Regimens Comparison for Breast Cancers of Positive Lymph Nodes
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|ClinicalTrials.gov Identifier: NCT01134523|
Recruitment Status : Recruiting
First Posted : June 2, 2010
Last Update Posted : March 15, 2013
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Epirubicin, CTX, Paclitaxel Drug: Epirubicin, Paclitaxel||Phase 3|
EC-T regimen: epirubicin 90mg/m2 day1, CTX 600mg/m2, day 1, 21 days per cycle *4cycle. followed by paclitaxel 175mg/m2,d1,21days per cycle, 4 cycle.
ET regimen: epirubicin 75mg/m2 day1,paclitaxel 175mg/m2,d2,21days per cycle, 6 cycle
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 3 Study of Regimens Comparison for Breast Cancers of Positive Lymph Nodes|
|Study Start Date :||May 2010|
|Estimated Primary Completion Date :||May 2018|
|Estimated Study Completion Date :||May 2020|
|Active Comparator: Group A: EC-T regimen||
Drug: Epirubicin, CTX, Paclitaxel
Epirubicin 90mg/m2 and CTX 600mg/m2 on day1 of each 21-day cycle, 4 cycles; followed by Paclitaxel 175mg/m2 on day1 of each 21-day cycle, 4 cycles.
|Experimental: Group B: ET regimen||
Drug: Epirubicin, Paclitaxel
Epirubicin 75mg/m2 on day1 and Paclitaxel 175mg/m2 on day2 of each 21-day cycle, 6 cycles.
- PFS [ Time Frame: 5 years after all the recuiment ]
- OS [ Time Frame: 5 years after all the adjuvent treatments ]
- Safety [ Time Frame: 5 years after all the recruiment ]Assessing for Hematology and Non-hematology toxicities, including all SAEs.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01134523
|Contact: Peng Yuan, M.D.||86-10-8778 email@example.com|
|Cancer Institute & Hospital. Chinese Academy of Medical Sciences||Recruiting|
|Beijing, China, 100021|
|Contact: Peng Yuan, M.D. 86-10-8778 8114 firstname.lastname@example.org|
|Principal Investigator: Binghe Xu, M.D.|
|Sub-Investigator: Peng Yuan, M.D.|
|Principal Investigator:||Binghe Xu, M.D.||Chinese Academy of Medical Sciences|