Docetaxel+Carboplatin vs Epirubicin+Cyclophosphamide Followed by Docetaxel as Adjuvant Treatment in Triple-negative Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Chinese Academy of Medical Sciences
Information provided by (Responsible Party):
Peng Yuan, Chinese Academy of Medical Sciences Identifier:
First received: June 14, 2010
Last updated: March 13, 2013
Last verified: March 2013
Triple-negative breast cancer (TNBC) has a relatively bad prognosis whereas there is no standard regimen. Some data showed that platins could improve the efficacy of advance TNBC. In this trial, it is the hypothesis that TP (docetaxel plus carboplatin) has a better efficacy than EC-T (epirubicin plus cyclophosphamide followed by docetaxel).

Condition Phase
Breast Cancer
Phase 3

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Docetaxel Plus Carboplatin Versus Epirubicin Plus Cyclophosphamide Followed by Docetaxel as Adjuvant Treatment in Triple-negative Breast Cancer

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Disease Free Survival (DFS) of 5 years [ Time Frame: 5 years after mastectomy ]
    local recurrence, distant metastasis, the secondary primary malignancy

Secondary Outcome Measures:
  • Safety Profiles [ Time Frame: Up to 24 weeks ]
    All adverse events occurring during chemotherapy are to be recorded in the case report form, including hemotologic and nonhemotologic toxicities.

Estimated Enrollment: 500
Study Start Date: June 2010
Estimated Study Completion Date: June 2020
Estimated Primary Completion Date: June 2020 (Final data collection date for primary outcome measure)
epirubicin(90mg/m2 d1) plus cyclophosphamide(600mg/m2 d1),21 days a cycle, for 4 cycles followed by docetaxel 75mg/m2 d1,21 days a cycle, for 4 cycles
Docetaxel(75mg/m2,d1)plus carboplatin(AUC=6d1),21days a cycle,for 6 cycles


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
female, 18-70 years old, pathologically confired breast cancer, after tumor rescetion, no other treatment except surgery

Inclusion Criteria:

  • Triple-negative breast cancer
  • Older than 18 years old
  • Have tumor resection surgery
  • Sufficient organ function (marrow, heart, liver)

Exclusion Criteria:

  • Other malignancy
  • Other serious disease( marrow, heart, liver)
  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 identifier: NCT01150513

Contact: Peng Yuan, M.D. 861087788114

Cancer Institute & Hospital Chinese Academy of Medical Sciences Recruiting
Beijing, China, 100021
Contact: Peng Yuan, M.D.         
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Principal Investigator: Peng Yuan, MD Chinese Academy of Medical Sciences
  More Information

Responsible Party: Peng Yuan, Associate Chief Physician, Chinese Academy of Medical Sciences Identifier: NCT01150513     History of Changes
Other Study ID Numbers: CH-BC-007 
Study First Received: June 14, 2010
Last Updated: March 13, 2013

Keywords provided by Chinese Academy of Medical Sciences:

Additional relevant MeSH terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors processed this record on January 19, 2017