Info on clinical trial with "Oral Faslodex/Fulvestrant"?

[friesianfan]

Hi everyone,

After 3.5 years of positive response on Ibrance/Letrozole, my wife has seen some progression--so yesterday, she began a new clinical trial (ACT16105) which is a Phase II trial of SAR439859, a Sanofi compound. From my (limited!) understanding, this is an attempt to develop an oral Selective Estrogen Receptor Degrader (SERD) that acts somewhat like Faslodex/Fulvestrant--obviously without the intra-muscular injections. (Sorry if my explanation is not totally accurate, but that was the gist of my understanding!) It is being tested against traditional meds such as Fulvestrant, Anastrozole, Letrozole, Exemestane and Tamoxifen--but my wife was "randomized" into the SAR439859 so has already had a couple days of the pills--so far, so good as far as side effects.

I believe this trial is being undertaken at nine different locations, including here at Dana Farber in Boston, where my wife has been undergoing her treatment since diagnosis in March 2017.

Wondering if anyone else is involved in this trial, or any other trials (I am aware of a few others, although this seems quite new) involving SAR439859? Would be interested in any feedback from this group.

Thanks so much as always,

Dave

PS Those of us in parts of New England got a few inches of snow for Halloween Weekend!

[Hidden]

Hi friesianfan,

That's so interesting! I'm glad to hear that an oral alternative to the injections is in trial...not that the injections are a huge deal, but they are a "pain in the butt"!

It's awesome that your wife is participating, contributing to science/development...

But to your core question, I don't know of anyone else who's part of this trial, but am hoping someone who is responds...

My best to you both for a fun, snowy Halloween! Stay warm!

Lynn

[friesianfan in reply to Hidden]

Thanks, Lynn. Good to hear from you! One of the good components of this trial is that if this med is not working, she will have the option to drop from the trial and move right back to Ibrance or Faslodex or any of the other "standard of care" options--but the reverse was not true. If she had started on Faslodex or another second line treatment, I don't believe she would have been eligible for this particular trial--though I know there are a few others out there utilizing the same compound.

Take care,

Dave

[Sunnydrinking]

Hi

I have widespread MBC in the lung, liver & bones diagnosed in May 2018.

I had been on ibrance for nearly two years but unfortunately I experienced progression in the liver back in June.

I commenced phase 3 of the Emerald clinical study on 31 July 2020. I am taking a daily oral SERD called elacestrant.

I am under Mount Vernon Cancer Centre in the UK.

As instructed, I take the rather large oral tablet at the same time each day, washed down with a large glass of water, 30 mins after a light breakfast. I then avoid eating & lying down for at least 2 hours afterwards.

I am pleased to advise that I have no noticeable side effects.

My latest scans indicated that I am stable.

I also have 4 weekly denosumab injections but the latest was stopped as I have a wobbly tooth that may need to be extracted.

I hope I continue to remain stable on this medication & can stay on it for a long time 🤞

I wish your wife all the very best,

Jo

[friesianfan in reply to Sunnydrinking]

Dear Jo, Thanks for sharing your history and recent experience with another SERD. I have read a bit about elacestrant and note that they are doing some similar clinical trials to compare it to other standard of care options such as faslodex. It's so great to hear you are doing well as far as scans as well as side effects. My wife is only five days in, but so far, no adverse effects at all--now we just need to find out if it's working! :). Good luck with your tooth situation...my wife was one of the small % of people who got ONJ from her Zometa infusions and that was not pleasant, but eventually it healed. Hope all continues on a positive course for you and thanks again for sharing your experience.

Dave

[mariootsi]

A pill instead of shots sounds good. Please keep us updated.

[friesianfan in reply to mariootsi]

Sure will. Only five days in at this point, but no adverse effects whatsoever and feeling better than many days on Ibrance/Letrozole protocol!

[mariootsi in reply to friesianfan]

You know, I was taking Letrozole and it made me feel awful. I also find Ibrance and Faslodex is more easily tolerated.

[Rhwright12]

Good As someone who has been on IV chemo for all 4 years since diagnosis...I would totally love options not ncluding a trip to the office...😀

[friesianfan in reply to Rhwright12]

Exactly! Was encouraged to see the post above from Jo/Sunnydrinking regarding the SERD that she has been taking. Seems there are a number of similar products in development from Sanofi, Takeda and others that are being tested against current "standard of care" meds. Hoping that positive results will continue!

[Bettybuckets]

Hi Dave, my first job was at the Dana Farber! Later went to work for Pfizer Oncology... makers of Ibrance. I live in nz now and on ibrance for past 3 months. Good luck To your wife on the trial... thanks for doing it as some day we may all benefit from it!

[friesianfan in reply to Bettybuckets]

Thanks for your note and good wishes for my wife! Dana Farber is pretty amazing, and I'm sure it was really rewarding to work there. We are fortunate to have DFCI and so many other great hospitals nearby. I hope you have good luck with Ibrance--my wife had a good run with it for 3-1/2 years as noted above. I think you just joined the site recently? Even though I don't post often, I read my digest daily and have picked up so much helpful information over the past years. It's a great group--I hope you find it helpful!

Dave

[Bettybuckets in reply to friesianfan]

Dave, thanks yes new to this... I just had my first scan after 1st 3 cycles on ibrance and luckily markers and scans both good. I pray that I also get a good run like your wife. We have flights booked for Boston for April 1st god willing if CV and the election all calm down over there. Praying hard for everyone to be safe through these trying times!