Neratinib Clinical Trials

Kristy, glad to hear all is well so far!  I will keep my fingers crossed for you!

I received information from the clinical trial location near me.  I will have to switch oncs if I participate in this trial, since they will need to see me at this cancer center instead of the one I have been going to for the last 3 years.  I am OK with that, so I am going to call today and get the ball rolling!

*Hugs*

Kristin

Hi Kristy, sorry to hear about the diarrhea!  I guess that means you got the neratinib, not the placebo!  Is the immodium working?  Are you experiencing any other SEs?

I have a meeting with the clinical trial office in my area today.  If that goes well, we will set up an appointment with the study onc and get all the tests scheduled.  So, more to come!

Kristy, keep us posted!

*Hugs*

Kristin

I met with the clinical trial lady yesterday afternoon. I signed all kinds of papers, so now it is just a matter of them acquiring and reviewing my medical records (to make sure I really do qualify) and then I have to get a few easy tests done (ECG, chest x-ray, bloodwork). If all that comes back OK, I will be in the study! Plus, I still get to see my regular onc as well as the study onc! I feel better with all these doctors checking me out periodically!

So, right now, I just have to wait until they review my records.  I have a tentative appointment set up for 10/29.  If they review my records and all is still OK, I will have the physical exam and bloodwork done on the 29th, and they will also give me the scrips to have the ECG and chest x-ray done.  If all does well, I should be starting around the middle of November!

I am planning on going on this too.  Would like to join in on this discussion. I am finished with herceptin as of Aug 09.  I am scared stiff that things will come back.  I had a PET scan that showed a small something on my right side a week and a half ago.  I then had a follow up ct scan and bone scan. Both of these came out normal.  I cannot repeat the PET scan until Jan. However, she said I could start the Neratinib when the trial opens here. She does not think my spot is anything to be concerned with but...I am.  Has anyone had  a simular experience??

Corinne

Welcome Laura and Corinne- I need company on this trial. I am almost 2 weeks in and other than constant diarrhea, I feel fine. I don have a little bit of queasy stomach and am experimenting to find out what to eat when I take the pills- they tell you to take them in the morning and take them with food. I take Immodium as needed since diarrhea is a daily thing - hopefully my body will adjust soon- the research nurse said it usually does within 2-4 weeks of starting- AND it looks like I am getting the real drug since I have the strong side effects.

Kristy

Hi Everybody,

I am getting really excited about this trial and hoping to join it soon as well. Little history as you may be confused by the Stage IV dx in my signature. I was dx in May '07 with Stage IV due to a mediastinal node that lit up on PET. I had 3 rounds of Abraxane, Cytoxin, and Herceptin and then showed up NED on follow up PET. All signs of cancer.... GONE! I finished out 5 more rounds of Abraxane and 2 years of Herceptin and have remained NED this whole time. I made the very difficult decision this summer to have a double mx with immediate TRAM reconstruction. I did this at Vanderbilt University hospital in Nashville. The surgery was very successfull and I am so grateful to God that he led me in that direction. Despite the clean PET and a clean breast MRI right before my surgery.... they found a 1 cm "spot" of DCIS in the right breast.

Anyhoo, short story longer, I met with a new onc. at Vanderbilt and she mentioned this trial. She said that given my response to chemo and Herceptin they would like to restage me to 3. Also because they never biopsied that node to get a definite dx. Obviously I am beyond thrilled by that! I am 2 hours away from Vanderbilt so I tried to arrange to get into the trial through my local onc. He told me he could work with Vandy on the trial but so far he has done nothing to get me in.

So I took it upon myself to call the trial Onc. yesterday and we are now playing phone tag. Please keep your fingers crossed that I will get in this trial. Being that my staging is so sketchy I am scared to death of doing nothing.  

Anita

Neratinib is orally administered- right now you have to take 6 little pills to get the 240 mg dose but they are apparently working on a single tablet that should come out during the study. The current pills are very small so taking 6 really isnt a problem.

IMHO, they are NOT KIDDING about the abdominal cramps and diarrhea as side effects- they are both intense. I changed my med time this morning to a later morning with more on my stomach (instead of first thing in the morning with a very small food volume) to see if I have less of the cramps and diarrhea- otherwise Immodium and Pepto tablets are going on my walmart list because I will run out taking so much of them!!!!!

 Kristy

She didnt share specific articles and what I have found has been on reviews on the trial websites!

Kristy

Hi Mountains1day - your pathology is very similar to mine - I was also diagnosed in February of 2008 . My tumor was about the same size as yours but it was only a grade 1 (well differentiated). My Her2 status was 4.5............I had a year of Herceptin which ended in April of '09...........so I guess I could consider enrolling in this study except, like you, I wonder if it's worth the side-effects since my risk for recurrence is already so low (my onc said I only have a 7% risk now.) My onc didn't follow normal chemo protocols for me........I never had any of the Taxol's, but instead he  put me on a "light" chemo, Navelbine, every two weeks for 4 months, with the Herceptin which continued for a year. What chemo did you get with Herceptin? I am always nervous that the Navelbine wasn't strong enough........although my newest onc is the third one to tell me it was fine - there was some Finland study showing that Herceptin given with ANY chemo is effective. 

Anyway I wanted to thank you for posting this info about the study - and wish the women good luck who are going to be enrolled!

Lori, there are studies in Europe showning that 18 weeks of Herceptin is enough. There is even the FinHer study that tested using just 9 weeks of Herceptin. My onc told me not to worry if I had to quit Herceptin early (though I ended up doing fine on it and she had me take the whole year). Unfortunately, there isn't any head to head study of 1 year vs 18 weeks (or there may be a small one underway but I haven't found any results from it. So we don't know if there is some advantage to getting Herceptin longer but it probably isn't much of a difference and you've had 6 months.

Kristy Ann,

If you don't mind me asking, how did they know your intramammary node was positive?  Did they remove it?  With my tumor, also less than a cm, also high HER2+, they only removed the sentinel node which was negative.  The oncologist just told me that it was possible it could be in an intramammary node because it was in the inner portion (right in the cleavage area) of my breast.  I guess inner tumors can tend to drain centrally rather than axiallary?  They also didn't do a Ki67 on me.  I think they didn't do anything else because the onc basically said that with what I had, it really didn't matter whether it was stage I, II, or III, it would still be the same treatment.  She didn't even really give me an official "stage" on my reports, although, looking through all the criteria, it should be stage I (unless the intramammary node was infected.)  I guess I'll never know.  Please share any more of you experience.  It might help with my peace of mind!

weety911 and Brenda,

I had a mastectomy - I had one area of IDC that was < 1cm and another area of DCIS- on opposite sides of the breast. The IDC was located on the outer quadrant and the DCIS was near the nipple. The positive IM node was found by the pathologist after the mastectomy- so completely unknown at the time of surgery and the sentinel node biopsy. They only took 1 sentinel node- was negative during surgery so the rest left alone. Because of the Positive IM node I had chemo and radiation. My Ki67 was also 70%. I am only 6 months out from my last Herceptin so I was eligible for the trial and my onc highly recommended it- she is so excited about neratinib!

I was Stage 1 until they found the IM node and they changed it to Stage 2- there is some controversey about those IM nodes when they are positive- and my oncologist went the more aggressive route since I am also still in my 40's with young kids. Having the radiation after a mastectomy was also a somewhat controversial choice and the radiologist told me that some doctors would disagree with his recommendation.

I talked to the research nurse today and we are going to try to treat the diarrhea a little more aggressively and see if we can get this thing to settle down- the good news is that it appears I am on the real drug and not the placebo! I bought the 48 gel cap pack at the drigstore this weekend and my 17 year daughter thought that was a hysterical thing to carry around in my purse!

Feel free to ask any more questions weety- you can send me a private message or ask them on here- I try to check in most days (weekdays anyway) since I run around a lot with kids on the weekend.

Kristy 

Kristy

Thanks orange1. I'll call them tomorrow and see what they say.

I am confused about the IM nodes, I had a ct scan right after dx that showed up negative would that have shown whether or not I had a positive IM node.

My ki-67 was 16%, I am thinking about the trial in January, but my Onc states Herceptin should have taken care of my situation, no nodes, no LVI, however very aggressive tumor and I am not sure about IM nodes???

Weety 911, they may not have sent your tumor out for FISH testing (to determine copy ratio).  Since you were 3+ you are considered positive and eligible for Herceptin.  It wouldn't make sense to test your further for 2 reasons: 1. cost 2. avoid conflicting results.  the ICH test (that showed 3+) and the FISH test (that shows gene copy number) agree in about 95% of the time for tumors that are ICH 3+.  If for some reason the two tests did not agree, and you had a low gene copy number, your insurance company could have tried to deny you Herceptin.  This would be terrible because in at least 1 study, H has been shown to help improve odds for ICH 3+, even in the absence of a positive FISH test.

Typically ICH 2+ tumors are sent for FISH testing because for these tumors, ICH and FISH results are consistent only about 25% of the time.  Some instituitons may do FISH testing only(and not do ICH testing), because it is considered more accurate (but is more expensive).

Brenda - good luck - let us know how it goes.