Neratinib Clinical Trials

jap

Hi everyone,

Well, I just had a long talk with the nurse in charge of the study at MGH (where I am being treated) about unblinding the study.  She claims in the case of recurrance they would probably test the new tumor to make sure it is HER2+ and then give Herceptin again (perhaps with other chemotherapy) -- unblinding the study would not be neccessary.  I am not sure I believe this...   

What have others found out?

Jo Anne

Cranegirl

Dear My2boys, My heart goes out to you. Damn this CANCER.  We do everything they tell us and it still comes back. It makes you wonder if they really know what theyre doing to fight this. I know your in a good place.My sister went to Sloan Kettering and they are so good. Lets hope and pray its just a recurance and surgery will take care of it. Kinda like cutting down a tree and getting a little sprout where the tree was. I hope thats it. Your in my thoughts. Please keep us updated on your condition.God Bless You. Cora

my2boys

To all of the ladies here....Thank you again for all of your support and prayers.  I started chemotherapy yesterday AC/TH.  I will probably be sick starting tomorrow.  I am very sad, but hoping for the best and sad that my husband and kids will have to go through this again with me.  Hate that my hair will come out again, it was just starting to look beautiful.

Jo Anne - Thanks for all of your support.  You sound like one strong lady.  Unfortunately your nurse is not correct about the treatment options.  In my case, the Herceptin was not doing its job as the tumor was growing back, although slowly while I was still on Herceptin.  So they are considering adding Tykerb to the mix.  Even if a patient has had herceptin in the past, in most recurrent Her2+ they will consider adding one year of Tykerb in addition to Herceptin for life.  If you look at your contract,  there is a paragraph about how Tykerb (Lapatinib) and Neratinib are the same class of drugs.  Therefore, they need to know if you were exposed to Neratinib before trying Tykerb.  It's so simple for them to let me know and it won't compromise the study at all since I was told to stop taking the pills once I was re-diagnosed.  If I was already exposed to a drug just like Tykerb, I would then be free to choose another option....there are so many new drugs being made available.  My oncologist is in agreement with me that unblinding is the way to go, so I am sure she will help me do what needs to be done.  I will keep you posted.

My friend works for another laboratory and she is trying to get the name of somebody at Wyeth who is in a position to help me.  I hope she is successful. She claims that it is not the laboratories decision what my treatment plan will be and that they have no right ot deny me information that could help me and my doctor design a treatment plan that could save my life.  She was very firm and said that her laboratory would never be so bold as to refuse to unblind a cancer patient who was fighting for her life.

I contacted Shulmann Associates....also listed in your contract and they claimed to have contacted my trial doctor regarding this matter.  I hope they can resolve it soon.

Cora - You are so right about MSKCC.  They are and have always been just wonderful.  I couldn't be in better hands right now. Thank you. 

I thank God that I caught this cancer once again and I thank God for all of my Breast Cancer.org buddies who are fighting this with me.  You really have helped me to carry this cross....all while you are carrying crosses of your own.  You ladies are truly amazing and I am glad that my experience may have helped some of you to question your contracts.  I honestly don't want any of you to have to go through something like this while dealing with cancer/chemo/rads and heartbreak all over again.

Love,

Anne

vickib

Dear Anne, I am so sorry you are dealing with this and having to deal with chemo all over again as well. You are in my prayers! 

KristyAnn

Anne,

Praying for you and your family and so sorry you have to go through this again.

Carolyn,

Hang in there and talk to your research nurse- I got dose reduced twice finally landing on 160 mg (4 pills) per day as the dose I can tolerate. The nurses will help you and there are protocols that will allow you to stop for a few days and then start at a lower dose if you want to continue.

I just picked up my 6 month pills- Im over half way finished now and counting the days LOL- want to eat ice cream again some day!

Kristy

gramma23

Kristy Ann, I am off of it for a while now and the next step down I will start at 200 mg. I know one thing if I had to take this if I had cancer I would rather die. I have a urinary tract infection I think now! I can't win. I could handle a little diarrhea I think but the nausea ,heart burn and stomach cramps are just too much. You would think they would give people the dose they could tolerate but then if they don't start high I guess they would not know. I feel mostly better today but I quit taking it on Monday and it has taken me until today to not feel bad. I can't imagine if I took it for a year how long it would take to get my system clear of it. Thanks for your encouragement. the nurse did tell me they could go down to 120 mg. If that is so why start with double that amount?

I hope everyone that is taking this is doing better than I am

Carolyn

KristyAnn

Carolyn,

I alwasy wondered why they didnt start at 120 and then step up to find the tolerated dose instead of th eopposite- there was another trial with this drug that did do that I believe.

Anyway, I landed at 160 since I had the same problems at 200 that I had with 240- my biggest issues were that the diarrhea was causing huge drops in my potassium and magneisum levels and it took weeks to get them back to normal. I am stable now and they wont even think about moving me back up in dosage LOL

Less than 170 days left- but whos counting !!!!

Kristy

Cranegirl

Gramma23, Try taking the pills at night before bed. I dont know why but that cuts the nausea. Any time I took the pills in the morning, I was naseated for two days. Try it, it might help. Cora

gramma23

I wanted to take them at lunch at least because I don't eat a lot at breakfast but they say in the morning but I may ask to do it later. I have a urinary tract infection right now so I have to wait a while to go back on them. I was still sick yesterday with loose stools and nausea but today I feel better but then I have not eaten anything yet. I want to be able to do this and not wimp out but we will see. I know I would not take this even if I had cancer with the side effects as bad as I had. thanks for your support.

Carolyn

annamari

gramma 23  I have always taken my pills at noon.  It is my best and most regular time wise meal.  I eat half my dinner then take my pills and after that finish my dinner.  I do have some diarrhea and stopped taking imodium because I was worse with it than without.  I think the main thing is to take it at about the same time every day. 

My 2boys : you are in my thoughts and prayers as you are again  in the war zone.  May you have complete healing of this wicked disease          

gramma23

annamari,I will try that. I took it the first day at lunch with food but the cramps started within 5 to 6 hours afterward. It went downhill from there. I start the pills again on Tuesday if I can take them with antibiotics because I have a urinary tract infection again. I will take 200 mg this time. Are you taking a reduced dose? I had a bad time with chemo too though so I was not surprised to have this and was really hoping for the placebo! I could not go without the immodium. I could not eat or drink for 3 days and got dehydrated. I think the nausea and heartburn was worse than the diarrhea though. If I can't do this I will have to stop this time for good because I can't work and do all the things I need to do with the side effects. I wish I could just go down 2 pills instead of one but we have to go by the rules. I guess at least I know I am taking the real med and it may help me keep cancer at bay. I hope anyway. I am still battling my low blood count though. I still take the Procrit and have wondered if that may be part of my problem. Before I started this trial I was going to try to do without it but I can't go below 9 on the hemoglobin and take this. How long have you been taking this? thanks for the info!

Carolyn

annamari

gramma23.  I have been very blessed to have had only a few side effects from the chemo.  Only minor ones.  I had surgery after the chemo and healed from that OK too.  Radiation took the greateat toll on me.  I still have some pain from that and a combination of that and the mx.  I am doing Ok on the pills now but I still need to stay off dairy.  I get diarrhea again then.  My blood levels are good as well as my muga heart scans.  I do get a bit SOB but I atribute that to age.  I know there are people who can't tolerate every medications thrown at them and it's no crime to say my body can not handle this.  You give it your best try and you need to be able to live a normal life --if we really still have one.  I hope that you will be OK no matter what decission you need to make.  Blessings to you!!!!!

gramma23

Well, I am out of the study! I took the 5 pills as my lowered dose on Monday and within an hour I was getting sick but they had gotten me some anti nausea med for under the tongue. by evening before I left work I was throwing up and lost everything in my stomach I thought but then on the way home I started getting sick again. I had to pull over and throw up out the door. I was afraid a car was going to sideswipe me. I managed to get on home and then yesterday evening I was able to eat a small amount of food. My stomach is still a mess but in a few days I should be better. I just don't know how anyone could live with this.

Annamari,I am glad you can do this. I was sick the whole 6 months I was on chemo and even the Herceptin gave me side effects so I guess I should not have expected anything else. As for the radiation I had a lot of problems with that too. I was cooked to a crisp. I am still in pain from it and it was a year ago in Feb. I finished. The doc told me it could take up to 3 years to get rid of this pain. Why don't they tell you that before you start? I was not wanting to do the radiation because I just felt like it was a bad deal and I wish now I had listened to my self. the docs said I had to do it because of the stage my cancer was but I guess it is after all my choice. I wish you the best too and hopefully you won't have to worry a day about cancer returning since you were able to do this.

Carolyn

KristyAnn

Carolyn,

Sorry you are having to drop out but I certainly understand the life issues- Im pretty sure I would have had to drop too if my nurse had not kept with me working on dose reductions. I only take 160 mg (4 pills) and I tolerate it with a lot of lifestyle intervention- no dairy and several other limits. However, Im counting the days until its over (Im in my third quarter of this). I didnt have a hard time with chemo at all- not side effect free but nothing bad at all so I was really surprised I had such a violent reaction to this drug.

Kristy 

my2boys

Hi Everyone,

FYI - They unblinded me and I have the peace of mind I need to continue on with this fight.

Treatments are going very well.  Feeling very good and very active.

Good Luck to all of you and thank you again for your help.

KristyAnn

my2boys,

I am SO thankful you were successful in getting unblinded- I will continue to pray for you in your treatment journey!

Kristy 

gramma23

My2boys, I am happy for you to know what you were taking. I am certain I was taking this awful medicine and I would not choose this again. I hope they can find something that is not too hard on you. Have they said what you will be taking? I wish you health!

KristyAnn, I am glad you can do this but I am not sure how you managed it. I did have a rough time with TC and so I guess I should not be surprised I could not take this. Monday when I took the 5 pills within an hour I was sick and after throwing up I started burning real bad when I went to pee. Like a worse urinary tract infection I had ever had but then I was taking Zofran for nausea so I am not sure which was hurting me. the nausea med gave me a terrible headache too. I do not think even if I had cancer I could take this. I was not this sick on TC. I go today to finish the tests to end my trial. My nurse said not to feel bad I could not do this. I still can't eat very much and have lost 5 lb already. I do need to lose weight but not this way!

Carolyn

Carolina59

my2boys, so glad to hear that they unblinded you and that your tx is going well. May you continue to feel well and soon be NED. 

ipursuit

Hi ladies,

my2boys, I am glad that they have unblinded you and hoping the new treatments go easily and successfully for you.  I see you have deleted all of your posts since news of your recurrence, and I would hope that Pfizer/Wyeth is treating you well in exchange for removing the comments.  I hope that you will be able to post and participate in this wonderful support site going forward, since you will need it more than many of us.

I just took my second day's dose on the trial.  I had read parts of this thread before going thru the prelims, but held off on reading it all until after I started yesterday.  I read all the posts, which took a heck of a long time.  So far I am having minimal (but distinctive) SEs - queasiness, bloating, belching.  I NEVER have these, so I expect it's the meds.  I have a "cast iron" stomach and have gone many years without ever being nauseated by anything.  With chemo (TCH) I had horrific SEs - but was told that most of it was probably due to the steroids (dexamethasone) rather than the chemo.  I had horrific constipation and bloating so bad I couldn't even sit or sit up.  I have a strong tendency to "stopping up".  As a result, I'm hoping I have an easier time with this med. 

I am on the trial thru a new doc in Atlanta.  They have had 4 women just go off the trial because they couldn't work and travel with the SEs.  To follow up, the nurse coordinator contacted Wyeth/Pfizer, who assured her that there are many on the real drug that are having few to no SEs.

Having read thru everything here I have a few questions for you ladies.  Several have mentioned the color of the pills inside (white) and out (salmon), I thought that Wyeth would have the pills look identical, since otherwise the doctors/nurses running the trials would figure it out and not be "blind".  But then someone else said that the FDA might not allow them have the real deal be identical to the placebo. bonbon6565 mentioned that her pills were OVAL.  Mine are rounded rectangles/oblongs that are very tiny (3 x 10 mms) with W104 printed on them. What do yours look like?

Secondly, I have been thinking about why Neratinib might cause the difficulty with dairy.  Being a major dairy fan, I anticipate this may be my biggest issue if I am getting the real deal.  The lactose in dairy products is broken down in the small intestine by the enzyme lactase.  I am wondering if maybe the N is suppressing the intestine's production of lactase or killing off/suppressing the cells that produce it. Since cells in the GI tract have such short life spans, it would make sense that the SEs manifest within 1 - 3 days. Has anyone tried Lactaid with dairy?  Maybe that would help?

Wishing you all good days today and in future.

Ellen

suemed8749

Anne - I'm so glad to hear that you were unblinded and tx is going well. You're in my prayers and wishing you all the best.

Carolyn - Hi from a fellow TCH camper! Wow, I can't believe how this drug affected you. Hope you're feeling better soon. The data gathered on your adverse reaction is very valuable to this study - so you contributed a lot even though you had to quit.

Welcome, Ellen. My pills seem to be identical to yours, and I've had very subtle side effects ( if any). I've been in the study for 3 months, and I'm fairly convinced that I'm getting the placebo, although, as my trial coordinator points out, I had very minor SEs from TCH and Herceptin, so who knows.

vickib

I am so happy they unblinded you!! Good luck with your new tx.

beebusted1

Anne: Glad you now have the peace of mind to concentrate on your treatment and getting better :>

Ellen: Mine look like mini advils, I think everyone's look the same. It appears for the most part that if you f tolerated chemo and herceptin fairly well, you're able to tolerate the neratinib the same..just my observation.  While I don't have the extreme SE's of some, my bowels and stomach have never been 100% since starting 6 months ago and I do tire easily. Good luck and feel better.

mare

KristyAnn

Mare,

I think I was the exception- I tolerated chemo and herceptin really well but I had the extreme side effects with neratinib- finally managing after two dose reductions. I also tire more easily but I dont know whether its the neratinib, chemo, radiation, hysterectomy or just the whole combination of the last two years- I suspect the neratinib has some fatigue effect but I just cant separate it from everything else Ive dealt with and Im holding my own pretty well with it right now!

 7 months down 5 to go!!!!

Kristy

gramma23

I am so glad all of you can do this. It was last Monday I took my last one and was throwing up more than I ever did with chemo. I got sick again last night at work. the others are going to think I just get sick on Mondays. I was about to pass out last night though instead of nausea. I am not sure what happened it just hit me all at once. I am beginning to think I am never going to get better. It could be my blood count I guess. My tummy is still not 100% after those 5 horrible days of Neatinib. I will be ya'lls cheer leader. I appreciate everyone that can go through this.

Carolyn

annamari

Hi everyone!! I would like to wish everyone of you a Happy and Blessed Mother's Day tomorrow.  Enjoy your childern and your mothers.  I do have a Question.  Have any of you gals developed a sudden onset fever for no seeable reason.  I have and Blood work, Chest X-ray and urine clear.  An emerg GP put me on antibiotics...I'll be in contact with the trial nurse on Monday.

ipursuit

gramma23/Carolyn - I remember your travails from the TCH topic/thread last fall and summer.  SO SORRY to hear the Neratinib has been such a problem for you!  You have been through so much over the past year, I certainly hope that things start to go better for you.  You deserve to have an easy time now,

 Annamari, no fevers for me - of course I am either one of the 20% with no intestinal SEs or one of those on the placebo.  I'll bet your problem is something totally unrelated,  Let us know what happened. 

KristyAnn - Mine has been the opposite of your experience.  I had horrific SEs from the TCH - my doctor thought the worst were from the crashing coming off the steroids, and was unable to work at all.  Now I am feeling pretty good, but very tired still.  I have to sleep at least 7.5 hours nightly to be able to function.

All the best to you ladies!  Anyone who starts on the trial or is having few SEs, please report.  I would be most interested to hear about your experiences.

E

gramma23

Ipursuit, I am happy you are doing well. I feel okay right now but I had to have another procrit shot yesterday. My blood hemoglobin was at 11 though which is pretty good for me. I don't go back for a month now and if I am still at 11 or better I am going to not take the shot. I may even stop at 10.5 to see if I can maintain at that and if I can I can deal with that. I do not think I will ever be up to normal with my other problems. I also sleep a lot it seems right now. Maybe we just need to rest for a while. work gets me down still and I am only working 4 to 5 hours a day. I didn't work for 7 months and I sure don't know how anyone did it but I guess they were stronger than me. I am a wimp! I really would like to get my port out but the onc says indefinite. and the day I had to have fluids during the trial med I was glad to have it so I won't complain I guess.

Keep up the fight everyone. I can at least be your cheer leader. I wish I could have done more. I am hoping they could at least used the tumor to get some information and research. I guess I will never know.

Carolyn

annamari

I was put on antibiotics and I'm feeling better.  Still don't know why I ran a temp but I'll be OK.  I'm flying to see my sis in Ont.  she has colon cancer and is now terminal.  I will be back in about 8 days barring any unforseen circumstances.  Gramma 23 you are not a wimp.  We all dilike this disease and what it does to us.  Get feeling on top of the game soon.  Hope everyone is doing well and see you back on line then.

Boo307

ipursuit,

I expect to start the study in three weeks.  I have the screening testing scheduled the end of May and hope to do as well as you. 

Boo307 

gramma23

Boo307, I hope you do better than I did. I think I was the exception rather than the rule. Kristyann is doing good and in fact almost finished. Must be about 4 or 5 months left for  her but you may have to lower dose or 2. I hope you can do it.

Carolyn