Lapatinib and/or Trastuzumab Treatment Optimization Study

Good luck on the study!   I'm not in a study, but I've been on the combo of herceptin and tykerb for over a year now and find the combo muuuuch easier than chemo!  PM me anytime if you have questions :>  lisa

TonLee-

I had my first appointment w/ chemo dr yesterday and given infor on this very study.  Have you started yet?  They said the trial is closing in a couple of weeks.  I am very green at all of this- was just diagnosed 4/18/11, had bi lateral mastectomy left side and just had a port put in.  I am still learning all the lingo on this board but would really appreciate someone to talk to about this clinical trial and anything you have found out.  What made you decide to do this?  any kind of feedback you have would be so much appreciated.

Yaya42,

 I wanted to do this study and was excluded because I have had abdominal surgery that affects my ability to digest food and that was a disqualifier for me.  I did extensive research on this, however, so maybe I can shed some light.

What science is finding with Her2 positive breast cancer is that there are actually 3 Her receptors that are at play in the progression of the disease.  Herceptin contains antibodies that bind with the Her 2 receptors on the cancer which renders the cancer cells unable to multiply.  It doesn't kill them per se, as chemo does, but it "turns them off".  It also binds with the Her 2 receptors on non-cancerous cells - thus, you get a few side effects like a runny nose, brittle nails, etc. - but NOTHING like chemo, so Herceptin is very well tolerated.

Lapatinib is a monoclonal antibody, much like Herceptin, that binds with the Her 2 receptors in the cancer cells, but it also binds with Her 4 receptors in cancer cells.  Research shows that the Her 4 receptor can come into play for some women and actually kick start the cancer - allowing it to multiply - even when a women has taken Herceptin to turn off the Her 2 receptor.  Researchers believe that this is what may be happening for those women for whom Herceptin doesn't work - the Herceptin is binding with the Her 2 receptors, but the Her 4 receptors are becoming more active and allowing the cancer to grow.

If you enter the trial and get Herceptin for a year, then you are getting the gold standard treatment that every Her2 positive woman gets - so you don't have to worry about being under treated.  If you get Herceptin for 6 months and Lapatinib for 6 months, then you are getting treatment for the Her 2 receptor and the Her 4 receptor, which may give you added insurance against the cancer coming back.  Some women may worry that they are getting Herceptin for only 6 months instead of a year, but there are two reasons not to be very concerned about this:  Number 1 is that there are studies in Sweden showing that women on 9 weeks of Herceptin do just as well as women who take 12 months of Herceptin, so certainly 6 months should be plenty; also, the Lapatinib counteracts both Her2 and Her4 receptors, so you are getting the "coverage" that you need.

 If you are in the arm that doubles up on Herceptin and Lapatinib for 12 months, then you have hit the gold mind of all solutions.  

Currently, there are trials for another Her 2 monoclonal antibody - Neraptinib.  As I understand it, it addresses Her 2 receptors, Her 4 receptors and Her 1 receptor.

The real discovery will be when they find a monoclonal antibody for the Her 3 receptor, as researchers have discovered that the Her 3 receptor up regulates the Her 2 receptor.  In other words, the Her 3 receptor is a "crutch" for the other Her receptors - if it is in good working order, then it helps the other receptors resist medications such as Herceptin, Lapatinib and Neraptinib.  If the Her 3 receptor is disabled totally, then it is believed that the Her 1, 2 and 4 receptors can be shot down very easily.  Finding an antibody for the Her 3 receptor will make the news much like the discovery of Herceptin did.

All in all, in my opinion, you can't go wrong with this trial.  If, for some reason, you are not chosen for the trial, then consider a different trial when you are finished with your year of Herceptin - the Neraptinib trial.  It is for women who have positive nodes who are within a year of finishing their Herceptin treatment.  It is an oral medication and you have a 50/50 chance of getting the medication or a placebo.  

I hope this helps.  Kelly

skmarm- thank you - thank you so much!  Yes i had another conversation with the lady that would be monitoring the particpants and completely agree with you - I cannot go wrong with this clinical trial so I am going to participate.  I cannot express how much I appreciate you taking the time to explain this to me, in layman's terms.  This will help my family to understand as well.

Tonlee-thank for you the reply.  Yes, aren't we all sorry we are here? lol.  But at this point, I cannot think of a better place to go for such good information and education- and knowing that I am so not alone in this.

Thank you again ladies- and good to luck to all of you as well!

skmarm- I got into group3 with the lapatinib!  Still can't believe it.  Started chemo 6/2- feel pretty puny but better than I did last 2 days.  the other great news is that all my body scans came back clear- brain, bones, organs, chestwall, all clear!  all i have left is micro cancer cells in the blood stream.  Considering the tumor in my left breast was over 9 cm, I feel like walking miracle. 

I think this is the ALTTO trial?   I enrolled in this trial just a few days ago.  I do not know what arm I have been randomized into,  But should know within the next week.  My first chemo is scheduled for 6/16...so I should know soon.  I am keeping my fingers crossed that I will be randomized into an arm with both herceptin and lapatanib.  Either way, I think this trial is a win-win situation and I feel blessed to qualify and participate.  It feels good to help myself and help future breast cancer patients at the same time.  If you think this trial is a possibility for you...Call your oncologist NOW.  The enrollment deadline is June 10th.  Happy thoughts everyone!