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

Chinese Academy of Medical Sciences320 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

320

Conditions

Breast Cancer

Interventions

EC-TDRUG

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)

TPDRUG

six cycles of TP (docetaxel: 75 mg/m2 or paclitaxel 175 mg/m2 d1; carboplatin AUC=5, day 1)

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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)

Locations (1)

Cancer Institute & Hospital Chinese Academy of Medical Sciences

Beijing, China

Outcomes

Primary Outcomes

Disease Free Survival (DFS) of 3 years

local recurrence, distant metastasis, the secondary primary malignancy

Time frame: 3 years after mastectomy

Secondary Outcomes

Safety Profiles

All adverse events occurring during chemotherapy are to be recorded in the case report form, including hemotologic and nonhemotologic toxicities.

Time frame: Up to 24 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.