Neratinib Clinical Trial

[DanaRT]

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

[Cranegirl]

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

[DanaRT]

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

[Cranegirl]

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.

[Julie2]

Hi Cranegirl,

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

Thanks,
Julie

[DanaRT]

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?

[SuzEQ]

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.

[mnts1day]

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.

[DanaRT]

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.

[Brenda_D]

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?

[Cranegirl]

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

[TSund]

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.

[Sandra in GA]

Is this drug similar to Tykerb (lapatinib)?

[Cranegirl]

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

[TSund]

So how do the 3 compare to each other?


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

[Cranegirl]

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

[Mary Anne in TX]

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

[Cranegirl]

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

[Sandra in GA]

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

[KRISS]

I just started this trial on Monday and am not having that good of time. The diarrhea is uncontrollable for me even with prescription drugs. They say they will probably either cut my dose or take me off for a week and restart. I never had this much trouble with herceptin or chemo. Very glad to be taking part and giving back but this could be a very long year!

[StephN]

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.

[chrisy]

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

[KRISS]

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?

[Sandra in GA]

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

[TSund]

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

[KRISS]

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.

[KristyAnn]

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

[KRISS]

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!

[TSund]

Are (file://\\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.

[KRISS]

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.

[TSund]

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!!

[TSund]

...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.

[KristyAnn]

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

[DanaRT]

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...

[KristyAnn]

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

3 normal days in a row- this looks promising!

Kristy

[Patty F]

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.

[carykim]

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

[KRISS]

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!

[carykim]

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?

[Ellie F]

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

[vlcarr]

I finally looked at where these trials are being done and they are doing this trial where I'm being treated. I'm going to talk to my onc when I go for my final chemo on 01/28. I will finish herceptin in June.

I don't know if I could do this or not since I did the Tykerb trial. Part of me says yes, but the other part says no.......

I had the potassium problem on the Tykerb but really didn't have the diarrhea issue that most people experience.

If I can do this one I know I feel torn about wanting this to all be over but also wanting to do what I can to help others and to avoid recurrence.....

My tumor was Grade III, and on some paperwork my onc did for my employer she said this about prognosis, "Tumor features are concerning for a very high risk of distant relapse". When I asked her what my odds are for a recurrence she said 15 to 20%. My FISH score was 6.31 (the report says HER-2/CEP 17 ratio) and I think someone her told me that is my FISH.

I've had severe stomach issues while on TCH and am so looking forward to those being gone and have not been able to work at all due to the side effects. I still have 6 1/2 weeks of radiation that will start around March 1st. I also realize I may not get the real thing if I do the trial. I was able to work while on the Tykerb trial.

I also could not afford to not work. I'm very fortunate that I've been able to keep my paycheck coming because so many people at work donated their annual leave to me. I received over 700 hours of donated leave through a program we have called leave sharing. I have over 25 years with my employer and traveled all over the country so a lot of people know me. I also joined another program we have called the leave bank so I can get an additional 240 hours from that when my donated leave runs out.

I know no one can tell me what to do but the point of my rambling is to ask those of you who've been fighting this battle longer than me for your opinion.

I had such great results with the Tykerb trial. Am also wondering if that would exclude me from this trial but they seem to be unrelated.

Wishing I had a crystal ball........

[v-ness]

please excuse my ignorance. i assume one must be completely done treatment to take part in this trial, yes? just thinking ahead. i will complete herceptin in october and there is a trial site near me. i would happily apply to take part if they are still accepting people at that time. valerie

[carykim]

You have to be within 2 years of your last Herceptin and currently NED to enroll.

Vanessa--I read on another board that a few women finishing up Herceptin "prequalified" for the study so they could just roll right in after their last infusion. Worth inquiring if you aren't burned out on treatment come October.

I'll cut and paste some info I saw on another thread:

Must have received Herceptin within 2 years and be NED.
The main purposes of this study are:
1. To find out if Neratinib helps to prevent cancer from returning, or if it may help to delay the time until the cancer returns.
2. To find out how Neratinib affects overall survival.
3. To learn about how Neratinib affects the occurrence of brain metastases.
4. To learn about the safety of Neratinib.
Approximately 3850 subjects is expected to take part in this study. It is expected that you will be in this study for 5 years (one month for screening, one year receiving the drug and 4 years follow-up) Follow up tests every 3 months include ECHO or MUGA of the heart.
Herceptin and Neratinib are alike only in the aspect of each being able to target HER-2 (erbB-2). And may pose the same side effects such as ventricular dysfunction and congestive heart failure.

Based on safety information from the subjects who have received Neratinib in research studies to date, the following side effects have been identified:
1. Diarrhea - most can be controlled by anti-meds.
2. Dehydration
3. Anorexia - lack of appetite - weight loss

4. Nausea/Vomiting
5. Rash
6. Abdominal pain
7. Elevated liver function tests that may indicate liver damage.

HTH,
cary

[DanaRT]

Well, I after talking with my onco at length we decided I would not be a part of this trial. I am somewhat relieved. I will keep reading this thread to see how you all are doing.

Love,
Dana

[vlcarr]

Just wanted to let you know that I cannot do this trial. My participation in the Tykerb doesn't allow me to do this one. I'm still very happy I did the Tykerb trial and I will be cheering for all of you on this one.

[KRISS]

Hello Ladies
Sorryit took me so long to tell you about my 1 month visit. Had a nasty infection that kept me in bed but doing great now. All my blood work looked great as well as my ekg. They kept me on the 200mg for a month and just this past Monday they upped me to 240mg. All is going well. I still have not had a normal stool and am starting to think I won't until I'm off of this but it's the least I can do. Hope you are all doing well. Keep us posted and I will do the same. Have a blessed day.

[eva226]

Hi, my name is Eva. My doctor offered the Neratinib clinical trial. I was diagnosed with bc in March 2007. I had 8 sessions of chemo with ac/taxol, did 33 sessions of radiation and a yr of herceptin. I have been doing well, NED. I've been debating whether or not to join the clinical trial. Could anyone offer some advice?

[Midwest Alice]

Hey, we have another sister who has started the process to get approved for this trial. JenniferS.

Praying for you as you proceed!

Keep us posted,

Alice

[Laya6680tx]

Hi Ladies,

Just wanted to get into contact because I recently started the Neratinib trial (7 days ago) and have also experienced severe side effects. Dehydration to the point that I had to leave work on my second day of a new job to get IV fluids from my onco nurses.

I was told to stop taking the pills until my stool is back to normal, then I will start taking 5 pills instead of 6. Initially my onco had me inject myself with an anti-diarrhea med because the Lomotil and Immodium did nothing to stop the floodgates after they were opened. Apparently, this injection (which stopped the diarrhea completely), isn't something they are using on the study to treat the side effects. So, I must start lowering the dose.

As it is, I don't eat meat; I cut out all dairy before I started because I was told what it may do to my system, so as far as diet goes, I'm pretty much existing on rice/beans and fruit. I understand how the anorexia side effect may become a problem. Hopefully, on a new dose, things won't be so bad.

Any dietary suggestions are appreciated :) Thanks!

~Bethany

[KRISS]

Hang in there Bethany. I did well on the 5 pill dose and in fact going to ask to go back to that. Tired of feeling "not right". The GI system is constantly on the go making noises and causing discomfort. Oatmeal has become one of my favorite things. I seem to keep it in my system longer than anything else. Keep us posted. I was feeling normal within 48 hours of stopping the drug so I hope you are too!

[1rarebird]

I posted this question at BC.org but haven't yet received any feed back. Maybe my luck will be better here.

I believe I read somewhere that Neratinib possibly may help prevent "cross talk signaling" between the Her1 and Her2 receptors, or the Her1 or 2 receptors and ERs. If this is true, could it be part of why Her2+ cancers can sometimes exhibit resistance to trastuzumab (Herceptin), and would Neratinib or even Laptinib help prevent such cross talk between (among) the receptors?

I don't know if this trial's investigators are looking at this question too. This is complicated stuff for me to understand, but if the anti-cross-talk question is valid, it may give another reason to sign up for the trial.

Thanks

bird

Male Breast Cancer, DX 5/15/09, IDC, STAGE 1, HER2+++, ER+(95%)/PR+(75%), Ki67 40%, grade 3, 0/5 nodes, TX: mastectomy, TCH, radiation, Tamoxifen therapy planned

[KristyAnn]

I have heard that too- all I really understand is that Herceptin blocks Her2 and neratinib blocks other HER receptors. My onc mentioned that many times when they have a HER2+ person with a recurrence after herceptin, further testing shows there is also an abundance of other HER receptors (like Her3 and 4) and that neratinib may also block those.
Kristy

[1rarebird]

Thanks, Kristy--
I am glad to see that the chemo-brain didn't affect my memory that badly after all and that I wasn't imagining things regarding the cross-talk issue. I will keep looking in my files to find the actual paper on this.

I met with my oncologist again 2 days ago and he said that our treatment center is almost finished with the paper work to get approval so it can participate in this trial. He also mentioned that accrual is going well for the trial so far, but that due to the numbers (3500 or so) patients that are being recruited, he expected it to remain open for a couple more years. That should leave me ample time to get on on the trial after I am done with the Herceptin this July.

bird

[freyja]

Hey ladies and gentlemen,
Don't know if you remember but I was approved for this trial way back in January but my treatment center somehow were prevented from starting it for some technicality. Now they are back on board, and I should start in a couple weeks when we got all the scans and tests redone. I'll be here reporting on the progress.
Celeste

[Patty F]

Celeste...welcome to the trial. I am almost at the 6 month mark. Still have diarrhea daily but not as bad as it was when I first started. Just had a muga and ekg Thursday and I find out the result on Tuesday when I see the clinical trial Dr.

[weety]

I have heard on another breast cancer site that they have amended this trial and are no longer accepting patients that have node-negative disease.

[freyja]

I am doing the scans Tuesday and should start in the next week or so. I didn't hear anything about an amendment. I was positive for lymphatic involvement when I was biopsied, though.

[Savta]

Hello to all of you.
I have just been asked to participate in the Neratinib trials as well. I, of course, do not know if I will be receiving the drug or the placebo. But I wanted to ask those of you who are receiving the drug--how soon do you start with the side effects? I understand that side effects are generally controlable, but I wanted to know more or less what to expect.
I'm glad to have the chance to participate--and hope I get the real thing. Wish me luck!!!

[Sandra in GA]

Savta,
I wish you luck with the Neratinib trial. I was in a phase II study of lapatinib (Tykerb) for early stage breast cancer at Mayo clinic. I took the lapatinib along with the Herceptin for a year. From what I have been able to determine it is a "first cousin " of Neratinib and has similar side effects; diarrhea, some problems involving the toes and fingers, etc. I found that if I ate a low fiber diet and stayed away from milk products, I could control the diarrhea somewhat. I still had to take Imodium and Lomotil along. However, it wasn't anything I could not live with. For the first 12 weeks I also had Taxol which I think contributed to some of my problems. Good luck to you! I am very glad I had the lapatinib. I hope you get some side effects~ that should mean you are getting the real drug!

Sandra

[Savta]

So, today I officially joined the Neratinib trial. Seeing as I only took the pills 9 hours ago, I guess I can't determine anything out of the ordinary. My doctor told me there are some that get the real drug and don't have side effects, so that it doesn't mean that I am necessarily getting the placebo if I feel nothing. I'm hoping for the best. And keeping in mind, even if I am on the placebo--that is also a contribution to the study.
Anything to lick this son of a gun!!!

[Sandra in GA]

I am anxious to hear from you in a few days. I didn't have any side effects from the lapatinib at first~
Sandra

[1rarebird]

I've been puzzled by folks here reporting that their doctors have told them a lack of side effects does not necessarily mean the patient is getting the placebo. If this trial is truly double blinded, then how would the doctors know if the lack of side effects was due to a strong tolerance of the drug or the pill is actually the placebo? I suppose the "placebo effect" acting in reverse could cause someone to experience uncomfortable side effects, but I doubt this happens often. Anyway, I am puzzled by this---

bird

[Savta]

So here is how it's going so far. The day after I took the first dose, I had three bouts of diarrhea. I began taking the immodium and took precautions with my diet. Today, I had only two bouts and still watched my diet according to their recommendations. Now it's been 11 hours and have had no further incidence. Did I just have a stomach virus before? Is the immodium and diet controlling side effects? I don't know. It's just too much of a coincidence to get a stomach virus the day after I started the pills, don't you think? Anyway, we'll see how things develope. But I really don't think this is placebo effect in reverse.

[1rarebird]

Savta---It sounds like you may very well have been given the Neratinib. Good for you. I doubt those bouts were anything but your GI reacting to the new drug. I wish for you the best success with this, and thank you so much for joining the trial on everyone's behalf.

Good luck---
bird

[KRISS]

Hi Ladies and welcome to those of you who are just starting. I am in week 20 and doing great! The diarrhea is still a daily event but every now and then I get a slow day, haha. Savta I was the same as you. The affects started withing the first 18 hours and was wondering if I was just sick or if it was the drug. Hand in there as it does get better or maybe I just tollerate it more knowing I am helping out my sisters. Keep us posted and hope you all are doing well.

[Savta]

Thanks to all of you for words of encouragement. I seem to be into some kind of routine. About every 36 hours I get a really bad bout--but the immodium seems to control it for a while. My biggest problem now is that I am really weak. I don't eat much, because I'm afraid it will bring on the diarrhea again, but I am actually pretty hungry most of the time. I don't seem to be putting much protien in my body, and that may explain the weakness. I mostly eat toast, bananas, applesauce, mashed potatoes and a little clear soup. Any ideas what can give me energy and not get my digestive system too angry?
All in all, I'm doing o.k.--if I could just get pass this weakness and tiredness. Anyone else felt this way?

[Sandra in GA]

Savta,
I found that I could eat lean meats OK. The toast, bananas, applesouce, etc. sound like most of my other diet. I did find a "low fiber" diet that also included canned fruits, green beans, and asparagus. I just googled "low fiber diet" and read some of the sources. That helped me a lot. I really had problems if I tried to eat raw veggies, fruits, milk products and whole grain breads. (All of that stuff we normally eat for a healthy diet.) After I completed the year of lapatinib in Nov., I have been catching up on all the things I missed. I also ate more red meat than I usually do because my HGB was so low due to the Taxol and AC. As long as I ate it broiled I did not have problems. My husband said I became "meat and potatoes" girl. I hope this will help you.
Sandra

[EvansMommy]

I just started this trial - took my first dose yesterday morning, around this time, and just took my second dose. I haven't had any side effects yet. Is it too soon, or is it more likely that I am in the placebo group? I do feel a teensy bit crampy, but I'm thinking I am probably just imagining that because I don't really want to be in the placebo group! :)

[Savta]

I don't think it means anything just yet. Some of the women didn't feel anything for the first few days. I also read in Wyeth's website, that 15% of the women taking the drug didn't get diarrhea. Maybe you're in that 15%. Or maybe you are in the placebo group. Keep in mind. No matter what group you're in, you are contributing to the trial. The sooner they get the data, the sooner it gets to the FDA. Then we'll get the benefit.
Good luck--and mainly---stay well!

[freyja]

I too started just yesterday evening and no obvious side effects, yet. Hope it doesn't happen in the middle of ballet class tomorrow! I share the mixed emotions with you all. I never wanted to get diarrhea before, but I might be happy to see it this time!
Regardless, happy to help a trial like this.
Celeste

[EvansMommy]

Well, it's been five days now, and no side effects. I know that not everyone who gets the drug has side effects, but I doubt I am that lucky!

Oh, well, I'm probably on the placebo. That's ok - at least I am helping out, right? :) I feel very lucky to have had a complete response to chemo and to still be NED almost 3 years after being diagnosed, and I am thankful to be able to be part of a trial that might wind up helping a lot of other women in the future.

Of course, I am still holding out hope that the diarrhea starts soon. Haha!

[Savta]

I don't know what to think. I am 13 days into the trial. Had the blessed runs for the first 11 days--now, NOTHING!!! Could it mean that I have already gotten used to the drug? They say it usually takes 2 to 4 weeks. I am going to go back to a regular diet, because now I am sufferring from the opposite!
Like I said, I don't know what to think--so I won't. Every participant is contributing--so I just hope for the best--with or without the drug.

[EvansMommy]

Hi everyone,

Well, I have been on the trial for just over a week now, and still have not experienced any diarrhea. However, I have been feeling very fatigued for the past three days, regardless of the amount of sleep I have gotten. Also, I have been experiencing constipation for the past three days. It's not super bad, but usually I am very regular, and I haven't changed my diet, so I don't know what's going on.

Does anyone know if fatigue and/or constipation are side effects from Neratinib?

How is everyone else doing?

[Savta]

Well, I'm back to feeling the side effects, or what I think are the side effects of Neratinib. I always think I must be used to it by now, and then I have a few rough days. I, too, am much more tired than I used to be. Maybe residual effects of Herceptin? Maybe the havoc in my digestive system? I have my one month check up next week. I hope at least to have lost some weight!!

[KristyAnn]

I am approaching 8 months on the trial and I am definitely on the drug- had to be dose reduced twice to get to a tolerable level. My doc sees the side effects as knowing you are on the real deal but the lack of side effects - she makes no conclusions since some people are lucky and dont have the problems.

I have found eating a cheese stick- mozzarella- daily helps with the diarrhea- doesnt make it go away just less volatile. I avoid dairy except for the small amount of cheese but I have stuck with my regular garden type diet which is pretty high fiber- I do think it causes more problems but I couldnt find what I would want to eat for a year with my garden producing all kinds of good things - so I tough it out. I seem to be in a pattern of having a bad side effect day every 7-10 days- like my body tolerates it as well as it can and then falls apart for a day.

I keep immodium with me and some other small pill you put under your tongue to stop abdominal cramping- use as needed which is only about once per 7-10 days.

I am definitely counting the days until I am finished (Oct 6, 2010 is my last day BTW)

Kristy

[Savta]

Tomorrow is my one month check up. For the last week, the diarrhea and just plain lousy feeling have accelerated. I seem to have "bad" bouts every day--and giving in to popping Immodium. I am curious as to how tomorrow's blood work is going to go. But, I am having a rough time coping. I keep telling myself how lucky I am to be in the study, and apparantly receive the real thing--but, eleven months is also a long way away. I'm wondering when my body will adjust, as was promised.

[1rarebird]

I have wanted to join this trial since last summer when my oncologist first told me it would be available after I finished with my TCH regimen this July. But I won't get the chance. I unfortunately learned yesterday from his trials nurse that my gender makes me ineligible. I will have to find some other way to get exposure to a tyrosine kinase inhibitor like Neratinib. Perhaps there is a CAM regimen that would help.

Despite this set back, I am grateful to all the ladies who have signed up for the trial and by their efforts will advance the knowledge base for treating Her2 BC.

bird

[Savta]

So here I am, six weeks into the trial. I still get really bad bouts of diarrhea, and feel weak and queasy--but I do get a few good days in between the lousy ones. I still don't know what is good to eat--and I keep trying new ideas--so thanks for all the suggestions. I was feeling really out of shape, so I decided to go back to taking multivitamins, and I joined a gym. I go three times a week, and even on the bad days, it picks me up. Whatever works, right? In addition, my physiotherapist said that exercise in water is really good for the mild lymphedema. So I get that in too. It's all about staying well.

[ElisabethH]

Hello everyone - just want to say how useful it has been to read all your comments. I live in Madrid, Spain and have been selected for this trial here. I started on Thursday after all the usual tests. It has been particularly good to read about it all in English! My Spanish isn't bad, but when its so serious, you want to check things out in your own language - well, I did anyway! I couldn't find any info in England - so you all over there are helping!
I had diarrhea the second day, so I guess I am taking the real thing, which is actually good to know!
I also signed another agreement on Thursday to release my biopsy tissue samples for genetic testing - I apparently have the right to see the results, so that is a very interesting side issue.

[KRISS]

Well, just got back from my 6 month check in and am told I have to go off the drug. Blood work and Ekg are great but my muga dropped from 68 to 42. Protocol says off drug for 3 weeks then redo the muga if I am not above 50 then I am off for good even if it went to 49. Anyone else out there drop that much? I only went down 17 point during all of herceptin and went back up right away. Hoping this time it will as well. At least I will get a rest from the diarreha! Keeping you all in my thoughts.

[v-ness]

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

[ElisabethH]

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...

[KRISS]

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.

[v-ness]

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

[Victory]

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

[kiwigirl]

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

[candlegranny]

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

[Sandra in GA]

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.

[Jackie07]

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.

[KristyAnn]

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.

[v-ness]

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

[morkmunoz]

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.

[KristyAnn]

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.

[morkmunoz]

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!

[Savta]

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.

[DeenaH]

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.

[Savta]

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.

[Chelee]

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

[DeenaH]

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.

[ElisabethH]

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!

[Jackie07]

Thanks for the update, Elizabeth, glad you are doing well.

Both fish and scallop are 'protein' which takes quite a bit longer to digest than carbs - so I think you're correct that the 'deep frying' was the culprit since oil/fat takes the longest time to digest and it requires something from the gallbladder to dissolve the fat molecules.

Many of us have stayed on this forum long after we had completed our treatment. Don't worry about the attention issue. You will finish your treatment before you know it!

[Ginny1956]

I started the Neratinib clinical trail 13 Jan 2011. First day I knew right away that I had the real thing. Within 3 hours of taking the 6 pills I had severe stomach cramps, nausea and mild diarrhea. The next day after talking to nurse day before I took the pills after I had breakfast but 3 hours later had mild stomach cramps, nausea and diarrhea but worse than the other day. Day three I took pills 30 minutes after breakfast and other than a little nausea nothing else. My fingers are crossed that my body is getting use to it. I do find that when I get stomach cramps or nausea that eating a saltine cracker or two helps.

I was diagnosed with stage IIIC HER2+ breast cancer in June 2009. I had a double mastectomy, 16 rounds of chemo, 25 radiation and 52 weeks of herceptin.

[ElisabethH]

Hi Ginny - yes, I take my pills after breakfast and my worst case was that I used to have problems if I ate salad without any carbs alongside. I suffered the side-effects quite strongly for the first 2 months and thought at times "is it worth it?" and the answer was always "Yes!" There is a reason we are doing this and we are lucky not to be on the placebo - I tell myself. Now after 6 months, almost 7, I rarely have a problem with cramps. Perhaps I have learnt what I can eat, but also my body must have adapted. Only 5 more months to go!

[Ginny1956]

Today is my last day on trial. I kind of feel like my parachute has been taken away. All follow up tests are clear so I am still cancer free! The only side affects I had was hair loss and evening fatigue. The trial has stopped but participants will be followed for two years at Dr schedule. I am not sure if tests are still covered by trial. I will find out today.

[Ginny1956]

It is not what happens in life that matters it is how you live it.