Need to Change Treatment

[Trissh]

So I have progression after two years on Ibrance and Letrozole. I have an opportunity to participate in a clinical trial in my town in which I would be randomly assigned to Giredestrant, a promising oral SERD (monotherapy) or both Giredestrant with a new Pikc3a drug. My standard of care option would be fulvestrant and kisqali. Any experience that you guys have had with any of the above after progression on first line would be welcome! HR+ PR- HER2- and of course also have the Pik3 mutation (among others)... at least I did when Caris testing was done 2 years ago on my tissue. Thanks! -- Trish

[Cherry38]

Hi TrisshI have been on both treatments but not together. Riboclicib (kisqali) I was on with Lextrozle and the fulvestrant I was on with piqray for the pik3ca mutation.

I have been on two clinical trials, unfortunately for me I got progression but I have now found out I am triple negative after being diagnosed last year with er+,pr+ her 2 - with pik3ca at 49 de-nova.

I found Kisqali very tolerable and the fulvestrant injections with the piqray ok too.

A few aches and pains and a little sickness but for me I found them manageable.

I was on the Capture trial and Inav0121 trial in Australia. The Inav0121 trial was from Roche in America.

I think clinical trials are great and I am now awaiting to go on another one in Sydney.

I pray for you and wish you all the best on this trial. 🩷🩷

[Trissh in reply to Cherry38]

Cherry, thanks for responding, yikes, 49 is so young. That was my age when I first found my stage 0, DCIS.

Was the fulvestrant and piqray combo after progression on the Ribo/Letro? And if so, how long did it work if you don't mind my asking?

Also, was your inav trial inavolisib? How did you tolerate that? --Trish

[Cherry38 in reply to Trissh]

Hi Trish. My first line of treatment was Riboclicib and Lextrozle, I got more progression in my spine so I was tested for the pik3ca mutation and went on the Capture trial which was Capecitabine against the piqray and fulvestrant.

I got on Capecitabine arm A and again unfortunately I got progression in my liver. So my oncologist got me on the next trial, which I travelled a 4 hour round trip and I finally got on the piqray and fulvestrant which was up against inavaslib and fulvestrant.

I got more progression in my Ribs, but one thing I found was my liver was stable so the piqray or fulvestrant was working in some places, but not others 😬.

This time, though, I asked for a 2nd opinion and I had a bone biopsy done this time and my cancer changed to triple negative which isn't common, but it can happen.

I am on doxorubicin pegylated liposomal at the moment only had one cycle so far.

I am just waiting now for this clinical trial testing called CaSP my oncologist referred me. Hopefully they will find a treatment or combination to my cancer on biomarkers and more genetic counselling.

I think it's amazing the research teams on cancer, just so sad it's so complicated as we are all different even if we have the same status.

I hadn't heard kisqali and fulvestrant combination but it makes sense for her 2 negative. But I believe the piqray is more for the pik3ca.

I am concerned how many younger ladies are getting cancer and seems more aggressive.

My daughter has to start having mammograms from 30 since I had my genetic testing but I have told her just keep checking, she is only a teenager.

I am so sorry your cancer had come back, with mestatic cancer there is more hope these days.

I have two amazing children so I have to annnoy them for so much longer.

In 15 months I am on my 4th line of treatment which isn't good, so I have only really been on 3 cycles of each at the most, which is exhausting, in-between I have had 7 different rounds of radiotherapy and an oophorectomy.

Let us know how you go Trish. Your first line sounded very good, which I was hoping with the Riboclicib to last at least 2 years. I heard many ladies on this more than 3 years. Even the Capecitabine is another longer working one. Just not for me. My mum always said I was unique 🤣.

I hope other ladies can give you some advice on their experiences with these drugs, hopefully they have seen more of a difference, as my treatments have been short lived.

Praying for you, keep strong 💪 🩷🩷

[mplevine]

I am in a clinical trial, combo of Ibrance and ARV 471. Stable the last 2 years. It is a bit time consuming at first but it’s very valuable to be part of the solutions.

[Trissh in reply to mplevine]

Hi! is this second line? Stable two years on a new drug is awesome! How are the side effects? --Trish

[Trissh in reply to mplevine]

Hi! I wanted to check in to see how your trial is going? --Trish

[jillritc]

Hi Trissh. I was on Ibrance and Fulvestrant for just about 9 months, then switched to Verzenio and Fulvestrant when my white blood cell count went too low on Ibrance. I had to go down from 150 mg to the 100 mg dose of Verzenio after too many months of diarrhea. I've tolerated this dose pretty well for nearly 1-1/2 years. I've never had a problem with Fulvestrant- have been on it since May 2021. I had a slight progression on my right iliac but we are choosing to continue my protocol and am currently getting radiation at that site. I can't speak to Kisqali. Good luck with your decision.

[13plus]

Without any experience in these drug options I think the trial sounds promising. I've heard good things about the main test drug. Is this the PIK3 drug? gene.com/media/press-releas...

[Trissh in reply to 13plus]

Yes, inavolisib is the pik3ca drug and Giredestrant is the ER backbone.

[13plus in reply to Trissh]

Sounds good! Just make sure to ask lots of questions about what to expect commitment -wise, and that it is all covered financially! Otherwise the care is great. I ran into a problem this year on another trial that was run in the next state over from us. I thought my insurance covered them as Tier 1 and wasn't worried. Billed at $$$ later I finally found out that they are only Tier 2 and therefore all my "standard care" was charged at 50%. I'm still dealing with the fallout over that 6 months later. "Standard care" includes all the tests they will do on you that you would normally get done with your regular oncologist. EG. scans, labs, and in my case I was also charged for the Fulvestrant shots, even though it was part of the trial combo! I was none too happy to learn that belatedly.

But trials are good! Just got to make sure you understand all the implications properly

[Trissh in reply to 13plus]

Yes. just finished all the qualifying tests and labs and of course they were covered by the trial sponsor. I believe I was told that I would only use my insurance for like my regular oncology dr. I think the trial covers scans throughout the trial but I will double check. Also, there could be additional drugs for the side effects... I should ask about that as well and check with my insurance to see that everything else I need will be covered throughout my participation in the trial. Thanks for the heads up!

[TammyCross]

I was in a clinical trial for an oral SERD. I was in the arm that had only the SERD because I had already had progression on Ibrance (palbo), which the other arm took along with the SERD. We are all different, but for me, that year was the best I have had. No side effects at all and was NEAD ...until I wasn't and got thrown out of the trial.

[Trissh in reply to TammyCross]

What was the oral SERD you trialed, Tammy?

[TammyCross in reply to Trissh]

Didn't have a name. It was C-5 something. It doesn't matter. They stopped the trial and decided to invest their efforts in another medication for a different type of cancer. So it is not available in any way.

[Bettybuckets]

Trish thank you for taking the extra time to go into this study. We all need these kind of answers and it is very unselfish of you to participate!

[friesianfan]

Hi Trish,

My wife was on a trial for Amcenestrant, an oral SERD that was similar to Elacestrant, the first oral SERD that was approved. Like Tammy’s experience on a different trial, it was the best 13 months of the past seven years, until it stopped working. And also like Tammy’s experience with the Zeno Pharma compound, Sanofi stopped work on Amcenestrant after Elacestrant emerged as a leader (at that time). But there were many other SERDs in the running. Hope this trial works out for you, as that was the best QOL (as far as side effects) of my wife’s seven protocols to date!😀

Good luck,

Dave

[Trissh in reply to friesianfan]

Hi Dave, happy your wife had a great QOL on the drug but hate when they stop working. I guess the best we can hope for is a year on or so on these drugs subsequent to line 1. The hopeful part is that there a many in the pipeline! I did not have the ESR1 mutation 2 years ago but getting another biopsy next week and had ctDNA draw so I should know soon. I am really hoping to be randomized to the Inavolisib arm since I do have the PIK3CA mutation. I will let y'all know what's up. These trials are so interesting. --Trish