[Laurel]

Jaimiah,

You cannot be in another trial where dfs is the end point. If you are currently in a trial you may quickly exit that trial, have a washout period, and join the Neratnib trial, for NOW. However, if that is what you wish to do, you must move very fast as they are drafting an amendment to the parameters for qualifying where you will not be accepted if you were in another trial.

I am currently in the SWOG bisphosphanate trial. If I wish to participate in the Neratinib trial I must move fast. To enter I must quit the SWOG trial, and washout the other drug. This is a bit of a conundrum for me as I know I am receiving a bisphosphonate presently. Since I am on an A.I. I figure this is a positive thing regardless of whether it prevents bone mets. However, if I quit the trial my onc will not put me back on a bisphosphonate until I have osteopenia. If I join the Neratinib trial and I am one of the 50% who receive the placebo, how have I benefited myself?

The trial nurse said they are concerned there will be a large dropout percentage from the placebo group as they will know they are not receiving the drug due to its very classic side effects. It seems no one escapes the G.I. side effects if they are receiving Neratinib.

This is one of those times where I really wish I had a crystal ball. If I could receive a bisphosphonate to prevent the osteopenia, I'd move to join the Neratinib trial (assuming it has not been amended already).

Very difficult to decide...