NCT03735082

Apatinib Combined With Paclitaxel and Carbopatin Intensive Regimen in Neoadjuvant Therapy for Locally Advanced Triple-negative Breast Cancer

The Efficacy and Safety of Apatinib Combined With Paclitaxel and Carbopatin Intensive Regimen in Neoadjuvant Therapy for Locally Advanced Triple-negative Breast Cancer :Single Arm, Phase II Clinical Trail

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (estimated)
• Sponsor: Chinese Academy of Medical Sciences · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the efficacy and safety of Apatinib Combined With Paclitaxel and Carbopatin Intensive Regimen in Neoadjuvant Therapy for Locally Advanced Triple-negative Breast patients

Detailed description

Triple-negative breast cancer (TNBC) has the characteristics of early onset, high malignancy, less treatment, and resistance to treatment. Advanced patients have shorter survival than other subtypes. Changes in traditional chemotherapy regimens for breast cancer (ie, the addition of carboplatin) are potential ways to improve patient outcomes. Although anthracyclines and cyclophosphamide play a very positive role in the treatment of breast cancer, there are also small and serious long-term risks. Anti-angiogenic drugs are currently one of the few targeted therapies that have achieved some efficacy in TNBC. Apatinib, a targeted inhibitor of VEGF receptor 2 (VEGFR2), shows significant antitumor activity in the patients with breast cancer. Considering of current status of anti-angiogenic drugs in the field of breast cancer, results of apatinib in advanced breast cancer, and current unmet clinical needs, the investigator conducted this study to assess the efficacy and safety of Apatinib Combined With Paclitaxel and Carbopatin Intensive Regimen in Neoadjuvant Therapy for Locally Advanced Triple-negative Breast patients

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Apatinib	apatinib 250mg,qd,d1-14,14day/cycle
DRUG	Paclitaxel	paclitaxel 175mg/m2,d1,14day/cycle+carboplatin AUC=4,d1,14day/cycle
DRUG	Carboplatin	carboplatin AUC=4,d1,14day/cycle;

Timeline

• Start date: 2018-11-01
• Primary completion: 2020-06-01
• Completion: 2020-06-01
• First posted: 2018-11-08
• Last updated: 2018-11-08

Locations

1 site across 1 country: China