Neratinib Clinical Trials

anitach

All scans were clear last Tuesday - Woo Hoo!! So I took my first dose of Neratinib on Friday afternoon. So after 3 doses of 240 mg - no side effects - Nada, nothing, I can't even tell I have taken anything. So crap.... I'm thinking I got the placebo I know it is all for a good cause and all but I am on the fence of Stages 3 and 4 and really, really wanted the drug for extra insurance. Has anyone else not experienced any effects for the first 3 days? I hate to think about going for all the tests and Dr. appts. - my trial Dr. is 2 hours away - for a placebo.

snowgirlcathy

Things are like a roller coaster for me.  After a 'runs-free' day on Saturday, Sunday was back to the 'runs/nausea' events of last week.  Monday started out OK but then I got really nauseous last night through this morning.  No diarrhea though which is a good thing.  However, this constant 'sick' feeling and being ridiculously tired (maybe from the Gravol I take to control the nausea) is getting very annoying.  I'm not one to quit anything but I won't let this go on for long before I either get them to try reducing the dosage or go off the trial all together.  I spent 7 months feeling lousy then finally was getting back to my new 'normal' to have it all deteriorate again with this trial.  As much as I WANT to participate to get the benefit, I won't spend another year feeling like this - sick, weak and never to far from the washroom!

beebusted1

Anitach I feel your pain.  Today was day 5 for me and zip, nothing.  I had a few butterflys in my stomach yesterday morning, but other than that, I'm like you, no side effects. Who knows, maybe we are that small percentage who won't experience any side effects (I'm thinking positive here

k4katz

Anitach and Beebusted, I am in the same boat as you!  Have been taking the pills over a month now, and haven't noticed any side effects at all.  I am hoping that maybe I am just one of the 15% that don't get the diarrhea.  But, even if I am on placebo, I feel it is still a win-win situation for me since now I will be seen regularly by the study onc in addition to my regular onc.  It just makes me feel better to have someone look at me every few months and tell me that all seems fine!

Good luck to everyone just starting or getting ready to start!

*Hugs*
Kristin

beebusted1

k4katz you are absolutely correct. It is only a win win situation. We are doing something worthwhile no matter if we are "blessed" with the runs or not . May all of us be well and happy.

weety

Somebody else wrote a few pages back that even if you are getting the placebo, if you do happen to get a recurrence while participating, they would automatically provide you with the Neratanib.  Does anyone else know if this is true or not? 

anitach

Still not sure if I am having legit SE's or if it is all in my head!! I've been nauseous since yesterday afternoon. Not enough to even feel like I am going to throw up but just a yucky feeling. Had a few stomach cramps this morning too but nothing serious. Someone here at work pointed out to me that it took me a while to feel any effects from chemo as well so maybe that is part of it.

I know that I went into this knowing that I had a 50/50 shot at getting the real thing. The problem for me is that I will have to take off one full day of work every month to see my trial Dr. That's 12 vacation days next year - I only get 15. Besides that, I will have to travel 2 hours one way to get there every time. I just hate to think of going through all this without getting the benefit of the real drug. I know, I'm supposed to suck it up and take one for the team but being on the fence between stages 3 and 4, I feel like I'm at the bottom of the line-up and likely to strike out!!

Just a rant, not enjoying this nausea much today, hoping it is SE and not coming down with something.

Weety, my trial Dr. did tell me that if I were to have recurrence while on the trial that they would automatically make sure I was on the real thing so you are right about that.

Bee and Kristin, I'm going to keep my fingers crossed that we are all the very blessed boat of real drug, no SEs.

Merry Christmas everybody!

Anita 

vickib

Snowgirl - I know it is terrible now but I have been on it for several months and my sessions in the bathroom keep getting less frequent and I am now only going once or twice a day max. I did not go at all on Saturday. I hope you feel better soon!

Girls -  I cannot remember when the se actually started, definately within the first week for me but who knows, maybe you are the lucky ones! When will you find out what you are taking.. At the end of the trial?

beebusted1

Last night I started to get the feeling that I was going to have a date with the toilet, but nothing major. I felt exhausted and crashed early.  This morning I have been to the bathroom frequently but nothing that I can say is "explosive" or even resembles my bouts while on chemo. I too am questioning myself whether this is the real deal or not.  I guess I have to take a breath, let it go (no pun intended) and see where it takes me. I am fortunate that my doctors are closeby so I admire those of you who really have to sacrifice. Stay positive

KristyAnn

Hi Everyone,

Im back off the neratinib for the day due to a terrible day yesterday with Mr D (Diarrhea)- HOWEVER, my potassium was checked yesterday and was 4 so that is great- at least it appears I am holding my own with the potassium and magnesium now. Nurse said to not take meds today and try to get side effects tamed down. They may dose reduce again if it keeps building up to such terrible diarrhea- Im already reduced to 200 mg instead of 240 mg.

My clinic has about 7 or 8 women in the study and several they think are on the drug- Im the only one with the terrible side effects (go figure) so at least some people tolerate this a lot better than I do.

Lisa- Nurse and I are having conversations and trying to find the balance point with the dosage and a normal life.

BeeBusted, In addition to the diarrhea I have a lot of queasy feelings with this drug- maybe you are lucky and will only have the icky feeling and not all the other stuff!

Cold in Texas today- off work tomorrow which will be fun- indoor water park on Saturday with my youngest daughters 18th birthday party - so a fun weekend ahead!

Kristy

my2boys

Hi Ladies,

I go to see the trial doctor on Tuesday and I will bring all of my paperwork and consent forms with me.  I will tell him that I want to start the trial after the holidays.....in mid-January.  It sure is nice to be medication free for a change.....I wish this month could go on forever. 

I want to thank you all for sharing your journeys with us. 

Anne

KristyAnn

Im off the neratinib for the weekend- my ONC is at the San Antonio conference and the on call doc doesnt have patients in the study so my research nurse decided I needed to stay off a few days and try to let my body get back to normal- probably looking at a second dose reduction since I seem to be VERY reactive to this stuff!

Today was sure fun off the neratinib- ate normal food, didnt spend the day running to the potty- yesterday was a complete side effect disaster so this was a nice change AND I get to have the weekend like this!

Kristy

Lisa1964

I am very sure I will be leaving the study.  My SE's have been very severe. Explosive diarrhea, vomiting compounded by the SE's of too much Immodium and Zantac.  Then all the bathroom visits caused a UTI and yeast infection.  I spend my time in the fetal position and too much of that time sleeping on the bathroom floor becuase I dare not get more the 3 feet from the toilet.  And my SE's were not tapering off with time, they were getting worse.

I hate to be a quitter, but I can do nothing.  If I want to go to church on Sunday, then I do not take the drug on Saturday (and even that is not a sure bet).  If I want to ride my horse, I have to stop the drug at least 2 days prior - again, not a sure thing.  But this week has been the icing on the cake.  Took the last dose Monday and never left the house till midday Thursday.  My joints ache like an old lady and I am exhausted.  I have to be toxic between the neratinib and all the crap I have taken to overcome the mounting side effects.  I can't live like this.

Lisa

anitach

Lisa,

I'm so sorry you have been having such a terrible time. If your decision is final and you are at peace with it I hope you have the drug out of your system in time to enjoy your holidays. I feel bad for wishing for just a "little" SE just so I know for sure if I am on the real thing or not when there are those of you who are truly experiencing real thing and it sounds just horrible. I don't blame you at all for opting out. You have to factor in QOL in all your decisions. Praying that things get better for you very soon and you can enjoy sleeping in your bed and riding your horse again!

Anita 

beebusted1

Lisa you gave it a try, that's all you can do. I hope you feel better and recover quickly from the Meds. Thank you for sharing with us.  Happy holidays to you and your family.

AmyIsStrong

Lisa - I am sorry your SEs were so debilitating. But isn't your experience valuable to the trial as well, in that they see what can happen with that dose, maybe consider reducing it, etc.?  I would like you to believe that your suffering will help in some way. I don't fault you at all for your decision. This drug is obviously not right for you.

I hope you feel better soon.

snowgirlcathy

Lisa, don't feel like you've been defeated... as stated part of a trial is finding out that some people may just not be able to tolerate a particular drug or at the initial dosage they suggested.  I've seemed to settle down into a reasonable pattern just by changing the time I took the drug to after dinner - more food in my system and I guess I sleep through the initial nausea etc.  Didn't go to the bathroom at all yesterday!  Had reduced to 200mg from 240, then upped last night to 220... a single, non painful bout of D this morning but took 2 Imodium and we'll see how that does... for me it seems to be the dosage and food intake that are the issue.  I was also worried about the combo of Neratinib, Imodium, Arimidex and .5mg Ativan I take for anxiety issues but I'll keep my fingers and toes crossed that I've reached the 'balance' point.  Lisa, if my S/E's were as bad as yours I'd have made the same decision... they don't monitor you for 'quality of life' for no reason.  Merry christmas and hope your life gets back to it's normal enjoyment level! xoxo

KristyAnn

Lisa,

I am so sorry your side effects are so bad- have they talked about reducing your dose? I have already reduced once and expect another reduction next week- the nurse told me they could reduce like 4 times based on side effects and it sounds like you are in the Grade 3 side effetcs like I am. Im off the drug for 4 days until the research nurse can talk to my onc- I started at 240 mg, reduced to 200 mg- horrible side effects started at Day 8 after the reduction so I am expecting to drop to 160 mg next week.

I am fortunate that my nurse is very tuned in to QOL- I told her I took extra pants and a Depends to work to keep in the desk drawer and she knew we had problems to deal with LOL.

Dont feel bad if you have to drop out- but dont feel like you have to drop without looking at alternatives like reducing the dosage either if you are interested in staying in the trial.

Kristy

gk2bc0

You ladies are fast becoming my preferred discussion board! I am glad that you are so active in reporting on your SEs or lack thereof.  I think that no matter what, the most important thing is data collection. There will be people who cannot tolerate some drugs...that's what this is all about, testing and adjusting.  Even the tried and true drugs (tamoxifen) are still being studied.  Are you all reading the updates to the San Antonio Conference?  They are talking about what we are doing!  it's pretty exciting

I went back on the pills at 200mg on tuesday this week after spending a good 10 days recovering from my first attempt. After all the D for 5 days beginning on day 7, I was heading back to my usual constipated state.  That has been eliminated (ha!) and I now have the familiar pains in my stomach that preceded the big D last time. I am prepared this time, now that I know the drill, and I hope that the reduction will be my ticket. I have my one month EKG and bloodwork scheduled for the 22nd and I hope I don't have to make a trip into the office before then. 

 I'll be checking back over the weekend to see how everyone is doing.  Have a good one!  Gail

my2boys

Lisa,

I have always been one step behind you.....from our first TCH to our last Herceptin.  You are one of the strongest people here and I remember when you started treatment one week before me and I read about your SE's and I knew what to expect.  When you finished and were struggling with hair regrowth, I had the same issues that you did, but you always managed to inject a little humor which helped me to lighten up a bit too.

If these SE's are too much for you, then they must be just horrible.  I am sorry for all of the trouble that you went through to start this trial, but I also know how important those beautiful horses are to you and I would think that if you couldn't ride, you would be just so unhappy.

Your time in this trial has helped not just yourself, but others who will follow you.

Anne

tarheelrivergirl

Two weeks ago my doc recommended the Neratinib Trial. While doing my own research I came across this forum.  Thanks so much for all the posts! The good, bad, positive, negative, when to eat, what time of day to take the pills, immodium, potas/mag, levels, etc. 

Lisa1964

Thanks so much everyone for all of your support.  Anne, your post made me cry.

I am almost back to normal.  I have not called the trial nurse yet.  I wanted to get everything out of my system first.  I will call her Monday.  If she wants me to try a greatly reduced dosage and I will at least consider it, but there is NO way I can do my job at the 240 dose.  Right now I am not working, but I go back Jan9th.

I will keep you all posted.  Thanks again for your support and understanding.

Lisa

my2boys

Good luck Lisa.  I'm glad you are feeling better.

KristyAnn

Hi Everyone,

Had a GLORIOUS weekend without neratinib- but Im going back on tomorrow and staying at 200 mg. They are putting me on lomotil for the diarrhea instead of immodium since the immodium had no effect at all on me. The doc wants to see if I can tolerate the 200 mg dose with this other anti-diarrheal medication. My onc just got back from the San Antonio conference so maybe she learned something there about neratinib- I wont see her until January 4 but I will be sure to ask!

Kristy

tarheelrivergirl

Hi everyone,

I came across the poster sessions from the San Antonio conference that address Neratinib in case you want to follow the links below.

http://www.posters2view.com/sabcs09/viewp.php?nu=5081

http://www.posters2view.com/sabcs09/viewp.php?nu=5095

http://www.posters2view.com/sabcs09/viewp.php?nu=5108

vickib

Hi Ladies -

I am sorry there are so many of you that have suffered such terrible SEs, I wish you all the best and hope they will be able to find a dose that will work for you. QOL is very important!

I wanted to let you know that I just got my results from my CT and the spots shrunk. It seems to be working again.

Hugs to all,     

KristyAnn

YEAH VICKI on the shrinking spots!!!!!

I started back this morning and also started on the lomotil- by this afternoon or tomorrow I will probably know if there is a difference LOL.

Kristy

weety

I had an interesting experience today.  I went to UCLA  for a second opinion on where to go next in my treatment and to get "guidance" on any clinical trials I might be a candidate for.  The doctor I saw works very closely with Dr.Slamon, but she did not even know about this Neratinib study for early breast cancer.  She kept telling me it was only available for metatastic disease.  I didn't want to sound too vain, but I finally pulled out the pages I had downloaded on the study and showed them to her. She was very surprised!  I am wondering if this study is just not well known because it is relatively new or if it is just not widely advertised.   She seemed to think it was a good study to pursue, though, even though it only has a 50/50 chance of getting the real thing.  She said the preliminary data of neratinib on advanced disease looks promising.  But she also said it would take a long time (and a lot of participants) to  get  enough data to be able to show much, based on the fact that herceptin/chemo already reduces the recurrence rates to such a low percentage.  For every 100 people that sign up for this study, only about 7 of them will even get recurrences in the first place.  And if Neratinib does its job like they think, even fewer than 7 will get a recurrence.   I guess that means this study will probably be open and recruiting participants for quite some time.  I won't be finished with herceptin till the summer and when I asked about it still being open then, she replied, "most definately." 

KristyAnn

Well I am back on the neratinib and A LOT better- they switched me from Immodium to lomotil for the diarrhea and it has made a world of difference! I am staying at 200 mg on dosage!

I never made it 2 days without the terrible SEs before so hopefully this will stick and stay like this!

VICKI- I may have made it to tolerable like you! I did notice on the posters from the San Antonio conference that is said average time for the diarrhea to settle down was 30 days but the range was something like 10-149 days!!!!!

Kristy

tarheelrivergirl

Hi,

Have any had problems with neuropathy while being on neratinib?