Neratinib Clinical Trials

Just found this great website, pretty interesting as I was asked for the trial.  Almost finished Herceptin, and I'm wondering what do you think about it as "old timer"? Should I or shouldn't?

Am I right that there is a lot of s/e for those who probably have the N and not much for those who probably have the placebo?

Was pretty well on Herceptin and don't feel great thinking of starting again to feel bad...

You guys really rock, there is a lot of good info in your posts. 

Shell

Shell, even those that get the real stuff have different reactions to it. I know Kristyann has almost finished but she had to lower her dose a couple of times. I could not even get past a lower dose one time. I took my dose of 5 for a lower dose and within the hour it was hurting my stomach.by evening I was throwing up. the main thing is make sure if you do this they don't charge you for the tests they do to make sure you don't have cancer. I have been charged for most of my tests and I am tired of fighting about it so since my insurance paid for them I guess I will just pay my part and be glad it was not more. I think if I knew what I know now I would go to another doc for the trial instead of my onc. this way they make sure they don't charge you but they charge the study group. I am sure they are double dipping with that. for me this was a bad deal all away around. for others it is a good thing so you will only know if you try. I would say why do you want to try? Make sure you know all the s/e possible and what can be reversed and what can't if you get the real deal. also make sure they don't charge you for the tests. I thought I was but I guess I was not meant to do this. I wish you the best.

Carolyn

Thank you all for your reply.  Working in a research center with bc study, and having battle this IBC, I have pleny good reason to take part of the study. Particularly that I would be the first one to take part of it.  And yes everything would be paid, even the parking for the visit.

But, I also have neuropathie I deal with everyday due to chemo and some fear of being sick that I deal (you all know wath it is I think)... I went through all my chemo treatment without not much nausea and no problem on the other side (diarhea or constipation), so I'm not sure at all I am ready to deal with diahrea and nausea... even for one day.  Now that I'm back to work, I need all my energy everyday.

Still thinking of it, thanks again for your input, it is very usefull!

shell

Shell,

Like you I had few problems with diarrhea and nausea while on chemo. My main issue while on Herceptin was neuropathy.  Interestingly, neuropathy has been my dominant SE while on neratinib.  I have stopped twice for 10 days each time going down to 5 pills because of foot and leg cramps and pain. The leg and foot pain seems worse at night.  My joints hurt in my arms and legs.  Towards the end of the 10 day period my pain & cramps were about 90% gone. Being in this trial has not impacted my ability to work full time; however, I probably don't exercise as much when my feet and legs are bothering me. My potassium has been low, but taking a supplment has helped greatly. Headaches. Mild to moderate bouts with diarrhea, but never to the point of having to take anything for it. My finger nails have taken a beating each time I have started back to neratinib.  Personally, I'm glad to have the chance to be in the study. Much of what I've read in various medical journals appears promising.  I have the same oncologist for this study that I had during chemo. I think that it's got to be a plus to be followed more closely regardless of if you end up on the placebo or the trial drug.  I hope some of this is useful. 

Thank you very much for taking the time to answer me, you really are amazing women!

Will surely let you know what will be my decision.

Take care,

Shell

I am new to this forum.  I hope it is ok to post on this thread.

A little over year ago my Mom had a mastectomy.  There was no follow-up radiation or chemo as the Oncologist felt that this was optional in her case (the tumor had good margins and there was no spread to her lymph) She was told that she had a 7% chance of recurrence within 10 years.  A few weeks ago, at her routine checkup she asked her surgeon about pain she was still experiencing a year later.  He examined her and felt several lumps that had not been there at the previous checkup.  This lead to a round of tests which revealed that she had stage IV metastatic breast cancer with a local recurrence and bone mets throughout her skeleton.  She is HER2 +, but negative for hormone receptors.

 She has been told that she is eligible for the Phase III first line study to test the efficacy and tolerability of neratinib + paclitaxel vs herceptin + paclitaxel. If she decides not to enter the trial her oncologist will treat her with radiation for the local recurrence, chemo (taxatere) and herceptin, as well as bondronat for skeletal support.

 The one thing that concerns us about the study is that they want to delay radiation until after the first round of chemo (12 weeks) is complete.  We are wondering whether this poses a risk or if it is safe to wait with the radiation.  We also want to be sure that neratinib is at least as good as herceptin.  She has not been randomized yet, so we don't know which drug she will be getting.  We will be making a final decision this week as we are anxious for her to start treatment.

Finding it terribly stressful to come to a decision, but very excited about what these drugs could do for her.

Hi annamari

 Thanks for responding!  Very helpful to hear from someone who has been there.  How did you tolerate the Taxotere?  I have read that the SE's are heavy going!

Yes her Onc would know best, the question is which one?! Her original Onc recommended the radiation plus  Taxotere and Herceptin.  We saw the second Onc for a second opinion and she recommended the clinical trial.  She is also the chief investigator in the trial.  She seems very excited about it and called it a "great opportunity." We are attracted to this trial because it is not a blind study - she would know which drug she was getting.  The sponsor would cover all her costs. She would get a a lot of additional screening and personal attention.  We could also pull out at any stage.  We just want to be sure that we are getting the best advice and that the study is not being prioritized over the individual patient. In a way I feel like we have more to lose because we have not tried any other treatment path yet.  It is one thing to go with a trial if she has already tried something else and has stopped responding, but to start with a trial seems like such a roll of the dice!  On the other hand if we went with the first Onc my Mom's insurance would not cover the full costs of the treatment and we would have to pay a lot of money for the Herceptin, especially if she was on it long term- although that is not our primary motivation.

We will probably seek a third opinion to see if that helps us make up our mind.  My Mom feels really strongly that she wants to go with the trial and in the end it is her decision.  We can only support her in reaching that decision.

annamari: all the best for your recovery! How long has it been since you were first diagnosed?  

Vashti

I was diagnosed Dec 15, 2008.  It has been a long haul and in the USA I know you have to pay for a lot more of your treatments than you do in Canada. My treatments were all covered by health care and the neulasta was covered by my work health benefits,  I can understand your Mom's position becuase I'm sure she is thinking of the financial aspect as well plus the increased testing she will recieve without cost to her or the rest of the family.  A third opinion is a good idea. I hope and pray that which ever treatment she takes she will tolerate it well.  When I had taxotere. I lost my hair on my head and my body,  my finger and toe nails, very low neutophils which put me on neulasta which is also very expensive about$2700.00 per shot which I had to take the day after my chemo.  Nothing is easy about this disease.  If I don't reply for a while in the near future it will be because my sis will have passed away.  She has fought colon cancer for the last 5 years and my not make it through the night.  I will have to travel to Ontario for the funeral.  I truly wish youal the best and keep us posted.

Oh yes, just an FYI - we are located in South Africa.  Without the trial, even with insurance there would be an amount we would have to cover, and even with good incomes, savings and everyone pitching in, it would be virtually impossible for us in the long run.  I am talking "sell your house and that still won't be enough" type of money.  So we definitely hate making a financially motivated decision on this one but we are thinking positive and planning for a long survival and want to make sure that the medical costs will be covered and that we will still be able to keep a roof over our heads.  We are assured that all costs will be covered by the sponsor, including long term Herceptin, but I am definitely going to double check on that, based on the experiences others have reported on this thread!

Vhasti oh you and your family are in my prayers.  Most people I know do not have radiation at the same time as chemo.  Standard course of treatment is chemo than 2-3 wks off (testing) and than radiation for 5 to 6 wks.  So don.t worry that's totally normal.  

I had TCH and yes I lose all my hair. 6 treatments every 3 wks with herceptin and than continued with herceptin alone for a total of 17 treatments.   Biggest daily problem I had with TCH constipation and I mean it was bad.  The problems with the neratinib reported by women on this site is extreme diarrhea.  On the bright side maybe the two will balance out.  I will be stating the neratinib study this month. 

 I am really interested to find out how your mom makes out with the study, since it's the way she wants to go let's embrace it and pray for the best outcome. 

I wish money was not our roadblack but that too is why I am going into thisneratinib trial.  At least my testing with be covered.

got to go for my 3 motnhs check up.  have a great day everyone.

Vashti,

Good luck with the trial - they are seeing really goos results in the trial with the Stage IV women- one nice advantage if she gets the neratinib is that they think there is a possibility it can cross the blood brain barrier which might help if mets have already started- herceptin does not cross the blood brain barrier.

 I had terrible side effects with neratinib and the answer to what happens if you get vomiting and diarrhea at the same time for me was - sit on the toilet and throw up in the trash can! At the time is seemed like the less messy and easier to clean up- I also learned to keep plastic liners in all the trash cans!

Kristy

2 weeks ago I went to spend some time with my sister and traveled by air.  I wore a compression sleeve because I do not want to get lymphodema.  I took an aisle seat and had no problems.  I work full time and doing OK  I take my pills at noon and other that some diarrhea and some fatigue I can continue with a normal life.  My sister passed away last night and I will be flying to Ontario again tomorrow.  Blessings to all.

Hi all, been awhile since I posted.  I was so bummed about Anne that I had to take a step back. We go/went to the same trial nurse.  If you are still reading the posts Anne, you are in  my constant thoughts and prayers. To all the new gals, hello. I joined the trial not only to do everything I could to fight this crappy disease from re-visiting, but also its my way to pay homage to all those tough ladies who did it for me with herceptin.  I can't thank them enough. One thing I have learned is that no two people are alike in their symptoms or how they tolerate treatment. If you are on the fence about joining and see people who are having a really tough time, that doesn't necessarily mean you will.  I have been fortunate that my SE's have been mild.  Lately my only complaint is severe pain in my hip joints. It got so bad, I had an xray to rule out anything. (I take kickboxing when I can and thought I might have injured myself, but I stopped in April and it is still severe). Wishing you all a happy, healthy summer. Keep the faith and fight on :>

Mare

Vashti, Im so sorry about your Mom.  The important thing is that she will be getting either Herceptin or Neratinib. This Her2+ cancer doesnt respond very well to chemo so at least she will be getting one of the drugs that knock this down. Ive heard stories of the cancer count going down unbelivably after Herceptin has been given. Plenty of woman have stayed on Herceptin for years that have matastatic disease and led generally normal lives. I only have 89 days left in this trial. For me its been relatively tolerable. Lot of joint pain and very tired. Ive only had to reduce my dose once. For me taking the drug at night on a full stomach has kept the nausea and Big D at bay. Im very ready for this to be over. Herceptin was much easier. I wish you luck and please keep us updated about your Mom. God Bless, Cora

I go for my Muga on  tues and if they told me I had to stop takeing the drug Id be relieved. Im so tired. Tired of being tired and tired of hurting. Id just like to get back to normal feeling. This is probably the worst Ive felt mentally since my diagnosis. Even laundry seems like a huge chore. I just cant seem to get things done. My bills dont get paid, my house is dirty, my plants all dying. Its like someone took the wind out of my sails and Im just drifting. Im really counting the days. I know it took me six months off Herceptin to finally start feeling good so Im hopeing this is the same. Right now it seems like an eternity but I know time does pass, even before we know it. If this drug does what its supposed to it will be worth it but for now, its so hard. I thank God my kids are pretty much grown and for take out. Im very strong but looking back, I dont know how Ive done this. Its been a long haul. One foot in front of the other, and off we go!  Cora