ALTTO Trial

olduser

My partner, Joyce, just started the Phase III ALTTO trial a few weeks ago. There are four arms of the trial. Her arm goes like this: 12 weekly treatments of Taxol/Herceptin, followed by 6 weeks of radiation, followed by 34 weeks of Tykerb. The purpose of the study is to see if Tykerb works as well in the earlier stages of HER2+ breast cancer as it does for Stage IV cancers. From what I understand, Tykerb is the same type of drug as Herceptin, but it is a smaller molecule so it penetrates the blood/brain barrier, which Herceptin can't do.

 Is there anyone else participating in the ALTTO trial? I'm curious to hear your experiences. 

Mary 

ejlj

mary, I'm not on this study, but being that it's a phase III, have you heard any preliminary results.  The tykerb seems like it would be an extra insurance plan for brain mets.  I hope it proves promising.  best wishes  tina

debic

My sister and brother-in-law who are doctors just got back from a lecture on this.  They went because I am Her2 so they wanted to learn more.  They say that herceptin  is good for preventing met everywhere except the brain. Tykerb can help with this because it can penetrate the blood/brain barrier like Mary said.  It is funny I was just talking to my sister this morning about this.I had a year of herceptin I wonder if we will be able to Tykerb even after we are done treatment?

Debi

olduser

I haven't really heard anything about preliminary results from other participants. Apparently, the trial is world wide, with 8,000 participants. The doctor who is one of the leads for the trial is Edith Perez from the Mayo Clinic. From what I understand she was one of the doctors who helped get Herceptin approved for earlier stage HER2+ breast cancers. I guess the doctors are looking at the possibility of doing the same for Tykerb.

krcll

Does anyone know anything about the preliminary results? I am on this trial.

orange1

They will not perform even a preliminary analysis of the data until a predetermined number of "events" (recurrences) have occurred.  Otherwise if there was a slight trend favoring one treatment or another, even if it were so small it was due to chance, everyone would start going on the treatment that trended a little better and investigators would never be able to fill the required enrollment for the trial, and the world would never learn which treatment regimen was truly best. 

Even after the predetermined number of events have occurred to trigger a preliminary analysis, the results must be dramatic (like they were with Herceptin) to cause the trial to be stopped early.  This is done to ensure that there is enough data to make statistically sound conclusions.  If the data do not support early stopping (after the preliminary analysis) it does not mean that there wasn't an advantage of one treatment over another, it just means that it wasn't so overwhelming that it justified stopping the trial early.  It may still show statistical significance, with clinically useful differences between the therapies. 

It is unusual to achieve results dramatic enough at the preliminary analysis to justify stopping the trial.  I expect it will be difficult to achieve that in the ALLTO trial because with anti-Her2 therapies (Herceptin and lapatinib) in the mix - it will take a long time to accumulate the required number of events.  Women will not have recurrences very often because of anti-Her2 therapies - and you can't improve on a non-recurrence.

To all women participating in this trial:  Thank you!!