I hate that you are faced with this difficult decision! The risks associated with travel and COVID19 limit our options which stinks! Hugs! Theresa
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Moth ~ Sorry you did not get into the arm desired. Maybe the radiation will work and be a great choice. ~Kar
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Today my clinical trial onc said that the AZD9833 trial will be going into phase 3 soon! AZD9833 is an oral SERD similar to Faslodex but without the shots in the butt! I asked him if there was any new data for me to review but he said no. He said people seem to tolerate it well though. There are some weird side effects with the AZD but so far they are manageable. I am also experiencing side effects from the Everolimus which is the drug I combine the AZD with. I have been on the trail for 1 month. There are only a few of us in the AZD9833/Everolimus arm and it's limited in patient size (I have the only spot at my cancer center in Utah). The other arms of my trial include AZD9833 alone or AZD9833 with Ibrance. There are about 250 patients involved in the entire trial from about 3 countries. ~Kar
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KarPC - so glad about this study moving forward. I like your cohort because I got my longest run of 6 months on envirolimus/Faslodex. Glad your SE are manageable. NO SHOTS!!!!
MOTH- I hope you can get expanded access or equivalent and get the SABR. I have no known side effects from my 4 day SBRT treatment. Regular radiation can be a bear- but maybe if you get it- a teddy bear. 😉
Dee
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Moth, i'm sorry you didn't get into the other arm. But i am hopeful that the localized rads still calms the beast. best thoughts, dee
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moth, I'm sorry to hear you didn't get into the SABR trial. Ugh. Can you get a second opinion about next step? Also have you been you checked for the P1K3CA and ESR1 mutations? Zapping the sucker sounds like an effective option. Sending warm hug
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moth- I live just outside of seattle so if you do decide to come, I’m happy to help.
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For those who are triple-negative, there is an itsy-bitsy teeny-tiny snippet of early data from a phase II trial (MARIO-3) that looks promising in the SABCS2020 Abstracts (p812). They are testing a drug called eganelisib, which targets tumor-associated myeloid cells to improve immune attack, in combination with checkpoint immunotherapy (atezo) and nab-paclitaxel. Only four of six patients had measurable disease, but of these one had a complete response (tumors went away) and the rest had partial responses (tumors shrunk) for an overall response rate so far of 100%. So maybe immunotherapy is really going to work well for TNBC, once they can counteract the immune shield of the tumor. Need to see how durable the responses are and lots more patients tested.
Conclusions: The novel triplet regimen of eganelisib, atezo, and nab-pac shows promising antitumor activity (4 responses/4 evaluable patients),irrespective of PDL-1 biomarker status, and has manageable toxicity. The expansion phase of the phase II study is currently enrolling.
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Here's an excellent paper on Oral SERDs https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4708081/.
According to the paper which was written in 2015, it is not known whether or not the mechanism of SERDs (including Fulvestrant) is the same. If it is the same, and we have already progressed on Fulvestrant, the Oral SERDS are unlikely to work. Anyone know if more has been learned since this paper was published?
Piqray/Alpelisib is the only treatment I have been on since Tamoxifen (my first line of mets treatment) where I experienced dramatic shrinkage. But I started slowly progressing shortly after that. Still, ended the treatment with net shrinkage. I didn't have any bad SEs except for high blood sugar which I reversed on a Keto diet.
Just started my 14th cycle of Trodelvy/Sacituzumab Govitecan. So far, stable and feeling pretty good except for my usual mouth sores (pre Trodelvy) and some fatigue that increased with each cycle. Didn't need any Nivestym for low Neutrophil levels until cycle 9. This cycle, I only passed the Neutrophil threshold after being tested a second time (lot of jumping jacks and yoga between tests!). Hope wants me to add a second shot after treatments so I will take shots on day 3,4,10 and 11. Scans on the 11th.
Hugs, Susan
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Cdk 2/4/6 update
It didn't work. Off the trial. Dr Hamilton is having her intake nurse check on 4 "anti-estrogen" trials to see if there are openings and I can qualify.
I posted more details on the liver Mets thread.
Dee
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Crap, Dee! Sorry to hear that, and very interested to see what newer trials they find..
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SusaninSF, Yeah for 14 cycles on Trodelvy, that is truly remarkable!! What are your main side effects? The chemo payload on these drugs is apparently so strong that they no longer use them as regular chemo because the toxicity is too high, but when its targeted just to the cancer they are well- tolerated. I assume you lose hair and maybe eyebrows and have to take anti-nausea like regular chemo?
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Susan, Also your question about SERDs is a good one- the paper from 2015 is too old to answer that- all those early versions of SERDs bombed out in clinical trials, which is why its taken forever for any to get to market. I haven't a good idea what was the problem, but read reviews that suggested that the SERD has to both inhibit ER activity as well as degrade it, and maybe the earlier drugs were just focused on the degrading part. So, in a way we lucked out with Faslodex, because clearly it works for reasons that have not been fully understood.
However, Faslodex has bioavailability issues and the SERDs can reach much higher levels, so I think the hope is we will respond to them even if we progressed on Faslodex. At least in the trials I've seen, previous Faslodex is allowed. Also, it can depend on what the SERD is combined with, since you last had Piqray with Faslodex and are now on a chemo, it seems like you might be able to go back and test a SERD with a CDK4,6 inhibitor or with a CCR5 inhibitor, something you haven't seen before?
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Hi everyone,
I started a trial (for a TTK inhibitor) in September, but the first scan showed enough progression in the various mets around the heart that I'm out of the trial. I will be speaking with my oncologist tomorrow about ideas and I thought I'd see how people here were doing. There's always such great discussion.
Alabama Dee I am so sorry to hear that your CDK2,4,6 trial didn't work for you. Good luck with your next steps. SusaninSF - how great you are still on the Trodelvy trial. Both your trials are ones that in a non-Covid world I would be interested in pursuing. But with 14 day quarantines on each return, it really seem impossible to pull off.
My oncologist in Ottawa has in the past floated a PLK4 inhibitor trial, but I'm leaning towards asking about abemaciclib. I might be able to get it via compassionate access. I know there isn't knock down evidence about using abemaciclib after previous palbociclib use, but really my best responses have been to hormonal treatments.
I wish I could qualify for these new SERD trials...I used fulvestrant 2x for nice long periods (once standalone for 18 months then again with GDC-0077 a pik3ca inhibitor for another 18 months). I also had bazedoxifene in a trial with palbociclib - it's a SERM with SERD like characteristics.
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NewGardener,
You have been at this game for a long time now. You and your MO seem to be very skilled in picking treatments. Good for you! One question: is your cancer ductal or lobular?
Re the use of Abemaciclib, which you mentioned, Cure-ious posted an OncLive article on the Ibrance thread which talked about this. Look at Case 1 in the Link below (again, courtesy of Cure-ious):
https://www.onclive.com/view/bardia-brings-clinica...
I had mentioned Abemaciclib to my MO a while ago as a follow up treatment and she said that the studies aren't there. However, I have seen it referenced in footnotes in other articles, so I think that more and more MOs are starting to consider this even for patients who have been on CDK4/6 drugs before. In fact, I sent the link to my MO and raised it with her as a possible treatment. She said she would read the article (it helps that she knows the author of the article well.)
Please let us know where you go with your next treatment.
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