Neratinib Clinical Trials

I'd say discuss it with your Onc first. They may already be in the trial. If not or they don't want to be involved then contact the registry. Just goodle the Neratinib sight, it should give you locations of all the trials in your area. Contact them and they can lead you from there. Good Luck, I'm in month 4 myself. Going good except for the occasional diarreah.

Just an update here.

 I'm still on the pills, waiting to see the onc this Wednesday.  I still have on loose stool per day,and taking 1 antiD pill (2mg) per day.   I stopped eating yogurt and cheese, and take 2 X-strong Tylenol when belly hurt too much.

It's manageable, but hope he will reduce the dose.

I also have the mouth sores and acne. The acne can get really bad at times. You would think I was a teenager again. I also have at least 1-2 noise bleeds a day. Not really anything big. Just when I blow my noise, since it seems to drip a lot, there is blood. Had a few sores inside my nostrils too. Still no period. Found out yesterday NOT to eat eggs & sausage before going to work. Must of been in the bathroom @ 5 times. Next month I hit the 6 month mark. 1/2 way through. Thank God. Good Luck to everyone.  Leisa

I've had sores inside my noise as well. Almost from the beginning. It's really tender, hurts to blow it. Gets these little crusties in it. When I get them out it takes out lots of noise hairs. That really hurts. Just hoping this will all be worth it in the end. If it doesn't end up helping me at least it may help someone else. Good luck everyone. Leisa

Hi everyone

Just joining the thread since today is DAY 1 for me of the Neratinib trial.  No diarrea yet (Took the pills about 8 hours ago), but have had a headache, nausea and maybe it's psychsematic, but a really itchy right wrist.  I figure I'll know tomorrow if I got the drug for sure. Seriously, does everyone get this drug even though they say it's a double blind study?

Wow, I can't BELIEVE the list of side effects on this thread! The only ones they  talked about with me were the diarrea and maybe some heart toxicity (low chance, just like herceptin. When I was on Herceptin, I got bad nose sores and bloody noses at the end--guess I've got that to look forward to.

I'm really writing b/c I asked my Doc one more time today before starting why this trial was important for me--and he said it's b/c when cancer recurs in HER2+ women, it's generally more lethal and b/c I'm still considered young (42) we have to do everything we can to combat it. I'd never heard it put that way before--and now that I'm reading this thread, I see the "BBB" comments which I didn't know. Could that be what he was referring to?

And finally--is there a reliable statistic or figure that can say when it is MOST likely a recurrence will happen in someone with my DX (see signature for details).  It's sounding like 3-5 years is generally the most likely period in HER2+ ladies.

BTW, I finished my 12-mos of Herceptin in December, 2010.   Thanks!!!

Well day 3 on the trial and am starting to wonder whether I got the real deal or not.  Bad headache and pretty nauseous on the first couple of days, then nothing of note today (I heard the diahrrea would start almost immediately but so far nothing). Anyone think there's a chance it needs to build up in my system before any side effects kick in? Or maybe I flat out got the placebo--and my nauseous was psycho induced. Bummer. I admit I'm a little disappointed if I didn't get the real deal.

Okay, I'm confused ~ "BBB" comments?

Oh "Blood Brain Barrier", of course! Yeah I had no period while on Taxol/Herceptin then within a month of ending Herceptin I had a period.  I started on the trial before my next period would start and missed that one and haven't had one since. Just read this article about placebos and drug trials...interesting..  http://www.healthiertalk.com/placebo-pills-more-just-sugar-027

I spoke with the doc in my area who is bringing me back in to start all the prelim testing. I think it's blood work, an ekg and an echo? Is that right and is that all??

I get EKG's, echo's & chest x-rays, also blood work everytime.

Leighannmarie,

I am so glad you posted the link regarding the placebos.  I found that news to be chilling!   If the drug companies are making placebos with side effects which mimic those of the actual drug tested, I imagine their goal is to make the patient think that she's receiving the real drug.  Hmmmm... I've noticed that as participants in this study  begin the trial, they are often unsure if they're receiving the "real deal" or the placebo.  When the crummy side effects begin, there's a sigh of relief, that the trial drug is actually being administered.  I wonder if there's any way to find out what's in the placebo being offered in our trial?  The mere idea of providing a woman (who has already been through so much trauma) a placebo with nasty side effects is appalling to me.  Are there any women involved in this study who have had no side effects from the meds??

I was in the trial from January 2010-January 2011. I did not have the diarrhea/stomach cramping, etc. I assume I got the placebo.

Kward - Who is "they" - the drug company or the oncologist administering the trial? I know one woman on this site had a recurrence and had a difficult time finding out if she was receiving the drug or not so her onc could treat her appropriately.

Suemed--

Thanks for responding regarding your lack of side effects.  I wish you the best!  Is there anyone else out there who has participated in this trial with no side effects? 

SueMed - "they" meant my onc and research nurse.  They say based on the sysmptoms they can tell who is on the drug or not.  Even said to me "well we know you got the drug".

Karyn

Hi, I've been in the trial since November 2010 and had pretty mild early side effects that stopped after three months.  I have had very mild versions of some of the se's mentioned here besides the diarrhea: neuropathy in my feet and hands, mouth sensitivity.  No skin stuff.  My team believes I have the drug, but all side effects settled down and I stayed on the 240 mg to date.

It is true that some women who have the drug have no side effects at all.  I was also a chemo moose, never took the oral decadron with chemo, reduced the iv decadron to 2mg with my Taxol infusion, and never had either diarrhea or constipation with dose dense ACTH.  I didn't like chemo but I didn't really feel that ghastly compared to many other women.

I hope this helps.  One other thing, you really do have to tell the docs about every single weird little thing.  They know things about what they are looking for that we don't even notice.  I had some flleeting nerve sensations near my mouth and lips three days after starting that sent everyone into a tizzy.  I figured it was a tooth about to become a root canal or grinding casualty. They said it was a sign. It went away almost immediately, so it may not have made any difference. But they were clear that even those little things are big.

Warmly, 

Cathy