Canadians, palbociclib and clinical trials

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NewGardener
NewGardener Member Posts: 109
edited July 2017 in Stage IV/Metastatic Breast Cancer ONLY

Hi, I am just wondering about my fellow Canadians with metastatic breast cancer and their experiences with gaining access to the newest treatments and clinical trials.

After over a year, mostly working on my own and following a tip here on breastcancer.org, I enrolled in a clinical trial at Dana Farber last summer to receive bazedoxifene and palbociclib.The good news in that the new combo has broken my trend of less and less time for each treatment…so far I'm on my 9th cycle. The monthly travel is a challenge, but the quality of life is much better than on the navelbine which was the next recommendation in Calgary.

With the breakthrough designation given to palbociclib in the US it seems that most metastatic patients are being offered it if appropriate. I've been surprised that there hasn't been any fuss among Canadians that they are not being offered palbociclib with its potential to extend progression free survival and its relatively tolerable side effects.Are Canadian oncologists talking about it with their patients?

With immunotherapy now in the news, I am also wondering if any Canadians with metastatic breast cancer have been offered trials, and if yes, what?


Thank you for your feedback, Heather

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  • NewGardener
    NewGardener Member Posts: 109
    edited March 2016

    Hi Bon

    I agree I should cross reference with the Canadian forum, but I thought I'd start in the Stage IV group just to find the metastatic patients first. At this point the horse is well out of the barn for me so I'm not as interested in early stage trial info. In my lurking, I pretty much only hang out in the Stage IV forum.

    I've been thinking I might need to rename the thread "Canadians, palbociclib, clinical trials and Unicorns" because Canadian metastatic breast cancer patients in trials seem very rare.

    I did learn today from an inquiry sent to another group that Health Canada has granted palbociclib a notice of compliance by Health Canada, which apparently means that it is officially allowed to be sold in Canada, however the treatment will not be available for prescribed use until closer to the end of April. Of course, then the provinces will have to agree to cover the costs.

    Heather




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  • LindaE54
    LindaE54 Member Posts: 2,054
    edited March 2016

    Heather, I'm so happy you're starting this tread. I haven't participated in any clinical trial yet, but it is in my "tool box" for the future. I've been waiting anxiously about palbociclib/Ibrance. I live in Quebec and it's usually one of the last province where new meds are approved. It would also be interesting to see how Stage V gals obtained unapproved meds, if any, and what clinical trials they participated in. I didn't even know that a Canadian could participate in a clinical trial in the US.

    I keep on asking my Onc when Ibrance will be approved. She said I would see it in my lifetime (however long that will be?) and would very much like that to be my next tx. I don't want to get my hopes too high as Quebec has a different an entirely different approval process. Do you know if it is approved as first line tx only? That is one of the things my Onc said.

    I hope Stage V Canadian gals will chime in. I'm so glad you're doing well on this trial.

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  • NewGardener
    NewGardener Member Posts: 109
    edited March 2016

    Hi Linda

    It is frustrating that each province is so different - I have been thinking that I need to start helping the advocacy movement to get more equitable coverage across the country. I also wish that they would make it easier for patients to find and travel to trials if they aren't being held in their own cancer centre.

    One thing I learned in my search for clinical trials is that the sooner the better for participating. I found several interesting phase 3 trials, but I was ineligible because I had already had too many lines of treatment, or had already had the control drug (letrozole, fulvestrant).

    It is possible, but expensive, for Canadians to go to US trials. The big centres have staff to help international patients. One has to pay for non trial costs, which may include consultations, scans, blood tests, and that sort of thing. They provided me an estimate up front. My Dana Farber oncologist sends my Calgary oncologist updates.

    I do not know whether palbociclib will be available for non first line treatment initially in Canada...but it does look like you have the fulvestrant plus palbociclib potential still. There are also also cdk4/6 inhibitor drugs like palbo that are still in trials by other drug makers in Canada (I think they are LEE 011, abemaciclib).

    Thank you

    Heather




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  • LindaE54
    LindaE54 Member Posts: 2,054
    edited March 2016

    Heather, we certainly need advocacy. If you decide to, let me know if I can of any help. It's interesting that you say the sooner the better for clinical trials and a good point that I will consider. There is also another interesting trial called "Sandpiper". I started a thread for that a while ago, but not much response.

    Hoping to hear more from CDN gals.

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  • NewGardener
    NewGardener Member Posts: 109
    edited March 2016

    I have not met anyone who is in the sandpiper trial (fulvestrant +/- taselisib). I couldnt qualify because of my prior fulvestrant and everolimus treatments.

    Before I started the palbo/bazedoxifene trial I tried to get a new biopsy done to send the sample to foundation one for genomic testing, in part to see if my tumour had the p13k mutation. Would you believe the first biopsy didn't get enought material and the second biopsy didn't get viable tumour. I was all set for number three but now my white cell counts are too low on palbo so the idea is on hold.

    Have you seen that a Canadian company (in BC) contextual genomics is now offering genomic testing? I haven't investigated it yet (or brought it up with my Calgary onc) but it made the news a week or so ago.



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  • LindaE54
    LindaE54 Member Posts: 2,054
    edited March 2016

    That's a bit frustrating. I heard about the genomic testing in BC. In fact, it's GG27/Dee in BC who inquired about it. She gave some info on the bone mets thread about that. I'm sure she won't mind you pm'ing her if you want more info.

    Good luck with your next biopsy.

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  • GG27
    GG27 Member Posts: 2,128
    edited March 2016

    Hi Heather, Been away from the computer & didn't see this thread til just now. I don't know if this is the place you're talking about, here's a link. It's very expensive.

    CTOAM

    There has been quite a lively thread about it on the Canadian MBC FB page. One of the women called there today for some information, here is a quote from her "some of what he said made sense to me. But, they charge 200 an hour. so with the genetic testing, you get 15 hours of consultation. what's that - another 3,000. so we are clsing in on the 9,900 they say on their website"

    Also in BC there is a new POG program, Personalized Onco-Genomics. It is available to all cancer patients in BC. I called my MO to find out if I qualify. They need 5 biopsy's & they wouldn't take them from bone only like I have, so I am keeping that one in my pocket in case I need it.

    POG Program

    I don't know much about any other trials at this point. My MO isn't very forthcoming with information, so I've just left things right now because I'm stable at the moment (touch wood)

    Also, Inspire Health is now free to all cancer patients in Canada. Not a Clinical trial but supportive care.

    Inspire Health

    But I'd sure be happy to do anything I could to help out on a project to get more information out. I don't want to travel to the US for any treatment. Feel free to PM or post here if I can give you any more information. I've added it to my favourites. cheers, Dee

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  • NewGardener
    NewGardener Member Posts: 109
    edited March 2016

    Thank you for the extra information. I will PM you about the facebook group - I would be interested in joining if that is an option.

    CTMAO and Inspire are new to me. From what I can tell, contextual genomics just does the test, not any consultation. The referring oncologist would then sort of possible options, if any.

    http://contextualgenomics.com/2016/03/14/contextua...

    Out of curiousity, have you made any contact with Canadian mbc patients about immonotherapy-related trials?

    Thanks!

    Heather

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  • Stage_IV_in_Montreal
    Stage_IV_in_Montreal Member Posts: 15
    edited April 2016

    hello - I'm an infrequent visitor to this board. I'm in Montreal Stage IV and currently just started Navelbine. I just tried to find the Canadian MBC Facebook page you mentioned but couldn't find it. Would appreciate correct name of page or how to access it. Thanks

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  • barbe1958
    barbe1958 Member Posts: 19,757
    edited April 2016

    Another Canadian here interested in the combo of Letrozole and Pablo. Will be seeing my onco next week. I hope he doesn't laugh at me with my hopes so high. But I read about it in a magazine AT the Cancer Centre!!

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  • NewGardener
    NewGardener Member Posts: 109
    edited April 2016

    Hi Stage 4 in Montreal, I will send the link by PM.

    Good luck with the Navelbine. It was the drug my oncologist had suggested that I start next before I jumped to the US trial.

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  • NewGardener
    NewGardener Member Posts: 109
    edited April 2016

    Hi Barbe,

    I only just now saw your posts in the Canadian section, I have been travelling. I hope you can find a way to get the letrozole/palb combination next, but if not immediately there are other alternatives that may work great too

    Good luck! Let us know how it goes.

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  • Joy73
    Joy73 Member Posts: 6
    edited April 2016

    I'm not sure if this has been mentioned here but there is an expanded access study of Palbociclib and Letrozole in Canada. It began last month and included 100 women across Canada. There are 15 of us in the study at Tom Baker Cancer Centre in Calgary. It includes hormone positive, post-menopausal women for whom letrozole is their first hormone treatment. The study would not accept women who were using Zoladex to shut down their ovaries so I had an oophorectomy done at the beginning of March so that I could be included in the trial. I am on the 2nd month of the trial now. I had to be pulled off of the combination 2 weeks into the first month because of a low white blood count. The study monitors your bloodwork every 2 weeks so hopefully my white count will stay higher this time. If anyone would like more information on the study let me know and I will provide what I can.


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  • NewGardener
    NewGardener Member Posts: 109
    edited April 2016

    Hi Joy73

    That is excellent news to hear that you got into the expanded access trial for palbociclib at TBCC. I am sorry to hear that your initial blood counts were low, I hope they rebound. My counts have been low but always high enough. I am now on cycle 10.

    Last week I was talking to my Calgary oncologist (I only talk to him sporadically since I am really under the care of the Boston onc these days) and he mentioned the expanded access trial at TBCC was now closed.

    Of course, it is hugely frustrating to me that they didn't create a trial for metastatic people who are not newly diagnosed so they could also benefit from the treatment. Instead they offer more toix chemotherapies. For the rest of us, we will still have to wait to see what the various provincial committees decide about palbo.


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  • LindaE54
    LindaE54 Member Posts: 2,054
    edited April 2016

    Joy, so happy to hear you're part of the trial and hope your white blood count behaves!

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  • Joy73
    Joy73 Member Posts: 6
    edited April 2016

    NewGardener - My oncologist told me that they will be starting a trial at TBCC combining Ibrance and Fulvestrant, Would you be able to be a part of that trial? I can definitely understand your frustration that they did not include individuals who were not newly diagnosed.

    LindaE54 - Thank you for your encouragement! I hope my counts behaves as well!

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  • barbe1958
    barbe1958 Member Posts: 19,757
    edited April 2016

    Joy, how did you find and get included in time? I'm envious.....but is it a blind study where you don't know if you have the goods?

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  • NewGardener
    NewGardener Member Posts: 109
    edited April 2016

    Hi Joy73

    I probably wouldn't qualify for a fulvestrant plus palbo trial either...I had fulvestrant for 18 months or so back in 2012-2014. The Boston trial I am now on combines bazedoxifene with palbociclib.

    Nonetheless, thank you so much for the heads up about the new trial. I may know of others that could qualify. Hopefully their oncs bring it up, but it is always good to advocate for oneself too!



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  • Joy73
    Joy73 Member Posts: 6
    edited April 2016

    Barbe1958 - My oncologist is on the trial team & he referred me to the study. He thought it would fill up fast. The 100 women are all receiving Ibrance. It is not a blind study. The good news is that I have heard from the team that there may be expanded access across Canada even before the trial is over. If you have any questions for the trial team I would be happy to ask them for you.

    NewGardener - Hope everything is going well with the Boston Trial. I've heard there is a support group for metastatic breast cancer at HCC. Do you anything about this group?

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  • NewGardener
    NewGardener Member Posts: 109
    edited April 2016

    Hi Joy73 - There are now even two "in-person" support groups for metastatic cancer at Tom Baker. It is one of the strengths for AHS I think. I will PM you the contacts. Heather

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  • LindaE54
    LindaE54 Member Posts: 2,054
    edited July 2016

    Saw my MO yesterday and she wants to enroll me in the NCT02630693 clinical trial. It's a protocol that tests two different schedules of palbociclib combined with a hormone therapy as second line tx (no placebo). They are currently recruiting in most provinces with a total of 180 participants across Canada.

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  • Husband11
    Husband11 Member Posts: 2,264
    edited July 2016

    They are not yet enrolling in this trial in Manitoba. It's still in the process of being set up here.

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  • NewGardener
    NewGardener Member Posts: 109
    edited July 2016

    Linda, that is great that they are opening a trial and that you may be able to participate. I have heard that the trial may be in Edmonton too.

    I just started round 13 of my trial (which is 125 mg of palbociclib plus bazedoxifene). I am still travelling to Boston each month.

    I hope the various provincial authorities get their act together (with maybe price cooperation from Pfzer) so all Canadians will get access to the drug instead of the current piecemeal.

    Good Luck!



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  • LindaE54
    LindaE54 Member Posts: 2,054
    edited July 2016

    Thank you NewG. And same to you as you start round 13.

    MO told me yesterday that Ibrance can be obtained on an exception basis in Canada for first line tx only. She's confident that Ibrance will be approved as second line tx, but it may take a while. Fingers crossed.

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  • Sary
    Sary Member Posts: 46
    edited July 2016
    FYI - I live in Ontario and I was just approved by Pfizer for "bridge funding" for Palbociclib. It was almost too easy. The only question they asked is who I have insurance with. From what I understand, they will cover the funding and in the meantime I am supposed to petition my insurance company to add Palbociclib to their approved drug list. I have been on Letrozole since December and that didn't seem to matter (and I was previously on Tamoxifen).
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  • LindaE54
    LindaE54 Member Posts: 2,054
    edited July 2016

    Sary - that's great news! Would you mind giving me your Pfizer contact? You can pm me if you prefer.

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  • guidinglight
    guidinglight Member Posts: 16
    edited July 2016

    Mom was approved for ibrance and faslodex, both covered by drug companies. She was previously on leterzole and the E/e combo. We live in Ontario, no insurance.

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  • GG27
    GG27 Member Posts: 2,128
    edited July 2016

    That's amazing that Pfizer is covering the drug. I was told the only way I could get it without insurance was to pay for it myself ($6,200 per month) or go on the Palestra trial. I'm in BC.

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  • guidinglight
    guidinglight Member Posts: 16
    edited July 2016

    Moms onc worked with the drug access coordinator through the cancer centre in Kingston, ON. She communicated with the drug companies (Bayshore). They denied the first time, then the onc wrote again and demanded it. No fully covered. Ibrance is delievered to house and faslodex if delivered to hospital.

    I would try again. Because when she was approved (about 2 weeks ago) they said their requirements changed and she could not have it at no cost.

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  • dancingdiva
    dancingdiva Member Posts: 475
    edited July 2016

    hello CDN ladies!!!!

    I'm new to this wonderful stage IV. Pfizer sent me the first month of Ibrance free while the insurance was figured out. Found out today that it was denied because it's not the first line of treatment.

    WTH does that mean? First line after being dx stage IV ? So when I was stage 3 taking tamoxifen what line of treatment was that? Or the chemo before that?

    Very upset I was denied.

    d

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