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
 

Re: Neratinib Clinical Trial
 

Hi Kriss -
Nice to see you, but not your symptoms. At least you must be getting the anti-cancer effect along with the side effects. Let us know how the rest and restart goes.

Perhaps your diet must be adjusted as well. The gals on Tykerb found that to be usually the case.

Re: Neratinib Clinical Trial
 

Kriss,
Hang in there, hopefully they will be able to find the right dose for you.

I remember last year at San Antonio when they reported the results out on the initial Neratinib trials, diarrhea was universal (In the study participants, not among the people hearing the report) Afterwards Dr. Love commented in the Alamo Mentor session that it sounded like prep for a colonoscopy!

But interestingly enough NOBODY had discontinued the trial due to this. The population in that study was Stage IV patients so that may have made a difference, but it did seem that most people eventually were able to manage the side effect.

Good luck, thank you for participating in the trial

Re: Neratinib Clinical Trial
 

Thanks ladies for the support. After going to the bathroom 37 times in a 24 hour period and vommiting they took me off the drug for 10 days. After one missed dose I feel like a new person, almost back to normal. This will at least get me through the holidays. I plan to try it again. They are not sure yet if I will challenge the dose a gain or since my reaction was so violent start me at a lower dose. Steph, what kind of changes did they make to their diet? I'm trying to do low to no fat. I don't eat red meat, and have been trying to cut out dairy. Is there anything in particular?

Re: Neratinib Clinical Trial
 

Kriss,
When I was on Tykerb, I had problems, but they were not as severe as yours. I learned to take two imodium along with one Lomotil as the very first sign of a cramp. I had no diary and went on a low fiber diet. I could not eat fresh fruits and veggies. If you Google "low fiber" diet you will find some helpful information. The only green vegetables I could eat without problems were green beans and asparagus. I also switched to white bread as whole grain did a number on me also. Basicially, I just stopped those healthey habits I had developed as far as eating fiber was concerned. My dosage had to be lowered, but I feel that I was very lucky to have the opportunity to take the drug. I also found that a baked potato usually gave me no problems. I basicially ate meat, bread, and potatoes. Good luck and keep adjusting your diet. I took my last Tykerb Nov. 17th and within two days my stomach that I had had for a year completely disappeared. I am now eating fruit, veggies, and drinking more milk that I need. You will be too!!
Sandra

Re: Neratinib Clinical Trial
 

Kriss,

Ugh. Hang in there!

Kind of an odd "blind" trial when the side effects are so evident. Did you react upon the very first dose? How many doses did you take?

Wishing you luck,

TRS

Re: Neratinib Clinical Trial
 

I took the 1st dose at bedtime and the symptoms started first thing in the morning. By the 3rd day it was unbearable. They started me again on Monday and dropped my dose to 200mg. I started the lomotil at the same time. this time around it is not as bad but still not great. The diarreah started immediately but only maybe 8 or 10 times a day. I changed my diet again using some of the guide lines Steph had tried and think it is all helping. I feel very fortunate to be part of the trial and am pretty confidant that I am getting the real thing. But honestly I am just so pleased that I can give back or pay it forward. I know without all those brave women that were part of the herceptin and many other trials I may not be here to do this. So I will take the diarreah and all the other stuff. Have a blessed day ladies.

Re: Neratinib Clinical Trial
 

Kriss,
I started the trial on Oct 7 and have the violent side effects like you did AND I ended up with severly depleted potassium and magnesium from the diarrhea. They found all that at my 1 month appointment and I spent the next two months trying to get potassium and magnesium back to normal and going through dose reduction.
I reduced to 200 mg and have almost as violent a reaction as the 240 mg, uncontrollable diarrhea with lomotil and immodium and still had problems with potassium and magnesium.
I got reduced again to 160 mg and it has been a WORLD of difference- I think we finally found a dosage my body can handle!!!!!

Talk to your nurse if it is still that bad- she should have the guidelines to get you to a dose that is tolerable!

Kristy

Re: Neratinib Clinical Trial
 

Wow, at least I know I'm not alone. I have my 1 month on the 18th and am very interested to see what my levels are. Will the increase your dose again after some time or will you always stay at the 160mg? I would find it ineresting to see if the body starts to tolerate it. Thanks for sharing Kristy Ann and good luck to you!

Re: Neratinib Clinical Trial
 

Are you allowed to take supplements during this trial? Perhaps a regimine of really good probiotics would help some. I'm not certain of the mechanism of this diarreha, but usually it is caused by an upset of the natural flora of the digestive system.

Re: Neratinib Clinical Trial
 

becuase I have not been eating well during this I tried to take supplements as well as Ensure. Both caused be to vomit which I never did during chemo! I always thought I was pretty tough but this is literally kicking my butt! I will talk to the nurse Monday and see what she says about using pro bi's. I'm a zookeeper and we have several animals under my care on them. Maybe I should see if they want to share.

Re: Neratinib Clinical Trial
 

I also wonder if L-Glutamine would help; it is good for the stomach lining. Ruth took bentonite (clay?) at the early stages of her chemo. It held off the diarreha longer than others however she eventually had to move to some imodium as well.

A zoo keeper! How wonderful!!

Re: Neratinib Clinical Trial
 

...and, is this something causing acidity like chemo does? Ruth would have been lost without her Omprazole during chemo, I wonder if something like this would help.

Re: Neratinib Clinical Trial
 

Im not sure of the mechanism of the diarrhea but nothing I tried could control it. IF you have side effects on neratinib they normally tell you to eliminate dairy as it seems to make everything a lot worse- and that was true for me.

160 mg is great- I had a weekend with no diarrhea this past weekend- first time since I started the trial in early October.

Kriss, There is a protocol for increasing the dosage back if it has been lowered - not sure of the "rules" but my nurse did say they probably would not try that with me because of the severity of the potassium and magnesium problems and their implications.

Kristy

Re: Neratinib Clinical Trial
 

I am watching this thread frequently. Not responding much though.
Kristy, Glad things have settled down. Is that 160 mg per day or twice a day?
Kriss, a zookeeper! Exciting. Maybe the ensure is too rich on an empty stomach. I would be tempted to not eat if the diareha (sp?) were a problem.

I think I would be a good candidate for this trial. At first my onco didn't think I qualified because I am NED. That's a criteria, hello....will know soon. My next appointment is 1-22.

Hang in there all and thanks for reporting.

Love,
Dana

P.S. My hair is now as long as Kriss'. I should learn how to post a new picture...

Re: Neratinib Clinical Trial
 

I take the 160 mg all at once in the morning!

3 normal days in a row- this looks promising!

Kristy

Re: Neratinib Clinical Trial
 

Kristy
Glad things are going better for you. I take 240 mg but I find I have less symptoms if I take them at night. Still have trouble with the diarrhea but nothing like you have had.

Re: Neratinib Clinical Trial
 

I enrolled on Tuesday and am on day three of the pills at the 240 mg dose. First day just a little light-headedness. Audible gurgling in my belly at night. Yesterday a bit of nausea while working out but all seemed like they could be psychosomatic because I so don't want to be in the placebo group.

Day 3, the diarrhea began! Two immodium at onset and another with each loose movement that followed. Not a ton of cramping. Just had dinner and am wondering if I'm in the clear for the rest of tonight. Sure hope so.

Nice to know I'm not alone in this, as always.
xo
cary

Re: Neratinib Clinical Trial
 

Well I'm on day 12 of my resart at 200mg and for the last 2 days my life has been almost normal. Only going to the bathroom 2x a day. Wow. I take my pills at night as well Patty. See the doc on Monday and am interseted to see if they will bump me back up to 240mg. But everyone hang in there and think of all the good we are doing not only for ourselves but for countless others. Have a blessed day!

Re: Neratinib Clinical Trial
 

Took so much immodium on day 3 (when the diarrhea first started) that I was stopped up and bloated day 4.

Day 5 I was back to wishing for diarrhea to get some relief from the unbearable constipation! Careful what you wish for. It started right after dinner last night, but I figured I'd wait to start the immodium in case it was a one time bout. Ha. Had three more "experiences" in the bathroom and took 2 immodium, then one more with the next loose movement and passed out from exhaustion.

It's 2 in the morning on Day 6, and I'm up with that gurgling belly that's been a precursor to the runs each time. I wonder how long I can last on this constipation-diarrhea roller coaster.

I did also get dry heaves and severe hiccups on day 4 when I had the post-immodium-overdose constipation. Almost as if being stopped up on the bottom was forcing it to try to come up instead, but it was too far down my digestive tract.

I wonder if this would be happening if it was delivered via infusion like Herceptin? Maybe oral is just not an ideal pathway?

Terri--you mentioned bentonite clay. How much did Ruth take? I'm gagging at the thought of ingesting that powder, but at 2AM with the gurgling getting louder, I'm desperately eyeing the container in my medicine cabinet. It's labeled for face mask (beauty product) but is pure clay. Perhaps Ruth had it in pill form--that would make more sense.

KristyAnn--any physical symptoms of potassium/magnesium deficiency? or it just shows up on blood work?

Kriss--Looking forward to a report of your appointment this week and the results of the blood work. This is your first blood draw, right?

Re: Neratinib Clinical Trial
 

Thanks to you all for putting up with these side effects. You are bringing hope to the rest of us.
love Ellie