Neratinib Clinical Trials

Hi Nerats gals, Lean, I am still in the dark too, first I had nothing much to indicate I am taking the drug, but now to the day one month on the trial, Im still not sure, even though I have had consecutive days with Diarrhea, I more link it to a Infection going on in my blood that is not recovering and or an intestinal bug !!!  I asked the study doc for a copy of my blood test so I can see for myself what my count from all angles show ! Haemorrhoid bleeds verses loose stools the source I think !!! Only mention it since we can all talk D talk...

KAKA - I did not have the "rash" or acne they warn you about but did get pimples in my nose that were painful and had more mouth sores.  I'm on 5x day.

Did I just read that someone else is having boils on this drug? Me too and they are literally a big pain in the ass and everywhere else they pop up. I haven't had any kind of rash, but do get the nose sores/pimples/bleeding. Bad acne, mouth sores & neropothy of the hands & feet. I am on the 6 pills a day & have been since the beginning. I'll be done in December. Good luck gals.

Bonsoir à toutes

Mon onc m'a proposé l'essai. Je dois donner ma réponse le 30.09. Vous m'apportez beaucoup dans vos expériences. Je pense accepter mais j'hésite encore. La diarrhée est elle vraiment invalidente au début du traitement. Je poste en français, j'espère que vous pourez me lire. Bises à toutes 

KAKA

Idem pour moi pour le traducteur, le déchiffrage est difficile. Mais c'est une grande chance pour moi de pouvoir avoir des informations car sur les forums français aucune personne ne parle de l'essai neratinib. Quels sont les autres effets constatés avec le neratinib. Mon onco me parle de diarrhées principalement mais j'ai vu sur le forum des problèmes d'acné et de furoncle.... C'est systématique pour toutes les personnes ? 

So my mom is in one of the clinical trials for neratinib.  Here is the thing - the trial she is in has like 18 people in it - all taking chemo and herceptin as well as the neratinib at the same time - all stage IV of some sort.  The dose is the 120 mg (3 pill) dose.   Every person that I've ever heard of taking this has had some sort of diarhea mixed in with the treatments, but so far my mom has had none - other than what the chemo had already caused.  I was afraid that it was a placebo she was on, but the clinical trial nurse has assured us multiple times now that it is the real thing and there is no chance it is a placebo.  Has anyone else ever had the 120 mg dose and never had "d" ?   Is she a medical mystery?  Or is it the grace of God?   Thoughts?

Kward70, you and I have similar diagnosis and treatment. I've been in the trial since May.

I'm still not sure if I'm on the drug, but I "feel" like I am, even though I don't have 'explosive' diarreah regularly.  I still have nose sores (and I ended Herceptin in Dec, 2010).  I also have gone on trips and forgotten to take my pills with me.  When I come back and started them again, I usually have loose stools every day for about a week.  I also get shooting tingly feelings in my head and up and down my arms only occasionally (like when I was on chemo.)

This is going to sound gross, but even when I go #2 and it's not soft, there's still a funny kind of medicinal odor to the stools. Which makes me think I might be on the real thing, but just without the primary SE's?  Is this possible?

I feel like my docs know whether or not I'm on it but just don't want to let on :-) Thanks for all the info!

Gemini 1/2 - I bet you are on the drug.  my Onc does not know if I got the placebo or not but she says they can generally predict bc of the side effects. 

Karyn

Geewhiz, that doesn't sound like you at all!  I've been getting a little skittish approaching that 2 year mark, though, too.

I'm scheduled to start on the trial next week.  I still have to do the bloodwork, echo, and meet with my onc.  Cleared the CT scan and bone scan this week (woohoo!!).  I'm getting a little nervous as I'm reading lots of stuff on here that wasn't in any of the literature on the drug.  I never quite got all of the feeling back in my fingers after Taxol, so the idea of more neuropathy....yikes!

New update to report on SEs in the last week, and I'm wondering if anyone else has experienced something similar.

Last Tuesday, I had the final step in my reconstruction, the nipple tattoo. The doc gave me some antibiotics to talk for 5 days.  About 3 days in, I started getting diarreah, and not just normal d, but similar to the experiences I've heard other women on this thread have. Absolutely zero warning and Immodium hardly does anything, even on the maximum dose. 

 I've also had a fever of about 100.5 the last few days, aches, chills and some pain around the nipple area.  So there may be an infection...

Focusing on the diarreah for a mintue, I'm wondering if the Neratinib (assuming I'm on it), and antibiotics  don't mix.  I've never had this kind of a reaction on antibiotics before, so I'm wondering if the combination of both drugs is causing the explosive diarreah. 

I'm eating lots of bananas, and started with priobiotics today.Anything else I can do to minimize the D? I took my last antibiotic today...Thanks!

Gemini - I took antibiotics in the past with lots of D - (biaxin was one of the worst) and had bad gas and D after my exchange last year. 

K

Thanks so much CBM for your note. I feel much better after reading it. I'm writing this from the hospital actually. They checked me in out of fear my implant was infected. Turns out its not-yeah-but I did have something that was causing the fever, diarrea and redness on my breast.  They pumped me full of antibiotics so I'm good to go now. I think--tho no one has confirmed--that the diarreah was a combination of the neratinib and antibiotic. They tested me for CDif, and I was negative. By the time I started taking probiotics it was too late.  I'm sorry to hear of your neuropathy. I hope it goes away once you're out of the trial. Take care--

Clostridium Difficile, a bacterium that really gets going when the antibiotic you are taking gets rid of all the good bacteria along with the bad.  It's very serious, especially in older folks and among those whose immune systems are compromised (which is why they are on Keflex, or one of the newer potent antibiotics).  I am told it's the first thing they check for if you get diarrhea after a course of antibiotics, because it's hard to get rid of.

If you haven't encountered it, you probably would never have heard of it, and that's a good thing!

Cathy 

Hi!

Just got back from my trial doc. All poked and prodded, except ekg follows tomorrow.

All my gripes they acknowledge as se's. The mild depression is fleeting, and the doc attributes it to occasional tiredness, a common se. My neuropathy he is saying he believes is pre-existing from the chemo. It only shows up when I am swimming laps.

I am not taking the drug for a few days this month...I am having reconstruction next week and since we don't know how the drug interacts with anasthesia, he suggests I come off it just prior and after a day or so. Has anyone had surgery while in the trial?

Did I read somewhere that some early trial results were going to be released soon?

I start the trial today!  We've got a jam-packed busy weekend, so I'm hoping if I have any SE's, they are managable.

Geewhiz, I just went through all the details with my trial nurse yesterday and it specifically says how long to stay off the drug if you're having reconstruction surgery.  I think it was 4 days before and 3 after, but you might want to ask......