Canadians, palbociclib and clinical trials

dancingdiva, are you able to get into the Palestra trial? I know that it is available in QC but not sure which facilities. I will be starting it as second line on Tuesday. I don't blame you for being upset. GG

Wow Linda, I had no idea that it would be available in 3 places in Quebec. We have one... one

Ezoka - you should start with your MO. He/she should initiate the request. Good luck and keep us posted.

DD, you got it. Commercialized drugs may not be provided, at least in Quebec. Fas is approved by Health Canada but not funded by provinces, hence all the huff and puff. Any news on Ibrance/Letrozole for you?

The trial nurse called this am. She agrees that it's absurd to have to pay that amount of money to be on a clinical trial and could restrict participation. She however thinks that Fas is provided?! She is checking with hospital pharmacy and will let me know. I also wrote to Health Canada to see if this is standard practice.

NG - thanks. How are you doing?

glad to hear Linda!

My onc agreed this was my first line of tx for mets so he had to call the insurance. Then they changed their minds! So yes I'm finally approved.

But the pFizer lady was saying they would keep giving it to me if onc thought i needed it. Not sure about the free funding. I'm guess I'm not used to getting things for free. So glad insurance approved.

d

Hi,

I just found this thread now! I have been off the board for a while but came back looking for help to find out what comes after palbociclib. (I post for my sister who was diagnosed in 2008 and has been Stage IV since 2013 and called me today to tell me it's over for palbo).

She was originally in the Paloma trial but ended up in the placebo group. When she progressed and was taken out of the trial, she tried to get palbociclib through special access in Canada but was refused. We ended up going to Dana Farber in Boston to get it. It was out of our means (10k/month) but luckily my brother was able to pay. Several months later palbociclib was approved in Ontario and my sister was doing pretty well on it till November (10 months). However, a CT found progression of the tumour in her neck in November, and now the bone scan is back showing progression too, so she has to switch to something else.

I am wondering what other people have done after palbociclib stopped working. I know there is exemestane+everolimus. Are there any other options? Would anyone have advice or suggestions that could help us?

Thank you for any help!

Hi Linda,

Thank you for your answer! My sister was on Faslodex as part of the Paloma trial, and it worked really well (she stayed in the trial for more than a year, responding to Faslodex + placebo). When she went on palbo it was with letrozole. That combination worked well for about 10 months, but no longer (maybe partly because they had to reduce the dose below the recommended level because her white counts kept crashing).

When they biopsied her neck tumour it came back still E+/P+ but Her2 inconclusive. I don't know if it is possible to try a Her2 drug if it's inconclusive (they measured it two different ways and both times it came back inconclusive). Maybe the doctors would consider it inappropriate? (Maybe the government wouldn't pay?) I don't know.

Thank you for mentioning Xeloda. The idea of chemo, even oral, is going to be stressful but maybe it's not so bad.

It sounds like otherwise the option is Afinitor/Aromasin, if she is not appropriate for Her2+ treatments.

Gill

Hi Heather, I didn't get into the clinical trial because I failed their testing as they say. In other words they said I had no progression and didn't qualify. Which was good news of course. It was hard to determine if there was progression because of a lot of inflammation caused by different fractures. I'm still on Letrozole. My Jan bone scan came back stable and abdo US was clear. We're staying away from dye contrast as long as possible with CTs because of allergic reactions. Still waiting on results of CT scan of neck and chest. My breast TM doubled since Oct so we'll see if that's hiding something. First time they went up in 3 years. MO is not overly concerned but may want further investigation is she's not satisfied with CT.

Wow crazy travelling but so happy to hear you're doing well. Nice to hear from you.

Update: Chest CT showed progression, new axillary lymph node mets, new sternum mets and lung nodules but those nodules are so small, we don't know if it's cancer or benign. It's a wait and see approach for those. The clinical trial of Ibrance + Fas (no placebo) we looked at is no longer recruiting. So moving on Fas alone.

Hi Heather - MO looked at other possible clinical trials but none are

available/adequate. I was given 2 choices, Fas or A/A combo. I'd rather stay

away from A/A just now and enjoy a good QOL with Fas. Quebec gov protocol would

have been A/A but I have medical insurance through my ex-employer as a retiree

and can choose the sequence of tx. MO was concerned that my insurance would not

approve A/A later, frankly I'm not sure but I think they would. Anyway we

decided that we would cross that bridge when we get there. MO was happy I can

get Fas and prefers it to A/A. I see you were on A/A for a while. How was it

in terms of SEs?

Pat, I asked my MO last week re approval of Ibrance as second line tx, but unfortunately she hasn't heard anything. Let us know what you learn.

Thanks Heather - I will bring it up.

Linda - haven't been on bco for a while so just saw your posting - sorry to hear you have progression. I've been on fas shots for over two years now and doing well on them - tm's are low, some shortness of breath and certain times of the cycle pretty fatigued but nothing like when I was on AA (I only lasted I think six months). I am in Ontario as you know and Pfizer has "donated" the fas shots - set up by my cancer clinic (they filed all the papers and got approval in record time) the actual shots themselves don't bother me - I have two fabulous nurses (used to have one that nearly killed me) - I have the shots very high up now and that might be the trick - get on the faslodex thread - there is a list of what you need to know at the top. PM me and let me know how you're doing - I am still campaigning to get to Paget(sp) bakery to see you.......

Gill, I hope this biopsy will give a straight answer. Will they biopsy the liver? Soft tissue is easier to get the pathology than with bones. Sorry about her new progression as well. Take a look at the A/A thread, some are on different dosages to help manage SEs or start at a lower dose to gradually increase the Afinitor. I wish your sister the best with this tx if equivocal. Gosh the waiting and the unknown must be so hard.

I've had only one loading of Fas so far and shots went very well, nurse said she was a pro at it! Next loading is Friday and my regular nurse is on vacation so we'll see how that goes. No new SEs to speak of really.