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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Completed; Phase 3; Phase 2

Conditions: Breast Cancer

Treatments: Drug: EC-T; Drug: TP

Study type: Interventional

Funder types: Other

Identifiers

NCT01150513

CH-BC-007

Details and patient eligibility

About

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).

Enrollment: 320 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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320 participants in 2 patient groups

EC-T

Active Comparator group

Treatment:

Drug: EC-T

TP

Experimental group

Treatment:

Drug: TP