Continued Access

**I wrote this 3 weeks ago, but forgot to edit it and hit post**

I went to DF yesterday, and when I sat down for my blood draw, the nurse only pulled enough tubes for my CBC panel, chemistries, thyroid numbers, and tumor markers. I said, “oh, I’m on a trial,” and she said, “yes, I see that, but today you don’t have any trial tubes.”

Oh okay….. I sort of had a momentary panic because I had never experienced a no trial-tube-blood-draw. In fact, I used to go down to DF every other week, JUST FOR BLOOD DRAWS. It was a 4-5 hour round trip just so they could make sure my body was still doing okay in this trial.

But today, as I was sitting in the chair, port accessed, discussing the week with the lab nurse when I got a call from my research nurse. She said that things would change a little going forward because the trial had been moved into a new phase. From this point on, no new patients will be enrolled in the trial, and those of us still on it (not many) are being granted access to the medications through something called “continued access.”

Let me be completely transparent about this move by the trial sponsor: no more breast cancer patients will EVER be doing this combination of drugs, at least not under any FDA approval. The combo of abemaciclib, anastrozole, and pembrolizumab in the breast cancer setting didn’t garner enough positive and impactful results to cause this study to move onto Phase 2. So yes, it has worked for me; Still, most participants couldn’t continue on this combination of drugs because they either had progression or couldn’t tolerate the side effects (toxicity or quality of life).

As you know, I’m no longer on the immunotherapy, but I still take the abemaciclib and anastrozole. Even though abema and anastrozole are FDA-approved drugs that I could have access to outside of a trial, I am still being followed on the trial; therefore, the trial provides me with the medications so they can collect longitudinal data.

I haven’t gotten all of the information about what this all entails for me, but essentially I have fewer scans and less paperwork to do. I’ll still be followed closely, but the trial required a closer following than most get outside of clinical trials. I will continue to have visits every 3 weeks, but now some of those will regularly be online, and my scans will get moved out to every 12 weeks.

I am continuing to rock all of the dozens of pills I take every day, but I’m tapering off the steroid. I have been feeling good and am looking forward to this holiday season. I have a lot to be grateful for, that’s for sure!