Joe
05-18-2009, 07:47 AM
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 (mhtml:{4FFD6ED7-B030-4B66-83D0-857525759766}mid://00002170/!x-usc:http://clinicaltrials.gov/ct2/show/NCT00829166?term=T-DM1&rank=3)
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 (mhtml:{4FFD6ED7-B030-4B66-83D0-857525759766}mid://00002170/!x-usc:http://clinicaltrials.gov/ct2/show/NCT00679341?term=T-DM1&rank=5)
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 (mhtml:{4FFD6ED7-B030-4B66-83D0-857525759766}mid://00002170/!x-usc:http://clinicaltrials.gov/ct2/show/NCT00781612?term=T-DM1&rank=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) (mhtml:{4FFD6ED7-B030-4B66-83D0-857525759766}mid://00002170/!x-usc:http://clinicaltrials.gov/ct2/show/NCT00567190?term=NCT00567190&rank=1)
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) (mhtml:{4FFD6ED7-B030-4B66-83D0-857525759766}mid://00002170/!x-usc:http://clinicaltrials.gov/ct2/show/NCT00545688?term=NCT00545688&rank=1)
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
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 (mhtml:{4FFD6ED7-B030-4B66-83D0-857525759766}mid://00002170/!x-usc:http://clinicaltrials.gov/ct2/show/NCT00829166?term=T-DM1&rank=3)
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 (mhtml:{4FFD6ED7-B030-4B66-83D0-857525759766}mid://00002170/!x-usc:http://clinicaltrials.gov/ct2/show/NCT00679341?term=T-DM1&rank=5)
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 (mhtml:{4FFD6ED7-B030-4B66-83D0-857525759766}mid://00002170/!x-usc:http://clinicaltrials.gov/ct2/show/NCT00781612?term=T-DM1&rank=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) (mhtml:{4FFD6ED7-B030-4B66-83D0-857525759766}mid://00002170/!x-usc:http://clinicaltrials.gov/ct2/show/NCT00567190?term=NCT00567190&rank=1)
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) (mhtml:{4FFD6ED7-B030-4B66-83D0-857525759766}mid://00002170/!x-usc:http://clinicaltrials.gov/ct2/show/NCT00545688?term=NCT00545688&rank=1)
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