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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
Chinese Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring positive lymph node

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

First Posted
June 1, 2010
Last Updated
March 14, 2013
Sponsor
Chinese Academy of Medical Sciences
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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

Learn more about this trial

Regimens Comparison for Breast Cancers of Positive Lymph Nodes

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