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Old 05-18-2009, 07:47 AM   #1
Joe
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Genentech Clinical Trials T-DM1 and Omnitarg

T-DM1 & PERTUZUMAB TRIAL LISTINGS
T-DM1
1. EMILIA: An Open-Label Study of Trastuzumab-MCC-DM1 (TDM-1) vs. Capecitabine + Lapatinib in Patients With HER2-Positive Locally Advanced or Metastatic Breast Cancer
a. ClinicalTrials.gov Identifier: NCT00829166
b. Recruiting; Global
c. Ph III
d. Condition: mBC
e. Interventions: Drug: capecitabine; Drug: lapatinib; Drug: trastuzumab – MCC-DM1
2. A Study of the Efficacy and Safety of Trastuzumab-Mcc-DM1 vs. Trastuzumab (Herceptin®) and Docetaxel (Taxotere®) in Patients With Metastatic HER2-Positive Breast Cancer Who Have Not Received Prior Chemotherapy for Metastatic Disease
a. ClinicalTrials.gov Identifier: NCT00679341
b. Recruiting; Global
c. Ph II
d. Conditions: mBC
e. Interventions: Drug: docetaxel; Drug: trastuzumab; Drug: trastuzumab – MCC – DM1

3. A Study of Trastuzumab-MCC-DM1 (T-DM1) in Combination With Pertuzumab Administered to Patients With HER2-Positive Locally Advanced or Metastatic Breast Cancer Who Have Previously Received Trastuzumab
a. ClinicalTrials.gov Identifier: NCT00875979
b. Recruiting; Global
c. Ph I & II
d. Conditions: mBC
e. Interventions: Drug: pertuzumab; Drug: trastuzumab – MCC – DM1

4. An Extension Study of T-DM1 in Patients Previously Treated With TDM-1
a. ClinicalTrials.gov Identifier: NCT00781612
b. Enrolling by invitation; US
c. Ph II
d. Conditions: mBC
e. Intervention: Drug: trastuzumab – MCC – DM1
.
Pertuzumab

1. A Study to Evaluate Pertuzumab + Trastuzumab + Docetaxel vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-positive Metastatic Breast Cancer (CLEOPATRA)
a. ClinicalTrials.gov Identifier: NCT00567190
b. Enrolling
c. Ph III
d. Condition: BC
e. Intervention: Drug: pertuzumab; Drug: docetaxel; Drug: placebo; Drug: trastuzumab
2. A Study of Pertuzumab in Combination with Herceptin in Patients With HER2 Positive Breast Cancer (NEOSPHERE)
a. ClinicalTrials.gov Identifier: NCT00545688
b. Recruiting; Conducted outside of the US
c. Ph II
d. Condition: BC
e. Interventions: Drug: pertuzumab; Drug: Herceptin; Drug: docetaxel

Regards
Joe
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