Re: Neratinib Clinical Trial
 

i was interested in taking part in this clinical trial. when i first read about it there was a site in springfield, MA which is near me, but now it says "withdrawn" next to springfield. the next nearest site is in worcester, which is a good hour from me. i wonder if those of you taking part in the trial had to go to the actual site of the trial for every single test they do on you? are you able to do any of it at your 'home' hospital? i live 2 minutes from my hospital, so it's a hell of a lot more preferable than an hour+ commute on an awful turnpike. add to that, i already missed some work for cancer and i'm no more interested in missing more than my bosses are. there are also several trials in boston, but that's 2 hours. i'd be happy to go on occasion for an all day series of tests etc. but can't give up a lot of time. how much time do you estimate you spend at the hospital for this trial when you take part? i would be eligible for one for early stage BC and my own oncologist said she'd be willing to support me in any way to take part in it and called me a "great candidate" (not sure why!). since Herceptin is drawing to an end for me in october i figured it was time to look into this. thanks for any info you can provide, besides the diarrhea. ;) v

Re: Neratinib Clinical Trial
 

I have to go to the hospital managing the trial - it's about an hour for me too, and they don't fast track me through ecg or onco consult which means I spend a lot of time there. For instance I have to have an ecg on the 15th and the onco appt on the 16th because for some reason they don't 'do' ecgs on the 16th.... VERY annoying - I teach at a University so will still be on holiday, but I'm definitely thinking twice about continuing, but mainly because of the diarrhea...

Re: Neratinib Clinical Trial
 

I don't find it too bad. My Onc sets up my bloodwork, ekg, muga and his visit on the same day and usually takes 1/2 the day. The fact that after the first visit or 2 you go to every three months makes it doable for me. I have been taken off and put back on twice now and am doing fine. Once was for the diarreaha and the other due to major drop in muga. You just kinda have to look at it as paying forward. Good luck to you.

Re: Neratinib Clinical Trial
 

that sounds OK and doable. even though boston is farther than worcester or hartford, the likelihood of being in a better hospital is greater. dana farber or something. plus my sister lives out there and i could make it a social/medical visit. like you, i believe in paying it forward. i've given gifts to others with breast cancer, but helping test a drug that could help save lives - what a true gift that would be for so many more people. valerie

Re: Neratinib Clinical Trial
 

hi ladies,

i have been asked to participate in Neratinib trial here in New Zealand, by reading your messages i know that diarrhea is the most common side effect. But I read that it may also changes the liver function. For those of you who are taking neratinib for more than six months does it cause any liver problem? Thanks to all of you.

Victoria

Re: Neratinib Clinical Trial
 

Hi Victoria. Welcome I to live in New Zealand I just wanted to say hello. Sorry I can't answer your question there are lots of knowledgeable people on this sight who may be able to help.

Regards
Jacqui

Re: Neratinib Clinical Trial
 

I am so confused. I saw my oncologist today and asked him about clinical trials that I could be involved in. I am half way thru my radiation treatments. I have had 14 treatments and 16 more to do. he told me i didnt qualifiy for any clincal trials cause they did the standard treatment on me and it worked. I am in remission he said. but i feel helpless just waiting to see if it will return. has anyone heard of this? i thoiught you can go in trials if you are NED.. but doc said what would we prove if there was no cancer to test trial drug on? anyone heard of this? so I dont need a trial? i am a little confused on this. thanks for your input.... bonita

Re: Neratinib Clinical Trial
 

It depends on the kind pf trial. With the vaccine trial I just completed, you have to be NED and have completed your last standard treatment (Herceptin) within six months. They are looking to see if you have recurrances and follow you for five years. Maybe your rad onc was talking about radiation trials.

Re: Neratinib Clinical Trial
 

Bonita,

Since you are on Herceptin till next June (1 year), you won't be considered for clinical trial until you finish the one-year Herceptin.

Think of yourself as being in the giant, clinical trial and you are assigned to the arm using Herceptin to treat Her2 breast cancer. And the trial has shown that Herceptin works on you (because of the neck node disappearance.) That's a very good news.

Re: Neratinib Clinical Trial
 

I am on the early stage trial and will actually finish on Oct 7. I take 160 mg after being dose reduced twice due to severe diarrhea which resulted in really low potassium levels. I have not had any change in liver function or my MUGA but I was dose reduced really early - dont know if that made a difference or not.

For the early stage trial you have to be NED and finished with a year of herceptin I believe.

Re: Neratinib Clinical Trial
 

what a shame. they no longer want anyone who was diagnosed stage 1. i was looking forward to applying, despite the unfortunate side effects. oh well. valerie

Re: Neratinib Clinical Trial
 

I just started the trial last Wednesday and am thinking I have received the "real thing". I've had diarrhea since the second day, which my oncologist was hoping for. Imodium seems to be controlling it well. I also am having some nausea. I did fine with Herceptin and am hoping the side effects will slowly diminish. How have others done on it? I am new to this site and am anxious to talk with other women.

Re: Neratinib Clinical Trial
 

I just finished the trial on Oct 7- I had severe side effects so we knew I was on the real drug, was dose reduced twice and finally managed at 160 mg (4 pills)- I had diarrhea until the last month and controlled it mostly through avoidance of milk products and extremely high fiber meals.

Re: Neratinib Clinical Trial
 

Well, I ended up getting out of the trial. My side effects were so severe that I couldn't function. I didn't like the idea of taking extra medication just to ward off the side effects of the first medication. In a way I feel I am giving up too quickly, but the side effects were worse than all my chemo side effects put together and then I had to take 3 months off of work! Was quiting stupid? I am struggling with my decision!

Re: Neratinib Clinical Trial
 

I am glad to report that I am nearing the half way mark--almost six months since I started the trial. The first month or two were pretty difficult. But I just kept in mind that I was doing all I could to prevent recurrance. I still have a few bouts of diarrhea two or three times a week. But I can say, it NEVER prevented me to do the things I wanted to do. I travel, and go on outings--always checking out where the rest rooms are--but I carry on. And I know that whatever lies ahead, I have done as much as I can to stay well.
Another thing--after seeing the movie "Living Proof" I kept thinking where we would all be if those women hadn't taken part in the early trials for Herceptin. Before I began, I made up my mind that there was also a moral obligation to do all I could, to make sure my daughter, and granddaughters would have a cure--if G-d forbid, they needed it.
It's easy to be optimistic when you're feeling good--and like I said, I never felt I couldn't cope. But if you'll refer back to one of my earlier posts--after one month on the trial--I admitted that 11 months seemed a long way off.
Here's hoping that the decision you make is the best one for you.

Re: Neratinib Clinical Trial
 

I am considering this trial. I would have to drive almost 2 hours to the hospital running the trial (UCSF), but the doctor said I could do all bloodwork here at home. I love going to the city, so it wouldn't be too bad.

I have a question for those of you on the trial. Was Tykerb/Lapatinib an option for you? If so, why did you choose to do the trial instead of Lapatinib? This is the decision I have to make, but I have until January 7th to make it since I am doing rads now. I also have an appointment on November 22nd with Dr. Slamon to get his opinion on Lapatinib vs. Neratinib.

Re: Neratinib Clinical Trial
 

Lapatinib was not offered to me. At the time, the trial for Lapatinib was offered only as adjuvent therapy, and I, like you had neo-adjuvent. I am now on the Neratinib trial for just over 6 months and doing o.k. I still have several bouts of diarrhea a week, but many days of none. Liver functions and echo-cardiagrams are also o.k. I was just happy to keep fighting any way I could.
I am really interested in knowing what Dr. Slamon's opinion is of Neratinib. All the buzz I hear is really optimistic.
Here's hoping!
Good luck with whatever you decide.

Re: Neratinib Clinical Trial
 

DeenaH,
This is just a wild quess on my part but I think some weren't offered the Tykerb/Herceptin combo because it wasn't an approved combo till this last yr or so? When I had a recurrence last yr in 09 I went out to see Dr. Slamon. He recommended Tykerb/Herceptin. After seeing Dr. Slamon I saw two other onc's with good reputations and both of them told me Dr. Slamon was wrong...that I "had" to add a chemo for Tykerb/Herceptin to work. They were both adamant about it.

I called UCLA up and told them what I was being told and was reassured me that this combo works great. Not long after that it came out at that yrs ASCO conference that it was now an approved combo with good results. Some of these onc's are just not up to date it seems on alot of the newer drugs and combo's. UCLA as you know is cutting edge! So that is my theory on why many of these ladies weren't offered Tykerb first. Many onc's don't even know this combo works. Hopefully some will chime in.

Chelee

Re: Neratinib Clinical Trial
 

That is interesting Chelee. That makes me feel even better about my onc, since she was the first one who suggested the Tykerb/Herceptin combo. I also talked to her the other day about the UCSF trial with Neratinib. She would be behind either option, but also really wants to know what Slamon thinks. It does make sense that I can't work backwards. If I try the trial, I can always switch to Tykerb/Herceptin, but I can't do it the other way around if the combo doesn't work, or I progress on it. Taking Tykerb automatically disqualifies me from the trial. Decisions, decisions! I am just feeling so blessed that I have options like this.

Re: Neratinib Clinical Trial
 

Hi all

I went for my 6 month check in December and all was fine. The last two bloods have shown low protein, probably because I'm living on a diet of pasta! have found I can eat salads and vegetables as long as I have carbs as well. Diarrhea down to almost 0. Had fish and chips the other day when visiting London and that was disastrous - maybe it's the deep frying? Did seem to have trouble with scallops on New Year's Eve, so maybe it's a fish thing.
As to the liver question - I have had to sign a new agreement as I was told someone on the trial had died of liver failure, but I was assured the person was taking Neratinib alongside chemotherapy, which I am not. I now have to have a liver function blood test every six weeks which is a bit of a pain, but my onco is going to use the next one on the 27th to check the tumour markers as well, so not a wasted visit. Liver function fine so far.
It's good to think I've passed the 6 months, but somehow I may miss the attention when it is all over!