PALLAS Trial: Palbociclib (Ibrance) - Stage II & III, ER+, HER2-

Hi Liz520-

Welcome to BCO! We understand being nervous, and wanting to hear from others who're on the same trial. We hope you've gotten some good information here, and that if you decide to join the study, it goes well!

The Mods

yes Muska the enrolment criteria is 6 months from end chemo or 12 months from surgery assuming that they happen in that order...if you neoadjuvant chemo one would consider Penelope B - still AI plus palbo


Interesting though the duration of palbociclib in Penelope B is 12 months.


I asked why 2 years in Pallas and 12 months in Penelope - no clever answer to that.


But maybe one of the USA onc might be wiser - we are still waiting to get the thing approved on PBS for Stage 4 in Australia

Very interested in this thread

Thanks for your support. I do have mixed emotions about which arm I might be on...can't make some people happy no matter what, eh? The two year duration and possible side effects do scare me, however if it might come back I want to have done everything I could have. However if I am one of the lucky ones with this behind me I don't want to over treat. What tipped the scales for you to try it Licata519

Muska - good thinking.

Although it would be interesting if they could extrapolate from neoadjvant chemo to post surgery chemo.

Well - I am in the same boat as Liz and Licata - very mixed feelings about whether I should take this drug or not - and of course no one can answer that question now. Due to be randomised in July and grateful for the opportunity but concerned about the side effects.

hi there,

Just wanted to post if its OK, joining the Pallas trial too. Just quite anxious about side effects, I am finding it harder to relax about them as it is a choice this time as opposed to chemo, plus 2 years seems like a very very long time!

How soon did anyone notice feeling any different and has anyone NOT experienced any side effects, particularly hair loss. Thanks, hope everyone is doing well.

Hi

Lenn13ka, thanks for that info. Well done on sticking with it that far, I'm sure it will stand to you. Can I ask you by how much did your hair thin, I know I should be more worried about my immune system, but my hair has just started to grow back so don't really relish the thought of losing some/ all if it again for 2 years? Or did it thin and then grow back as you were still on the drug? Thanks for your help.

great, thanks for that Lenn13ka. Would anyone know exactly what they test in the blood tests during the trial? I presume they check CA tumour levels? Just wondering about it - I couldn't find any info online about it.

Hi Hopeful17, no they don't do any monitoring for recurrence other than the regular office exam--feeling lymph nodes and listening to lungs. The blood work is to monitor white blood cells, which can go low because the palbo inhibits their production. They do the full CBC panel.

hi

Just wondering if anyone experienced any calf swelling while on Palbociclib. Nothing major, as in definitely not sign of a blood clot or anything, but just puffiness and tight feeling in both lower legs?

Thanks

I went onto this site hoping to find more from others on the PALLAS trial. There was so little in the forums that I decided to join and post. I can't figure out how to add my diagnosis and treatment to my profile but I will update that when I figure it out (that area of my profile is not edit-able). I am trying to answer some of the questions that have come up while I tell my story.

I started on palbocilib on the PALLAS trial 9 months ago. I am also on letrozole. I had a few colds back to back right after starting (I have kids so usually have a bad winter as I get all their colds) and was very tired so wondered if the palbo was to blame but once spring sprung and the viruses abated, I have had good energy levels. My counts have been OK all along so have remained on schedule on the full dose. Over the last month or two I wondered if I was losing more hair than usual and now I am convinced my hair is thinning. I have very thick hair to start with so it took a while for me to realize this. After paying a lot for scalp cooling in order to keep my hair during chemo, I am finding this tough but I want to have no regrets and do everything I can to avoid getting a recurrence so I'm sticking with the trial.

As others have pointed out, the drug (which would cost thousands a month if you had to pay for it) is free on the study but you (or your insurance) have to pay for visits and labs. Every now and then they send of a "research tube" when my labs are drawn but I am not sure what tests they do and if they would report back any positive findings from that. Otherwise, regular labs are CBC and Chem Panel (including liver function tests). Labs and visits are frequent to start with but quickly get down to every 3 months. My regular followup would have been every months if I was not on the trial.

Why did I opt for this trial? Both my medical oncologist and radiation oncologist (who are in different centers) were very enthusiastic about the drug and the trial. I trust them both and value their opinions. I worried about "using up" my chance at this drug in the event of a recurrence but they both assured me "it doesn't work that way". They explained that everything we know about treatment of early stage disease has come from treatment of people with mets. All of the following were first tried only in people with mets and then brought to the early stage disease ladies: chemo, radiation, tamoxifen, aromatase inhibitors. There were some factors in my cancer that were a little unusual but not necessarily quantifiable that made my docs feel there was something that made me more high risk. I was relieved to be randomized to the trial. Having done all the research and agonizing over the matter and deciding to join the trial I think it would have been hard if I had not been randomized to receive the drug and wanted to acknowledge all those ladies out there that went through this.

I have had a few other symptoms that may be due to hormonal changes, letrozole or the wear and tear of getting older (I am 50) but I am in denial about those symptoms for now. I am trying to prioritize exercise, good food and sleep and this seems to be helping.

I hope that this might help others thinking about the trial or on the trial and I look forward to hearing more from others on the trial.

Bumping this thread to see if anyone is on the trial or starting soon. I'm meeting with the Trial rep in 2 weeks and she'll enter my info and see if I'm randomized. I just finished rads yesterday and I'll be starting Tamoxifen as well. Let me know if there is another thread I could follow about Ibrance, besides the Stage 4 only thread. Thanks!!

Hereandthere, my labs and visits with the trial rep are covered as well as the med. Nothing from the trial is billed to myself or insurance. I wonder why it's different for you, something seems off there.

Hopeful17, I will do it if I'm randomized to be on it. I'll know on Nov 7. I'm just now getting hair after chemo as well, it's think so a little thinking I could handle. I had a lot of issues with low neutrophils during chemo so I'm hoping that's not an indicator of how this might go if I'm put on it. I would drop to 0 during my AC part of chemo and would have to be hospitalized and isolated, they had to cut it by 20 % but it still happened. Taxol was a bit better but I had to miss because it dropped so they had to lower that dose too. Hoping for the best anyway.

Thanks for the reply, I'll let you know if I'm picked:)

OCDAmy, you know if you're on the drug, no placibo. I know there is bloodwork but I don't think there will be scans. I'll ask that at my next appt. You are followed even if you are not randomized for the study. I was told that my info will be plugged into the computer and it will factor in my treatments so far and then either pick me or not. The rep said the randomization factors in different patients with different treatment plans so that there is an equal representation of patients/plans. I have read above that some have to pay for labs and visit some but my Trial Rep said no, the only visits that I would pay for or that insurance would be billed would be by my regular MO followups that I would have had anyway. Oh, and you are free to leave the study at anytime. The thing I wanted to hear and did was that they will work with you on the dosage and taking breaks if needed.

I am just starting on Tuesday. How have you got on