Neratinib Clinical Trials

suemed8749

I LOVE the talk about the low recurrence rate among those of us who are node-negative Her2+! Thanks, thanks, thanks. Since I haven't had any of the nasty gastrointestinal side effects, I figure I'm getting the placebo, so this is GREAT news!

Hope everybody is feeling well and keeping those side effects at bay. Kristy, I used to go to a women's retreat every year, and one of the end of camp awards was The Golden Toilet Seat, given for obvious reasons. Wish I had one that I could send you - you deserve a special honor!

my2boys

Well....My cancer came back. 

I have spent the past month back and forth to doctors and Pet Scan to determine the extent of the recurrence.

My onocologist requested that I be unblinded from the study since I was told to discontinue the pills and she is considering putting me on Tykerb because Herceptin obviously didn't work for me.

The Clinical Trial office that was always so nice has turned cold and the drug company is refusing to unblind me.  The people at MSK have tried explaining to them that Tykerb and Neratinib are in the same family of drugs, so it is necessary to unblind me, but the drug company thinks they know more than the people at Memorial Sloan Kettering.

If I had it to do all over again I would not have participated in this trial.  Their refusal to unblind me could cost me my life.  I asked the Clinical Trial Coordinator if she was willing to explain this to my kids, since their mom could very well die from their refusal to help.  If I die, THEN they will tell my family what drugs I was on.  They were all nice and cooperative until I had a recurrence, then their attitude changed.

Of course the professionals at Memorial Sloan Kettering continue to rise above this nonsense and will do what they need to do to try and get me through this.

The people at Wyeth should be ashamed of themselves for gambling with my life.  I thought I was in good hands....guess I was fooled.

AmyIsStrong

I am so terribly sorry to hear that you are facing more of this, my2boys.  I hope that your medical team will do the fighting with Wyeth and not leave it to you to do. You have enough going on right now to deal with.  If you don't mind, it would be so helpful to get more details - how did you find the recurrance and what are they going to do?  You are in our thoughts/prayers. PLEASE stay active on the site - either on this thread or another, to get the support you need right now.

I don't understand what the unblinding means and why it is so important. But I totally respect if you don't feel like writing more about it right now.

Amy

traceyz

WELL LADIES.....I THOUGHT I WAS GONNA BE ABLE TO GET IN ON THIS BUT MY BLOOD COUNT WAS LOW AGAIN!! GRRRRRR! NOW THE TRIAL DOC SAYS I NO LONGER QUALIFY FOR THE STUDY. BECAUSE I HAD A COMPLETE RESPONSE TO CHEMO AND AFTER CHEMO MY NODES WERE CLEAR. PRIOR TO CHEMO I HAD 1 NODE BUT SHE SAYS THEY GO BY WHAT YOUR NODES LOOK LIKE AFTER CHEMO. SHE DID SAY THAT THOSE OF US WHO END UP WITH CLEAR NODES HAVE A LOW RISK OF RECURRENCE AND IT MAY NOT BE WORTH THE EFFECTS OF THE DRUG IF YOUR RISK IS ALREADY SO LOW. BUT IT WOULD HAVE BEEN GREAT TO KNOW THAT I HAD DONE 1 MORE THING TO REDUCE THE RISK. BUT I AM TRULY THANKFUL FOR THE COMPLETE RESPONSE TO CHEMO AND HERCEPTIN!!

I AM SO PROUD PROUD PROUD OF ALL OF YOU LADIES WHO ARE DOING THIS. I PRAY FOR THE AFFECTS OF THIS DRUG TO BE MAJOR AND I ALSO HOPE THEY FIND A WAY TO DO SOMETHING ABOUT THE SIDE EFFECT. WE REALLY ARE ALL WORRIORS!

YOU ALL AMAZE ME!!

jap

my2boys,

I am sorry to hear that the cancer came back and am very upset that the drug company wouldn't give you the information you need.

Do you have the contract that you signed when you started the study?  I believe it states that the study would be unblinded if the cancer returned while on the drug.  This is legally binding.

Whether or not its in the contract, I think they will be more responsive to a call from a lawyer than a doctor.  Doctors have to keep on good terms with drug companies;  lawyers do not.  Then there is the FDA -- perhaps a committee on ethics in drug research?  I certainly would call the FDA ask is there is a section of their agency that deals with these sorts of problems.

I think if you turn up the heat using more powerful advocates, you will get the right reponse.

Please let us know what happens.

All my best wishes,

Jo Anne

traceyz

MY2BOYS,

SORRY TO HEAR ABOUT THE RECURRENCE!! I TOTALLY AGREE WITH JAP!! MAYBE A CALL FROM A LAWYER WOULD SHAKE THINGS UP A BIT. IT PISSES ME OFF THAT YOU ARE BEING TREATED THIS WAY. IT SEEMS THE VERY COMPANY THAT IS SUPPOSE TO BE HELPING YOU HAS NOW TURNED THIER BACKS. BUT I DO BELIVE THAT WHEN I WAS BEING CONSIDERED FOR THE TRIAL I DID READ THAT THEY WOULD HAVE TO UNBLIND IT IN THE EVENT OF A RECURRNCE. SO PLEASE GET A LAWYER INVOLVED, SOMETHING TELLS ME THEY WILL THEN COOPERATE. ITS JUST A SHAME THAT YOU HAVE TO FIGHT WITH THEM AT THIS TIME!! GRRRRRRRR!!! WELL PLEASE KNOW WE ARE ALL HERE FOR YOU AND I WILL BE PRAYING FOR HEALING. SOMETHING TELLS ME YOUR GONNA WIN!!!

TRACEY

suemed8749

my2boys - Joining in to say how sorry I am to hear your news and that you are in my prayers.

Estepp

What Tracey said! AMEN!

carykim

(((my2boys)))  so sorry to hear this news. Angry that you aren't getting the information you need. Sending you strength to fight another round.

I had to take a week off and step down in dose to five pills a day. Relieved to read what someone said about them starting us off so high to make sure it's effective. Max dose was just too much for me, diarrhea-wise. Five seems to be ok. Not taking immodium, avoiding dairy and alcohol helps too. 

The lower leg/foot cramping continues. Also have cuts that don't heal on my fingertips. Top of my foot soreness is keeping me awake right now as well as the sudden realization that when I was at my three month check up this week, I answered a question about hair loss very matter of factly that it wasn't bothering me. It actually has really been falling out, but I didn't really think it could possibly be related. Now that direct question has me thinking, "hmmmmmm...." I put my hair up in a pony tail and it felt so thin all of a sudden. Anyone else finding hair issues?

cary

gramma23

I started my pills yesterday and within 6 hours my stomach was killing me and hurt off and on all night. If I got up and ate a few crackers it would relieve it. Has anyone on this board felt this way or is it something else? I can say here in Oklahoma this study is closed to anyone that is node negative. I had a large tumor and 4 nodes involved. If I can not work because of this I can't do it but I will give a little bit to see. I have been on the boards with a few of you before. I appreciate all the input from everyone. My doc and study nurse was surprised I knwe so much about this trial. they are clueless or at least seem to be. could be an act.

Carolyn

my2boys

Thanks for the support ladies.  I am still in shock and cannot believe that some drug company employee who never even met me is determining that I will not be unblinded.  What's worse is that my clinical trial doctor and his assistant who were so supportive have done a complete 180 and sided with the drug company.

I am hoping that my oncologist at MSK can get to the bottom of this.  As for a lawyer, I wouldn't even know where to begin to find one who handles things like this.  Nothing like calling around looking for attorneys to battle drug companies while on chemotherapy for the next five months.

I begin dose-dense chemotherapy on Monday, followed by radiation.  As far as a follow up drug goes, it's basically a crap shoot, since Wyeth won't tell my doctors if I was on the drug or not.  This is just heartbreaking for me, my husband and my kids.  They are so young.......this is so unfair.

My guess is that the drug company wants me to disappear now that they're done with me.

jap

I am very upset about my2boys situation and am determined that something be done about it.

I have called Pfizer (who has bought Wyeth) but got the runaround.

I think a more effective way to get the information is to have my2boys' member of Congress call the Federal Drug Administration.  This agency must approve all trials (including this one)and drug companies want to avoid any problems with them.  This would take only one telephone call to explain the problem (make sure you get a real staff person, not a college intern).  The senators representing NY are Schmer (1-202-224-6542) and Gillebrand (1-202-224-4451).  Ask for an aide that deals with the FDA.

Is there anyone on the list from New York who could help?  I am from Mass.

The oncologist might still be able to help but the ones I know do not want to alienate the drug companies.

Meanwhile I am still working on Pfizer (1-212-733-2323).  I think if they know that many more people are concerned about their irresponsible behavior they will give my2boys the information.

My thoughts are with my2boys and hope the dose dense chemo takes care of the cancer quickly.

Jo Anne

1rarebird

I am not sure what to "unblind" means in the context of a clinical trial.  I am guessing that it means t that the trial's administrators will tell the patient whether they are receiving the drug being tested or something else.  If I am correct, and my2boys needs to know whether she has been receiving Neraptinib and the administrators won't tell her, then would it be possible to have a laboratory analyze the contents of the medication (pill) to see if it only contains inert ingredients (the placebo) or does it have a compound in it that would indicate the presence of the drug?  If this were possible (and I assume the oncologist would have to be willing to provide a sample of the pill unless my2boys has those in her possession already) , then going at this problem this way might be faster and produce the needed information without the drug company's help.  Just a thought and probably I am missing something here that makes my suggestion unworkable---- None the less, I can't imagine what it must be like for my2boys to be caught in this bureaucraic medical nightmare.  I wish for her the best of luck.

bird

gramma23

1rarebird, this sounds like an excellent idea but you must give all the med back and that is the reason you keep a log of when you take the med so they can know how many are left.

Do ya'll think that any of the med whether the placebo or the real drug make a person sick? I know my stomach reacted immediately so I was wondering if even the placebo would do this.

I do hope the best for you my2boys

Carolyn

Carolina59

my2boys, I am so sorry to read about your recurrence. I had posted to you a page back about where you enrolled in the study (I'm in NYC), but since met with my onc. who did not recommend it.

You must be reeling from this news, with the added insult of Wyeth/Pfizer's unwillingness to be forthcoming. I agree with other posters that there must be a way to get this info. I would certainly be willing to make phone calls for you if necessary.

And what are they going to do to you if you don't give one tablet/pill back to them? I say, crush it and give part of it to a lab, and give the rest of it back to them--tell them it got stepped on just like they are trying to step on you. Don't give up, girl. This is your life, and you WILL get that info by hook or by crook. It's YOUR medical information.

I have a 5 y.o. daughter (she was 2 when I was diagnosed), and I know what it means to fight to be there for your child(ren). Prayers are with you. 

my2boys

Oh my goodness....thank you ladies.  Your posts made me cry.  Just feeling like I am not alone really helps.  I did try Shumer's office....no answer.  Do you believe that?  Then I tried Gillibrand's and a recorder answered and left me on hold....sigh.  I finally hung up.  I will continue to try and get through to them both.  Thank you Jo Anne. 

I had a long talk with my oncologist today.  She said she will do whatever she can to help me.  She told me that we have a few months to work on this, since I will not be taking Tykerb until follow up.  She made me promise to concentrate on getting through the chemotherapy for now.  I will need all of my strength for that.  It starts on Monday.  She promised that this will not go on the back burner for long and she will do whatever she needs to do to help me feel better.

As for the cancer, I found it myself.....again.  Lump growing right where the original one was.  I'm batting two for two in finding my own cancers.  Both times I felt it and pushed to be diagnosed.  Remember ladies, you are your own best chance.

As far as the pills go, I returned them to the clinical trial coordinator right after I was diagnosed.  They also took more blood and did and EKG for my official exit from the trial.  I did check the contract and although mine doesn't say they will unblind in the event of a recurrence, it does have a paragraph that talks about how similar Neratinib is to Tykerb which is why I need to know if I was on Neratinib before starting Tykerb.  Makes perfect sense and wouldn't hurt their trial one bit to fill me in.  What it could do is stop me from taking a drug that probably won't work and leave me to seek another course of action.

I should know more information by the end of next week.  Apparently there is a group of doctors at my oncologist's office, who will be meeting to discuss the importance of my situation and they will determine what, if any action needs to be taken by them.  They will then be contacting the clinical trial doctor, and he is the one who needs to pressure the drug company to unblind me. What stinks about this whole thing is that some employee at a drug company is holding all of the cards for me and I have absolutely no say in this......talk about kicking somebody when they are down! 

Once again, thank you so much for all of your PM's, posts and concern.  A recurrence stinks, but when you have people lifting you up, it helps it to stink a lot less.

Love,

Anne

jap

my3boys,

You are definitely not alone!  All of us care about one another AND we could all be in this situation unless the drug company is challenged.  I plan to get back to work on this when offices open on Monday.

Meanwhile I will check my contract (which I haven't signed) and demand an addition if it needs it.

It would probably help if everybody checked their contracts and asked to add a section on unblinding in case of recurrance -- and ask your oncologist/study director to contact the drug company (Pfizer).  They must have a telephone number I can't get.  I keep talking to some woman in India who is trying to be helpful but knows nothing about the trial.  

I will report on what I find out at the beginning of the week.

Best wishes,

Jo Anne

P.S.  I am going to try those senators too.  Their staff seems to leave work early.

tarheelrivergirl

my2boys, I am sorry to hear of your recurrence.  I am furious to hear of Pfizer's unwillingness to unblinded you. I plan to bring this up to my oncologist next week.  This is a definite problem that must be addressed right away for you, as well as for all of us.  I wonder how long the drug stays in your system and if it's possible to go to "LabCorp" or some other place and have your blood analyzed to see what drugs are in your system?  They might be able to at least detect an "unidentifiable" substance in your system.  

Carykim, I've gone off the drug for a second time (10 days off and have been told that they will probably do a dose reduce) due to foot and leg cramps. The tops of my feet keep me awake at night, too.  I have felt like a very old woman. My finger tips have cuts and my nails are brittle. However, as I've said before this is exactly the same response that I had while on Herceptin.

gramma23

I have only been on this drug since Thursday and I am ready to quit. I am so sick and I can't put anything in my mouth to eat. I do not know how anyone can handle this even if they had cancer to come back. At least with Chemo I knew I would have a short time I would feel better. Why can't they make this more user friendly. I will try until next Thursday when I see my study nurse again but they need to lower my dose or something. I can't work and do this! I guess if I was fighting for my life I could but right now I just can't!

Carolyn

mthomp2020

Jo Anne, I'm sorry to hear that the trial people are giving you such a hard time about unblinding.  I really do think it's unethical given the circumstances.  They're probably unhappy with you since you're skewing their numbers already.

Maybe everyone on this trial needs to accidently "lose" a pill down the drain!  That way, if they have a recurrence while on it, you'd have something to take to the lab. 

Carolina59

my2boys, thinking about you starting chemo tomorrow and want to wish you well. Your doc is right, you have to focus on getting through the chemo now, and I hope she will contact the powers that be (MSK must have some influence as an institution) so that you can get the info you need. In the meantime, if you need some of us NYers us to make calls to Schumer and Gillibrand for you, let us know.

Hugs to you, Carolina

ipohgirl

Dear Ladies,

Hi there! Just got my bottle of neratinib this afternoon, will start tommorow. Trial doc said to take all six of them -  i weigh 49 kg - during breakfast.

Am thinking thru issues after reading about My Two Boys' experieince. Wyeth should hang its head in shame for doing this. For me, I did ask about the unblinding and the lab doc plus theonco promised that they would unblind in the case a recurrence occured during the next five years.  And, one could join the other trial for mets should mets occur. But I have not checked out this point in my contract yet. And, I am too sceptical to think they will act angelically should unfortunate events happen to us after mytwo boys' experience.

Mytwo boys, My prayers and thoughts are with you. I also wish to thank you  for sharing your experieice since this will help all of us on the trial. Like you said, it is a matter of life and death and the drug company doesn't seem to understand this simple point. For the herceptin trials, I understand that those on placebo were given the real deal when occurence happened. Also, could you please tell me when you started on neratinib? Did you do TCH before that?

One suggestion, ladies. For all of us on the trial, do you all think it would help if we add the date when we started this trial? This will be easier for us to compare the SEs as well as monitor important milestones like three months, six months, etc.  Also, besides the Big D, I think it is important to point out the heart issues involved since most of us started on a healthy heart  (despite the herceptin), otherwise we won't get in. I find the idea of heart damage quite alarming since one might die of a heart attack or stomach ulcers before BC rears its ugly head again......

Hugs,

Ipohgirl

traceyz

ANNE,

YOU ARE STRONG GIRL!! YOU REALLY CAN DO THIS AND COME OUT THE WINNER! HECK YOU HAVE ALREADY WON BECAUSE BY STAYING ON TOP OF YOUR BREAST HEALTH YOU FOUND THE CANCER YOURSELF. AND I HATE TO SOUND LIKE A POSTER CHILD FOR BC BUT AS YOU KNOW EARLY DETECTION IS OUR BEST WEAPON! NOW YOU JUST HAVE TO TAKE THE HEALING DOSES OF CHEMO...I KNOW...YUCK!! BUT ITS GONNA KILL THE CANCER AND YOU WILL NEVER HAVE TO GO THROUGH THIS AGAIN!!! DONT ASK ME HOW I KNOW THAT BUT I DO!!! WE ARE HERE FOR YOU!! TEAM ANNIE IS READY TO CHEER!!!! LET THE HEALING POWERS BEGIN GIRLFRIEND!!!! GET ER DONE!!

TRACEY

vickib

My2boys - So sorry to hear your news. Surely they will release the info so you can get on to the next drug. My prayers are with you!! 

Boo307

my2boys,  my thoughts and prays are with you.  I can't tell you how much I appreciate knowing about the issue of unblinding in the event of metasteses.  I spoke to my Clinical Research Coordinator about starting the trial next month.  I asked him about unblinding in this event and he went through the perspective of the trial protocol and explained how it would somehow spoil the results. 

I asked to then help me understand the issue from the patient perspective and the need for the oncologist to know what the patient has received in order to most effectively treat the cancer.  He was a bit stymed and didn't seem to have thought through the question from that angle.  He acknowledged that there is a conflict between the priorities for the study and the priorities for the patient and will discuss it with someone and get back to me. 

He mentioned that they are amending the trial to change a couple items; 1. Node negative women will no longer be eligible (I got in just under the wire) 2. Adding blood testing every 6 weeks to follow liver levels, I think he said ALT specifically.

Has anyone developed elevated liver levels?  Since they have been enrolling women for six months I wondered if this closer monitoring had to do with a problem they have found? 

Boo

fightinhrd123

Since the amendments i have to go thursday and resign consent.  I wonder if we all do?  Maybe i wont be so anxious to resign with this whole unblinding thing!!!

ipohgirl

Dear Ladies,

I looked through the contract and it was silent on the unblinding.  Thus, the onco and trial doc just gave me verbal assurances. No good, right? I suppose the all those involved in the trial are mainly looking out for Wyeth's interest. Would be interesting to hear from those who were in the herceptin trial.

 In this case, I really have to reweigh the trial since the consequences of not knowing what you received could greatly jeopardise your chances should recurrence happens in the next five years......

Hugs,especially to mytwoboys.

Ipohgirl 

allwin

I was on the neratinib clinical trials from January to February, all in all, 42 days. Unlike the trials you are on, mine is comparing neratinib against a combination of lapatinib and capecitabine. I took 6 pills daily and suffered the same side effects as all of you. I had to take lomotil to help control the big D. I was able to keep the big D to an acceptable level without reducing the dosage. Unfortunately, the drug did not seem to work for me; my markers and calcium levels were too high; I was experiencing pain in my tumor. At the end of the 2nd cycle, my oncologist felt it was time to bail out since I was not getting anything from the drug and to prolong it might work against me.

It was heartbreaking to have to leave the trial but I had to face reality. I am now on lapatinib and xeloda; started on 12 March and am responding well to the drugs. Unfortunately, the mets in my spine seem to be worrisome and I will be seeing the radiologist soon to see about radiotherapy. Though I am not on the trial now, I still read all your posts as they had provided me with a lot of insights and comfort right from the day I joined the trial.

For My2boys, keep your chin up. I know how you are feeling right now because I was feeling really depressed having to leave the trial. It took me weeks to get over the depression. I am feeling better now but with radiation at the back of my mind, I am back to having this feeling that this journey is really a tough and rocky one and each day brings with it more setbacks. I will still fight on and so must you.

beebusted1

Anne: I haven't been on the boards in weeks and just read your initial post.  Since we share the same oncologists I am dumbfounded.To say that my confidence has been shaken is putting it mildly. My brother in law is a doctor and I'm going to find out if he knows anyone at Wyeth.  Unfortunately we all know we are guinea pigs for a money making product...wether the drug works is generally secondary to most. I am crushed for you. Every morning i start my day with a prayer that a) no one else has to suffer this insidious disease and b) those of us who do, are healed and watched over.  You will be at the top of the list. Remember that a positive attitude and positive energy is everything.  We are all behind you. My next appt. is in June, maybe we can finally "unmask" each other Be well and stay in touch.  If you would like to give me your email address, we can talk off the blog.

Mare

gramma23

Ipohgirl, I was with you on another discussion group. I did start this trial med last Thursday and got sick right away. that evening after I took it at noon. I could not eat or drink anything from that evening until Monday. I got dehydrated and got some fluids yesterday. I am going to try a lesser dose next week but my stomach is still rolling and grumbling. I don't think I can do it if it keeps acting like this. I am not sure anyone even with cancer could take this for a year being sick everyday. I want to help but I need to work and live what life I have left. I know if the BC comes back I will have to take something but at that point I will not work. I also can not let this medicine keep me from working because I need my job for the money. I do not work for the fun of it because I don't have fun at work! I could not even cook my husband meals which is important to me. he has to be on a special diet so I need to be available to help him. I just hope a lesser amount will help me get through this. My liver function was good and my blood count was up a little but then I just got a shot 4 days before for that. I also know with the fact I can't get my blood count up I have 3 times more chance of a recurrence. This is another reason I wanted to do this. If I could help anyone else I would but I can not do this under the side effects I was having.

My2boys, I wish the best for you. Fight and don't give up and take whatever they can give you so you can be cancer free. I see many woman at the cancer center I go to that has been fighting for several years. they are doing good and you can too.

Carolyn