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Old 07-25-2011, 11:37 AM   #1
chrisy
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Join Date: Sep 2005
Location: Central Coast, CA
Posts: 3,207
Exclamation Genentech update on T-DMI early access program

Genentech has informed us that screening of new patients for enrollment
in T-PAS (T-DM1 Patient Access Study) will be discontinued on
September 6, 2011. Please read this message from Genentech for details:

"This is a difficult decision, but we believe continuing with T-PAS enrollment
would make it difficult to enroll the clinical trials and collect the overall
survival data we believe will be needed for full trastuzumab emtansine (TDM1)
approval in the future. People currently enrolled in T-PAS will
continue to receive trastuzumab emtansine per the protocol.
In addition, Genentech is opening a new Phase III, registrational clinical
trial for people with previously treated HER2-positive mBC (third-line
setting, known as the TH3RESA clinical trial). Screening of new patients in
T-PAS will be discontinued on September 6. This coincides with the
opening of enrollment of the third line trial, TH3RESA, for at least one U.S.
site. TH3RESA will help support FDA approval of trastuzumab emtansine,
as it is designed to confirm if trastuzumab emtansine can improve the
survival of people who have already been treated with other HER2-
targeted medicines. Closing new enrollment in T-PAS was a difficult
decision. However, we believe it is in the best interest of the majority of
people with HER2-positive mBC, as this is necessary to help us conduct
the clinical trials needed to support FDA approval so that access to T-DM1
will not be an issue."
__________________
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

Last edited by chrisy; 07-25-2011 at 12:00 PM..
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