Oral Faslodex?: I read a while back... - SHARE Metastatic ...

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Oral Faslodex?

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I read a while back that an oral version of Faslodex was in the last stages of clinical trial. I

Ican't find any information on this though. Does any one have info on this?

Merry Christmas all and may the new year be better for all of us🙏

Anja

Btw I had quite a reaction to the first shots of faslodex :(

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17 Replies
kduck profile image
kduck

I did San Antonio BC conference, oral version of falsodex is coming in February! You can check the LBBC website! It was a very interesting virtual conference

in reply to kduck

THANK YOU! Great news❤️❤️ and now I know where to check.

mariootsi profile image
mariootsi in reply to kduck

Wow!

Arisgram profile image
Arisgram

Research elacestrant. Fingers crossed it's here soon!

in reply to Arisgram

🙏🙏🙏❤️❤️

friesianfan profile image
friesianfan

Dear Anja,

Your question was very timely, as I was just about to post my wife's GREAT news from her recent clinical trial results on an oral alternative to faslodex. A number of members on this site had asked to stay in touch after I posted a couple months ago about my wife's good fortune to enroll in the AMEERA-3 Phase 2 clinical trial in late October (after having progression after 3.5 years on Ibrance/Letrozole) which is focused on developing an oral SERD as an alternative to faslodex and a number of other alternatives. The Sanofi compound, SAR439859, has since been named Amcenestrant, which sounds a little similar to the compound Arisgram mentions below (elacestrant) which I believe is targeted to be one of the oral alternatives to fulvestrant (Faslodex) in the future. If you use the search button in the upper RH corner and enter "Oral Faslodex" you should see my prior post which has more details about this clinical trial. You can also Google any of the terms above to see more details, or here is one of many links to the trial which also shows one of the PIs around the globe who is here at Dana Farber: onclive.com/view/next-gener...

So this week, my wife had her first CT scans, biopsies and bloodwork since beginning the trial only two months ago (when they did a LOT of baseline testing--biopsies, CT and PET scans, bone scans, full body scans, and hourly bloodwork to track changes over time.)

Results: Her primary tumor, which had shown growth and shape changes this summer and early fall while on the I/L regimen, had decreased in size by about 20%. Her tumor markers decreased after seven or eight months of steady increase on the I/L protocol, and all of her blood chemistry readings were either improved or steady! All in just two months on this oral medication and with almost no side effects (a few moderate hot flashes along the way.) Great news all around, and her primary onc as well as the trial staff were ecstatic about the results!

Another woman on HealthUnlocked also mentioned the recent LBBC conference a couple weeks ago, featuring, among others, Dr. Nancy Lin (my wife's onc) from Dana Farber. She gave a really helpful presentation on some of the recent and upcoming advancements in treatment options and then answered a lot of questions from the audience (handled very skillfully by the moderator, I might add!) Dr. Lin did mention some of the work around SERDs that is relevant to Anja's question as well. See below for the link:

lbbc.org/programs-events/as...

All in all, this was great news, which made our holidays very special and helped immensely, after the inevitable progression that we discovered a few months ago...

Wishing all of you the very best for 2021 (can it get any crazier?) and well beyond!

Dave

in reply to friesianfan

Oh Dave, how absolutely wonderful to read this! There's so much hope and optimism in your message.If I understand it correctly, these great results are achieved being on Faslodex only?

I will check out every link and all information. Thank you so much for sharing. Yes, 2021 must be a better year for all of us.

Hugs to you and your wife and hope and prayers for continued success ❤️

Anja

friesianfan profile image
friesianfan in reply to

Hi Anja,

Glad you saw my response, it does indeed provide optimism for the future. And just to clarify, yes, the amcenestrant is the only cancer-specific med she is taking during the trial. She has stopped Ibrance and Letrozole. While it is not quite the same as Faslodex, it is a new SERD that I believe tries to utilize a similar approach to slow the progression with somewhat better efficacy and much better quality of life due to the oral form (pill once a day) with few side effects for most patients.

Wishing you all the best!

Dave

in reply to friesianfan

Thank you, Dave, for the clarification. Yes, you said it...better quality of life!! Oh how wonderful to feel reasonably well without the debilitating side effects of the Ibrance/Letrozole like I was experiencing.

So hopeful❤️

TammyCross profile image
TammyCross in reply to friesianfan

I am a bit confused. I am starting a PHASE 1 clinical trial of an oral med that my oncologist says is like fulvestrant. Must be a different one. It comes from Zeno, ad is called AN-c5001. I don't think it has a real name yet.

I am a little skeptical because I was on Fulvestrant and Ibrance for two years, doing great, now progression, whether I am on Ibrance or Fulvestrant alone. So if the Fulvestrant injections didn't work, why should this? Oncologist said it is probably more effective. Trying to avoid going more aggressive since it is growing slowly and there is time to try different things.

Encouraging news, and great for your wife.

friesianfan profile image
friesianfan in reply to TammyCross

Hi Tammy, I am not familiar with your medication, but I do know that there are now a number of oral SERDs being tested, from a number of different pharma companies. For my wife's trial, you could not have already used Fulvestrant to participate in this trial, just FYI. But from what I have read (and heard, very recently, as my wife's onc presented at the recent Living Beyond Breast Cancer conference, which folks on this site seemed to follow and she did mention the new research in SERDs) the oral SERDs are doing quite well in the trials, and there is a lot of optimism. Let me know if you are interested in more info, and I can send you some links. My wife is still having great results on her scans--her tumor markers have continued to drop and there has been some additional shrinkage in her main tumor. Mets in her spine and pelvis seem stable as well and quality of life is better than Ibrance/Letrozole combo.

kduck profile image
kduck in reply to friesianfan

That’s wonderful news! Is your wife taken only oral serds? How long has she been doing the trial? Do you know when the fda will approve the oral serds?

kduck profile image
kduck in reply to friesianfan

Could you send me more info about the trial?

friesianfan profile image
friesianfan in reply to kduck

Hi there, regarding your questions above, my wife joined the trial last fall just after it began, so she has been on it just over six months. She had been on Ibrance and Letrozole for 3.5 years since her de novo MBC diagnosis. Her current drug on the trial (amcenestrant) is her only cancer-related medication at this point.

I don't have any detailed info about the timeline for FDA approval, but I believe the first trial with 62 patients reported out last summer and the trial my wife is on just filled up with just under 300 patients. I am pretty sure there are Phase 3 trials also underway with amcenestrant as well as some of the other SERDs. You can read about my wife's trial at this link from last November:

onclive.com/view/next-gener...

The above article featured one of the PIs at Dana Farber, where my wife goes for her treatments. Here is another, more recent, article about a newer trial for the same medication:

onclive.com/view/trial-expl...

And finally, here is a short article that summarizes the positive results in my wife's trial as well as a number of the other SERDs currently in trials:

clinicaltrialsarena.com/com...

There are lots more articles out there, I just grabbed a few that were short but informative summary pieces--hope they are helpful. And good luck with the next steps on your journey, as I have followed your path a bit through this site.

Dave

kduck profile image
kduck in reply to friesianfan

Thank you so much for the info

in reply to friesianfan

Wow Dave! Thank you very much for your post. I sincerely appreciate this information.

Thrilled your wife is benefiting from this.

geewisdom profile image
geewisdom

Yahoo!!!!!

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