Neratinib Clinical Trial
 

I was wondering if anyone has been involved with this clinical trial for early stage Her2+ breast cancer survivors.

http://clinicaltrials.gov/ct2/show/NCT00878709

Thank you.
Dana

Re: Neratinib Clinical Trial
 

I just started this study on 9-1. So far so good. I still dont know if Ive got the drug or placebo.

Re: Neratinib Clinical Trial
 

Hi Cranegirl, Thanks for responding. Is this an IV administered or pill form? Did you go through a lot of testing to make sure you were eligible?
What part of the country do you live?

Love,
Dana

Re: Neratinib Clinical Trial
 

Hi DanaRT, Sorry its been a few days. I was out of town. The drug is delivered in pill form. 240 mg is the dose. Right now its six pills a day but soon a 240 mg pill will be available. I had to do a few tests to qualify for this study. A muga, a mamo, an EKG, chest Xray and some blood work. I believe you had to have taken Herceptin within two years of starting the study. There are a few side effects to the drug, the main one being diarrhea, so I thought for sure Id know if I was recieving the drug or the placebo. But so far Ive only had a consistant headache. Ive had a few other symptoms but Im not sure if its a side effect or I am attributing everything on the drug. I was the queen of side effects with TCH and Herceptin but if this is the Neratinib its been very easy. I live in southern California and Im doing the study with Breastlink Research and Dr. Waisman.

Re: Neratinib Clinical Trial
 

Hi Cranegirl,

I heard good things about this drug. Congrats for participating in the trial. May I know what stage are you?

Thanks,
Julie

Re: Neratinib Clinical Trial
 

Dear Cranegirl, Glad to hear from you again. My onco told me last week that I do not qualify since I am done with treatment and am NED. I hope you're doing well with the trial. Keep us posted. How long will you be involved with it?

Re: Neratinib Clinical Trial
 

My understanding of the trial is 50% get the drug 50% get placebo. The drug has a high rate of diarrhea but can be controlled. You have to be within 2 years of your last chemo to qualify so there is some time for those of us who may not be sure if this is the right trial, especially since 50% get placebo. I'm currently on a bisphosphonate trial which addresses the ER+ aspect of this disease but I do want to be sure the Herceptin took care of the Her2+ part as well. Of course, I can only participate in one trial at a time (and don't want to risk being in the placebo group) but I'm curious if other similar trials targeting Her2 will open soon. Anyone have info. on the vaccine trials for early stage? My onc is not too optimistic about the vaccine approach working, I'll ask more on why next time but if others have discussed other trials for early stage disease with their oncs, I am interested in hearing more. Thanks.

Re: Neratinib Clinical Trial
 

DanaRT,

I believe your onc could be wrong. I see you had Herceptin until 12/08, that would make you eligible for the Neratinib Clinical Trial as I understand they want participants who have completed Herceptin treatment within 2 years. That would mean you have until 12/2010 to make up your mind. Also, you must be NED.

Re: Neratinib Clinical Trial
 

Thanks, mnts1day, I am going to print some information and send it to the research nurse. I am NED but have never had any scans. Will let you know what I find out in the next two weeks.

I like the fact that it's a pill and not an IV. My post has been gone since February.

Re: Neratinib Clinical Trial
 

To the ladies in this trial, do you have to go to the cancer center to get your pills or do they send them to you?
Who pays for the scans and pills?

Re: Neratinib Clinical Trial
 

You go get the pills in a months supply at your Dr. visit. The Study pays for everything.
Cora

Re: Neratinib Clinical Trial
 

Ruth has been asked if she wants to participate in this trial. She is really, really torn. She is so ready to be DONE.

As I understand it, this drug is similar to Herceptin but will cross the blood/brain barrier, unlike Herceptin. This is possibly a huge plus. Feels to me like a bigger "punch" than the AI treatment she is currently on. (will switch in 6 months from Tamaxifen to Arimidex or Femara)

Does anyone know more about this drug or the studies that have been done so far?

I even wonder if she might be better choosing this trial than to endure the Arimidex/Femara AI side effects. If she gets the diarreha she can be pretty darn sure she doesn't have the placebo. I realize they do not target the same receptors, but certainly it's the HER2 that's the much bigger issue, yes?

Thank-you for any replies.

Re: Neratinib Clinical Trial
 

Is this drug similar to Tykerb (lapatinib)?

Re: Neratinib Clinical Trial
 

No, this drug is very similar to Herceptin but it is a smaller molecule and crosses over the blood brain barrier. Cora

Re: Neratinib Clinical Trial
 

So how do the 3 compare to each other?


All 3 are biological drugs as opposed to chemo, correct?

Re: Neratinib Clinical Trial
 

Good question. I'm going to ask the study Dr. that.
Cora

Re: Neratinib Clinical Trial
 

It got rave reviews and interest in San Antonio last December. I think I'll ask about it in Nov. when I see my onc. ma

Re: Neratinib Clinical Trial
 

I got this from the nurse prac, my onc being too busy to call me back. Tykerb and Neratinib are very similar, both being a small molecule and crossing the blood brain barrier. Almost like sister drugs.
Cora

Re: Neratinib Clinical Trial
 

That is what I had assumed becuse they both seem to have similar side effects (diarrhea) as well as cross the the brain barrier. I was told that the Herceptin attacks the HER2 cells on the outside and the lapatinib (Tykerb) attacks the cells on the inside. From where I stand, it feels good to know that I am attacking them from almost all angles. Thank you for the info concerning Neratinid. I am unfamiliar with it.
Sandra

Re: Neratinib Clinical Trial