Neratinib Clinical Trials

gramma23

deenah, I am so sorry about your diag. As for the trial it is true you may get the placebo. I know there is another med close to that med that is not a trial. I would see if I could find a sure thing. MD Anderson is a great hospital but they only have the meds they have but possibly they have some other ideas for you. I have had friends that went there and some did good and some did not. My brother was in there one time also but they found his was not cancer at that time. Keep positive. Trust in God! I know you are scared and I would be also. I wish you the best and hope you find a good treatment plan that you know what you are getting and not wasting time doing a trial you may not be getting the meds you need. this is my opinon but I tried this drug and I was definitely on the real stuff. I think you can tell if you are and if you feel you are not you can quit at any time for any reason. Just a thought for you. I could not take it but you might be able to. Kristy Ann did and even though she felt kinda bad she made it.

My thoughts will be with you.

KristyAnn

Deenah,

Keep asking questions about all your options. I am on the neratinib trial and actually finish after TWO MORE DOSES- yeah!!! The side effects are tough- well they were for me- I actually ended up being dose reduced twice in order to even be able to stay on the drug. I have not had any heart toxicity or liver problems at the 160 mg dosage I am taking (which is 2/3 of the original dose)- I have heard others having problems with liver function.

They think I may be having some thyroid trouble currently which may be related to my original radiation- supposed to have an ultrasound this week so we shall see.

Anyway,

THURSDAY is my last day in the trial, Wednesday is the final MUGA scan and i can wait to eat ice cream for my birthday next week (its been making me sick all year in the trial so I gave it up)

Kristy 

cbm

Deenah--I saw your post and had to respond.  The women in my Onc's practice who were 3c have been on Herceptin for several years after chemo, surgery, and rads.  I have two friends whose cases sound a bit similar to yours and both had 4+ years of herceptin (one is a doctor and qualified before the trials were done).  After my first year I asked for either a second year or inclusion in the neratinib trial (thinking they would turn me down for year two), and my doctor told me to take the second year of Herceptin, the trial is double blind and you could get the placebo.  I just finished my second year and now I'm in the first step for inclusion in the trial--I go for Echo (no MUGA), chest Xray, and all the rest next week.  

Good luck,

Cathy 

Boo307

Wow your plate is very full, but you seem to have a good handle on proceeding.  Why are you focused on the Neratinib trial when starting it would be 1 to 2 years away? 

As to your question about the effect of Neratinib on the heart, I don't  remember seeing problems in the phase II trial.  I think they have us get MUGAs because apparently there is a close connection between HER2 protein in the heart as well as in the cancer, so they are very watchful to stay on top of any problems developing.

I have been on the trial for four months and it hasn't been a big deal for me.  I get a little diarrhea from time to time, and I consume all the dairy I want.  Remember you can stop the trial anytime you want if it isn't working for you and of course they would reduce the dose a couple times before you would even get to that point.

My research nurse was very reasuring to me when I started.  She worked with patients in the phase II trial and she said they are very aggressive in managing adverse side effects to minimize patient discomfort.  She is available to me any time, even answers emails over the weekend!

I don't understand why you have "mets" in your diagnosis line when you are stage IIIc. 

Keep up the great work and you truly understand that no one cares about your body as much as you do!

deenah

Thanks everyone!  I still have several opinions to get, but I'm just trying to weigh all of my options.  I am asking about the Naratinib trial just in case I don't end up doing more than a year of Herceptin.  Right now I am leaning toward taking the extra year if my Dr. offeres it (She is leaning that way as well).  I also may go ahead and add Laratinib to it. 

I have an appt on Monday at Stanford, November 5th at UCSF (with the Dr. wanting me to do the Naratinib trial) and on November 22nd with Dr. Slamon at UCLA.  After all of that I hope to have a good gut feeling about how to proceed.  I guess all of this research just keeps my mind busy so I don't think too much about the bad stuff.

Boo - I don't know why my profile says mets.  I'll have to change that.  Thanks for pointing it out!  Must have accidentally hit that button.

KristyAnn

Im finished!!!!!!

Boo307

KristyAnn,  congratulations!!!  Please stay in touch with us on this thread so we can know how you are doing.  Your very detailed, timely information has been a tremendous help to me on my journey.

Deenah,  I can't believe how 'on top' of your diagnosis and treatment you are.  You have definately gone to the source of the state of the art treatment options.  This publication may be of some help to you.  "Treating the Her2-Positive Breast Cancer Patient: Challenges and Controversies"

http://www.eoscme.org/assets/634009769018151966.pdf

Boo 

leighannmarie

Yay, KristyAnn!!! Congratulations!!!!  

Jaimieh

KristyAnn, Congratulations!!!  I was watching this thread thinking about joining the trial but I wasn't eligible by the time I was ready. 

suemed8749

Good job Kristyann! Enjoy the ice cream!

tarheelrivergirl

KristyAnn, Congratulations!  You deserve all the ice cream you desire...money should be no object! I have appreciated your comments on this board, thanks, and don't be a stranger.  I have 69 days til I'm finished.  I've been wondering "which drug next?"  Since I'm triple positive & node negative, I'm not sure if they will even continue to follow me as part of the neratinib study and/or how much they will follow me since I'm not the group they were initially including. 

morkmunoz

I just began the study last Wednesday and I'm pretty sure I got the "real thing".  Diarrhea began the second day of taking the meds.  I'm on daily Idodium, which seems to be working.  I'd love to talk to other women who are doing this study.  What symptoms are you experiencing?

I am a teacher and can't afford to have diarrhea for a year!  I hope it improves...

Sarah

tarheelrivergirl

Sarah,

I understand your work related concerns with SEs. I too work full time and was equally concerned at the beginning.  As you perhaps have already read folks in the trial have a wide range of experience.

For me, the SEs have greatly improved since the beginning.  Hopefully, they will for you too. 

During my first several weeks on neratinib I had moderate diarrhea a couple of times a day, but nothing that couldn't be controlled with over-the-counter meds. I've had little to no diarrhea over the past few weeks and I've got 68 days left. Fatigue, leg and foot/toe cramps and pain have been my biggest SE. I've dose reduced twice and have settled on 5 pills. Cutting back to 200mg has made this tolerable for me. The pain was worse at night, but a "little" ambien helped.  Someone else here best described it, as if she had worn "killer high heels." Also the tops of my feet were sore. My potassium was low, but has improved by taking a supplement. I also take a B12 shot, which has helped with fatigue. I get the B12 when I go in for blood work so I'm not making an extra trip.  I tried taking the B tablets, but it didn't seem to help at all.

Hard to believe its been 10 months since I started this trial. All in all I'm glad to have had the chance to be in the study. Good luck!

leighannmarie

Interesting what you said about foot pain.  When did this start?  I've been experiencing neuropathy like stuff in my fingers and toes.  I had problems with this on taxol but it had gone away so, I have been wondering why it is coming back.  Could be neratinib?

leighannmarie

Interesting what you said about foot pain.  When did this start?  I've been experiencing neuropathy like stuff in my fingers and toes.  I had problems with this on taxol but it had gone away so, I have been wondering why it is coming back.  Could be neratinib?

annamari

I also have been having crampy feet legs and hands.  I find keeping them warm help.  I believe it could be from the Neratinib.  I also had and still have some diarrhea.  I tried imodium but  it made me bloated I just try to control it with diet and not eat anything that aggrevates it.  I avareage 3-4 times a day.  Always look for where the washroom is whereever I go. 

congrats to Kristyann for finishing the trial.  and a very happy cancer free birthday. 

gramma23

KristyAnn,I am so happy for you. Please do stay in touch. My nurse said I would be watched for 5 years after I finished it but my onc has changed to another group so she was not sure what she would do but really I did not take it long enough to be a concern I think. I am happy for those who can do this. I did take an Imodium over the counter that helps gas and bloating in addition to diarrhea. It helped but that was not my biggest problem it was nausea and throwing up. I know I could not do that for a year. Exactly a week after I stopped the drug I had a black out spell at work but I never told anyone about it because I didn't think it had anything to do with the med since I only took it one day dose reduced. I think I had been off it for a week and then we tried it one day with one pill less and I threw up worse than I did on Taxotere.

I wish all of you the best.

tarheelrivergirl

leighannmarie,

I'm pretty sure the leg and foot cramps & pain, along with the soreness on the top of my feet showed up during the first month. I too had taxol & Herceptin, but that was about a year earlier; however, the leg & arm pain was similar to my experience with Herceptin. The cramping was new. The soreness kept me up at night. The literature does mention neuropathy as a SE. Seems like cranegirl, carykim & some others here have described the same sort of experience. I dose reduced twice each time going down to 5 pills.  Each time the pain & cramps went to "tolerable," but never completely disappeared. That's why I settled on 200mg.  Honestly, if it hadn't improved I probably would have quit the trial. Also, early on my nails took a beating and I would get cuts on my finger tips. My hair dresser swears that my hair has gotten thinner & the texture is a bit different. I haven't really noticed. I'm just glad to have hair back.

leighannmarie

Hmmm. Okay thanks Tarheel.  I have been on trial a little over a month.  My pain and stiffness is in my fingers and toes. Not so much on top of feet.  Did your doc say this is temporary or can it become a permanent issue if meds continued?  I had to reduce Taxol because my onc said it could do permanent damage. My right hand, surgery side, has the tingly neuropathy feeling.  I am a bit concerned that this may be beginning lymphodema.  I am also getting little nicks/cuts on my knuckles but, so far my nails are fine. 

tarheelrivergirl

leighannmarie, My doctor never said anything about temp/permanent SEs. I was one of the first in his group to go on the trial so I guess this was a bit of an unknown. The first time they cut me back to 200mg and the cramps & pain improved greatly; however, they were not sure that this was the cause.  After 10 days I went back to 240 mg and the SE returned. That's when he talked with the folks "on up the trial line." It was decided that I should stay on 200mg for good.  Maybe some of the others here on this thread will have more to say. 

KristyAnn

I had leg cramps during the trial also- I always thought they were from low potassium because I had severe diarrhea and reduced to 160 mg. They have been gone since I finished the trial- so not really sure whether it was neratinib or the potassium issue for me.

leisaparis

Hi ladies, I'm considering this study. I finished with Herceptin on Friday, the 15th. I have reconstruction scheduled for November 10th. They said if my insurance covers it, and all the tests come back ok, I can start after I heal. I called my insurance company to see if they will cover and they have to have paperwork on it sent to them. But they did say if this was considered experimental, then they didn't cover. So I got all that rolling. On one of the previous pages, I read about being able to do it even if your insurance doesn't cover. What would I have to do for sure if they will not cover? I am really interested in being in this study, since I am Her2+ with IBC. Any and all response would be greatly appreciated. Thank you in advance. Leisa

KristyAnn

During my time the study paid for the MUGA scans, radiology, EKG- all they filed on my insurance was my regular 3 month onc visits and blood work.

Kristy

Boo307

Has anyone run into confusion when having a MUGA related to the shortage of the medical isotope used?  I had it happen a couple of times and the technician couldn't really explain why there seemed to be a national shortage.  The problem is solved for now and here is the full story.  It seems that there is no US source for the isotope used for measuring the ejection fraction of the heart as well as some other procedures!  Our sources are in Canada and France.

"The shortage of technetium-99m (Tc-99m) that has plagued nuclear medicine departments for the past year should be coming to an end soon, because two reactors that are the largest isotope producers in the world have come back online as of early September.

Tc-99m is used in 80% of all diagnostic and therapeutic procedures that require medical isotopes in the United States. In oncology, Tc-99m has two primary uses. One application is in bone scans to identify metastases; the other is to measure the ejection fraction of the heart in patients who are receiving cardiotoxic chemotherapy. A small amount of Tc-99m also is used as a tracer in sentinel lymph node procedures.

The Tc-99m shortage was precipitated by the unexpected shutdown in May 2009 of the National Research Universal Reactor (NRU) in Chalk River, Ontario, Canada, after a heavy water leak. The shortage was compounded last February when the High Flux Reactor (HFR) in Petten, Netherlands, was taken offline for repairs on a cooling water pipe.

The NRU reactor went back online in August, and the HFR returned to production on Sept. 9. "The medical world has had to cope with serious shortages of isotopes and long waiting lists for patients. I'm happy and relieved that this difficult period has come to an end and that we can now focus on working hard to develop new production capacity," said Fred Verzijlbergen, chairman of the Dutch Association for Nuclear Medicine, in a statement."

See link for the full story http://www.clinicaloncology.com/index.asp?section_id=150&show=dept&ses=ogst&issue_id=674&article_id=16057

Boo

my2boys

Just checking in to see how you ladies are doing.  Kristy is almost finished?  Wow!  I see that beebusted is still on board too....hang in there.

I am done with chemo and I am doing rads...almost halfway finished.  I am on Tykerb which is kind of like Neratinib.  They just upped my dose to full since I am finished with chemo and I seem to be tolerating it fairly well.  Tykerb is only given for one year....I still have 8 months to go.  My hair is slowly starting to come back.....this has been a long road.

Glad you are all hanging in there.  Stay strong.

Hugs,

Anne

KristyAnn

I am finished Anne!!!!

cbm

leisaparis--Clinical trials and all the diagnostics, scans, surveys, treatments, drugs, and tests that go with them are paid by the drug company seeking to determine the efficacy of the drug being tested.  You shouldn't submit claims for any of that to your insurance company, and you have to be careful that they don't accidentally get sent there.  One of the best things about participating in the trial is the increased surveillance that you get, whether you have the drug or the placebo.  I got a bone scan and ct scan just to qualify me, that my insurance would have never paid for. 

I have to notify my insurance company that I'm participating in the trial (I get randomized next Wednesday after I get a note from my cardiologist, who has already said yes), because my insurance contract requires notification.  But at the radiology place I had to decline to sign the assignment of insurance benefits (because there are no insurance benefits; trials are fee for service between the overseer and the providers) and we had a brief exchange about what it meant.  I had them call the oncology clinic that is overseeing the trials because it's really important.

Best regards,

Cathy 

gramma23

All my tests and onc were paid for and my insurance never knew I was taking it. I did have a problem with the cancer center sending some things into the insurance but we got that cleared up. even my onc was paid for if I had to see him other than my regular visit. I did not get my Procrit paid for though. they wanted to keep my blood up so I got it every 2 weeks but now that I am not on the trial I get it every month and it is going down. I do not know what is next for me since my red blood count will not stay up. I had a ct, bone scan and heart fraction done from the trial and then when I had to drop out I had to have my heart fraction and something else redone. It had gone down a lot so I am glad I did not stay on it very long.

Carolyn

beebusted1

Boo: Anything related to the clinical trial should be covered by the study (Wyeth). That includes bloodwork, MUGA, any meds you might need prescribed and ekg etc. If they aren't doing that for you, you need to speak up and ask why.

Anne: You are soo in my thoughts and prayers, I have been wondering how you are doing so Iglad you touched base. I have my last trial appt. Nov. 18th and then I am done the first week of Dec. All in all it hasn't been too traumatic for me. Stay strong and let me know how you are doing :>

Well fellow Neratinibers I am in the home stretch and glad I did this. My SE's weren't as severe as some. My latest and greatest SE has been some annoying dry patches all over my body, but thankfully I can manage. The SE's that have been constant for me is tinitis in my ears,loose stooI, and some leg cramping. I now know every nook and cranny in my bathroom from the seated position.

Have a great Thanksgiving all!

suemed8749

I love checking in here and reading about everybody's experiences. Since I didn't have the diarrhea, I have assumed that I was getting the placebo. However, since I started the Neratinib trial in January, I have had the strange top-of-the-foot cramps, which I never associated with the drug until I read about others on the trial also having it. And yes, tinnitus! Of course, I always think of anything in my head as potential brain mets, but thanks, beebusted - it's been driving me crazy lately. So maybe I am getting the drug, and just have the weird little SEs rather than the big one.



Anne - So glad to hear from you, and that chemo is done and you are tolerating Tykerb pretty well. You're in my thoughts.



Carolyn - Hi fellow 2008 TCH Camper. Hope they figure out what the problem is with your red blood count and get it back to normal. My butt was really dragging when I finished chemo severely anemic.



Happy Halloween everybody - hope it's great for all.