Neratinib Clinical Trials

Hi Leanna9 I am sorry to hear you have been pulled out, can you re-enter the Trial later ? since there is that years grace ! yes it seems you may of been on the drug, but for you thats how your body reacted to it, there must be still many question unanswered regarding Neratinibs side effect !

I am due now for the same 6 monthly check, in fact today was the day, but I am feeling a little under the weather after a big weekend with my mothers Birthday.

My last Echo was 60% and QT was in question as well ! My study nurse didn't book me a spot for Echo in time, now so looks like I may, very reluctantly, need to have a MUGA instead, YUK  

I am having further surgery next Monday to correct 2nd Mastectomy, So I have to be off the Trial Drug for 3 days it seems.

Thanks You for posting Leanna9, It gives me some insight of the possibility for me also, HUGS to you. 

Although I do miss the easy poops on the pills... back to my old constipated self (that sounds funny). 

geewhiz - even six months gives you a benefit... I almost bailed early on because the D was so bad - after does reducing it is much better and I have normal bowel movements now for the most part.  Not  sure if our bodies get used to the med  or if it stops working like herceptin can.  I'm still Loose but nothing like the past - one more month for me - it has gone quickly and my EF hasn't changed too much - a little dip but still within normal.

Karyn

Hi, Heather; I believe the purchaser of the license has said they will go to the  next level of FDA approval, but only for treatment for mets.  In other words not for prevention in early stage.  I believe the speculation has been that the risks and SE's are too much for too many to use the drug as a prevention strategy.  

I don't even know if they will evaluate the efficacy for prevention at this point. Perhaps someone else has better info or insight.

I know I am to be followed only for two years after the trial, I think twice per year.  I believe that had originally been for longer, but I'm starting to forget the administrative details.

Warmly,

Cathy 

Hi all, has been awhile. I just had my last follow up visit (eneded study 12/09t. I was told the drug was sold to a Japanese Company (Puma) .The hope is that those of us who were a part of the trial will be unblinded and we will know if we were, or were not on the drug.Good luck to those still undergoing treatment. Good health to all

Hi ladies, I am at the seven month stage now x5 pills, missed my six monthly ECHO due to a timing cross over of further surgery. I have reminded study team that its been missed and still no follow ups, requested to see my onc, so maybe Im not on the drug too, who knows ! don't care anymore.

Upon starting the new batch of trial drug, I feel differant ! strange, no sign of the D, but feel nauseated some days, also infections and nose pimples have reduced, which is all Fantastic, but I suspect there maybe a variation in batch-dispatch, also increased axillary nerve pain with lympedema now after two years from original surgery, dam, I thought I was going to get away with that one.

Cheers, regards Catherine   

Yes I agree, Thanks Karyn, I do feel my body has adjusted to the changes, and how amazing, is that ! as the simple fact that, our inner-bod-can adjust to the intake of a substance that is foreign, and or may help ward of internal foreign cells wanting to conquer its hoist ! yes again,  I do how-ever have the occasional episodes of the dreaded Deeee ! but, more often than not, lately is nausea and doubt ! Thanks again, and I look forwards in hearing from our newbies out there ! Girls, I hope you can continue our chatta !  

Hello Ladies. Catherine I'm right behind you having just hit the 6 month mark in the trial. Only had D a few times. I'm convinced I'm on the placebo but my onc insists that I could be on the real thing. He said about 50% of those he's treated showed no symptoms but were on the drug. Little confused by this as I thought it was a double-blind study. Do our doctors get to know whether we were on the real thing at the end? Interesting about maybe there being different batches. First 2 1/2 months I had hot flashes, felt gaseous, and had some serious munchies! No regular issues since then. I find it a little odd that I have to return the leftover pills each quarter and start a new bottle. Why not finish out bottle? Makes me wonder if there are different batches. Hope everyone is doing well and keep posting. I like reading the updates on everyone!

I doubt there are different batches - there would have to be informaiton in the study documents about that - which there wasn't and my team was not overly upset when I forgot to return my old pills.  They only want them back bc they need to account for all the study drug and unless you are on 6 per day you'll have extra. 

shelclaire, the ladies I knew with brain tumors where not on the trial, sorry if it sounded like they where ! didn't mean to relate the two sentences together, and by the way, one I know is doing well with treatment.

Has anyone got there reveal yet, and where you surprised at what they said ?

Its count down to my last 3 mths...

Hi, Deb and kara; I don't have any info on other trials, I'm sorry.  

I wanted to ask the group if anyone ever declined to sign a new consent form?  I was called by my clinic to come in to sign a new consent form, because the drug company wants to do my follow up for two years--which I think is less than the original consent, but now I don't remember.  I'm not clear on whether or not I can decline to agree to that if it is a reduction in the services I was expecting, or if I should, or if I can negotiate.  Any thoughts?  I have health benefits and no problems from the trial that I am aware of.  

 I don't want to be uncooperative, but I also went to a good bit of trouble for a year, only to see the drug license sold and the trial changed.

 Cathy 

Hi cbm  That's a very good point you have raised, and I guess I should of queried the same ! I remember thinking or expecting rather, that this may happen, when I heard about the sale and or read about the restructure, some reports did list what may take effect immediately and others speculated reduction in follow-ups and I think cost-cutting for fast tracking spoke loudly, so I count myself lucky to of got in when I did ! how-ever I wouldn't of thought you would be dropped from the trial for not signing, perhaps not covered by policy and procedure guidelines ! there maybe some trial officials that read what we say here, so does any-one out there care to add to these questions ? I still don't know if I am on the actual drug as I first thought, now I am back to taking a stool softener every so often, having said that I have progressed in taking a cocktail of pain relief meds that may also cause constipation ! so, I have stopped worrying about it as it was doing my head-in, still having the mouth sores and nose pimples.

Deb808 I have read about the combo you mentioned, and both where effective, but don't remember which had the most favorable of side effects ! I guess you know more by now ! I am very interested in finding out more about them and will PM you if I come across more data, so please let us know how you go, Take Care in your Journey for us all the pioneer warrior women of the future, she says while flexing me sagging muscles haha

Hi Ladies!



I bailed on the trial after a little over 6 months. Simply could not live with how bad I felt. But at the 2012 ASCO Conference held in Chicago first week of June, favorable results were still coming in with Neratinib. Google it, or someone a little more tech savvy than me can post a link.



Hugs!!

Hi KingPinkGirl,

I am sorry you had to go through so much trauma getting a good vein, Please look back on this thread where there has been some lengthy discussion re: MUGA imaging and the more popular alternative of an ECHO, the two give almost the same results and is less radiation exposure verse the Ultra-sonic waves of an ECHO with no nuclear meds needing to be injected...If you have an implant, then they work around it, I am assuming you have already had to have many MUGAs in the past having had Herceptin, so there is no need to put your-self through more unnecessary radiation exposure and stress related to what you have recently experienced...ask you Trial Team, the cost I think ends up being similar for Trial funding.

Good-Luck, three weeks to go for me and looking forwards to the end, regards Catherine...    

I have terrible veins too, kngpinkgirl!  I always tell them to just stick the vein on the top of my had because that Almost always works.  It will be a year next month since I ended the trial.  I made it the whole year without too many bad side effects.  I recently saw my labs from when I was on the trial and was suprised to see that my red blood count was low as well as my liver function test.  My doc. never told me.  They were never Really low so, I guess doc. didn't think it was worth mentioning.  My next appt. with research dept. is in Sept.