Neratinib Clinical Trials

leighannmarie

Yeah, no idea which study he is referring to.  He was just making a general statement that he was surprised by a couple. He had one person who had severe reactions but she was also on Tykerb and Chemo.   I am still curious about variations in the pills.  Well, dang it!  Why did I have to do the CT?  My veins are horrible and I had to get stuck 6 times.:(  Did you do ECG?  I did that so, hoping I can avoid MUGAs with that.  Mammos were clear today though ~ Hurray!  

EDIT:  The Study paperwork does say a CT is needed if chest xray is not done.  And looks like MUGAs too.    Well, for some reason they never seem to have trouble with my veins for the MUGAs.  The nurse called me yesterday to inform me that my "mameogram" was negative.  LOL 

Roxi65229

Hi all. It's been awhile since I checked in. I've read everybody's post and it sounds like everybody is doing okay with the drug. My SE's are tolerable though the D thing is getting pretty old. Yeah for negative mammos!

KristyAnn

Hi Roxi,

I have been wondering how you are doing- yep the big D gets really old- I am literally counting the days until I am finished. The first two months before I was dose reduced was horrible- now Im tolerable at 160 mg but the big D and need to be nearby a potty all the time is wearing me down!

46 days but who is counting LOL

Kristy 

jap

Hi everyone,

I have been on this trial since June with no SEs.  I was sure I was on the placebo but on oncologist just told me that some women get no SEs from the real thing.   She has stage 4 women who she knows are on the real thing but have no SEs.

She thinks that women might experience no SEs because it has been a significant period of time since they were on Herceptin.

Does this make sense to any of you?  Have women with significant SEs taking N. right after finishing H.?    I started the trial almost a year after I finished H.   That's why my oncologist thinks there is a chance I might be getting the real drug.

Please let me know what you think.

Jo Anne

suemed8749

Hi Jo Anne - Interesting theory! I started Neratinib 9 1/2 months after finishing H, and I have no side effects. When I told my onc (he also is my clincal trial onc) that I thought I was getting the placebo, he said, "Who knows? Maybe you're a moose." (Uh, I think that was kind of a compliment.)

Do we get to know when we're finished?

Sue

gramma23

I do not think we ever get to know anything. according to my study Nurse she will never know anything. My onc told me since I was so sick he was sure I got the real thing but he does not know either. As for the tumor study that we have to give permission for them to have I really wanted to know the results they find but I was told no one would know except the people doing the research. Even though I could not take the med at least they got my tumor material and hopefully it will help someone with a cure. I took the pill for 4 days and had to quit because I was so sick but the diarrhea was not the reason just sick to my stomach and could not drink even water without throwing up. I was off it for a week and took a lower dose of 5 pills and by the time it hit my stomach I was throwing up. The last thing I threw up was the coating of the pill. I know because I saw the pink color of it. it took me a few days to feel better. I was real sick on TC also. I am glad some of you are doing good on it. I had to have a CT, a MUGA, a biopsy of a lump in my breast and a place on my face that my onc thought might be cancer but was not.I had a bone scan and EKG also. I was so tired of  tests by the time I started the trial and didn't even last long.But at least I was not found to have any cancer so that was good. I have a new lump but onc said it was from the biopsy and mamo was good so I go back in 6 months to have it checked again and after that I do mamos every year.

Good Luck everyone with this trial. I have to be your cheerleader since I can't do the trial. kristy you are my hero.

beebusted1

Jo Anne: Hmmm makes me wonder. I started 7 months after I finished Herceptin. I have no major side effects either, but then again, I can't tell what is normal and what is not anymore.  I am convinced Chemo screwed up my bowels forever. Right now the only SE I'm fighting is terrible ringing in my ears which I also experienced while on Chemo.  Sounds like a symphony of high pitched fan belts blasting away. I figure it will be years before we find out anything. I don't think they have passed the 300 mark let alone 3800 to close out, then all those people need to be on it for a year, then they dissect the data, yada yada. Be well everyone :>

KristyAnn

I finished Herceptin in April of 2009 and started the trial in October 2009- so about 6 months and I am the se queen- finishing the trial at a 160 mg dose (4 pills instead of 6)- no other ladies at my cancer center are having any side effects- so who knows? They are sure I am on the real thing but dont have a clue about all the others

43 days to the finish line!

Kristy

gramma23

I started the trial Neuratinib 10 months after I finished Herceptin. they told me you have to be in the year after herceptin to be part of the trial so they were in a hurry to get me in. We did all the tests and biopsy's and I started it. I did not last long because I was so sick. I do not think it is how long you have been off Herceptin but apparently a person can either tolerate it or not. It is like the TC some do well others don't. I didn't.

I am proud of you KristyAnn! Most people I have known have not been able to finish it. One lady that was on the web site I was on lasted about 4 weeks I think but just could not do it. I know she was dose reduced once at least but just couldn't do it.

Good Luck to the rest of you. I wish I could have helped.

Carolyn

leighannmarie

Started the trail yesterday.  I was told to take pills 1 hour before or 2 hours after eating at night.  That is not what it says on the bottle.  I took them before I went to bed at 10pm.  Woke up at 5am feeling a bit nauseated.  Feeling a little bit crampy and like someone punched me in the gut.  I was told to call my doc right away if I get diarrhea.  Seems a little silly to me unless it is severe.

KristyAnn

Leigh Ann,

The diarrhea is the most common side effect and can become really severe so Im sure they want to know at the first sign so they can monitor you.

Kristy

leighannmarie

Oh, okay.  so far just mild to moderate cramping and a bit sick feeling after meals.  These go away and I think, okay I must be on placebo and something else is upsetting my stomach.  Then I get all crampy and yucky feeling again and think maybe not.  I am going on a longish car trip tomorrow so I hope the cramping doesn't give way to severe diarrhea. :O  Tonight will be dose #3.  After the first two I got this weird empty stomach hungry feeling before the cramps.  I take them at 10pm so, weird time (for me) to be hungry.

leighannmarie

Yay! Made it through the weekend trip without too much problem.  Had loose stool and took a pepto that helped.  Had ice cream Sat (this was scary ~ we all went out for ice cream and I didn't want to explain why I didn't want to get any so, I ate half of it) and had some loose stools today but the pepto kept it in control.  Cramping and nausea are better.  

weegirl

hello everyone,

I'm new to this board and recently went on the trial after finishing herceptin 11 months ago and I KNOW I got the real pills....I was sooooo sick. Diarrhea non stop, would even wake me up throughout the night, nausea,  and vomitting a couple times... I handled chemo better than this!

All the immodium I took for the D caused me to get so gassy and unable to pass it that I was in severe pain and then took took Zantac for acidity, stemitil for the nausea, and Ovol for the gass but every pill I took was causing more se's so I hate to say it, I couldn't and didn't want to even try reducing the dosage and stopped it all together.

I wish I could have kept going, but honestly, chemo was a breeze compared to this stuff. Oh and I forgot to mention acne...it is either acne or a really bad rash on my face and neck plus my mouth got very dry as well.

Take care all....keep up the fight!

KristyAnn

Sorry about the difficulty weegirl- neratinib definitely has some nasty side effects. I am finishing the trial in 34 days but it took two months of adjustments and two dose reductions to get to a level I could tolerate.

gramma23

weegirl , I was like you. It was much worse than the bad side effects of TC. I tried one dose reduction but just one day of less and I was so sick I knew I would never make it. My husband was getting scared for me also because I could not eat or drink anything without being so sick. I had to respect his feelings too but I think I would have died if I had not gotten off it. It is like everything else some people do better or worse than others. I just hope those that need it can handle it better than I did

I am happy for you KristyAnn for being almost finished. Just shows some can managed it.

Carolyn

tarheelrivergirl

KristyAnn,

What SEs do you still have with only 30 something days left? Do you and/or your doctor think that the SEs have lessen due to being dose reduced, toleration over time or some of both? Also, have they noticed any change in your ECHO or EKG?

Thanks.

KristyAnn

I sitll have diarrhea most of the time- not the explosive sudden onset that I had at full dosage but I have not returned to normal bowels for the whole year. I still do not go anywhere without a bathroom available in close proximity!

I stay away from most dairy since it seems to make it all worse- this HAS lessened with time and I am tolerating a little dairy now.

I developed the rash about halfway into the trial and it continues in a fierce manner- I have some prescription cream to help with it but it doesnt clear up completely- hoping this will go away next month when I am finished.

My most severe side effects were dangerously low potassium levels due to the extreme diarrhea I had- so this was treated medically and was resolved with the lower dose.

I havent had any change in liver function or in my MUGA- and I wonder if that is because I am on th elower dose- 160 mg instead of the 240 mg (I only take 4 pills).

My birthday is about a week AFTER I finish the trial and everyone is planning on an ice cream cake since I havent had ice cream in a year other than maybe 1 tablespoon (and it made the big D worse)

Kristy

leighannmarie

I am having tension like headaches since I started this trial and am now getting panic attacks worrying about brain mets.  Anyone else experience this?  Of course don't know if I am on placebo or not.  Had diarrhea and cramping  for a couple of days when I started and a couple days after eating a lot of buttercream frosting.  

Roxi65229

Hi all. Sorry I've been quiet for awhile. I get headaches, stomach cramps and nausea. I've got my diarhea diary down to a science. I'm good for about every three days. Nothing for a couple of days and then you guessed it, the big D. I started 363 days after my herceptin. We rushed to get into the trial. Tomorrow is my second heart scan. Kristy, I really miss my yogurt! And Gramma, sorry you couldn't stay on the drug. 

KristyAnn

Hey Roxi,

Glad you showed back up LOL- I can tolerate a small carton of yogurt every few days and Ive done well with frozen yogurt. I am 11 1/2 months into the trial and have my first normal non Big D last week- boy will I be glad when I am finished!

leighannmarie

Roxi, my experience is similar to yours.  Anyway I am doing a head CT on Monday just to make sure cause the headaches are really freaking me out!

leighannmarie

Ackk!!  Went away for the weekend and forgot my pills.  The big D is hanging around anyway..  Two weeks into the trial and the occasional D is now daily for the last week though I have been a nervous wreck over this crappy head ache stuff!  

Roxi65229

Praying your CT is all clear on Monday!

KristyAnn

17 days until I am ifnished!!!!!

gramma23

KristyAnn, I am happy you are almost finished. I am so happy you got through it.

Carolyn

leighannmarie

Brain Scan All Clear!!  

KristyAnn

YEAH leighannmarie!!!

13 days left!

suemed8749

Great news, leighannmarie!

deenah

Hi all,

 I am new to this thread because it was suggested to me by a Dr. at UCSF that I qualify for this trial.  I was diagnosed in March with stage IIIc HER2+++ BC.  It had spread to my mammory nodes and to nodes in my neck, and the tumor was 7cm.  I had to do chemo first (4 dose dense A/C followed by 4 dose dense Taxotere with Herceptin).  I am still on Herceptin every week and will be for a year..  The first PET showed a huge fireball in my breast and at least 7-8 tumor filled nodes in the axilla.  After chemo the PET showed no cancer anywhere except a little in my right breast.  I had bilateral mastectomy almost 4 weeks ago and when the path report came back, even the Dr.'s were shocked.  I still had a 3.2 cm tumor in my right breast, 18 nodes out of 51 removed were still positive for cancer, and they found granual sized cancer in the fatty tissue between levels 1 and 2 in the axilla.  The surgeon assumes there is still cancer in the mammory nodes as well as the neck nodes.  I felt like I did the day I was told my cancer was stage IIIc.  I am still considered IIIc based on the path report.  It is assumed that there is still microscopic cancer under my arm.  And who knows where else!  I have rads next and am getting opinions from Stanford, UCSF, CTCA, possibly a phone consult with MD Anderson (thanks to a personal connection), and I am probably going to do a consult with Dr. Slamon at UCLA to see what we should do next. 

When my UCSF doctor recommended this trial, I got chills, because I had read some of this thread several weeks ago.  I have a very sensitive GI tract anyway, so I am terrified about the side effects, and that they last so long.  Other than the side effects, does anyone know if there is any heart toxcicity with this drug?  My onc wants me to go on Lapatinib with Herceptin once I finish rads and continue that combo for the rest of my year on Herceptin.  She may even extend the combo to 2 years.  I can't do this trial until I finish Herceptin and/or Lapatinib.

It also scares me that I could get fake pills when I could be doing something else.  Stage IIIc is scaring the crap out of me.  The fact that the chemo didn't work as well as they had hoped scares the crap out of me.  I am just scared!  

Do you really think this trial is worth doing?  I am also looking into the HER2 vaccine trial that is going on in Seattle.  I already have the paperwork for that one.  I also have a friend who is on that trial, but the dr. at UCSF said they are trying to get her in the naratinib trial too.