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
Sponsor:
Information provided by (Responsible Party):
Peng Yuan, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01150513
First received: June 14, 2010
Last updated: March 13, 2013
Last verified: March 2013
  Purpose

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 ] [ Designated as safety issue: No ]
    local recurrence, distant metastasis, the secondary primary malignancy


Secondary Outcome Measures:
  • Safety Profiles [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: Yes ]
    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)
Groups/Cohorts
A
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
B
Docetaxel(75mg/m2,d1)plus carboplatin(AUC=6d1),21days a cycle,for 6 cycles

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders 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

Criteria

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 ClinicalTrials.gov identifier: NCT01150513

Contacts
Contact: Peng Yuan, M.D. 861087788114 yuanpeng01@hotmail.com

Locations
China
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
Investigators
Principal Investigator: Peng Yuan, MD Chinese Academy of Medical Sciences
  More Information

No publications provided

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

Keywords provided by Chinese Academy of Medical Sciences:
TRIPLE-NEGATIVE
BREAST CANCER

Additional relevant MeSH terms:
Triple Negative Breast Neoplasms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Docetaxel
Carboplatin
Cyclophosphamide
Epirubicin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 16, 2014