NCT04138719

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 520 (estimated)
• Sponsor: Hebei Medical University Fourth Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer
• Triple-negative Breast Cancer
• Nab-paclitaxel

Interventions

Type	Name	Description
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；

Timeline

• Start date: 2019-11-20
• Primary completion: 2026-10-20
• Completion: 2028-06-20
• First posted: 2019-10-24
• Last updated: 2025-09-11

Locations

1 site across 1 country: China