Neratinib Clinical Trials

Hi, Friends; I was randomized for the trial today and got my first dose!  I've been reading about your experiences for a while; I had to go through a number of tests and scans to meet meet the inclusion criteria.  So even if I get the placebo, I got a chest and abdomen CT and a Bone Scan, and now I know what I don't have after all my treatment.  

I just wanted to introduce myself. I was diagnosed in June of 2008:  Stage 2a, Grade 2, IDC, DCIS, ILC, LCIS (all in one tiny little tumor). Er+, Pr+, Her2+, 1/14 nodes, Bilateral Mx with no recon.  AC/TH and 2 years of Herceptin. 

Thank you for all the informative posts, you all helped me decide to participate and helped me have a conversation with my doctor.  My onc office is a trial site with 8 patients and they have asked for more. 

Warmly,

Cathy 

Hi, Kelly; thanks.  I had the oncology office notify my insurance company and we followed up with a confirmation letter.  I learned yesterday that scans and imaging are not normal for the protocol; I apparently got those because of my family history and the nature of my tumor (mixed).  So I regard it as a bonus.  The material says that you get those if you present symptoms or your bloodwork is not normal, before they let you in.  You do have to have a chest x-ray.  

Warmly,

Cathy 

I had CT of chest and abdomen as well before I started. I had normal blood work and no recurrence symptoms. I didn't have a bone scan though. I don't think they would bother with the scans in node negative patients.  They are not enrolling node negative patients in the study anymore.  I enjoyed the loss of appetite the first couple of months (lost weight)  but I'm not noticing that side effect anymore.  

Hi, Sue and other friends.  I got the second year of Herceptin because I asked for it, I think.  I came to the end of my first year and told my oncologist that I didn't think I was quite finished, that I had a huge lymph node and did not have radiation (I had only one node but it was 2cm), and that was willing to do another full year if it was available.  He said okay.  That was it.  I kind of thought there would be push back from somewhere, so I asked about this trial back then.  He said that with the Herceptin, I knew what Id be getting, but with the Naratinib, I'd be randomized. so the Herceptin was better for the moment.  When I was done, they asked if I wanted into this one and I said yes.  

I am on my 4th does and I don't know if I have drug or placebo.  Day one I had sort of a tummy thing but we had eaten out the night before and I sometimes react to richer food than I'm used to.  However, nothing the next day.  Now, on the 4th day, my aches and pains are much worse--back to the world of Arimidex.  I had alleviated most of that with a switch to Femara this past summer, but I noticed it's back suddenly.  My doctor said that with some women, the se's are immediate, with others, it's within three months, and the biggie is the diarrhea.  I'm not that kind of girl--iron tummy all the way.  I was hoping for the loss of appetite.  Nope. 

I'm glad you all are here to share this with.  I said before I'm cool with either the placebo or drug; I just want the attention!  I believe in early detection as the only way to go. . .

Warmly,

Cathy 

I am considering joining this trial, and have some questions.  I have already met with the doctor running the trial, and she said "this trial was made for you", so I assume I qualify.  I asked if it were possible to get a placebo, and she said no.  Everyone in the trial gets Neratinib.  I've followed this thread off and on since learning about the trial, and it seems like most of you are randomized.  I would not join this trial unless I knew I was getting the drug because Lapatinib is another option for me.

Also, I am scared of the side effects.  Mostly I am scared of nausea.  I think I could handle the diarhea as long as I could control it with meds.  I guess you don't know if you are going to be one of the ones with bad side effects until you try it huh?  I do like the idea of paying it forward.  I might be willing to at least give it a shot.  If it's really bad and effects my quality of life too much, I can always fall back on Lapatinib.  On the other hand, if I take Lapatinib, and it doesn't work, I am automatically disqualified from doing a Neratinib trial.  

Congrats on finishing the trial KristyAnn!  Thanks for the info about the trials.  The trial they that was suggested for me was for women who did neoadjuvent chemo and had residual cancer with positive nodes.  That fits me to a T.  But, I read through the paperwork last night and it does say you could get a placebo.  The doctor told me I would definitely get the real drug.  I emailed her to clarify because I won't do the trial if there is a possibility of placebo.  Especially since I found out yesterday that my insurance company will pay for Tykerb.  I've heard Tykerb has some diarhea issues too, so I guess I'd better get used to the idea!  I've always had constipation issues, so this will be new for me!

Kelly - I just got an email from the doc on the Neratinib trial, and she confirmed that there is a placebo arm, and I wouldn't know which arm I am randomized to.  She said that since the side effects are so bad, I would know within a week or so if I am on the raal drug or not, and if I am not, I can drop out of the trial and go on to Lapatinib with Herceptin.  She wants me to stop my Herceptin in January to start the trial, and I am not supposed to finish Herceptin until mid June.  I don't like the idea of that at all, but am reserving judgement and decision until I meet with Dr. Slamon on the 22nd.  I can't start any new treatment until after rads anyway.

As for Lapatinib, I was told the same thing you were.  That I couldn't get Lapatinib outside of trial since I am not stage IV.  But, my insurance approved it within 24 hours of request.  I had heard that it is approved for early stage if given with a chemo drug (can't remember which one), so I called my insurance company after getting the call from my onc's office that it had been approved. I verified that there are no restrictions, and my copay is $50 per month (it costs about $3500/mo if paid out of pocket).  So, I don't know if it's a fluke, or if I just have really good insurance, but I am thankful either way!

Good luck Kelly!

Kelly - Thank you for that information!!  I knew Lapatinib and Neratinib addressed additional receptors, but didn't know the details.  It's good to know Neratinib would address the same receptor as Herceptin in addition to the others.  I didn't know that.  We'll see what Dr. Slamon says. 

My feet are killing me.  I have no diarrhea, no stomach stuff, but my feet hurt, not just when I am standing on them, but during the night, and on top as well as the bottoms.  I left Taxol in January of 09 with just a tiny smidge of numbness behind my toes.  Now it extends along the sides of both feet and the balls of both feet.  I explained to my husband that I stepped on a nickel and it stuck to my foot--I heard it on the hardwood floor, but didn't feel it.  That's new.  

I also have new hot flashes.  I had almost left those behind but they started up again and they are a bit longer and more intense, and are followed by chills.  Even outdoors (it's till warm here in FL).  

By tomorrow I'm going to call the research nurse.  Anyone else have tingling/numb feet?  Hands are stiff and achy but not numb and not tingling.

Thanks,

Cathy 

Hi, Kelly; thanks for your kind thoughts and good ideas.  I called the research nurse and she is going to check with my doctor and the study doc (at their practice).  She was noncommittal and said he might want me to see a neurologist and confirm the extent of the SE, if it is an SE.  The don't assume anything, I guess.  On my home journal I noted the neuropathy for the first time only five days after starting.  

It's not horrible but I want to find out how reversible it is. . . . I called them to ask for a vitamin supplement, like B12 or something, but haven't heard back from them yet.

I also find I am unusually cranky so I might be either really fatigued or in more pain than I realize.  But I now completely believe I got the drug so I'm happy.  Most of the time.

Warmly,

Cathy 

Well everyone I finished on Thursday and had my last muga yesterday. All in all it went fast and was pretty painless. I wish everyone remaining on the trial and those to come "run free days, solid bm's and dairy all around ". Seriously, as I said to my trial Dr., if I had to sum it up, my main SE's were loose bowel, ringing in my ears, and some headaches. Toward the end, dry skin and foot cramps. I know we won't find out our status for at least 2 years but it was worth it. Good luck ,good health and happy holidays.

Mare

Dear All,

Just received a call from doc saying to sign an addiitional agreement due to new results of neratinib on the liver, She said  I could go see the announcement first before I sign the docu. by Dec 14.  Nurse would not disclose further info.

Anybody inforned of the same on this board?

I started in April this year and might be on placebo since not much effects.

Cheers!

Ipohgirl 

Hi ipohgirl - I've been on the trial since January - like you, I might be getting the placebo since I've had few side effects - but the recent posts regarding ringing in the ear and foot cramps have me wondering since I've definitely noticed both of those. Didn't even think to relate them to Neratinib until I read about them here.

Anyway - I don't know what liver results have been seen, but I had to sign a new consent form (September?) and have a blood draw to check my liver enzymes. Am scheduled for another blood draw in about two weeks.

Best wishes to all!

I had my first follow up visit yesterday and they think I'm on the drug.  Foot neuropathy, major major hot flashes, change in bowel habits.  I'm not usually symptomatic; I tend to breeze by stuff, but I noticed "different" different about a week after declaring that I surely got the placebo.

They did extra liver checking and extra bloodwork.  But I go back the end of December and after that it's every three months I think.  

leighannmarie--the hand thing is a little like lymphedema, now that you mention it.  When I went for check-in yesterday the p.a. was all over my right hand (did not have nodes removed that side) and my watch was clearly leaving marks.  

I thought some of this was the Femara kicking in after five months or so of no Femara symptoms, but it is more likely the neratinib.

I guess this is great news. . . .

Cathy 

Hello, Ladies,

I had been following this study last year, but then was excluded based on no nodal involvemnet.  I'm just curious if there had been anymore (good) news about neratinib at the San Antonio conf this year???  I haven't seen anything, but I figured you girls would know.