Regimens Comparison for Breast Cancers of Positive Lymph Nodes

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Chinese Academy of Medical Sciences
Sponsor:
Information provided by (Responsible Party):
Binghe Xu, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01134523
First received: June 1, 2010
Last updated: March 14, 2013
Last verified: March 2013
  Purpose

To compare the efficacy and safety of EC-T and ET regimen as adjuvant treatment of breast cancer patients with positive lymph nodes


Condition Intervention Phase
Breast Cancer
Drug: Epirubicin, CTX, Paclitaxel
Drug: Epirubicin, Paclitaxel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 3 Study of Regimens Comparison for Breast Cancers of Positive Lymph Nodes

Resource links provided by NLM:


Further study details as provided by Chinese Academy of Medical Sciences:

Primary Outcome Measures:
  • PFS [ Time Frame: 5 years after all the recuiment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • OS [ Time Frame: 5 years after all the adjuvent treatments ] [ Designated as safety issue: Yes ]
  • Safety [ Time Frame: 5 years after all the recruiment ] [ Designated as safety issue: Yes ]
    Assessing for Hematology and Non-hematology toxicities, including all SAEs.


Estimated Enrollment: 1000
Study Start Date: May 2010
Estimated Study Completion Date: May 2020
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01134523

Contacts
Contact: Peng Yuan, M.D. 86-10-8778 8114 yuanpeng01@hotmail.com

Locations
China
Cancer Institute & Hospital. Chinese Academy of Medical Sciences Recruiting
Beijing, China, 100021
Contact: Peng Yuan, M.D.    86-10-8778 8114    yuanpeng01@hotmail.com   
Principal Investigator: Binghe Xu, M.D.         
Sub-Investigator: Peng Yuan, M.D.         
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Investigators
Principal Investigator: Binghe Xu, M.D. Chinese Academy of Medical Sciences
  More Information

Additional Information:
Publications:
Moebus V, Jackisch C, Lueck HJ, et al.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 May 10. [Epub ahead of print]

Responsible Party: Binghe Xu, Chief, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT01134523     History of Changes
Other Study ID Numbers: CH-BC-006
Study First Received: June 1, 2010
Last Updated: March 14, 2013
Health Authority: China: Ministry of Health

Keywords provided by Chinese Academy of Medical Sciences:
positive lymph node

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Epirubicin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 22, 2014