NATALEE TRIAL

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.

Hi! I’m on the trial. And I’ halfway thru the first year

Did you decide to join, Mariadelpilar?

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

thank you Georgia1!

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

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:)

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!

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.

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

@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.

Thanks for your info! I appreciate it.

I am about to add Kisqali to anastrazole.

@tnsplayer "Five months on Kisqali and anastrozole with no bad side effects." Is good to hear!

I do do my best to exercise, but I might just take up tennis!

Thank you! My insurance denied payment, but my pharmacist is filing an appeal based on recent Natalee trial data. I may be done with the three years before I start using Medicare.