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NATALEE TRIAL

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mariadelpilar
mariadelpilar Member Posts: 37
edited March 2021 in Stage II Breast Cancer

My dr. wants me to join the Natalee trial which is based on the success of the Monaleesa trial for women with Stage 4 breast cancer. the drug is Kisqali (ribociclib) tablets. It was administered in 6 mg tablets for the Monaleesa trial and will be given in 4 mg for the Natalee trial. The problem I am having with it is the large percentage of side effects for the women in the Monaleesa trial. I am stage two, two nodes involved, and two unifocal tumors in the right breast. I just don't know if the benefits outweigh the risks. I did surgery, then chemo for 4 cycles, and i am going to start radiation for 7 weeks, followed by an aromatase inhibitor. If this treatment lowers my chances of recurrence to 10%? what am I really gaining other than more side effects? The purpose of the study is to see if this medication will work on lowering recurrance rate to women with early stage breast cancer.

I know that there are a lot of you out there pretty savy with research, so I would really appreciate your input.

thank you soooo much.


Comments

  • sugarcactus
    sugarcactus Member Posts: 3
    edited March 2020
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    Hey Mariadelpilar,


    This sounds like the study I joined about five months ago. I had stage II with a high chance of recurrence and a level 3 grade tumor. It was in one lymph node. I had a left mastectomy, then four rounds of chemo, then a ton of radiation. Then, I had a month or so off to recover before starting therapy. I decided to go all out because I figured I could scale back the medicine but couldn't join the study later. I am therefore doing ovarian suppression shots monthly (the needle is huge but actually doesn't really hurt), an AI once every day, and the 4mg Ribociclib. I also take Effexor and barely notice hot flashes.

    Frankly, I'm surprised at how well I'm doing. The main side effects I have had are some fatigue, some vaginal dryness, and perhaps hair thinning, but I exercise about 45 min of cardio a day plus yoga and weights regularly. I still have a sex life. The weird thing is I now sleep about 8-9 hours a night at the minimum, which is weird as most people sleep less in menopause. I also got local vaginal estrogen to use which is not supposed to get into your bloodstream and cause problems. Also I am on the younger side of things, 42.

    Also, you immunity can get lowered, which is the main draw back for me, especially with the virus outbreak. My immunity is lower than normal but my oncologist insists that the numbers look good still and I haven't been sick in over a year and a half (knock on wood). I am being very careful and self-quarantining right now as much as possible (but I also am a teacher and live in the middle of the Seattle outbreak!).


    I am thankful for this decision as I had a high chance of recurrence and the longer I can push of recurrence, the more treatments there will hopefully be. The Kisquali is only for 3 years and then just the AI for up to 5 or maybe 10 years.


    Hope that helps a little bit. :)



  • mariadelpilar
    mariadelpilar Member Posts: 37
    edited March 2020
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    thank you for your reply, sugar cactus! I am having the exact treatment you had. I couldn’t have the onco type tests because I had two different tumors right next to each other. I will do the trial because my oncologist said I had a high probability of recurrence also. I’m so happy to hear you aren’t experiencing major side effects! I hope I have the same experience. Besides a couple of women on this site, I don’t know anyone who is on the trial.

    Can you have your students use hand sanitizer after recess and after lunch to minimize your exposure to germs? I used to teach also and that was always a concern. I am also concerned about starting radiation in the next week or so and going to a dr s office every day during this virus outbreak. I had the regular flu just before my 4th round of chemo and was scared to death they would cancel it. So glad I’m done with that! Still have the port in.... can’t wait to get rid of it

    My radiologist didn’t really explain why I’m getting 7 weeks of radiation. Most people get 5-6, right? How many weeks did you get? Did you get the regular radiation (photon) or the poton? ( I probably misspelled Both!)

    Good luck to you. Stay safe, healthy, and happy.

  • HOPE012119
    HOPE012119 Member Posts: 19
    edited April 2020
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    Hi! I’m on the trial. And I’ halfway thru the first year :)


    Did you decide to join, Mariadelpilar?

  • mariadelpilar
    mariadelpilar Member Posts: 37
    edited April 2020
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    hi hope012119,

    Thank you for responding, can you tell me if you’ve had side effects while on the trial? I’m especially worried about QT and lowered immune system.

    Thank you!

  • HOPE012119
    HOPE012119 Member Posts: 19
    edited April 2020
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    I have not had the QT prolongation SE which is a relief! They said all my ECG tests were ok. I should have asked specifics (Regarding what’s acceptable and where my reading fell in the range). But I haven’t for that issue. Mostly because it goes over my head.

    My counts are low a lot. Especially as time has passed but then they bounce back up a bit. The neutropenia for me is not febrile neutropenia so that’s also a relief. I won’t lie, being immune suppressed is on my mind a lot lately. But I’m trying to be careful and hoping for the best.

    I don’t know what my recurrence odds are beyond that generic 30% we all hear. I often wonder if it’s worth the risks especially during the current situation.

    Can you enroll in the trial at your cancer treatment center? I had to go to another hospital

  • Georgia1
    Georgia1 Member Posts: 188
    edited April 2020
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    Just thanking all of you for enrolling in a clinical trial. Hundreds, if not thousands, of women will thank you in the future. Your participation is so important!

  • HOPE012119
    HOPE012119 Member Posts: 19
    edited April 2020
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    thank you Georgia1!

  • mariadelpilar
    mariadelpilar Member Posts: 37
    edited April 2020
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    thank you Hope12119,

    I am thinking about doing the trial and see how I do with my blood count. Like you , I'm worried about a suppressed immune system, but I also don't want a recurrence! From all the research I've done seems like stage 2 breast cancer is pretty curable even with node involvement, and since I didn't have the oncotype test, I don't know how my oncologist knows my recurrence rate? By the way, can I ask you how many rounds of chemo you had? I had 4 but when I told my dr that I may not join the trial, my dr said that if she knew I wasn't going to join the trial she would have given me 6 rounds of chemo! This sounded to me like she wanted to punish me😞thank you for writing back.

    Ps. 30% recurrence rate is only if you have surgery only accosting my Dr.Did you have radiation? My oncologist and radiologist said that chemo lowers the chances to 15% and if you add radiation it goes down to 6%!

  • HOPE012119
    HOPE012119 Member Posts: 19
    edited April 2020
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    Hi Maria,

    I did 8 rounds of chemo (dose dense AC-T) before surgery. I didn't have a complete response (not surprising for hormone positive). I had the bilateral mastectomy and had to get the axillary lymph node dissection after two nodes that looked like they had resolved during chemo turned out to be positive. I did 5 weeks of radiation. After I finished rads, the radiation Onc shared that 6% figure with me so when the medical Onc suggested doing the Natalee trial after I completed all those months of treatment, I was like why would I do that when my risk for recurrence is so low and I've already thrown everything including the kitchen sink at the disease. The medical Onc said the 6% was for local recurrence but the systemic recurrence risk is around 30%. I'm not sure if that figure was specific to me or in general perhaps? At that point I had a few tears! First and only time during an appointment. Thank you for explaining how lowering the risk thru treatment works! That makes sense! So maybe that 30% figure was specific to me. I was too upset at the time to ask clarifying questions about the data and was thrown off by the prospect of doing the trial and all the unknowns that went with it. It's so much to process! What kind of chemo did you do? Is there a research nurse you can speak with about the trial? The research nurse has been so helpful to me. I'm happy I'm enrolled. The time between hearing about the tria and enrolling seemed to pass quickly. I wasn't sure which arm I wanted to be randomized to but in the end I was relieved I was randomized to the control arm and got the drug. If you're interested there's a Facebook group with a few people interested/enrolled in the trial. You should be able to search with the name of the trial to find the group.

    I would recommend enrolling in the trial! I understand it's a difficult decision. And please let me know if you have more questions.

    take care,

    Hope

  • mariadelpilar
    mariadelpilar Member Posts: 37
    edited April 2020
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    I did the same chemo as you. What does dose dense mean? I did 4 rounds every 3 weeks. I did 7 weeks of radiation!!!

    I would clarify with your doctor the recurrence rate.The 30 % recurrence rate doesn't seem accurate. The chemo is supposed to take that percentage way down, and then the radiation. I found this info in THE BREAST BOOK by Susan Love and also through other research online. I don't have an onco nurse. What state are you in?

    Did you have the oncotype test?

  • HOPE012119
    HOPE012119 Member Posts: 19
    edited April 2020
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    Hi! Dose dense is giving In less time than the standard time. I had 8 infusions over the course of 16 weeks, so every 2 weeks. Here’s an explanation:

    https://www.breastcancer.org/research-news/dose-dense-chemo-improves-survival

    The research nurse works at the hospital where I enrolled in the clinical trial at. She’s sohelpful!

    I didn’t have the oncotype test done.

    I will check out that book! Thanks so much for the suggestion:)

  • sugarcactus
    sugarcactus Member Posts: 3
    edited March 2021
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    Hi Natalee peeps!


    I’m almost done with year two of the trial but am so so tired, I may quit early. Anyone else having extreme fatigue? And I’m 42 and usually work out but not daily these days! My iron levels are low but normal low, so I may try a vitamin first..

  • srivak01
    srivak01 Member Posts: 3
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    Hello all. I'm about to go on Kisqali 400mg for stage 2A node-negative BC. My doc is recommending it since my oncotype score was 39 (not below the 25 threshold). I'm taking anastrozole. I did taxotere+cytoxan and I'm just getting myself back (hair, energy). Kisqali sounds like chemo lite. Would love to hear if members lost hair, felt nausea, fatigue on the 400mg dose. Love and healing vibes to all!

  • moderators
    moderators Posts: 8,074
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    Hi @srivak01, and welcome to Breastcancer.org! We're so sorry for the reasons that bring you here, but we're really glad you've found us. You're sure to find our community a wonderful source of advice, information, and support — we're all here you!

    We're sure others will be by soon to weigh in on your post, but this thread has been quiet for quite a while — so you may want to start your own new discussion in the Targeted Therapy or Stage II forums on experiences with Kisqali to reach more folks who can help. Let us know if you need help doing so!

    In addition, you may find this podcast episode helpful:

    We hope this helps and that we see you around the community. Please don't hesitate to reach out if you need anything at all!

    —The Mods

  • sarahmaude
    sarahmaude Member Posts: 338
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    I just wanted to write that I'm very interested in your experiences with the Kisqali for high risk stage 2/3 cancer. I am also stage 2A node negative with a high Oncotype score. I July, my MO said if I wanted, she'd prescribe Kisqali per the trial regimen, but as I'm doing Signatera, I said at that time I'd prefer to wait until that test came back positive. Now I'm hearing of others like me who are starting the Kisqali, I may revisit the discussion. If the S/Es are manageable, it might be worth me halving my change of recurrence.

  • tnsplayer
    tnsplayer Member Posts: 6
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    I take Kisqali also. Stage 3a micromets in one node. Oncoscore 17. On Anastrazole but I added Kisqali four months ago. I actually made an appointment with one of the researchers at UCLA to discuss the NATALEE study. The visit reassured me it was right for me. Technically I am not part of the clinical trial. That closed before I was diagnosed.

    I had discussed Verzenio with my onco but I didn't really fit the parameters of their study patients. And I didn't want to reduce my active life by having a lot of diarrhea.

    My hair is a bit thinner but so far I have no side effects. My white count is lower but not worrisomely low.

    I have a 10 to 18% chance of recurrence so I want to lower that even more and know that I did everything known to medicine to prevent a recurrence.

  • tnsplayer
    tnsplayer Member Posts: 6
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    I should add a big Thank You to those of you who were part of the clinical trial! The results are so promising.

  • srivak01
    srivak01 Member Posts: 3
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    Thank you for the replies. I haven't started the 400mg Kisqali yet. I'll post when I do. Good luck to everyone!

  • sarahmaude
    sarahmaude Member Posts: 338
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    @tnsplayer thanks for your post. According to my OncoType Dx my post chemo chance of recurrence is about 18%. Where did you get your recurrence percentages?

    Did you visit the NATALEE researcher in person? What stood out for you in that meeting? I'm really wondering if taking Kisqali is something I should consider. I do meet the parameters as referenced in the study, I believe, so my insurance could cover it.

  • srivak01
    srivak01 Member Posts: 3
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    Day 1 on Kisqali 400mg! I took the 2 pills with my dinner last night. No nausea…yet. I have a blood test and ecg scheduled in 2 weeks.

    @sarahmaude….my doctor recommended Kisqali. I was very hesitant because of the known side effects, but figured I would try it and stop if I couldn't handle it. My insurance (Cigna) originally declined to cover but agreed on appeal. My docs office did the appeal. It's very pricey (18K/month) if it's out of pocket.

    I'll keep posting about my journey. The Kisqali course is 3 yrs at 400mg/day for early stage BC

    Good luck to all!

  • sarahmaude
    sarahmaude Member Posts: 338
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    Thanks for your info! I appreciate it.

  • tnsplayer
    tnsplayer Member Posts: 6
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    Five months on Kisqali and anastrozole with no bad side effects. I play tennis several times a week, I walk, I travel.

    My recurrence risk is based on Oncoscore, RxClin and doctor's opinions. Oncoscore groups those with 1 to 3 nodes positive into one risk group so one doctor said my risk would be lower since I had only micromets in one node.

    As for insurance, my insurance approved coverage but the amount out of pocket is still substantial since Kisqali is classified as a specialty medication. The first month cost me over $3,000. Subsequent months cost me $700. But I think I will start over in January with first month $3,000 then back to $700. This is with a Medicare part D plan. It's a hit but I would pay anything to prevent a recurrence.

    I hope more results from the NATALEE study are released soon. Good luck to us all.