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

Phase 2

Completed

• Conditions: Breast Cancer
• Interventions: Drug: TP; Drug: EC-T

• Registration Number: NCT01150513
• Lead Sponsor: Chinese Academy of Medical Sciences

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2010-06-14
• Study First Submitted QC: 2010-06-24
• Study First Posted: 2010-06-25
• Primary Completion: 2016-01
• Study Completion: 2016-04
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-05
• Last Update Posted: 2021-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 320

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TP	TP	-
EC-T	EC-T	-

Primary Outcome Measures

Name	Time	Method
Disease Free Survival (DFS) of 3 years	3 years after mastectomy	local recurrence, distant metastasis, the secondary primary malignancy

Secondary Outcome Measures

Name	Time	Method
Safety Profiles	Up to 24 weeks	All adverse events occurring during chemotherapy are to be recorded in the case report form, including hemotologic and nonhemotologic toxicities.

Trial Locations

Locations (1)

Cancer Institute & Hospital Chinese Academy of Medical Sciences; 🇨🇳 Beijing, China