Anyone doing T-DM1 Clinical Trial in Adjuvant setting?

cellomom

This is so interesting.  I know I even asked my onc about T-DM1 and he advised me that I didn't qualify because of my stage.  Which of course, is a nice thing to hear, but the results have been so good that I always thought it would be nice if it were offered to other stages.  Can you tell me where to find out more information about this small trial that involves ladies with stages other than 4?  As you can see, I am similar to you. 

Thank you and be well.

Bump...is anyone doing this trial now.  It is the KATHERINE trial.  Ive included the link.  Just trying to find out info, may be a possibility for me.

http://www.clinicaltrials.gov/ct2/show/NCT01772472?term=katherine&rank=2

hi Celesteva, I think that we may be a rare group....I had heard that there are only 100 women worldwide in the study so far. Not sure if that's true??? I met with a new onc yesterday and if I am accepted into the trial I will need to transition my care to Karmanos cancer center in Detroit, Mi since they are an approved site for the trial. So I signed all the consents and had blood drawn just yesterday. Had a MUGA scan done earlier in the week etc. the only reason I may not be accepted into the trial is if I go past the 12 weeks post surgery cut off point. Right now I'm at week 10; the new onc says that I still have a good chance since "they" really want and need subjects for this study and so it's not uncommon for studies to make exceptions.  Lets definitely keep each other posted. Feel free to PM me. All the best and blessings to you  

Jut finished up TCHP (6 rounds) and have completed 2 rounds of herceptin. I am 3 wks post BMX. I am meeting trial coordinator tomorrow to sign up for KATHERINE. Won't know what arm I get into but MO wants me to get into the TDM1 side. Is anyone still in or has compledted the trial? Any advice on SEs or have they been minimal...Thanks.

Thanks for replying, I met with trial coordinator and my name is in the hat. I'll let you know what arm I end up in.

AYNIL, there's a Kadcyla thread in the Stage IV forum. I would also recommend http://www.her2support.org.

We were aware of the trial and my wife's medical oncologists at the James in Columbus recommended it. She called T-DM1 a "cancer bomb"! They are so optimistic about the trial that three out of four women in the trial will receive the T-DM1 treatment as opposed to the 1 of 4 who will receive the "standard of care" treatment of Taxol/Herceptin.

Unfortunately my wife was disqualified when an initial IHC test post surgery showed her as negative for HER2. Follow up FISH testing still indicates HER2 positive because of copy number.

Good luck!

I just signed up for it, they are doing the trial at University of Pittsburgh Medical Center. I refuse to read anything online anymore, as it only created anxiety... but did read some nasty side effects of TDM1 and it scares me. I just had my 10th round of herceptin and do okay on that. It's tough making a decision like this! I may back out but not sure what to do.