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RECRUITING
NCT04138719
PHASE2

Nab-paclitaxel Plus Carboplatin Versus Nab-paclitaxel Plus Epirubicin in the Neoadjuvant Therapy for Breast Cancer

Sponsor: Hebei Medical University Fourth Hospital

View on ClinicalTrials.gov

Summary

This is a multicenter, open, randomized, comparison study. Triple-negative breast cancer (TNBC) is a term applied to breast cancer cases that have \<1% expression of the estrogen receptor (ER) and the progesterone receptor (PR) and do not over express HER2. Neoadjuvant therapy is often used to reduce the size of tumors, especially in locally advanced tumors. The purpose of this therapy is to make part of patients operable and to facilitate breast-conserving surgery. The purpose of this study is to assess the efficacy and safety of the following two proposals: nab-paclitaxel plus carboplatin versus nab-paclitaxel plus epirubicin, in order to provide support for rational clinical application. The total number of patients to be included in this study is 520 patients.

Official title: Clinical Study of Nab-paclitaxel Plus Carboplatin Versus Nab-paclitaxel Plus Epirubicin in the Neoadjuvant Therapy for Breast Cancer

Key Details

Gender

FEMALE

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

520

Start Date

2019-11-20

Completion Date

2028-06-20

Last Updated

2025-09-11

Healthy Volunteers

No

Interventions

DRUG

Nab-paclitaxel + Carboplatin

nab-paclitaxel given IV at 125 mg/m\^2 on days 1, 8 and carboplatin given IV at AUC 5 on days 1 every 21 days x 6 cycles;

DRUG

Nab-paclitaxel + Epirubicin

nab-paclitaxel given IV at 125 mg/m\^2 on days 1, 8 and epirubicin given IV at 75 mg/m\^2 on days 1 every 21 days x 6 cycles;

Locations (1)

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China