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

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ClinicalTrials.gov Identifier: NCT01150513
Recruitment Status : Completed
First Posted : June 25, 2010
Last Update Posted : February 9, 2021
Sponsor:
Information provided by (Responsible Party):
Peng Yuan, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Breast Cancer Drug: EC-T Drug: TP Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Docetaxel Plus Carboplatin Versus Epirubicin Plus Cyclophosphamide Followed by Docetaxel as Adjuvant Treatment in Triple-negative Breast Cancer
Study Start Date : June 2009
Actual Primary Completion Date : January 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: EC-T Drug: EC-T
four cycles of EC (epirubicin: 90 mg/m2; cyclophosphamide :600 mg/m2, day 1) followed by four cycles of T (docetaxel : 75 mg/m2 or paclitaxel 175 mg/m2, day 1)
Experimental: TP Drug: TP
six cycles of TP (docetaxel: 75 mg/m2 or paclitaxel 175 mg/m2 d1; carboplatin AUC=5, day 1)


Outcome Measures
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Primary Outcome Measures :
  1. Disease Free Survival (DFS) of 3 years [ Time Frame: 3 years after mastectomy ]
    local recurrence, distant metastasis, the secondary primary malignancy


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01150513


Locations
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China
Cancer Institute & Hospital Chinese Academy of Medical Sciences
Beijing, China, 100021
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Investigators
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Principal Investigator: Peng Yuan, MD Chinese Academy of Medical Sciences
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Peng Yuan, Chief Physician, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT01150513    
Other Study ID Numbers: CH-BC-007
First Posted: June 25, 2010    Key Record Dates
Last Update Posted: February 9, 2021
Last Verified: February 2021
Keywords provided by Peng Yuan, Cancer Institute and Hospital, Chinese Academy of Medical Sciences:
TRIPLE-NEGATIVE
BREAST CANCER
Additional relevant MeSH terms:
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Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
 Neoplasms
Breast Diseases
Skin Diseases