newly approved combo of Fulvesterant and Abemaciclib

Hi Maizie,

This sounds like the trial to do- what is the number? Which PI3K inhibitor, and did you have testing that shows you have the mutation? Do you get to know which drugs you are given? Did you go onto this trial after Ibrance/Femara, or something else? And also, have you had other side effects, neutrophils, etc- the Abemaciclib is continuous dosing? Lots of questions, but any info is valuable- thanks!

I think this combo is now available as a standard treatment. It is no longer a trial. I haven’t updated the topic for my oral serd with ribociclib yet but long story short it stopped working and I had progression after 5 months. I am currently discussing options with my onco and abemaciclib with fulvestrant is my third choice should I not get into one of two trials we are hoping for. My first choice is a trial for a new class of drug called a SERCA - selective estrogen receptor covalent antigen. My second trial choice is for a drug that targets the AKT mutation that I have which I would take with Tamoxifen. Once I know where I land i’ll start a new topic

Hi all: Sorry for the delay in responding. Things got busy with the holidays and guests.

The trial doesn't have an official name. It's a Stage 1 trial. The protocol number is: I3Y-MC-JPBH. Title: "Phase 1B Study is Abemaciclib in Combination with Therapies in Patients with Metastatic Breast Cancer." The PI3K inhibitor is LY3023414. One study cohort is taking 150 mg every 12 hours and a second cohort takes 200 mg every 12 hours. I was in the 150 mg group, but had my dosage reduced to 100 mg because my phosphorus levels kept dropping. Who knew that low phosphorus could make you feel so awful? I also take 150 mg of Abemaciclib every 12 hours, then Faslodex shots monthly (500 mg). I also get a monthly Zoladex shot. (And Zometa every three months.)

Luckylegs: Diarrhea is definitely an issue. And nausea. It took me a long time to figure out what I can and can't eat. I have two prescription antidiarrheal medications and I almost always take one before I go out to dinner, or to a friend's house where there's food involved. I've had to give up some of my favorite foods, like fresh spring rolls and this amazing veggie / chicken salad I used make for dinner. I keep getting accused of being a picky eater.

SandiBeach: I have a BRCA2 mutation and, according to Foundation One, FGFR1 and ZNF703 amplifications. My oncologist said that PI3K inhibitors can still work for folks who don't have a PI3K mutation.

So far, everything's going great. I've had either stable scans or a significant reduction in lesions since April and my tumor markers have dropped from 800 in February to 71 according to a blood test on Monday.

Hi AnimalCrackers: I'm on the 11th round of treatment. (The first scan after starting treatment was in April.)

Always happy to make myself available for research!

Has anyone heard whether this is an option for those who progressed on Ibrance\fu!vestrant?

Marylark - my oncologist still has this combo on the table for me even though I progressed on ribociclib (Kisqali)/oral SERD and palbociclib (Ibrance)/letrozole.

Thanks AnimalCrackers. Good to know

Animal crackers- what is this drug? Do you have one of the mutations it targets?

Animalcrackers- interesting. so you will be targeting PI3K and AKT1 and taking tamoxifen?

Do you know if the oral SERD was a failure or only if the Ribociclib was the failure? Or who knows?

Hi all:

Thanks for tha happy dance, Animal Crackers! And good luck with the new trial!

NKB: This is my first Stage 4 treatment. A spotin the trial opened up shortly after I was diagnosed in December 2016.

As for the question about whether Abemaciclib is an option after Ibrance, I've asked the reverse (is Ibrance an option after Abemaciclib?). My MO didn't rule it out. If I recall correctly, she felt like it was something that needed more research. I'm happy to ask again.