Neratinib Clinical Trials

Well finally!!!

 I have an appointment next wednesday with the research nurse.  I'm ready for the trial!

It was delayed twice because of a bronchitis then couple month later for a pneumonia.  Also was soooo tired.  Now on the track.

Iago--my informed consent docs (July 15 2010 version) state that "..."the sponsor has changed the entry rules into the study and has stopped enrolling subjects with breast cancer that has not spread to the lymph nodes...."

The reason is stated to be that the updated trastuzumab trials (2009) suggest that subjects without cancer spread to their lymph nodes do slightly better than originally thought.

Warmly,

Cathy 

Hi, Iago.  I happen to agree with you and as a 2A it seems odd that I can be in the trial but you can't.

That said, if I understand the update correctly, your 5 yr OS with no nodes and after  ACTH is 97%, and I imagine they can't improve much on that, hence exclusion from trial.  It appears to compare to 80% for those with nodes involved.  

I just googled the San Antonio update to see what the study referred to, and there is a table in the summary.  I am not as good as many of the women here in interpreting all that, but I was curious about how nodes would be an issue.

Warmly,

Cathy 

Hi, Iago; I meant that I was stage 2A and it seems like you should be able to be in the trial if I am.  The table in the Trastuzumab Update article includes TCH also.  I couldn't get the table to print, so here is the link:

http://oncofacts.com/archives/2009-san-antonio-breast-cancer-symposium-trastuzumab-in-the-adjuvant-and-metastatic-settings-anti-angiogenic-therapy/

You are right, the trial is to prevent recurrence, not increase overall survival.  So there is much that can be improved. 

Warmly,

Cathy 

I started this trial almost 2 weeks ago and am having trouble with diarhea (even with imodium) and no appetite. I've told everyone that I have discovered the new "diet pill" Does anyone have any advice?

Finished all exams.  Seems everything is ok with me, have appt with the onc. Thursday to start the protocol.

Last week he told me that when you start having diarhea they stop you taking the pills for a week before going down to 5 pills. Is that how you are doing?

Sue in Qc.  

No, I'm still taking the 6 pills a day. How did they tell you to take the diarrhea meds? My dr's said to take 2 pills at first onset then 1 pill thereafter for each episode per day. If it exceeded 6 pills in a 24hr. period to call. If it went on for that long they may have to pump in fluids. I only had 1 day where I had 8 episodes, but not all 8 were water, some were just VERY runny. So I never had to go get fluids. Sorry so graphic, but it's the only way to describe it so you know exactly what I'm talking @. Some do have to have their dosage cut down, but I haven't. Hope this helps. Leisa

RKR...I got neuropathy of the hands & feet when I was in treatment with Herceptin. I don't agree that it is permanent. Once I finished treatment mine went away. Since I started the Neratinib trial I have not had it return. My biggest side effect is the diarrhea.

Surprise, this morning start with an chemo taste, diahrea, and cramps...  Cramps and bad taste started yesterday and got worse in the night.

Did some of you got that crap taste, will not stand that for a year for sure.

Regarding neuropathy, in my last two weeks of Taxol I had extremely mild neuropathy in both feet.   It  lessened during two years of Herceptin, until it was kind of a mild tingling behind my toes.  Shortly after starting Neratinib, it began to creep toward my ankles.  My doctor told me to pay attention and to start taking B6, and he said that if it got worse, I would have to stop the trial, because it could be permanent.  

It did not get worse; it seems a little better to me.  I'm five months in and it's my only symptom right now.   I wear UGGS in the house and I don't go barefoot.  I don't find mine to be painful, unless I'm on my feet for a long time. 

I don't think everyone gets the same symptoms; I had some tummy distress but it's long gone.  I have no neuropathy in my hands, although I have mild trigger finger in both , from the anti-hormonals,

I hope this helps.

Cathy 

I had to be dose reduced twice while in the trial due to terrible diarrhea- I ended up finally managing at 4 pills/day instead of 6 and managed to finish the trial.

Talked with the research nurse, we will decide if I stay in the protocol at tomorrow appt. 

She wanted me to keep taking the pills even if I was feeling bad - sorry I need to function in my everyday life.

This will be too bad.  Still feeling awfull after only 2 days on the pills. So sorry. 

CBM and Leiaparis,

Thank you for your thoughts on neuropathy.  Your comments are so helpful! I have an appt. this week to discuss this study with yet another onc. to see what his advice is.  Good luck with the journey.  I can't help but wonder if we'll ever stop worrying about recurrence.

Good luck Shellusea!! 

I talked to my onc today, and she said to me... they have changed the inclusion criteria, and I don't think you will be eligible because you didn't have node involvement.... and I said, um, yes, I did... and her face lit up and she said, so you do!!  She is having the study coordinator contact me.  I don't finish herceptin until July, but I am very excited, my onc said this study is proving very promising!  YAY!!

Hmm, so that node was good for something!!     And, yay on the real thing, but not the D and pain!!