Re: Neratinib Clinical Trial
 

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........

Re: Neratinib Clinical Trial
 

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

Re: Neratinib Clinical Trial
 

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

Re: Neratinib Clinical Trial
 

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

Re: Neratinib Clinical Trial
 

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.

Re: Neratinib Clinical Trial
 

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.

Re: Neratinib Clinical Trial
 

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?

Re: Neratinib Clinical Trial
 

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

Re: Neratinib Clinical Trial
 

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

Re: Neratinib Clinical Trial
 

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!

Re: Neratinib Clinical Trial
 

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

Re: Neratinib Clinical Trial
 

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

Re: Neratinib Clinical Trial
 

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

Re: Neratinib Clinical Trial
 

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

Re: Neratinib Clinical Trial
 

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.

Re: Neratinib Clinical Trial
 

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.

Re: Neratinib Clinical Trial
 

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.

Re: Neratinib Clinical Trial
 

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!!!

Re: Neratinib Clinical Trial
 

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

Re: Neratinib Clinical Trial
 

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!!!

Re: Neratinib Clinical Trial
 

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

Re: Neratinib Clinical Trial
 

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

Re: Neratinib Clinical Trial
 

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.

Re: Neratinib Clinical Trial
 

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

Re: Neratinib Clinical Trial
 

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.

Re: Neratinib Clinical Trial
 

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?

Re: Neratinib Clinical Trial
 

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

Re: Neratinib Clinical Trial
 

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! :)

Re: Neratinib Clinical Trial
 

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!

Re: Neratinib Clinical Trial
 

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

Re: Neratinib Clinical Trial
 

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!

Re: Neratinib Clinical Trial
 

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.

Re: Neratinib Clinical Trial
 

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?

Re: Neratinib Clinical Trial
 

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!!

Re: Neratinib Clinical Trial
 

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

Re: Neratinib Clinical Trial
 

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.

Re: Neratinib Clinical Trial
 

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

Re: Neratinib Clinical Trial
 

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.

Re: Neratinib Clinical Trial
 

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.

Re: Neratinib Clinical Trial
 

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.