Regimens Comparison for Breast Cancers of Positive Lymph Nodes
NCT ID: NCT01134523
Last Updated: 2013-03-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
1000 participants
INTERVENTIONAL
2010-05-31
2020-05-31
Brief Summary
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Detailed Description
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ET regimen: epirubicin 75mg/m2 day1,paclitaxel 175mg/m2,d2,21days per cycle, 6 cycle
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A: EC-T regimen
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.
Group B: ET regimen
Epirubicin, Paclitaxel
Epirubicin 75mg/m2 on day1 and Paclitaxel 175mg/m2 on day2 of each 21-day cycle, 6 cycles.
Interventions
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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.
Epirubicin, Paclitaxel
Epirubicin 75mg/m2 on day1 and Paclitaxel 175mg/m2 on day2 of each 21-day cycle, 6 cycles.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
70 Years
FEMALE
No
Sponsors
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Chinese Academy of Medical Sciences
OTHER
Responsible Party
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Binghe Xu
Chief
Principal Investigators
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Binghe Xu, M.D.
Role: PRINCIPAL_INVESTIGATOR
Chinese Academy of Medical Sciences
Locations
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Cancer Institute & Hospital. Chinese Academy of Medical Sciences
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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References
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Moebus V, Jackisch C, Lueck HJ, du Bois A, Thomssen C, Kurbacher C, Kuhn W, Nitz U, Schneeweiss A, Huober J, Harbeck N, von Minckwitz G, Runnebaum IB, Hinke A, Kreienberg R, Konecny GE, Untch M. Intense dose-dense sequential chemotherapy with epirubicin, paclitaxel, and cyclophosphamide compared with conventionally scheduled chemotherapy in high-risk primary breast cancer: mature results of an AGO phase III study. J Clin Oncol. 2010 Jun 10;28(17):2874-80. doi: 10.1200/JCO.2009.24.7643. Epub 2010 May 10.
Yuan P, Kang Y, Ma F, Fan Y, Wang J, Wang X, Yue J, Luo Y, Zhang P, Li Q, Xu B. Effect of Epirubicin Plus Paclitaxel vs Epirubicin and Cyclophosphamide Followed by Paclitaxel on Disease-Free Survival Among Patients With Operable ERBB2-Negative and Lymph Node-Positive Breast Cancer: A Randomized Clinical Trial. JAMA Netw Open. 2023 Feb 1;6(2):e230122. doi: 10.1001/jamanetworkopen.2023.0122.
Related Links
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http://www.ncbi.nlm.nih.gov/pubmed/20458045
Other Identifiers
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CH-BC-006
Identifier Type: -
Identifier Source: org_study_id
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