Neratinib Clinical Trials

Cranegirl

Im in my seventh month of the trial and still have constant foot pain as if Ive worn killer high heels. My legs and arms wake me at night with the pain and now my back is adding to it. I take the pills before bed to keep the nausea at bay. I too have gain a few pounds and have a little bloat in the middle. Im exhausted to the point that things are starting to not get done. Seems like someone just let the wind out of my sails. My stomach has settled down (not so loud) and I never got the marrathon D like most of the others. Some things have gotten much better while others have gotten worse. Hang in there. Its only a year and compared to what weve been through its doable. Cora

CaliforniaCloud

Well Ladies,

I was hoping to join you in the trial but I learned today that the study is no longer open to node negative women, so I'm not eligible.

Good luck to you all and thank you for being willing to join the study for the sake of your and your sisters' lives.

Cheers!

Cloud

AmyIsStrong

WOW - maybe I won't be able to get in either. I am supposed to meet with the trial dept of the hospital in May. Hmmm. I will keep you posted. Thanks for the update.

Jaimieh

Wow that means that I am out also....maybe it will open back up soon.

beebusted1

My oncology nurse told me that they were indeed closing it out to node negative patients due to the fact that herceptin has been doing such a good job in preventing occurrences. They want a wider variety of patients who might have the unfortunate fate of a relapse .

KristyAnn

Cary,

I had horrible problems the first two months with diarrhea and the low potassium that came with it- I also had the horrible cant unbend my foot issues. I have been dose reduced twice and was on mega doses of potassium for a while- finally got back into balance BUT now Im really careful to eat a lot of potassium rich foods on a regular basis and that seems to be keeping it in balance - Im on 160mg of the drug. Mashed potatoes are my friend, bananas, kiwi, smoothies and the mix is potassium rich, avocados etc- you can google and find the foods and then see what you like!

Kristy

AmyIsStrong

I spoke to the trial coordinator at the hospital where I am (was) hoping to enter the trial. She said that the latest paperwork they have says it is still open to node negative women but your tumor has to have been of a certain size (not sure WHAT size). She asked what size my tumor was (3cm) and said she'd get back to me. I'll let you know what I find out.

if the REASON they are closing to node negative women is b/c Herceptin is so successful, that is an awesome reason!

I'll keep you posted.

Amy

Boo307

I set up a consult today to meet with an oncologist to see about entering the Neratinib trail.  I spoke with a trial research nurse to review my situation and give me a read on whether I am eligible as I was node negative.  She said at her center they have just started enrolling women in the trial and node negative is fine. 

The issue of closing to node negative sounds like a center issue, not an overall trial issue.  Good luck.

Kristy Ann,

Thank you for all your sharing and encouragement.  We were in the same TCH 'class' and I appreciated then all you brought to the discussion.  Your experience helps me look past the SE if I get the Neratinib rather than the placebo.

Boo

traceyz

HEY LADIES!

I FINALLY HAD GOOD WHITE BLOOD CELL COUNTS AND WILL BE STARTING THIS DRUG APRIL 2ND. ANY WORDS OF ADVICE WOULD BE GREAT! HAVE A GREAT WEEKEND!!

TRACEY

suemed8749

Catching up on this thread - Hey, I have the weirdo foot cramps also! I've even pointed it out to my dh - look how bizarre my foot looks - I can't untwist it. Then it relaxes on its own. Since I've had none of the digestive side effects, I'm sort of excited that maybe I do have an actual SE.

I got into the trial in January with 2.2 cm node negative. I see my onc/research nurse on April 29 - I'll ask if they've closed the trial to node negative.

Welcome Tracey and hi to all the Neratinib trial participants. Hope spring has arrived where you live. 

tarheelrivergirl

Sue & Cranegirl,

Thanks for the feedback on your feet & legs. I think that's why it's important to list all the side effects in the journal.  Few people seem to talk about the other SE.  All else gets overshadowed by the diarrhea..  After 2 weeks off of neratinib I'm back on the meds with mild/moderate diarrhea and a runny nose.   During the 2 weeks off the foot and leg pain never went away completely, but eased up.  I cut the grass on Saturday and my feet and legs felt "crippled" all day Sunday. 

KristyAnn

Neratinib and sweet potatoes DONT go together well for me- just when I think Im going good, I eat something that throws my body completely out of whack and makes me miserable for 24 hours. I wish I could live on mashed potatoes until October when I finish my year but I dont think that would be very healthy!

Kristy

vickib

Catching up as well. Ya know, I had and still do from time to time have the leg and foot cramps but I knew it was the potas. and as you said the D did overshadow that side effect.

Kristy - I too think I am in the clear and then I will eat too much hot sauce on my Chipotle veggie bowl and then I am reminded I am not completely back to normal. TMI but Ouch!

I wish you all the best!

P.S. My last scan showed that the lesions in my lungs are still stable. Wahoo!

annamari

Great news Vicki!!!  I to have some trouble with foot and leg cramps.  I never thought much of it because I have them every so often normally.  It could also be somewhat worse than before and also be a side effect.  

ipohgirl

Dear Ladies,

Hidee! Happy to know everyone's doing fine and cheery.

I saw the trial doc last Thurs and signed the papers, who promptly arranged a series of tests for me. A couple of questions.

 1) About the side effects, she said I'll have to cope with them with my own medication. For diarheaa she said I'll have to purchase my own lomotil pills.........

2) She made me sign an additional statement giving Wyeth access to my tumour tissues for genetic research. When I asked for access to the research results, she said they might not be available.

About the mammos, it will be an annual one while the blood work will be every three months. She didn't mention anything about not accepting node negative girls.

Will go for a bone scan next week for my high calcium readings

Meanwhile, I will go away for a week long holiday starting today!

Cheers!

Ipohgirl.

KristyAnn

VICKI- so happy for the stable scans!

Ive been eating pretty plainly this week and its working a lot better for me!!!

Kristy

KristyAnn

Hi Everyone,

6 month check up tomorrow- MUGA last Monday was good- Im literally counting the days for the last half of this trial LOL- tired of grumbly tummy and big D being around all the time!

Kristy

Carolina59

Hi everyone,

Congrats to all of you who are making your way through this trial with some pretty bad SEs. I finished Herceptin in Nov. 2008, so I guess I'm closing in on my window of opportunity for this trial. Frankly, I wish I could just get a Herceptin "booster" every 6 mos. and call it a day. My onc. has been pushing the Zometa, but haven't been able to decide about that one either.

my2boys: I live in Brooklyn, and I'm wondering where you are enrolled in this study? I noticed you met with a nutritionist at MSK. I'm still being seen at NYU. It looked like the two closest sites are the Bronx and Staten Island. Do I need a referral from my onc. to be enrolled?

Oh, one last question: what is erbB-2? Is that somewhere on my path report?

Good luck to you all--you are providing a great service to all who come after you. 

AmyIsStrong

Well ladies - I finally got a definitive answer re the node-negative question. The trial coordinator told me that an amendment is being proposed for this protocol to exclude node-negative women from entering it because the recurrance rate after a year of Herceptin is so low already! (That was exciting to hear.)
But the amendment is not adopted yet, so node negative women can still enter and remain in the trial. But the window for entering will close once the amendment is adopted. Not sure when that will be but she said that if i wait until after my daughter's wedding and start in July, it will be too late.

They have an appt to see me Monday if I can get my onc records in hand by then to bring with me. No idea what my onc will say about that when I call them tomorrow. We'll see. I'd like to go up and meet the trial doc and see what is involved. After following this thread, I have a lot of questions, so THANK YOU to everyone posting here.

I'll let you know what I find out.
Amy

KristyAnn

Good Luck Amy if you decide to join the trial- it seems like a lot of oncologists are really excited about this particular medication- I sure hope it turns out to be great!

Kristy

Boo307

I had my consult yesterday with the study oncologist and team, and found I am eligible, so now the decision is mine.

I am trying to pull together the cost sharing information, who pays for what so I make an informed decision.  What did your insurance company pay for or not pay for.  Any surprises?

By the way there was no discussion about not being eligible for being node negative, just that I'm not in the target audiance of higher risk node positive and larger tumor participants that this oncologist is referring to the study.  First time anyone said I was in a lower risk group.

Would some of you pros, who started months ago, suggest starting with a bland diet?  What do you wish you knew when you started? 

I appreciate so much all the great information on this thread to have made me aware of the trial and the pros and cons of participating.

Thanks again, Boo

jap

Hi everyone,

I am getting close to entering the trial and am depressed at the prospect of being sick for a full year -- not being able to travel outside the country, go camping, etc.  I just spent a year and a half recovering from chemo, H., radiation, and low red blood cells.

For those of you who have been taking the real thing, how much has it compromised your life?  Can you go out for dinner?   Get work done?  Last for any length of time at social events?

My oncologist says the D. lasts just two weeks (she is the study director) but I have learned differently from this list.   Does it get better over time?

And does anyone know how much benefit we might get from it?

Thanks,

Jo Anne

annamari

Hi JoAnne  I am 3 months now and have never been told not to travel.  I would not go to a country that does not have a hospital around.  But there are other countries that USA and Canada where this drug trial is going on.  I would take all information with me when I go anywhere even to your G.P.  Also if you like to go camping Why not go take your pills with you and have fun.  Find out where the bathrooms are in advance and sit in the aisle row near the restroom on a plane and you should be fine.  I am planning to see my sister next month and noone told me I couldn't go.  I would wait a month to allow your body to adjust to the meds before you go anwhere.  That will let you know what you can do.  I was told they want you to live a normal life.  I believe that we are no more sick than a person with a mild cold.  Don't let this stop you from enjoying life. It's too short to do that. 

Hi Boo!  As for diet when you begin I suggest that you stay away from dairy products.  skinned fruit like grapes and other than that eat as normal as you can. If you have diarrhea think back to what you ate and eliminate that food or food group.  I know you can do it.  

To both of you I wish you success in the next year and enjoy life to the fullest.  Blessings to you all.

jap

Thanks for the reply.

I still have some remaining questions to anyone who is out there who hase been on the trial for a while:

1)  Do you have D. every day for a year?

2)  Do you need to take Imodium every day for a year?  Or even something stronger for a year?

3)  Do you continue to have fatigue for the entire time you have been on the drug?

4)  Have you needed to reduce the dosage for long periods of time?

Jo Anne

fightinhrd123

My study girl just called me and said that they just today closed it to people with negative nodes or people that had complete response to chemo cos our relapse rate is so low   I had a complete response, so shes going to go over everything with me next week and see if i still want to do it.  She also said due to liver problems, blood tests are now every 6 weeks!  Dont really like that idea~!!!

AmyIsStrong

I had a phone consult with the trial doc today, as she was sick and wasn't in the office. What a sweetheart - I wish she was my regular onc!  Oh well.

Anyway, she said yes, they are closing the trial to node-negative women but if I apply promptly, I can probably get in before it closes.

She said that Herceptin is a 'home run' in treating our kind of tumor, which, she said is only 20% of bc. But it sure seems to me that EVERYBODY is her2+ (but maybe it only seems that way). So she said that in order for Wyeth to demonstrate the efficacy of the drug, they need the control group to have more recurrance than the drug group, and that node neg women are not having enough recurrences to have a demonstrable difference.  What a GREAT problem to have!

Also on the topic of herceptin (but not pertinent to us directly) she said that the rate of recurrance is SO LOW for women who have had a year of H, that they are not getting enough women with recurrances to stage IV for them to do trials on. There are not enough women with recurrances to fill the trials! This makes me so happy. 

Not sure what I am goign to do about the trial yet.  She is getting back to me with some answers to questions I had - re the MUGA, finances, supplements I can/can't take during the trial, etc. Then I will decide.

I think I will probably go ahead with it. I just REALLY want to know I have done EVERY SINGLE THING I could to make sure this never comes back, you know?  I KNOW you all understand.

Amy

annamari

JoAnne:  I have so far never had my dose reduced so that means 6 caplets daily.  I do still have some diarrhea and found that imodium did not help.  I have decided to go without and am no worse than with the imodium.  Ussually 4-6X a day.  I work full time and still have fatigue so when I'm home I don't do any more than necessary.  Maybe part of it is age but everyone gets older and that could account for some of it.  Don't give up you'll do fine.  Most of us do.

KristyAnn

JoAnne,

I have been on just a little over 6 months and I have been dose reduced twice so I only take 4 tablets a day, I dont take Immodium every day- I use lomotil as needed which ends up being 2-3 days a week, I avoid dairy in the form of milk- I can eat cheese. I have had diarrhea every day for the 6 months- after I was dose reduced I am in a manageable state. I work fulltime, am travelling for business this week (started lomotil the day before to make sure it didnt happen on the airplane). I havent gone camping but I have not stopped any other activity SINCE I got dose reduced and under control. I dont expect to be put back on the higher doses and will finish the study at 160 mg.

I eat a high potassium and magnesium diet to compensate for the diarrhea BECAUSE I got out of balance the first month and it took weeks to get me back to normal- when I have more diarrhea, I also up the potassium in the diet. I also eat frequent small meals and rarely eat a large meal at all- seems to trigger the grumbly tummy.

Fatigue is moderate- I am also on femara- but I am managing fulltime work and a full household with 3 kids still at home- I dont really miss anything due to fatigue just cut back on optional stuff.

Im coping with it- trying to do anything to help reduce recurrence so Im in a good mind set to deal with it all. Romantic pursuits have sufferred the most it seems- between fatigue and not feeling very sexy with the tummy upsets and Big D--- makes sex a pretty low priority!

Kristy

Estepp

You know.. I just saw my onco a month ago. He STILL says he does not want me doing this.?? He said I had such a great response to chemo and rads...etc,,, he does not want the added heart pressure. Adriamycin....Herceptin... rads over heart...

he tells me the risk is just to high...

I hope I am making the right choice.

my second ONCO opinion told me the same thing.. to much risk on my heart. ( NO.. I have NO heart issues... so far itis fine)

Lord I hope I made the right choice by following the oncologists advice.

weety

You know estepp, my onc must have been talking to your onc. . .  I've been following this thread in the hopes of it still being open when I'm done with herceptin this summer, but now it looks like it'll be closed to me because of no-node involvement.  My onc really did not want me to do it.  She talked about the heart damage as well, but actually, she was afraid that being a part of this trial (when the chances of recurrence with herceptin are already so low) that it would exclude me from being able to pursue a trial down the road, if need ever be.  I'm more optimistic about it (not sure if that's the right word)--if this trial could prevent the recurrence in the first place, I wouldn't need to be looking at some other trial down the road, right? 

Anyways, from the experiences and conversations I've had with her, I don't think she is too crazy about early stage trials--she says over and over (about the BETH trial when I first saw her, and then again about the SWOG-bisphsoponate trial) that trials always way over-medicate you because they have to use the absolute highest dosage that was tolerable in order to get the best results in efficacy.  If the dosage was lower (and more tolerable) and it didn't get the results expected, then the question would always be--would it have passed if the dosage had been increased?  And NO company wants to spend $$$$$$ to find out it didn't get through!  So they over-compensate for this by giving more meds than they think may be necessary. 

I don't know the right answer.  Trials are necessary.  Trial drugs work and then get refined for the rest of the population.  People need to be in trials or we won't get new drugs.  I know all that.  Herceptin wouldn't be here without the trials.  ETC, ETC, ETC.  My onc does have a point, though, so I take it for what it is--one more factor to consider when choosing to enter a trial.