Neratinib Trial 09

[Mary Anne in TX]

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

[DanaRT]

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.

[Mary Anne in TX]

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.

[Patty F]

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.

[WolverineFan]

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

[Mary Anne in TX]

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

[Jaimieh]

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

[hutchibk]

Nuh - rat - in - ib.

[Jaimieh]

Thanks Brenda :)

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

[Rich66]

Trial link?

[schoolteacher]

Maryanne and Patty,

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

Amelia

[Mary Anne in TX]

http://www.oncologystat.com/news-and-viewpoints/news/To_Enter_Herceptins_Market_Wyeth_Pursues_Aggressiv e_Neratinib_Strategy.html

[Mary Anne in TX]

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

[Chelee]

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

[Mary Anne in TX]

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

[Laurel]

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...

[SuzEQ]

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

[Mary Anne in TX]

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

[Laurel]

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?????

[Rich66]

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?

[Joan M]

Mary Anne,

Great news that you're in the trial.

Joan

[Mary Anne in TX]

Thank you Joan! So far no Side Effects. Maybe I got the ol' Placebo! ma

[SuzEQ]

In response to Laurel's recent post and Rich's comments, wouldn't Zometa every 6 months be standard of care anyway, especially if you are receiving an AI? Not sure how they can prohibit this in the Neratinib study. I am on the SWOG307 study but if I had not gone on this, I would have been taking Zometa every 6 months anyway. The SWOG307 study is looking at higher doses of bisphosphonates in early stage disease to see if there is a survival benefit. There is an afternoon of bisphosphonate discussion planned for the San Antonio conference so I'm interested in any results that are presented. Neratinib may be a hot topic, too, so it should be an interesting conference. Will anyone be live blogging from the conference?

[Laurel]

The folks administering the Neratinib trial will allow bisphosphonates outside of the SWOG trial in cases of "documented" osteopenia or osteoporosis. No one may remain in SWOG and participate in the Neratinib trial. If you have a bone density test result that supports the diagnosis of osteopenia/porosis you may continue the bisphosphonate prescribed by your M.D., and even began receiving one for the condition. They are insisting you begin your bisphosphonate treatment for the documented osteopenia/porosis 2 weeks prior to beginning the Neratinib trial. I have not been able to secure a method around this restriction, so I will not participate in this trial and will remain in SWOG. I did have a bone density this week which in the words of my trial nurse at Hershey who reviewed the scans, "your bones are so tough nothing is going to break them!"

If I wish to pursue the Neratinib trial I must discontinue the Clondronate, wash out, and begin the trial. If after several months on an A.I. without a bisphosphonate I develop osteopenia, I would be permitted a bisphosphonate to treat the condition, at least that is my understanding, but I'd verify this if you are on an A.I. or are menopausal. To answer your question whether it is protocol to prescribe a bisphosphanate in conjunction with an A.I. in the absence of documented osteopenia, it is not. You can talk your Onc. into giving it to you "off label" which leaves you at the mercy of your insurance carrier to approve payment or not. Capital Blue Cross would approve Fosamax under these conditions for me.

I suggest you call a center where they are running this trial and begin a dialog and let me know if you are encountering the same restrictions.

[KristyAnn]

Hello Everyone,
I am new to the boards and am in the neratinib trial- I started Oct 7. We are pretty sure I am getting the real drug because I am dealing with severe side effects- but we are working on managing them and I continue on.

Diagnosed 3/18/08
Mastectomy, TCH -6 rounds
Herceptin 1 year
Radiation - 33 rounds
Neratinib- current

[Mary Anne in TX]

KristyAnn, sorry you are having bad side effects, but so glad you got in the trial. Will you let us know what you do to help with the symptoms?
Oh, yes, where are you doing the trial?
ma

[KristyAnn]

Hi Mary Anne,
I am in the trial at the Tyler Cancer Center in Tyler, Texas- my onc is very active and last time I saw her, she told me she had the most patients in the trial at that time- she is VERY excited about neratinib.
Currently I take immodium often and on a schedule to try to manage the side effects- I am on where near controlling them. I also eat a diet high in potassium and magnesium since I ended up on IV potassium after the first month on neratinib. Hopefully things will settle down a bit- another online friend in the Stage 3 trial said it took her side effects about 2 months to become manageable.
Kristy

[freyja]

Hi all,
I pulled this thread up because I just found out I might be able to take part in this trial. Any more info on your side effects or possible risks?
Celeste

[KristyAnn]

The most common side effect is diarrhea- in my case severe diarrhea but I dont think my severity is all that common. Ive been on since Oct 7 and am just now getting the diarrhea under management- I am also taking potassium supplements as the constant side effects were leaving me severely depleted.
Another patient in the same center where I go, has loose stools around 3 a day- so she has the side effect but she is on the really mild side.
Kristy

[Mary Anne in TX]

Good News with some not so good news!
I got put out of the neratinib trial because they couldn't get a good EKG. They did about 6 on Nov. 2 and about 4 more yesterday. They had the same trouble before my surgery but didn't think it was real. They thought I was just to stressed then....well, I was!
Anyway, I'm sad to be out, but incredibly glad they saw the problem. I go to the cardiologist on Dec. 7! I seem to have "electrical" problems!
Next!
Happy Turkey Day to all, ma

[freyja]

Sorry to hear that Mary Anne, and also glad for you that you were able to find out about that. I've been thinking that may be one of the advantages of consenting to the trial is the chance to be monitored closely and thoroughly examined, again. It seems like once you're out of regular treatment they don't really want to see much of you until you have something nasty pop up. I for one would rather be vigilant now, than sit and wait.
Keep us updated on your "electrical" issues. Would be interesting to learn more about that, for sure. Wonder if it's from Herceptin?
Enjoy your Thanksgiving and all the love in your life,
Celeste

[Mary Anne in TX]

I would recommend anyone go for this trial....the drug is so promising. Of course, it has to be appropriate in all the right ways, but I would do it again if I could. They marked my chart to allow me to take the drug as soon as it is approved as along as my heart issues get solved. I'll look forward to seeing more people get involved in trials.

I wanted to be in the trial so that I would be observed carefully and that I would have a "reason" (I don't always take good care of me) to go faithfully for the next 5 years! It's hard to go from such incredible care to being a "well" person!

Best wishes to all those volunteering. ma

[Chelee]

Awwww MA...I swear it's always something! I agree it's a good thing they found out there might be another problem before you got started on this trial...but I can sure imagine the disappointment you must feel. :( I so admire the way you and your onc work together and stay on top of your bc. It's awful to have have a plan of action and have it fold like that. (As you know I've had alot of monkey wrenches thrown in my plans the last few months...it's so frustrating!) So my heart really goes out to you. But that being said I really do believe something good will come out of this. Something even better! At least this trial brought this to your attention now so that your cardio doc can tweak a few things and get you back in good shape.

Hang in there MA...keeping you in my thoughts & prayers always.

Chelee

[Laurel]

Mary Anne, I am very sorry to hear your news! Hopefully they can get your circuits back in sync without much ado! It's always something, isn't it? Dang this mortal coil!

[Ellie F]

Mary-Anne soo sorry to hear for the moment that you can't join the trial but very glad they picked up the heart issue so it can be sorted quickly.

Could you tell me if neratinib is showing any promise for stage 4 bc?

Chelee, glad to hear from you and glad you're on the mend!

Ellie

[Mary Anne in TX]

Neratinib is the same "kind" of drug as tykerb. It is very promising and the researchers are very excited because it too crosses the blood brain barrier and seems to work very well. I understand that if it trials well, it will get consideration to be hurried up thru getting to all us patients. I just wanted to be part of finding out if it will help us destroy the "evil BC"! But the answer is yes, I think so. I'll bet some of the others will know more than me. ma

[Joan M]

Mary Anne,

I'm sorry to hear that you're no longer in the Neratinib trial over a heart complication. But perhaps you were "lucky" that the trial discovered the problem and it can be remedied.

Joan

[Ellie F]

Thanks Mary Anne
You have jogged my memory, my onc said exciting developments were happening with the p13k pathway and I think this may have been when he referred to it saying if we could block this we would have it under control.
Let's keep praying
Ellie

[Ceesun]

Please excuse my ignorance, but I am confused, are those who are NED pursuing this trial or is it for continued disease progression? Ceesun

[KristyAnn]

There is a trial for Stafe 3 and 4, but they recently opened a trial for Stage 1 and 2, NED, women who have finished Herceptin within 24 months- looking to see if neratinib can help prevent recurrence given after Herceptin. Im in the Stage 1/2 trial but Im not sure about everyone else on the board.
Kristy

[Jackie07]

See http://en.wikipedia.org/wiki/Neratinib

Also, from National Cancer Institute:

NCI Drug Dictionary http://her2support.org/images/spacer.gifhttp://her2support.org/images/spacer.gif

http://her2support.org/images/spacer.gif http://her2support.org/images/spacer.gif
neratinib
An orally available, 6,7-disubstituted-4-anilinoquinoline-3-carbonitrile irreversible inhibitor of the HER-2 receptor tyrosine kinase with potential antineoplastic activity. Neratinib binds to the HER-2 receptor irreversibly, thereby reducing autophosphorylation in cells, apparently by targeting a cysteine residue in the ATP-binding pocket of the receptor. Treatment of cells with this agent results in inhibition of downstream signal transduction events and cell cycle regulatory pathways; arrest at the G1-S (Gap 1/DNA synthesis)-phase transition of the cell division cycle; and ultimately decreased cellular proliferation. Neratinib also inhibits the epidermal growth factor receptor (EGFR) kinase and the proliferation of EGFR-dependent cells. Check for active clinical trials (http://www.cancer.gov/Search/ClinicalTrialsLink.aspx?id=453548&idtype=1) or closed clinical trials (http://www.cancer.gov/Search/ClinicalTrialsLink.aspx?id=453548&idtype=1&closed=1) using this agent. (NCI Thesaurus (http://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI%20Thesaurus&code=C49094))
http://her2support.org/images/spacer.gif Code name:http://her2support.org/images/spacer.gifHKI-272

[freyja]

signed the papers today! Having scans this week. I feel good about it. Thanks for the info everyone.
Celeste

[StephN]

Celeste - There you go again, just busting through life! Now dance your way through this trial and keep us posted as things go along. Maybe we need a special forum just for these trials?

I just know your scans will be fine and you will get your pills in a few days' time.

[hutchibk]

Thanks to all the trailblazers who are fighting for all our lives!!

[Patty F]

Just thought I would update my trial so far.....I started on 10/28. Some diarrhea and stomach upset but not too bad. The best thing about it is after I take my pills I have no appetite. I have lost 9 pounds in a month. I needed to lose some weight so this is a good thing for me. I have noticed some mouth soreness. Not like chemo sores...but when I brush my teeth there is some burning from the toothpaste. Other than those few things....I am feeling great.

[Midwest Alice]

Hey, You guys think I could get into a Naratinib trial? I could stop my Herceptin and do the Naratinib trial. Is it for peeps like me?

[freyja]

HEEE! Thanks StephN! It was just another circumstance of perfect timing. Finished Herceptin in August and and my cancer institute started this study in November!
There is a thread for this trial in the Clinical Trials page.
Midwest Alice, if you're on Herceptin I don't know if you'd want to stop it for a trial that may just give you a placebo...something to consider. I'm going for it because I'm currently not taking anything so why not try this? If I get the placebo then there's no difference and I help the study.

[Midwest Alice]

Thanks Celeste, If I have to go off Herecption I will keep this trial in mind.