Neratinib Clinical Trials

Options
13567…35

Comments

  • Brenda_R
    Brenda_R Member Posts: 509
    edited October 2009

    http://clinicaltrials.gov/ct2/show/NCT00878709?term=NCT00878709&recr=Open&rank=1

    Look up a trial site close to you and then email Wyeth and ask for the site information. 

    · Share on FacebookShare on Twitter
  • KristyAnn
    KristyAnn Member Posts: 793
    edited October 2009

    It is definitely possible ot have a negative sentinel node and a positive IM node- that was what I had and the ONLY reason I found out about the positive IM node was the good work of the pathologist who examined the breast after the mastectomy- it had not shown up in the mammogram or ultrasound that I had before surgery. I didnt have an MRI before surgery so I dont know whether that would have found the positive IM node.

    I looked at a lot of stuff after this was discovered and it is possible that the IM nodes DONT drain into the underarm lymph system- there is also the possibility that they would drain there. If the node is found before surgery there are some additional studies that can be used to see where it is draining but that didnt apply to me. The positive IM node was the reason they recommende both the chemo and rads for me- without it I would have been a surgery only patient.

    My onc said she sees positive IM nodes and positive lymph nodes together often but had never had a patient with a positive IM node and negative sentinel node- in fact, another onc in town wanted me as a patient for that reason- she was the one my surgeon recommended but I had to switch chemo facilities due to an insurance contract- which is OK because I got a top notch onc at the other facility.

     Talked to the research nurse yesterday and she is upping both the quantity of the immodium I can take and we are starting a proactive schedule with it for a few days to see if we can get this under control- I am happy for the weight loss I am getting with neratinib but this is  not the ideal weight loss method!

    Kristy

    Kristy

    · Share on FacebookShare on Twitter
  • mmm5
    mmm5 Member Posts: 1,470
    edited October 2009

    Hi All

    Called my breast center and IM nodes are most often identified during breast MRI at DX or with baseline scans. I had both so am not so concerned with IM nodes but that doesn't mean there wasnt a microscopic cell hiding out somewhere. I am curious as to what you all have found out about KI67 and it relation to LVI etc. This is one value I am a bit confused about and how it fits in to the whole puzzle.

    Are any of you experiencing any other side effects other than the nasty gastro issues?

    · Share on FacebookShare on Twitter
  • bluedasher
    bluedasher Member Posts: 1,203
    edited October 2009

    Weety, I had the ICH test as well so I don't have a gene copy number. My onc said that when the ICH is +3 with the lab they use and she has done a FISH, it was also positive. She said she would get a FISH to confirm if I wanted it but I didn't feel I needed that. My report said 100% for HER2+.

    I take some comfort in being so strongly HER2+ now that we have Herceptin - if any cells escaped the tumor the Herceptin should have gotten them. I'm not sure what the implication of my tumor being Grade 2 vs Grade 3 is - especially since I'm also hormone negative which usually means a more aggressive tumor. Were some other genes that they don't test for ones that make it less aggressive? Or is the grade, which is the result of a somewhat subjective look at the tumor slides, a less accurate test that doesn't mean much in my case?

    · Share on FacebookShare on Twitter
  • orange1
    orange1 Member Posts: 930
    edited October 2009

    My understanding is that grade is relatively subjective.  That is why patients were not were not stratified (sorted into treatment groups) by grade in the large Herceptin trials.

    Stratification was by:

    for B31: nodal status, planned hormonal therapy, type of surgery, intended radiotherapy and institution

    For N9831: nodal status and hormone-receptor status

    For HERA: region of the world, age, nodal status, type of chemotherapy and hormone receptor status

    For BCIRG: its not clear exactly clear, but it looks like they used nodes, hormone receptor status and tumor size.  Since the investigators didn't even report tumor grade, I think its safe to say patients were not stratified by grade.

    · Share on FacebookShare on Twitter
  • bluedasher
    bluedasher Member Posts: 1,203
    edited October 2009

    Lori, the study looking at 1 year vs 2 years of Herceptin is HERA. It also had an "observation" arm with no Herceptin. After 2005, they allowed women on the observation arm to "cross over" and get Herceptin because it wouldn't be responsible to deny them Herceptin. Many took that opportunity. They have released results of the 1 year arm vs observation but not on the 2 year. The most recent that I've seen is a slide set from March 2009 St Gallen.

    Almost 2/3 of those eligible crossed over. An interesting result is that those who crossed over had better DFS and OS than those who didn't which indicates that Herceptin provides benefit even when given late (but because crossover was voluntary and not randomized it is difficult to quantify the benefit).

    The slide set also says that after the review of the interim analysis at the end of 2008, they decided not to release results on the 2 year vs 1 year arms. My interpretation of that is that they haven't found that 2 years provides significant benefit. If they had, they would have published the results so people could start taking Herceptin for the longer duration. 

    Orange, that is kind of what I thought. 

    For BCIRG 006, they did use grade in one way - for node negative patients to enter, they had to be high-risk. One way they could be high risk was to be grade 2 or 3. Another was that they could be hormone negative. There were a couple of other criteria that could make you high-risk. It doesn't seem like a very high bar since HER2+ tumors are almost always grade 2 or 3. I haven't seen anything that indicates that they differentiated between grade 2 and grade 3. 

    For the HER2+ vaccine trial that is going on now, you also have to be node positive or "high risk" node-negative. In their case, high risk includes grade 3 or hormone negative or T2 or lymphovascular invasion or node micro-met.

    I guess any way they do it, it doesn't take much to be considered high-risk node negative with HER2+.

    · Share on FacebookShare on Twitter
  • weety
    weety Member Posts: 1,163
    edited October 2009

    Yes, I agree that grade must be quite  subjective.  My original biopsy came back with a grade 2.  By the time I got the mastectomy reports they had upgraded it to a grade 2-3.  Surgeon said we always go with the higher number.  I know my surgeon did order the FISH as well, because I remember seeing it on a vial that I had at the lab.  I can't seem to find any results for that, though.  I wonder what happened to them?????  Is the FISH test a blood test, or am I mistaken and it is done on the actual tumor sample?  I could have sworn I saw the vial that they drew blood into and it was a few days BEFORE my surgery!

    Bluedasher, besides my grade being changed to grade 2-3, I had a "weakly postive" ER status.  Again, no one ever explained what that really means, but my onc seemed to think that I would be put on tamoxifen anyways, more for the other breast than the affected one (because of my age and premenopausal status.)  I was breastfeeding at the time of diagnosis, so my estrogen would have been practically nothing.  But during the pregnancy a few months earlier, my estrogen would have been sky-rocketing.  I still wonder if this abrupt shift from lots of estrogen to almost none is what caused some of the hormonal receptors to change, or even  allowed the HER2+ to go out of control.  LOL, I could probably be a study case all by myself!

    · Share on FacebookShare on Twitter
  • Mountains1day
    Mountains1day Member Posts: 102
    edited October 2009

    Bluedasher - Thank you for that updated information on the HERA Trial. 

    I didn't know they decided not to release the results of Herceptin 1 year verses 2.  How else are we suppose to gather accurate information in order to make the right treatment choices?  If they haven't found any significant value than why not just say it? Because they don't want us to stop taking Herceptin? Profits? For those of us who are Her2 positive, node negative, less than 1cm tumors...there's just not enough data and it's frustrating to say the least.

    · Share on FacebookShare on Twitter
  • orange1
    orange1 Member Posts: 930
    edited October 2009

    Mountains, it is not as bad as all that.  

    From a desciption of the predefined study design:

    Enrollment of 4482 patients was planned to detect a 23 percent relative reduction in the risk of a disease-free-surivival (DFS) "event" (recurrence or death).  A total of 951 DFS events were required for the final analysis.  One interim efficacy analysis was planned after 475 events, with a significance level of P<0.001 required.  The independent data-monitoring commitee reviewed the data on patient enrollment, deaths, compliance and safety every 6 months and conducted the interim cardiac safety and efficacy reviews as preplanned. 

    This means they took an early look at the data after 475 events had occured (out of the 951 events requried for ending the trial).

    The 475 DFS events needed for the interim efficacy analysis were recorded on March 29, 2005.  The independent data-monitoring commitee recommended release of the results because improvements in DFS were highly significant, crossing the boundary for both the one and two year arms of Herceptin, as compared with observation (no Herceptin).  

    This means they stopped the trial early because the results were so dramatic that they were sure the results were not due to chance and that Herceptin treatment definitely reduced recurrence. 

    If I understand correctly, they will not release the results of the 2 year arm yet because the difference between the 1 year arm and the 2 year arm are not significant enough to justify early reporting.  That does not mean there isn't a difference, just that the difference between the 1 and 2 year arms isn't huge, like the difference between getting H and not getting H was.  It is rare that studies are stopped early because the results are so signficant.  We got lucky with the herceptin studies - results were so dramatic that there was justifcation for stopping the study early.

    If my understanding is correct, there havent been the required 951 DFS events yet, and the study will not end until that happens.  The bad news is that women coming after us won't know for a while if 2 years of H is better than 1 year of H.  The good news is that it probably means the rate of recurrences has fallen very low. If we've gone from 2005 to the end of 2009 without accumulating enough events to end the trial, this means that events have really slowed (or stopped) - women are not having many recurrances after the first few years.  Smile

    For comparision, the big Austrian zometa study that showed a 36% reduction in recurrence was not stopped early.  It takes a huge difference to stop a study early because investigators do not want to make the mistake of stopping early when the results could have been due to chance - thus generating incorrect results.

    · Share on FacebookShare on Twitter
  • bluedasher
    bluedasher Member Posts: 1,203
    edited October 2009

    I think I may have given the wrong impression Lori. They haven't said that they won't release the results eventually. They just decided that they wouldn't release interim results. I expect that they will release results when they have done the final analysis.

    Orange, is that 951 DFS events in the whole trial or the total in the 1 and 2 year arms? In the 2008 interim results they reported 458 events in the control arm and 369 in the 1 year arm. That's 827 events plus whatever events have occurred in the 2 year arm. 

    · Share on FacebookShare on Twitter
  • Mountains1day
    Mountains1day Member Posts: 102
    edited October 2009

    Thanks for the clarification Orange1-....I'm not "up" on the formalities of the way clinical trials operate but, I'm getting a better understanding here at this site.  I went into archives and realized all the valuable information about the HERA trial (like so many other worthy subjects) and so much has already been discussed, it's so wonderful!

    Bluedasher - Do you know when the final analysis date of the HERA study is expected to be? 

    For me, the thought of participating in the NERATINIB Trial (1 year more of protection) when I only had 6 months of Herceptin versus 1 year standard, seems counter productive.  Wouldn't I want to see if Herceptin is more valuable given longer first?  And, if this HERA concludes that 2 years is more valuable than 1 year H, I wonder if we would we be able to re-visit Herceptin to make up the difference?  Though, I agree with you ladies, by now, we would of heard something if it was significant.

    Lori

    · Share on FacebookShare on Twitter
  • Jaimieh
    Jaimieh Member Posts: 2,373
    edited October 2009

    Do you know if you can participate and stay in state if no one in your state has this trial going on ??

    · Share on FacebookShare on Twitter
  • magentagirl
    magentagirl Member Posts: 101
    edited October 2009
    Thank you for posting the website. My onc happens to be participating which I found out by contacting Wyeth and getting a phone number from them for the trial which happened to be the research arm of the onc I go to! So, that is good, although I worry what he will think of me if I don't do it. Someone was supposed to call  me today to spell out particulars but didn't. Plus you all are so smart-probably more so then who is going to call. i have two concerns. One is with the cost. I understand that Wyeth pays if one's insurance doesn't. But our insurance has a cap (I think it is a million) and I'm not sure I want to have three mugas and chest xray and what all on my tab, essentially shortening our coverage time. Also, I have very bad veins and only one arm to use and I am nervous about all the extra sticks for the MUGas and blood work. as I recall, for each MUGA they have to stick you twice. Do they have to stick you for an echo? And is it okay to have that instead of the muga? I would appreciate anyone's input on this. Thank you ahead of time. Now I am going to see Where the Wild Things Are.
    · Share on FacebookShare on Twitter
  • magentagirl
    magentagirl Member Posts: 101
    edited October 2009

    I just found out I am not eligible because my IDC tumor was too small. However, my DCIS tumor was the size if a "hockey puck". Does that mean that the DCIS does not express Her2? Only the invasive tumor does that? Just wondering.

    · Share on FacebookShare on Twitter
  • robyn33
    robyn33 Member Posts: 99
    edited October 2009

    I wonder the same thing, Jaimieh.  I live in MN (no trial sites) and consider traveling to South Dakota.  It would be nice to be able to be part of the study without having to go so far.

    · Share on FacebookShare on Twitter
  • weety
    weety Member Posts: 1,163
    edited October 2009

    Magentagirl, I am very curious about what size your IDC tumor was.  I just received the information packet for this trial in the mail today, and am seriously considering it (I still have to finish Herceptin first, though) but my tumor was less than a centimeter as well.  Maybe I won't be eligible afterall either!

    · Share on FacebookShare on Twitter
  • Mountains1day
    Mountains1day Member Posts: 102
    edited October 2009

    Magentagirl--In my study package, one of the procedures given to determine qualification is a Medical Review, to see if your tumor was erb-2/HER-2 positive.  You may be asked to sign a release to allow the study doctor to obtain a copy of the results.  It is to my understanding, that if they need to further test the original tumor, they would need x amount of slides and the smaller the tumor, the less amount of slides. I'm curious what size your IDC was too.

    · Share on FacebookShare on Twitter
  • KristyAnn
    KristyAnn Member Posts: 793
    edited October 2009

    Magenta Girl- what size was your tumor- mine was < 1cm also (9 mm) and I am in the study.

    Kristy

    · Share on FacebookShare on Twitter
  • magentagirl
    magentagirl Member Posts: 101
    edited October 2009

    Hmmmm. i was just going through all my records to find that info.  It seems that they only found the Invasive cells when they did the stereotactic biopsy and the only info I can see about the size of it is a note that I made that it was either 4 mm or maybe .4 mm. I will ask my onc when I go next week. They must have something that says more specifically. They removed my breast because the DCIS tumor was 5 cm, but then they found no invasive in that specimen. But as the pathologist explained to me, they don't test or look at all the tissue. So they had to go back to the stereotactic slides to test for Her 2 status which was +3.

    · Share on FacebookShare on Twitter
  • k4katz
    k4katz Member Posts: 240
    edited October 2009

    Hi everyone, I had an appointment this week to go over my records and get examined by the study doc.  Everything looks good so far and I just have to get an EKG, ECHO, and chest x-ray this week.  If all that looks good, then I am in! 

    Kristy, I hope your side effects start to fade soon!

    · Share on FacebookShare on Twitter
  • KristyAnn
    KristyAnn Member Posts: 793
    edited November 2009

    It will be 4 weeks on Wednesday and I am finally getting the relief from the side effects- not completely gone but MUCH more manageable!

    Kristy

    · Share on FacebookShare on Twitter
  • my2boys
    my2boys Member Posts: 339
    edited November 2009

    I'm glad you are feeling a bit better, KristyAnn.  I just finished Herceptin and I have been forwarding my paperwork to the Trial Doc to start the ball rolling.

    I have to go for the chest Xray, echocardiogram and bloodwork and then I will start.  I told them that I want to hold off for a month.  My body needs a break after this year.

    I will sign the consent in December and start in January.

    Thanks for keeping us informed of your progress

    Anne

    · Share on FacebookShare on Twitter
  • k4katz
    k4katz Member Posts: 240
    edited November 2009

    OK, I had my EKG and echo and chest x-ray yesterday.  Today I will meet with the nurse and hopefully get the medication and get started!

    Kristy, how long did it take for the diarrhea to start?  Just want to make sure I am prepared!  I am glad to hear that the side effects are starting to wane.  Have you experienced any other effects?

    Anne, I don't blame you one bit for wanting to take a break.  Plus, there is no real reason to hurry, right?  My clinical trial nurse said that they aren't any where near the 3800 participants they are looking to recruit yet.

    *Hugs*

    Kristin

    · Share on FacebookShare on Twitter
  • KristyAnn
    KristyAnn Member Posts: 793
    edited November 2009

    Hi Kristin,

    I had loose stools the day after I started but I thought it might be food related until about the 5th day- probably wasnt but it wasnt that bad so I didnt know- by the 3rd day after I started, I got out the immodium and by the 5th day I knew I had a serious diarrhea issue. Not everyone gets this but they say it is like 85%. I have a little bit of a reash on my hands- not sure if that is a side effetc or something else going on (I have allergies)- but nothing else.I have not had headaches which I have heard some other people say they got on the drug.

    I should say I also had terrible diarrhea during chemo (TCH) - I was trying to take 1 immodium at a time and I could not get control so I called my research nurse and she said to treat it like I treated it during TCH. My worst week was the 3rd week of taking it and I htink I topped out at 8 immodium in one 24 hour period for 3 days. Now I am managing with 2 immodium around dinner time.

    Terrible stomach cramps if you take it without enough food on your stomach- I tried taking it early morn with just a little food in me and it was bad so now I eat breakfast and drink my morning tea around 6-7 am, and take the med around 8:30 AM when I have had some food and liquid on my stomach- I usually eat a cracker or something small when I take it to put a little more cushion in there. I dont have the stomach cramps any more at all.

    I see my doc Thursday for the first month visit- only 11 more to go LOL!!!!!!!!!!!!!!!!!!

    Good Luck Kristen- keep us posted!

    Kristy

    · Share on FacebookShare on Twitter
  • k4katz
    k4katz Member Posts: 240
    edited November 2009

    Thanks for the info, Kristy!  That is definitely helpful.  I am glad your intestines are starting to settle down!  LOL!

    I got my pills and journal yesterday so today I will get started!  I am going to take them mid-morning since that is working best for you, Kristy.  I brought some crackers to work to take with them.

    At my appointment yesterday I had to fill out a little questionnaire on how I was feeling and my quality of life.  It took about 5-10 minutes.  Then the nurse did one last check of my lymph nodes and listened to my heart and lungs, and that was it!  I will go back on December 1st for my 1 month follow-up.  After that they only want to see me once every three months.  I have a 'diary' I need to fill out every day to record that I took the pills and describe any side effects I am experiencing.

    I will stop by tomorrow for an update!

    *Hugs*

    Kristin

    · Share on FacebookShare on Twitter
  • kim40
    kim40 Member Posts: 904
    edited November 2009

    Anyone know if this trial is available in Canada?  I'm on Herceptin until July 2010, but would love to particpate in something like this..

    · Share on FacebookShare on Twitter
  • KristyAnn
    KristyAnn Member Posts: 793
    edited November 2009

    Hi Kristin,

    I have the same journal - Im sure we all do! I put in my med time and have been putting how many immodium I take LOL- sometimes I put the time I take them too! My nurse will probably laugh at my journal tomorrow. We have to do the quality of life survey (on a little handheld) at each visit I believe.

    Pumpkin muffin mid morning with the medicine was good today.

    If you get side effects, try to manage them and hopefully they will subside within the first month.

    I dont know anything about the trial in Canada- might be able to find that online somewhere.

    Kristy

    · Share on FacebookShare on Twitter
  • weety
    weety Member Posts: 1,163
    edited November 2009

    Kim40, there is a link to the trial at the top of this page.  Click on it and scroll down to view all the study locations.  It also doesn't hurt to ask your center because I have found that my kaiser location participates in some of these trials, but they are usually not listed.  Plus, the research coordinator told me that they vote on new trials at the beginning of each month so even they do not currently participate, it could change by next month.

    · Share on FacebookShare on Twitter
  • suemed8749
    suemed8749 Member Posts: 1,151
    edited November 2009

    Thanks so much for this thread! I just emailed the trial coordinator. They are recruiting in Sedona, which is "doable" for me.

    Anything I can do to lessen the risk of recurrence is welcomed!

    · Share on FacebookShare on Twitter
  • mmm5
    mmm5 Member Posts: 1,470
    edited November 2009

    Sue

    They are also recruiting in Tucson through UMC, I am considering Jan trial!

    · Share on FacebookShare on Twitter

Categories