Anyone doing a Clinical Trial along with AI?

AnotherMichelle

So my MO told me today that I'm at "high risk" of recurrence/mets because there was residual cancer in a lymph node after neoadjuvant chemo. (I posted a question about this on the IDC boards.)

Because I'm high risk, he offered a Clinical Trial to take everolimus (Afinitor), which is used to treat Stage IV, for one year along with my AI (letrozole). They are testing to see if the everolimus offers disease-free progression benefit BEFORE mets. (For Stage IV, it offers an average of progression-free 6.5 months, which is not insubstantial in the metastatic context.)

Is anyone else participating or know about this trial? All information welcome and appreciated.

Thanks,

Kelli

Hopeful82014

Kelli, you can look it up on www.clinicaltrials.gov and find full details.

AnotherMichelle

Thank you, Hopeful!

live_deliciously

I went thru the trial of everolimus with tamoxifen. i git the real deig. there is a thread called swog trial or something similar . you can check out that thread a few of us went thru the trial completely. I just finished in october.

Hopeful82014

One issue to be very clear on, Michelle, is whether you'll be certain of receiving the study drug or run the risk of being randomized to a placebo. If you're certain to receive Afinitor, I'd say it's probably a great idea to participate in the trial (just based on what I've read about Afinitor). I'd at least give it very serious thought. Reaching out to members who might have done it already is a good step - it's always useful to hear others' experiences with a particular drug and trial.

Melgirl

Hi Kelli,

I'm not on that one but am on a similar one with Palbociclib (Ibrance), day 10. They may be similar. I don't see a thread here for it.

Melissa

Mom_of_twins

I'm also in the PALLAS (Palbociclib) trial, but unfortunately landed in the control arm. So just an AI for me. Melgirl, sounds like you're in the experimental Palbo arm? If so, how's it going?

Melgirl

Hi Mom, sorry you didn't get the drug. I had mixed emotions about getting it. I want the drug but not the side effects. I'm about day 14 now. I had my first CBC yesterday and my white count took a nose dive. I have had more fatigue and headaches but I'm not positive it's from the med. Also the whole time I was on chemo I had a rash on my face that is coming back now, so I think it may be my own weird reaction.

Mom_of_twins

Mel, thanks. I totally understand the mixed emotions. I mean, the nice part is the immediate gratification of not having to deal with side effects and to try to rebuild my immune system. But I was disappointed because of the potential long-term benefit. It's just the way it goes. Now I wish I could take Xeloda, but haven't found an MO yet that will consider it. I did have a consult with MSKCC that said that it "isn't wrong" to give to ER+ patients with residual disease, based on the Create-X study, but there's a more clear benefit for triple negatives.

I hope your counts recover quickly and that the side effects lessen as your body adjusts to the new medication.

Melgirl

thanks Mom of twins. Good luck to

Tigger123

Melgirl..sorry sent you a private message because I could not figure out how to reply here..

AnnetteZ

Melgirl,

I'm also in the PALLAS (Palbociclib) trial, I just got the news. I will start next week, I am terrified. How are you doing ?