Phase 3 study of Abemaciclib

Anonymous
Anonymous Member Posts: 1,376
edited August 2018 in Stage III Breast Cancer
Phase 3 study of Abemaciclib
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  • DKK
    DKK Member Posts: 58
    edited July 2018

    Has anyone started the Phase 3 study of Abemaciclib combined with standard Ajuvant Endocrine Therapy? This study is for Stage III with high risk node Positive, Early stage, HR Positive, HER Negative. Helps prevent recurrences. My oncologist asked if I would be interested in participating in the study. I want learn more about the benefits and side effects before I commit. Just wondering if anyone out there can give me some input or share your experience As always, thanks so much for sharing.

    The study is by Eli Lilly and Company

    Protocol # monarchE: 13Y-MC-JPCF

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  • sbelizabeth
    sbelizabeth Member Posts: 2,889
    edited July 2018

    DKK, I looked around and found the Phase 2 ended this year, and no information about recruiting for Phase 3. I'll sign up if I qualify!

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  • DKK
    DKK Member Posts: 58
    edited July 2018

    My oncologist just told me about it last week. From what I understand there has been a previous study but only with Stage 4 with cancer that has metastasized. FDA recently approved it for this stage only. It has proved to be very successful and now want to study Stage 3. You may have seen the “Relentless” commercials. I can’t find much information about the new trial either but some women have posted about using it in Stage 4 posts. I haven’t even seen it listed on my hospitals website for trials.

    Side effects are mostly diarrhea and they list many more of course. I want to do everything I can to prevent recurrence and live longer,but not convinced to go through the sickness again. The dose is a pill 2x a day for two years along with your endocrine therapy.

    I will post if I learn more, I will be talking to the nurse on August 15th.


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  • DKK
    DKK Member Posts: 58
    edited July 2018

    Here is one link I found ....

    https://apps.ohsu.edu/research/study-participation-opportunities-system/knight_viewstudy.php?id=STUDY00017504

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  • DKK
    DKK Member Posts: 58
    edited July 2018

    here is another article about Abemaciclib and success so far

    http://www.lbbc.org/news-opinion/cdk-46-inhibitors-what%E2%80%99s-new-and-what%E2%80%99s-left-learn

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  • Ausykaren
    Ausykaren Member Posts: 68
    edited August 2018

    Hi, I have been on the phase 3 trial of Abemaciclib for over 8 months. The main side effect is supposedly diarrhoea but I haven't had this. I don't seem to have any side effects apart from my white blood cells being slightly low but nothing to worry about says my oncologist. My oncologist thinks that this drug has the potential of being more effective than the endocrine therapy. If you want any more information you are welcome to pm me and I will try andhelp. Karen


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  • DKK
    DKK Member Posts: 58
    edited August 2018

    Thank you for your response Karen. Are you taking Abemaciclib with any other endocrine therapy! Are you taking 150 twice a day?

    Glad to seeare not so bad for you. May have more questions when I get started. Thank you!

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  • stephilosphy00
    stephilosphy00 Member Posts: 386
    edited August 2018

    I also want to participate even I am stage 2 instead of 3, not sure if I am qualified though!

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  • sbelizabeth
    sbelizabeth Member Posts: 2,889
    edited August 2018

    I poked around the internet a bit and found the Phase 2 trial. It looks like they're looking for patients who are just beginning their aromatase inhibitor treatment? For Phase 2, "prior treatment with anti-estrogen" was a excluding factor. I've been on Femara for six years.

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  • Ausykaren
    Ausykaren Member Posts: 68
    edited August 2018

    Hi DKK,

    Yes I take 3 50mg tablets twice a day and I am also on anastrozole. You can't eat for an hour either side of taking the tablets. Karen :

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  • Anna-33
    Anna-33 Member Posts: 192
    edited August 2018

    I am in at similar trial... PALLAS ... adjuant palbociclib inn addition to antihormones...

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  • DodgersGirl
    DodgersGirl Member Posts: 2,382
    edited August 2018

    I am on a similar trial, too SWOG-s1207 which is Anastrozole plus possibly Afinitor unless on the placebo.

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  • DKK
    DKK Member Posts: 58
    edited August 2018

    Dodgers girl, Anna-33, Have any of you suffered from bad side effects or hair loss?

    How long have you been on it?

    I just started my Anastrozole this week have to make a decision to take part by next week

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  • Anna-33
    Anna-33 Member Posts: 192
    edited August 2018

    I started 7 months ago... My only sideeffects are low white blood counts and some fatigue/tierdness...

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  • kdrake1007
    kdrake1007 Member Posts: 77
    edited August 2018

    My oncologist mentioned the trial to me back in May and said I'd be eligIble once I'm done with chemo in October. I'd love to learn more from others who are participating!


    Thanks!

    Kim

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