Phase III T-DM1

[Debbie L.]

Hi all,

I'm at NBCCF's advocacy conference in Washington DC. Anyone else on this list here too? It would be nice to say hello.

I picked up a flyer for Genentech/Roche's Phase III "Emilia" T-DM1 trial. T-DM1 vs. capecitabine (xeloda) and lapatinib (tykerb). I don't see it listed on this forum, so thought I'd post it.

Inclusion: HER2+, prior tx with both a taxane (alone or in combo with another agent), and Herceptin, documented progression of locally advanced or mets bc, LVEF >50%, ECOG 0-1.

Exclusion: Long list - the biggest ones to me look to be prior lapatinib or capecitabine, existing neuropathy grade 3 or greater.

Now enrolling - more info: www.clinicaltrials.gov (http://www.clinicaltrials.gov) or call the Genentech Trial Information Support Line at 888-662-6728.

Debbie Laxague

[runtolive]

http://www.ksdk.com/news/local/story.aspx?storyid=174101&catid=3

local healthbeat reporter kay quinn did a feature on tdm1..

[Faith in Him]

I'm confused. I thought some of our members had been on Xeloda/tykerb prior to being accepted into this trial. Was that the Phase II trial and there is a different requirement for the Phase III trial?

[runtolive]

the current phase 3 tdm1 trial is head to head against tykerb/xeloda

and the phase 2 trial is tdm1 against taxotere in first line setting.

currently there are no trials for patients with progression following tykerb/xeloda.

but dna is starting a new trial of tdm1 and pertuzumab in may..

[chrisy]

There was an earlier phase II trial that was far less exclusive, allowing up to 3 prior chemos and herceptin and tykerb.

[Rich66]

Is there some cross resistance issue between TDM1 and Xeloda? I keep seeing this as an exclusion.

[runtolive]

xeloda should hold no weight in whether to dose tdm1.

dosing depends on which trial you are attempting to get into..

the p2 taxotere vs tdm1.. for first line treatment or

the pivotal p3 currently .. emilia.. tdm1 vs tyk/xel for second line treatment..

these trials will be semi-muted.. because tdm1 will be approved based on the recently finished p2 trial for 3rd line treatment.. after patients failed tykerb/xeloda.. genentech antipates filing for approval in q1 2010, with approval by fall 2010, or in the next 15 months.

[chrisy]

Rich, the reason for the exclusion is, as runtolive said, because it is a head to head trial to see which works better - Tykerb/Xeloda or TDM1. It is "for" people whose next line of treatment would be tykerb/xeloda, so if you had previously had one/both of these fail, they would not want to put you in a trial where this was the "other" arm.

[Rich66]

Ah..so if later it is proved to have benefit, even if less than X/T, it could be an option for those who have had Xeloda previously. Just wanted to hear it wasn't biologically negated by Xeloda. I hope it proves to kick butt.