NCT04159142

Nab-paclitaxel Plus Carboplatin Versus Nab-paclitaxel Plus Capecitabine in the Treatment of Advanced Triple-negative Breast Cancer

Clinical Study of Nab-paclitaxel Plus Carboplatin Versus Nab-paclitaxel Plus Capecitabine in the Treatment of Advanced Triple-negative Breast Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 414 (estimated)
• Sponsor: Hebei Medical University Fourth Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center , open-lable clinical trial. 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. TNBC is diagnosed in 15-20% of breast cancer cases and tends to occur in younger women and have biologically more aggressive high grade disease. The purpose of this study is to assess the efficacy and safety of the following two combinations: i) nab-paclitaxel+carboplatin; ii) nab-paclitaxel+capecitabine in subjects with advanced TNBC and up to one prior line of systemic treatment for metastatic disease. Maintenance therapy with capecitabine after completion of combination chemotherapy.

Conditions

• 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 + Capecitabine	Nab-paclitaxel given IV at 125 mg/m\^2 on days 1, 8 and capecitabine given IV at 1000 mg/m\^2 bid, d1-14 every 21 days x 6 cycles；

Timeline

• Start date: 2019-11-20
• Primary completion: 2026-06-20
• Completion: 2028-09-20
• First posted: 2019-11-12
• Last updated: 2025-09-11

Locations

1 site across 1 country: China