Neratinib Clinical Trials

I just finished my Echo, EKG, chest x-ray and pre-lab work... meeting Aug 4th to pick up and start the pills.... thanks for all the great info on what to expect/not expect... I will keep you posted once I start. 

Less than a month to go for me!!  No obvious side effects so, it hasn't been too bad.  My menstrual cycle did stop and I have mild D here and there and was pretty nauseated the first month or so.  For the past few months my neuropathy has increased and I am getting joint pain in fingers and toes and the weird top of foot pain others have mentioned here this has been going on for a couple of weeks now.  Sometimes I get REALLY tired for no apparent reason.  I believe some nausea and D symptoms could occur from the placebo as well so, I don't take that as a true sign of getting the real deal.  I will wait and see if I notice a difference a few weeks after I quit the study.

Leanna - i think they will tell you once the study is finished but my onc and nurse say they "can tell" by the side effects who most likely has the drug.

Karyn

YAY KaKaCath.... a pill poppin' buddy!!  The clinical coordinator said the same thing as you, Karyn, that they try and "figure" out if you have the real drug or not.  I wonder how big the pills are that you have to take 6 of them... that's going to be the hardest part for me is fitting that in with my other pill soup at night... multivitamin, Calcium + Vit D, Tamoxifen, Aspirin (my own experimental recurrence preventer), Iron (when anemic which is usually), and a stool softener or 2 (when needed, which is usually!)  All those pills will be hard to take, but I will do anything if it gives me a better chance!!    I never thought I'd want the big D, but now, I think I do!! 

Hurray Kakacath!  I'm happy for you! 

Thanks, I was wondering the same, the size, and was dreading the possibility of horse tablets ! Thanks kward70 for relieving that thought, Feeeuuww, another box ticked, also to pop in the morning or to pop at night ! I know we must sound silly, us new poppers and alittle green around the gills... I too leanna9 am very used to taking stool softeners every second day, hoping that will change for now     

I USED to take colace daily but now that is not a problem.  I know when I'm going to have a bad day with D bc my stomach will be rumbling... I do think it improves as time goes on.  Maybe I'm used to it know - I changed my diet (Still eat dairy but also eat lots of bananas and "binding foods") - I found immodium and the rx helped but it took a few days.

KAryn

K4katz,

I am on a different study and did not change onc. They communite back and forth. you just don't have to see you current one as often. Keep your current one for when you go off the study, or if you need something that is not study related.

I maybe about finished in the vaccine trail I ma currently in and this one sounds good.

I take a multi-vitamin. If you lay the 6 pills side by side they would be the same size as the 1 vitamin. The D hit me within the first 4 hours of taking them the first time. It comes & goes depending of what I eat. They told me to avoid dairy also, but I can still have some, just have to watch how much. I've found that pork products are worse on me that dairy. Six months in and I had the first period I've had  in a year & a half. Something I could have done without. Good Luck everyone.

I've had 2 doses so far, in the evening, and haven't felt anything. 

Hi girls. Here is how it worked for me and I just finished a year in late July. Took 6 pills during the day for 2 days and nothing happened I was pretty bummed. After that on the third dayi had the d and cramps But vey manageable. I kept taking it some how and it became a routine. So since I dud like the fact that I would have about a thirty minute outburst s day. Lol I took them at night. I managed to time it daily and could still get out the door by 8:30 with kids. There were better days than others but never needed anything or no need to cut down. Feel free to find me on facebook Anderson kara or under the bag holder. I also started a radio show and if anyone would like to be a guest and talk about how cancer changes you I would love to do that. It is on blogtalk and the show is today's living. Feel free to ask cause I love to talk. Praying for all that if you get on the drug it does what it says.

Hello All,

Well, after reading all of your great posts for months, it's time for me to decide whether or not to join this study.  My last herceptin treatment is the 15th of the month.  I meet with the oncologists from the study tomorrow to ask a million questions before I make my final decision.  All of the comments you ladies have posted have been super valuable.  I know I want to ask about the details of treatment, amount of follow-ups, etc.   Howard Univ., the sponsor of my study, is 1 1/2 hours from my home.  I will go there for all tests, etc.  Here are some questions I'll have for them, as well as for you ladies who have been in the program:

If I'm feeling like I need medical attention, do I go to my regular doctor, or do I have to drive 1 1/2 hours to the study docs?

I'm pleased that neratinib crosses the blood/brain border, so it can attack any wayward cancer cells....but am terrified that it could cause harm that has yet to be discovered.  How safe is this stuff???

Years ago I  had 2 clots in one of my legs (due to a genetic abnormality).  That leg is permanently swollen and damaged.  The possibility of neuropathy of the feet is troubling to me, since there's already an existing leg problem.  Did any of you who experienced neuropathy find it to be reversable?

Those sound like whiny questions, but I'm scared of that part of the study.  The diahrrea, cramping, acne, etc. don't really concern me.  Well, of course they do, but I'm not afraid of them.  If you ladies can think of any other questions I  should ask tomorrow, I'd be very grateful for your words of wisdom!

I'm keeping you all in my prayers, and wish you the best.

RKR, I think it's a crapshoot...they don't really know for sure long term side effects. it does concern me too. I am super high risk, so I want to do everything I can, but I need to stay smart about it. the stomach pain and diarrhea has directly affected my quality of life ( read.. I am miserable).

My onc did tell me that he had someone on the trial who quit after a month, only to recur and die with brain mets.

You may not get a sound answer to your questions....maybe you could see how it goes, and make the judgement call if side effects arise?

Ladies,

Thanks for the input--it was most helpful.  The people from Howard were quite informative.  I'd misunderstood that I actually have quite a while to make up my mind.  The one question they couldn't answer was what is the rate of recurrence or incidence of mets in women participating in the study.  They claim that the data has yet to be published, however, they are certain that neratinib is totally safe(!)  I'm not cynical, but I do wish I could see the data collected thus far.   Since I teach, I think I'm going to start the study in the fall, after we've established the routines of the school year.   It sounds as if I should have the tests run in Oct. and actually start in November, maybe right before Thanksgiving.  (From what you guys are telling me, the frequent bathroom stops don't begin for generally 3-5 days.) 

Thanks leanna9, Yes I wish I could say the same that I had loose stools too, there is still a chance you may be on it, but not for this little black duck ! Oh well, its the 50-50% chance we took, So to all the lucky gals experiencing the diarrhea dilemma ! Spare a thought for us, your other half counter paths ! I will probably drop out from this forum topic now, as I can no longer have an input to the heading ! I am thinking whats the next ! Plan C for me now ! This first year after Herceptin is a crucial time for me, now I understand my Histopathology report reads my ( Mitotic activity is, 6 per 10/HPF ) being the tumor cell copy rate was above average and the likely-ness of recurrence is high, hence the purpose of the Neratinib trials, re: latest stats findings. Leanna9 I wish you and all the girls the very best for our on going battle, and hope you can continue with hormone targeted treatment, as again I wish I had hormone receptors, for the furthering of targeting treatment. I have to now rely on the workings of Herceptin with its cell taggings to help my immune identify the bad guys, except of corse the BBB, Take Care to you all xoxo