Regimens Comparison for Breast Cancers of Positive Lymph Nodes
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Epirubicin, CTX, Paclitaxel
Epirubicin, Paclitaxel
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring positive lymph node
Eligibility Criteria
Inclusion Criteria:
- patients with breast cancer after breast cancer surgery with positive lymph nodes age 18-70 years old
Exclusion Criteria:
- with other malignance disease
Sites / Locations
- Cancer Institute & Hospital. Chinese Academy of Medical SciencesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Group A: EC-T regimen
Group B: ET regimen
Arm Description
Outcomes
Primary Outcome Measures
PFS
Secondary Outcome Measures
OS
Safety
Assessing for Hematology and Non-hematology toxicities, including all SAEs.
Full Information
NCT ID
NCT01134523
First Posted
June 1, 2010
Last Updated
March 14, 2013
Sponsor
Chinese Academy of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01134523
Brief Title
Regimens Comparison for Breast Cancers of Positive Lymph Nodes
Official Title
Phase 3 Study of Regimens Comparison for Breast Cancers of Positive Lymph Nodes
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Unknown status
Study Start Date
May 2010 (undefined)
Primary Completion Date
May 2018 (Anticipated)
Study Completion Date
May 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To compare the efficacy and safety of EC-T and ET regimen as adjuvant treatment of breast cancer patients with positive lymph nodes
Detailed Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
positive lymph node
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A: EC-T regimen
Arm Type
Active Comparator
Arm Title
Group B: ET regimen
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Epirubicin, CTX, Paclitaxel
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Epirubicin, Paclitaxel
Intervention Description
Epirubicin 75mg/m2 on day1 and Paclitaxel 175mg/m2 on day2 of each 21-day cycle, 6 cycles.
Primary Outcome Measure Information:
Title
PFS
Time Frame
5 years after all the recuiment
Secondary Outcome Measure Information:
Title
OS
Time Frame
5 years after all the adjuvent treatments
Title
Safety
Description
Assessing for Hematology and Non-hematology toxicities, including all SAEs.
Time Frame
5 years after all the recruiment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with breast cancer after breast cancer surgery with positive lymph nodes age 18-70 years old
Exclusion Criteria:
with other malignance disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peng Yuan, M.D.
Phone
86-10-8778 8114
Email
yuanpeng01@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Binghe Xu, M.D.
Organizational Affiliation
Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Institute & Hospital. Chinese Academy of Medical Sciences
City
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peng Yuan, M.D.
Phone
86-10-8778 8114
Email
yuanpeng01@hotmail.com
First Name & Middle Initial & Last Name & Degree
Binghe Xu, M.D.
First Name & Middle Initial & Last Name & Degree
Peng Yuan, M.D.
12. IPD Sharing Statement
Citations:
PubMed Identifier
20458045
Citation
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.
Results Reference
background
Citation
Intense Dose-Dense Sequential Chemotherapy With Epirubicin, Paclitaxel, and Cyclophosphamide... Moebus et al. J Clin Oncol.2010; 0: JCO.2009.24.7643v1-JCO.2009.24.7643
Results Reference
background
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/20458045
Description
http://www.ncbi.nlm.nih.gov/pubmed/20458045
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Regimens Comparison for Breast Cancers of Positive Lymph Nodes
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