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Old 05-02-2009, 02:55 PM   #1
Debbie L.
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Phase III T-DM1

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 or call the Genentech Trial Information Support Line at 888-662-6728.

Debbie Laxague
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Old 05-02-2009, 09:03 PM   #2
runtolive
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http://www.ksdk.com/news/local/story...174101&catid=3

local healthbeat reporter kay quinn did a feature on tdm1..
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Old 05-02-2009, 09:17 PM   #3
Faith in Him
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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?
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2.5 cm, Er/Pr-, Her2+++
18/20 Nodes
03/07 CT & Bone scan - Clear
AC x 4, Taxol x 4, Added Herceptin
Radiation until 09/07
Herceptin every 3 weeks until 06/08
01/10/08 local recurrence -IBC
01/28/08 CT & Brain MRI - clear
02/08 - Navelbine & Herceptin
05/08 -MRM
05/08 - Gemzar & Herceptin - didn't work
09/08 - Hyperthermia rads
03/09 - Tykerb/Xeloda
05/10 - Tram flap to fix wound
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Old 05-03-2009, 08:24 AM   #4
runtolive
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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..
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Old 05-03-2009, 10:53 AM   #5
chrisy
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There was an earlier phase II trial that was far less exclusive, allowing up to 3 prior chemos and herceptin and tykerb.
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Chris in Scotts Valley
June 2002 extensive hi grade DCIS (pre-cancer-stage 0, clean sentinal node) Mastectomy/implant - no chemo, rads. "cured?"
9/2004 Diag: Stage IV extensive liver mets (!) ER/PR- Her2+++
10/04-3/05 Weekly Taxol/Carboplatin/Herceptin , complete response!
04/05 - 4/07 Herception every 3 wks, Continue NED
04/07 - recurrence to liver - 2 spots, starting tykerb/avastin trial
06/07 8/07 10/07 Scans show stable, continue on Tykerb/Avastin
01/08 Progression in liver
02/08 Begin (TDM1) trial
08/08 NED! It's Working! Continue on TDM1
02/09 Continue NED
02/10 Continue NED. 5/10 9/10 Scans NED 10/10 Scans NED
12/10 Scans not clear....4/11 Scans suggest progression 6/11 progression confirmed in liver
07/11 - 11/11 Herceptin/Xeloda -not working:(
12/11 Begin MM302 Phase I trial - bust:(
03/12 3rd times the charm? AKT trial

5/12 Scan shows reduction! 7/12 More reduction!!!!
8/12 Whoops...progression...trying for Perjeta/Herceptin (plus some more nasty chemo!)
9/12 Start Perjeta/Herceptin, chemo on hold due to infection/wound in leg, added on cycle 2 &3
11/12 Poops! progression in liver, Stop Perjeta/Taxo/Herc
11/12 Navelbine/Herce[ptin - try for a 3 cycles, no go.
2/13 Gemzar/Carbo/Herceptin - no go.
3/13 TACE procedure
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Old 05-03-2009, 11:37 AM   #6
Rich66
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Is there some cross resistance issue between TDM1 and Xeloda? I keep seeing this as an exclusion.
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Old 05-03-2009, 02:22 PM   #7
runtolive
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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.
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Old 05-03-2009, 05:08 PM   #8
chrisy
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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.
__________________
Chris in Scotts Valley
June 2002 extensive hi grade DCIS (pre-cancer-stage 0, clean sentinal node) Mastectomy/implant - no chemo, rads. "cured?"
9/2004 Diag: Stage IV extensive liver mets (!) ER/PR- Her2+++
10/04-3/05 Weekly Taxol/Carboplatin/Herceptin , complete response!
04/05 - 4/07 Herception every 3 wks, Continue NED
04/07 - recurrence to liver - 2 spots, starting tykerb/avastin trial
06/07 8/07 10/07 Scans show stable, continue on Tykerb/Avastin
01/08 Progression in liver
02/08 Begin (TDM1) trial
08/08 NED! It's Working! Continue on TDM1
02/09 Continue NED
02/10 Continue NED. 5/10 9/10 Scans NED 10/10 Scans NED
12/10 Scans not clear....4/11 Scans suggest progression 6/11 progression confirmed in liver
07/11 - 11/11 Herceptin/Xeloda -not working:(
12/11 Begin MM302 Phase I trial - bust:(
03/12 3rd times the charm? AKT trial

5/12 Scan shows reduction! 7/12 More reduction!!!!
8/12 Whoops...progression...trying for Perjeta/Herceptin (plus some more nasty chemo!)
9/12 Start Perjeta/Herceptin, chemo on hold due to infection/wound in leg, added on cycle 2 &3
11/12 Poops! progression in liver, Stop Perjeta/Taxo/Herc
11/12 Navelbine/Herce[ptin - try for a 3 cycles, no go.
2/13 Gemzar/Carbo/Herceptin - no go.
3/13 TACE procedure
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Old 05-05-2009, 10:14 AM   #9
Rich66
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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.
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