Neratinib Clinical Trials

KristyAnn

I was hoping to have reconstruction this summer and just found out you cant do that while in this trial- guess I have to wait until at least October when I am finished! Bummer- summer scheduling was going to be so much easier!

Kristy 

Roxi65229

Biopsy is negative! I start the trial on Wednesday. I'll be looking to all of you for your advice. Anything to help prepare myself before then?

suemed8749

 Kristy - That really sux - I didn't realize that this trial would affect reconstruction plans.You are certainly doing more than your share for science.

 Roxi - Yay for good news! I was right ahead of you - began chemo April Best wishes for minimal side effects. I'm pretty sure I'm on the placebo since my body doesn't seem to be affected at all. Good luck to you.

Sue

fightinhrd123

Kristy, I had recon, and i had been in the trial for about 2 months maybe, they just had me stop for a week.  I had a DIEP done, so a big surgery, and it was fine.

Laura

my2boys

Hi Everyone.  I thought I would pop in and see how everyone is doing. 

I am doing well.  Currently back in chemo A/C/TH.  Adriamycin was easy to tolerate and I am glad that it is done with.  Currently doing Taxol which is 12 weeks long, but other than this, it is very tolerable.  Back on Herceptin and now I am also taking Tykerb every day.

Tykerb is very similar to Neratinib.  This is why I needed to be unblinded before beginning this drug.  I will take these pills for one year and although the first few days were hard, my body seems to have adjusted to it very well.  I thought I would be banned from salad and dairy for a year, but after a week I was eating my beloved salads once more.  No need for immodium yet, but one never knows right?

Keep fighting the good fight and soon this will all be a distant memory. 

Warmest wishes to you all for successful completion of the trial.

Hugs,

Anne

KristyAnn

Nice to hear from you Anne- hang in there and hopefully the new meds will kick butt!

Kristy

Boo307

Anne,

Thanks for giving us an update and glad to hear so far so good.  I have thought about you often.

Boo

KristyAnn

90 days until I am finished!!!!! Finally made it into two digits!

Kristy

gramma23

KristyAnn, I am happy for you! I am glad you are doing good,

Carolyn

shelclaire

hello ladies,

 I started the trial on Tuesday and except for a big one hour of D yesterday I have not had any problem and am hoping I am not on the placebo. I drive 3 hours and have to stay overnight to get the pills the next day after blood and tests are done. How long before you noticed anything. Looking forward to sharing stories as we move forward.

 Thanks

Kara

beebusted1

Anne, so glad to hear from you. You are in my thoughts and prayers often.  Happy to hear you are tolerating the meds fairly well. After your plight I brought up our concerns over not unblinding you in the office.  Needless to say I didn't get an answer..actually it was if I hadn't said anything.Not something they are willing to discuss. My office visits have increased due to more frequent blood tests. Be well and please keep in touch.

my2boys

Thanks ladies.  I am still doing well, although they had to pull me off of Tykerb (similar to neratinib) for a few weeks because the diarreha was too severe.  I guess this is how these drugs work.  Just when you think you are tolerating them well.....bam!  They will put me back on at a reduced dosage.  This chemotherapy is much easier than the previous one. 

Sorry about your experience beebusted.  I have made my peace with the office that was conducting the clinical trial.  I am glad that I went back to my original oncologist for my treatments.  After hearing my plea for help and my oncologist's requests, the clinical trial doctor was the one who finally had me unblinded.  I still think he is a good doctor, I just had a tough time with his assistant.  I had to put it behind me or else I wouldn't be able to do what I need to do so I can be well again. 

Hugs,

Anne

KristyAnn

How is everyone doing?

We just finished a week of vacation which was great!

Kristy

gramma23

KristyAnn, how much more time do you have on the trial? You should be getting very close now! I am glad you had a great vacation. Have you had any infections while on the trial? I was wondering if that is what caused my biopsy to get infected. I don't think so but just wondering. It was weird because it seemed to heal fast. this was in April and he put 1 stitch in and left it a long time it seemed and it really irritated me but never got red or seemed infected until June after I had quit the trial. all of a sudden I had a very large lump and sore breast area. I noticed the biopsy spot was redder than normal. Well it was infected! I still have the lump and the mammogram showed a shadow so they think it was from the infection. Now I have a lump under my arm where they were supposed to have taken the lymph nodes out. I go to my onc tomorrow and so I will maybe find out if I still have infection or something else.

Carolyn

KristyAnn

I have about 70 days left- not sure since I cant remember the exact date of my next appointment.

 I havent had any infections on the trial- I did develop severe eczema- I have a tendency toward it anyway but it went way overboard while on nertatinib!

Kristy

Boo307

Hi all, I'm back from a high altitude hiking trip in CO with my daughter. 

Has anyone tried drinking regular milk?  I switched from lactose free after the first month and had just milk on cereal and coffee.  I have now tried drinking a cup or two and no problems.

I have random episodes of D once in a while and it seems to be on the days I forget to take calcium pills.  They seem to be offsetting the Neratinib.

I wish  you all a good weekend.  

Boo 

KristyAnn

I tried a scoop of regular ice cream this weekend (Baskin Robbins) and handled it fine. I get random days of diarrhea on occasion too and dont really see a pattern- I think my body handles a build up and then has a "bad day" and then I go on.

Kristy

Boo307

Kristy,

What a treat!  I'm glad to hear the ice cream didn't cause problems.  I find if I still to just a cup or two of milk I'm OK. 

I'm finding the Neratinib disruptions have settled down to just a bout of D once in a while.  Otherwise I feel great and just hiked Mt Elbert, the highest peak in CO, quite an accomplishment for me.  My oncologist encouraged me to challange myself and build my cardio.  In two weeks I head out for a week of canoeing the Allagash River in Maine, another first for me. 

Cancer changed my attitude toward all the things I've wanted to do, so I am checking them off my life list!

Best wishes to all this weekend. 

Boo 

KristyAnn

Sounds great Boo- I still dont push my luck with the dairy but that little scopp sure was nice!

62 more days!!!!! Im a little worried about coming off this drug since Ive had basically D or loose for a year! I better have the veggie soup ready or something!

gramma23

I got a call from my trial med nurse and they have some new things that have to do with this Neratinib. She wanted me to sign them informing me of the side effects. she said they could not mail them but I am going to meet her at my next appt for my blood tests. I am not sure why it is needed for me since I only got to 5 days of this. I admire ya'll that have been able to do this. I was so sick but then I was with TC also. Have you had to sign any new things that have come up?

Carolyn

KristyAnn

I had to sign a new form also- basically in the middle of the 3 months between visits you have to go in for liver tests since some people have seen negative things on their liver bloodwork. I havent seen the liver effects but I was dose reduced twice so I am only on 160 mg (4 pills a day). That was the only change I had to sign off on at my last visit- and I only have one more so its only 1 mid bloodwork until I finish (YEAH!!!!)

kristy

leighannmarie

I may be doing this trial.  I work full time and am in situations where I would not be able to run to the restroom.  I am concerned about the D if I (hopefully) get the drug.  I'm wondering if they put a laxative in the placebo but, not everyone gets D so, that is probably crazy thinking.  

Boo307

leighannmarie,

I stated taking 1500 mg of calcium in the weeks before I started the trial on the recommendation of the trial oncologist.  It made me somewhat constipated, and now if I miss taking the calcium the D seems to return.  I split the calcium dose into three times a day because I read that the body can only absorb about 400mg at a time. 

I eliminated all milk for the first month and have been able to add it in.  We all figure out what we eliminate for the year and what we can get away with eating. 

Best wishes and even if you don't have the trial drug, you still have the comfort of the close monitoring.  I have also appreciated the new relationship with my terrific trial oncologist. 

Boo 

suemed8749

Hi leighannmarie - Several women on this thread have speculated about what they might do to make the placebo seem more like the real drug, so the laxative is not crazy thinking at all. But I've been on the trial since January and have had NO side effects, so I guess I'm on the placebo and, if so, they haven't done anything to create any side effects. Good luck if you decide to join the trial.

Boo - I admire your accomplishments! I hope you have a wonderful adventure in Maine. We're under an extreme heat alert here in Phoenix, and canoeing in Maine sounds like heaven.

Sue

1rarebird

Even though I am excluded from this trial because I am male, I asked my oncologist this very same question.  He told me that it would be unethical for the drug company or the participating trial centers to add a laxative or any other symptom causing substance to the placebo.  He said it just isn't done because the results from the trial would be suspect if this practice were to happen and the information got out, which he said it would..  So I'd say don't worry about an adulterated placebo being administered to you.  If you get symptoms they  will because of the drug.  Good luck---

bird

KristyAnn

My docs office saud the same thing- they have several women in the trial and I am the only one with side effects- so they KNOW Im on neratinib but really dont know about the others- they could just be the lucky ones who dont get the terrible ses.

55 days left!!!!!

leighannmarie

Thanks for the replies.  I'll ask about the calcium.  I don't drink milk and I guess I could do without most dairy but, what about yogurt or cheeses?  My trial doc will be the onc I have had from the beginning.  He is wonderful.  Anyway I meet with the research coordinator on Monday to get started with paperwork and blood work.  

KristyAnn

I can eat cheese (hard cheeses) a little and also yogurt- ice cream is a definite NONO or it was until lately- I can now eat maybe 1/4 cup on occasion without problems- of course I am almost done with the year on neratinib LOL.

High fiber diets are also problematic for me which is hard becuase I eat a lot of vegan foods etc although I am not vegetarian- just like majority of meals to be meatless. I have to be really careful with some things like black beans or I can end up with D for a couple of days!

No problem with gladiator smoothies at smoothie king!

leighannmarie

Hmmmm.  Yes, giving up beans,  vegetarian, fresh veggies, high fiber breads that will be tough.  I wouldn't miss ice cream.  Here is another question do the placebo pills taste different than the real drug?  Are they coated in some way?  How do you know you are getting the real drug?  My onc said he has had a few women w/o symptoms that were on the drug and some that dropped out because of bad side effects that were on placebo.  Anyway I think I turned white when the research coordinator walked in with the huge bottles of barium sulfate that I have to take for my CT Scan.  I have not experienced that joy yet.  Thurs after work I do Mammos then CT.  Yucko.

KristyAnn

Leighannmarie,

Just start out staying with your normal routine- some people dont have side effects and wouldnt have to change anything or might hav eto change something different. My side effects are extreme so the doc is confident that I am on the drug but the other people in my clinic are not having problems so they really dont know whether they are on it or not!

Your onc should not know who is on the drug and who is not since it is a double blind study- unless he is talking about the other study for Stage 3-4 women who do know what they are taking.

I didnt have a CT scan when I started- I had one when I was first diagnosed as part of staging but nothing since. I get MUGA scans every 3 months (only one left!!!)

 Good Luck and keep posting about how you are doing!