Neratinib Trial 09
 

I spent the last couple of days doing mammo, muga, blood work, EKGs, chest x-ray, etc to get in the Neratinib Trial AND it's done, I'm in! I go Monday to get the meds and instructions on use and what to do about side effects! This drug is the one that I was so excited about last year at the San Antonio Symposium. (Thanks again Christine and Joe for allowing me to go).

I'd be lying if I said I didn't have any hesitation about the trial and the possible side effects, but those little fears are so much less than the possible benefits of this drug. I'm takin' these pills each day starting Monday in honor of our super warriors in the midst of battle right now. I do think a lot about those on this board who day by day fight to receive a new drug to hold back the growth of tumors, who fight with insurance companies to pay for appropriate meds, and who struggle to continue the fullest life possible while doing daily battle.

I'm also very selfish...I have a 10 year old who depends on her grandma to be there every morning to send her on her way to school and life's adventures. I'd surely like to finish that job over the next 10 years and get her in college and into adulthood. Whatever happens, she's surely given me purpose and strength.

I'll keep ya posted on the drug as I get into the next few weeks. I might get the placebo too!

If anyone else is on the trial and would like to share this thread for sharing ideas on side effects and experiences, that would be great.
ma

Re: Neratinib Trial 09
 

Mary Anne, I am happy you posted that you're beginning the Neratinib Trial. I am going to talk to my onco in January about it. Thanks to Sheila for helping me pronounce it correctly!

I will be following your progress, Mary Anne. I am anxious and excited for you. Give your sweet granddaughter a small squeeze, what a lucky girl she is to have you. 10 years old, I love that age.

Re: Neratinib Trial 09
 

thanks, Dana! Let me know when you get in.
she is at a great age...sometimes I wish she'd stay 10 and other times I wish for her to grow up and be able to take care of herself, but I know she has to get the lessons first.

Re: Neratinib Trial 09
 

Mary Anne
I started this trial on Wednesday. I know I have the real thing. I started with side effects on Thursday. So far just diarrhea and some mild stomach upset.

Re: Neratinib Trial 09
 

Congratulations, Mary Anne. That is great news!!! Please keep us posted on how it works for you. Btw, I understand all too well how kiddos can give you strength, purpose and the will to fight. My children are at the very center of it for me!! May you have even more than 10+ quality years with your granddaughter!!

Hayley

Re: Neratinib Trial 09
 

Hayley, thanks a million. She is one cool kid!

Patty, they told me to be prepared when I come Monday with Imodium; so they think those side effects are pretty constant.
I'm glad to have someone to walk this walk with! I'll let you know later this week what happens. ma

Re: Neratinib Trial 09
 

How do you pronounce it ?? We do not have anyone currently in Maryland participating :(

Re: Neratinib Trial 09
 

Nuh - rat - in - ib.

Re: Neratinib Trial 09
 

Thanks Brenda :)

Does anyone know can you be on another trial at the same time as this one ??

Re: Neratinib Trial 09
 

Trial link?

Re: Neratinib Trial 09
 

Maryanne and Patty,

I am excited to see that both of you have been accepted into the trial. Please keep us updated.

Amelia

Re: Neratinib Trial 09
 

Re: Neratinib Trial 09
 

I picked up my pills today.....6 a day until January when it changes to one pill!
I'll start them tomorrow morning....just got home.
I got to meet another participant, Gwen, too.
ma

Re: Neratinib Trial 09
 

Hi MA, I can only imagine the mixed emotions you have about the possible side affects, yet the excitment of the actually benefit you could have. :) So far you & your onc have done a great job of going after "it" aggressively. There is alot to be said about peace of mind and knowing you did everything available to keep cancer from recurring...so I admire you...and personally want to thank you for doing this. You are part of a study that can, & hopefully will help so many others woman that will be unfortunetly dx. These newer trts are so important as I don't have to tell you. I am so proud of you...way to go. MA...you went after your bc with both guns blazing & you haven't stopped...this just proves it! Good luck and keep us updated. Big hug coming your way! You go girl.

Chelee

Re: Neratinib Trial 09
 

Thanks a million, Chelee. It means a lot for you to say what you did. My onc thanked me today for accepting the challenge and that too, made the task even easier. I do feel that it's the support and knowledge I receive here that gives me the push to do whatever I can to give back for what I've gotten. ma

Re: Neratinib Trial 09
 

Jaimiah,

You cannot be in another trial where dfs is the end point. If you are currently in a trial you may quickly exit that trial, have a washout period, and join the Neratnib trial, for NOW. However, if that is what you wish to do, you must move very fast as they are drafting an amendment to the parameters for qualifying where you will not be accepted if you were in another trial.

I am currently in the SWOG bisphosphanate trial. If I wish to participate in the Neratinib trial I must move fast. To enter I must quit the SWOG trial, and washout the other drug. This is a bit of a conundrum for me as I know I am receiving a bisphosphonate presently. Since I am on an A.I. I figure this is a positive thing regardless of whether it prevents bone mets. However, if I quit the trial my onc will not put me back on a bisphosphonate until I have osteopenia. If I join the Neratinib trial and I am one of the 50% who receive the placebo, how have I benefited myself?

The trial nurse said they are concerned there will be a large dropout percentage from the placebo group as they will know they are not receiving the drug due to its very classic side effects. It seems no one escapes the G.I. side effects if they are receiving Neratinib.

This is one of those times where I really wish I had a crystal ball. If I could receive a bisphosphonate to prevent the osteopenia, I'd move to join the Neratinib trial (assuming it has not been amended already).

Very difficult to decide...

Re: Neratinib Trial 09
 

Has anyone discussed the mechanism of action with their oncologist and how this may impact, positively or negatively, the outcome with this drug? My understanding is that Herceptin and Tykerb are reversible Her2 inhibitors, neratinib is irreversible. So, what does this mean for the patient? Also, the interaction between Her2-Her3 appears to be the key to this disease. Does neratinib have any effects on this? I plan to discuss with my onc today but would love to compare notes with the group. Thanks!

Sue

Re: Neratinib Trial 09
 

I thought I read that it impact Her1, 2, 4....would that sound right? It is intended, I believe, to fill in where Herceptin and tykerb don't work. ma

Re: Neratinib Trial 09
 

Update on some things that will inhibit one's ability to be accepted into this trial: you cannot be in a trial where DFS is the end point such as the SWOG trial with bisphosphonates. Furthermore, you may not be taking a bisphosphonate without a history of confirmed osteopenia or osteoporosis. In my case my insurance will pay for Fosamax without any authorization, and thus without the need for documented bone loss, however this will not fly with the Neratinib trial. You can exit the SWOG trial, have a washout period, and then enter the Neratinib trial. Likewise, if you are on a bisphosphonate prophalactically while on an A.I. to prevent bone loss, you will have to discontinue the bisphosphonate unless your bone density scan shows osteropenia or worse.

Always those irksome caveats with these trials! How do you roll the dice?????

Re: Neratinib Trial 09
 

So the Nuh - rat - in - ib trial explicitly disallows all bisphosphonates? Hmmm..on reread, you are saying bisphosphonates are ok if documented bone loss. That's lame. Either it risks skewing the results or it doesn't. Have you had a bone density scan?