Neratinib Clinical Trials

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  • k4katz
    k4katz Member Posts: 240
    edited November 2009

    Day 2 for me...so far no side effects!  I am thinking that maybe I got the placebo.  Or maybe I am in the luck 15% or so that do not get the diarrhea!

    Kristy, yes, I did the QOL survey on a handheld.  It was pretty cool!  I guess that is how they are doing it at all the study sites.

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  • weety
    weety Member Posts: 1,163
    edited November 2009

    Does anyone know the answer to this question: If you enroll in a clinical trial that would make you ineligible to enroll in a different clinical trial at a later time, are you still ineligible if you only receive the placebo?  Just wondering since this trial has the placebo arm.

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  • suemed8749
    suemed8749 Member Posts: 1,151
    edited November 2009

    Thanks, Michelle. I just opened the reply email giving me the Sedona contact phone number, but Tucson would be easier. I see my onc on Tuesday, so I'll ask him if he knows about it. Maybe we can car pool to Tucson!

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  • mmm5
    mmm5 Member Posts: 1,470
    edited November 2009

    Yes I am considering it for January, however the Onc down there who I see for Bisphos trial states it may be overkill for Her2 no nodes if we completed a year of Herceptin. Let me know what your ONC says, I like to hear several opinions.

    Let me know what you think, and I am hope you are doing well!!

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  • KristyAnn
    KristyAnn Member Posts: 793
    edited November 2009

    Hi Everyone,

    I just got home from 5 hours in the chemo room getting IV fluids and potassium- seems that horrific diarrhea from this trial did a real number on my potassium. My level was 2.7 so I didnt have to be hospitalized but I did have to have IV potassium- and its a really slow drip. The onc also gave me fluids since she thought I was a little dehydrated (not terrible though). I have to hold off the drugs in the morning until my potassium is resolved- they are hoping between the IV and the potassium horse pills for tonight and the next two days will have that fixed in the morning when I go back for another blood draw and retest.

    They warn you that serious diarrhea is a possibility- and Im proof of that BUT I am still in the study and just have to figure out how to manage all this. It has improved this week- the nurse and I both think the low level is probably due to the 3rd week when I had a really rough time with the side effects. Oh I also lost 11 pounds in the first month of the trial- I was trying to eat carefully so that is not all due to the diarrhea- but they also weren happy about that much weight loss!

    Kristy

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  • vickib
    vickib Member Posts: 1,184
    edited November 2009

    Hello! It has been a while since I have been on the site and gave up trying to find others in the trial. I am so happy you started this thread! My Onc is the one that brougth this up to me, he was and still is very excited about the drug. I have been on the pills since May and so far, it seems to be doing it's job. The first set of tests after taking Neratinib for 6 weeks showed the mets (I have several small spots in my lungs) shrunk in half, after that, there was no change but I guess I am OK with that as long as they do not get bigger or spread. I am also Estrogen + and have no doubt if I were able to take something with this (Faslodex etc), it would kill the rest of nasty the SOBs off! My Onc said I can stay in the trial as long as it keeps working and I will be happy to do so! The stomach problems have subsided a bit but it does still flare up once in a while but that is usually after I eat something spicy, fried or dairy (not very smart but sometimes I just can't help myself) but other than that, I have had no other problems. I am looking forward to hearing about all of your success stories and wish you all the best!  

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  • KristyAnn
    KristyAnn Member Posts: 793
    edited November 2009

    Hi Vicki,

    Glad you came back- how long did it take for the stomach issues/diarrhea to settle down? Im in the new trial for Stage 1 and 2 women and ended up on IV potassium yesterday because of the severity of the diarrhea.

    Kristy

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  • RebeccaAnne74
    RebeccaAnne74 Member Posts: 6
    edited November 2009

    I'm IV HR2+ and this is the trial Doc told me about yesterday.  In my particular area, it's not a blind study.   I have my Muga on the 13th to make sure my heart is up to it.   I am hoping to get in.

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  • KristyAnn
    KristyAnn Member Posts: 793
    edited November 2009

    Hi Rebecca,

    There are a number of neratinib trials going at this time- the one for Stage 3 and 4 has been open a while longer, the new one for the early stage women just opened this Fall and is a double blind study- Ive in my second month and my onc got me in pretty quickly once it opened up in our area.

    My potassium was 3.3 today so I was released back to my normal schedule- have to get it checked again next week on Thursday!

    Kristy

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  • vickib
    vickib Member Posts: 1,184
    edited November 2009

    Hello again!

    Kristy, I am so sorry you had to go through that! The diarhea is pretty bad in the begining, just make sure you drink plenty of fluids and eat potas. rich foods. Hopefully that will work. It took about 2 months for it to get better, I still go a few times a day and it is always soft (sorry if that is tmi) but it is not nearly as bad as it was. Did they tell you to stay away from dairy? That would get me every time!

    Rebecca, I hope you get in sweetie! I will pray for a good MUGA.    

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  • my2boys
    my2boys Member Posts: 339
    edited November 2009

    Hello Ladies,

    I set up the meeting with the doctor for December.  I plan to start at the end of January since I wanted to take a short break from meds for a bit.  I had all of my records transferred to the doctor and they mailed me a pile of paperwork and a consent to fill out.

    I'm a little concerned about the liver toxicity.  Anybody know anything about that?

    Looks like I will be on board after the holidays!

    Anne

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  • KristyAnn
    KristyAnn Member Posts: 793
    edited November 2009

    Thanks Vicki,

    Things are starting to get better- what I described as "managed" to the nurse- not Controlled by a long shot!

    I had my yearly Gynecological exam this morning and all I could think about was not having diarrhea during that LOL!

    Kristy

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  • vickib
    vickib Member Posts: 1,184
    edited November 2009

    Wow, you are a brave girl going to the Gyno! Smile I just told my Husband what you said, we both chuckled.. Not at you but just the conversation in general. You will be thinking about and talking about pooping more than you could have ever imagined. Right now it is hard but hopefully soon, you will feel better. I have had several occasions on my way from work where I did not know if I would make it so I would have to unbotton my pants and run into the house (knock on wood) I made it.. That is all we talk about during my Dr. appointments! How many times a day blah blah blah.. I hope you do not think I am taking this too lightly but to me, laughter is the best medicine and has really helped me through all of this. Also, I started taking my pills around lunch time, it seemed to work best for me so I would be home when the worst of it hit. 

    Anne - I am not sure about the liver, seems with any of the meds that are offererd, there is always something that comes with it. Sorry I can not help you with that but I will check my paperwork. if there is anything else I can help you with, please let me know.

    Have a good night ladies!

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  • yellowfarmhouse
    yellowfarmhouse Member Posts: 279
    edited November 2009

    HI all,

     How did you get into the early stage clinical trial?  Did you email wyeth or did your onc get you connected? 

    I'm interested if I can find a site near my home.  Any idea if someone dx in '05 would qualify?  I had chemo, rads, Herceptin for stage 3a with 4 positive nodes. 

    Thanks,

    Wendy

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  • k4katz
    k4katz Member Posts: 240
    edited November 2009

    I am on Day 7 now.  No diarrhea or any other side effects to speak of!  Maybe I am in the lucky 15%, or maybe I got the placebo.  I guess I won't know for sure until next November! 

    Wendy, I emailed Wyeth to get the number of a study site near me.  I did call my onc to let him know what I was up to, but other than that I have been working with the staff at the study site.  I believe that you need to be within 2 years of your last herceptin treatment to qualify.  I just made it under the wire as my last herceptin was in December 2007.

    Kristy, sorry to hear that you have had such a hard time of it!  Hopefully the worst is over and it will start getting better from here.

    Rebecca, good luck to you, I am hoping you get in!

    Vicki, I am so glad that it is working for you! 

    Anne, sorry, I don't know about liver toxicity.  Definitely discuss with the doctor.

    *Hugs*

    Kristin

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  • suemed8749
    suemed8749 Member Posts: 1,151
    edited November 2009

    I talked to my onc's nurse practitioner today. She didn't know anything about the study, but she called me as I was driving home, and it turns out that my onc is actually going to be an administrator for this trial. She gave me a contact number (actually, she said that contact would probably be calling me). So I may be joining you soon.

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  • KristyAnn
    KristyAnn Member Posts: 793
    edited November 2009

    Vicki,

    No offense taken- Ive started marking how many times a day in my diary so hopefully I will notice if there is imporvement LOL. I tae about 3 Tablespoons of mac anc cheese last night after weeks of NO dairy and it was a mistake- back to NO dairy I go!

    In my case, my oncologist nurse called me to go into the office to get on ther trial- I didnt even know about it!

    Kristy

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  • Gayleebug
    Gayleebug Member Posts: 166
    edited November 2009

    Hi all

    I was (and still am) considering joining the trial.  I was the first person in my area to contact the local coordinator and get preregistered (in August).  At the time the coordinator said she hoped she would get the go-ahead to start the trial in late Sep or early Oct but I never got a call back saying it was starting.  In the interim, I decide to go ahead with reconstruction in late October and my ps strongly advised against participating in the trial until I was fully healed from the recon.  She was worried the Neratinib could interfere with the DIEP free flaps "taking" or healing properly.  Sooooo ... I guess I will wait maybe 6 months from now and see if I'm still eligible.  I really really really want to do this!!

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  • KristyAnn
    KristyAnn Member Posts: 793
    edited November 2009

    Well my potassium was down again yesterday- but only to 3.1 so I didnt have to get an IV- just take Potassium tablets once a day and also Magnesium tablets twice a day- to try to keep me in balance. Only problem is that Magnesium can cause diarrhea- well that one made me laugh!

    Go back next Thursday for another Potassium/Magnesium checked- hopefully I will be like Vicki and get this a little more stable by 2 months (that would be December 7).

    Going to Beavers Bend this weekend- skipping the Mg tablet on Saturday since I dont want to ruin my weekend running to the potty!

    Kristy 

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  • vickib
    vickib Member Posts: 1,184
    edited November 2009

    Oh Kristy! I am so sorry about all of the problems you are having, it will get better!

    Are you still feeling OK Kristin? I hope you are in the 15% as well!

    Rebecca - Any news on the MUGA?

    Anne - I have not had a chance to check my paper work.. It may take a while to find the info on the liver. 

    I hope you all have a fantastic weekend!

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  • meco
    meco Member Posts: 20
    edited November 2009

       Wow what a pleasure to have come across this site. I am also starting a trail for Neratinib for early stage breast cancer. I qualified and meet with my onc on Tuesday. Tests for Muga etc being set for Thursday (we hope). I'm a little nervous about the heart having been on Herceptin and AC. Sounds like you know what drug you're on if you get diarrhea. Wow Kristy seems like no fun at all!!! Anything you guys can share would be greatly appreciated.   Thanks.

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  • my2boys
    my2boys Member Posts: 339
    edited November 2009

    Hi Everyone.  I am following each of you and I am hopeful that I will start in January.  I told the doctor that I wanted to take a short break from meds.  I had my last Herceptin 2 weeks ago.  I must confess that I am a little worried about the diarrhea issues, but its just something I will have to deal with.

    Thanks for your input Vicki.  If you find out anything about the Liver, let me know.  In the meantime, I will question the doctor when i see him in a few weeks.

    Have a lovely evening everyone!

    Anne

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  • anitach
    anitach Member Posts: 191
    edited November 2009

    Hi All,

    I met with onc. last Wednesday and they restaged me to IIIC due to the mediastinal nodes not being biopsied at diagnosis. The doc. said they would like to give me the benefit of the doubt since I responded so well to treatment originally! So, I will go on the 24th go get bone scan, CT, MUGA, echo, and labs drawn. The onc. is hopeful that I will be able to start the neratinib (or placebo) sometime in December. I also have an appt. with my PS to schedule getting my nipples reconstructed. The onc. said that the surgery would not impact my participation in the trial at all but does anyone know if the PS will be willing to do the surgery if I am on treatment? I had the TRAM flap done in July and would really like to get everything "over with" as far as that is concerned!

    Kristy Ann, I really hope you get your potassium leveled out soon!! Thinking of you....

    Anita 

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  • KristyAnn
    KristyAnn Member Posts: 793
    edited November 2009

    Hi Everyone,

    Well the bloodwork last Thursday had my potassium at 3.1 which was low and LOWER than it was after the IV and 3 days of potassium tablets SO now Im on 1 potassium tablet a day (in the blender in my morning smoothie) and also 2 Magnesium tablets a day- well I am supposed to take Magnesium tablets a day but guess what- they cause diarrhea!!!!!!!!!!! I didnt take them Sat or Sun because we were on  a retreat at beavers Bend, Oklahoma but I am back on them today. I am also eating foods high in potassim and Magnesium in an effort to get this all back on track. Fortunately I like the potassium and magnesium rich foods and they are generally very healthy- I also noticed that my protein powder (Isopure) is high in potassium and magnesium.

    I go back this Thursday for another blood check on my levels- fortunately I actually feel great which makes it a little easier dealing with these side effects and my onc is so excited thinking that I am on the real drug that she is VERy encourgaing and supportive- so that helps!!!!!!!!!!

    I think I am in the unusual group on side effects also- I think it is around 85% get diarrhea but not that many have it to the degree I am fighting.

    Kristy

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  • k4katz
    k4katz Member Posts: 240
    edited November 2009

    Oh Kristy, I am sorry that you are still having to deal with this!  Glad you are feeling OK though and you sound very upbeat so that is good!

    I still do not have any side effects.  I talked to my study nurse about that and she was not so sure that I was on placebo.  She said it really is possible that my body just tolerates the drug well.  I am not so sure, but I guess it doesn't really matter since I will just keep taking the pills every day until next November!

    Kristy, keeping fingers crossed that this all resolves for you really soon!

    *Hugs*

    Kristin

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  • KristyAnn
    KristyAnn Member Posts: 793
    edited November 2009

    Kristin,

    15% dont have the side effects at all and then most dont have it like I do- so Im in the other end of the spectrum. My study nurse has another patient that they think is on the drug and she went from 1 bowel movement a day to 3- so she falls under the side effects but nothing like what I am having! Mine is so over the top that they are pretty sure Im not on the placebo but Im also an extreme case. I also reacted like this to TCH and ended up in the hospital after chemo 1 with neutropenia and low potassium. Diarrhea is not the only side effect and I dont have any of the other ones listed- so that is wierd too- I figured I would get them all when this hit LOL.

    The magnesium supplement seems to be causing a lot of its own issues- Im going to try to eat A LOT more magneisum and potassium foods to see if we can do without the magnesium capsules. The potassium tablets dont bother me so those are doing OK. ....And I just thought I was a label reader before this LOL!

    Thanksgiving is coming and I am thankful that I have this medicine as an option, that my mammograms were able to detect that nasty little tumor before it was any worse, thankful for Herceptin and thankful that mashed potatoes and sweet potatoes are high in potassium!!!!!!!!!!!!

    Of course I am also thankful for amy family and friends (online and in person), my wondefully supportive hubby, and lots of other things.... Anyone else want to chime in with some Thanksgiving thoughts?

    Kristy

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  • Estepp
    Estepp Member Posts: 6,416
    edited November 2009

    I spoke with my oncologist yesterday about this trial, as I just ended Herceptin. He is NOT recommending me for this.

    He said with me doing AC chemo... Rads over the heart... Herceptin.... the toxicity, to the heart, is just too big a risk for me..:(..even though.. right now... my heart is fine..

    Anyone else do the AC and STILL getting advice to do the trial?

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  • AmyIsStrong
    AmyIsStrong Member Posts: 1,755
    edited November 2009

    Just called and left my onc a msg on this to see if I might be a candidate. Very interesting. I will finish Herceptin in April. I wonder if the trial will be full by then.

    Also can you do this while on Tamoxifen?

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  • my2boys
    my2boys Member Posts: 339
    edited November 2009

    Does anybody know if the heart toxicity is reversable, like with Herceptin?

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  • KristyAnn
    KristyAnn Member Posts: 793
    edited November 2009

    My onc said they are not seeing much heart toxicity with this drug but are monitoring it closely through the studies - Im thinking they are not really sure in this area with the drug!

    Kristy

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