NCT03775928

Compare Apatinib Plus Capecitabine Versus Capecitabine in Maintenance Therapy for Patients With Advanced Triple-negative Breast Cancer

Phase Ⅱ Study of Compare Apatinib Plus Capecitabine Versus Capecitabine in Maintenance Therapy for Patients With Advanced Triple-negative Breast Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Cancer Institute and Hospital, 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 patients who receive apatinib plus capecitabine or capecitabine for maintenance therapy of patients with with advanced triple-negative breast cancer

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. Maintenance therapy after combination chemotherapy can prolong the disease control time in patients with advanced TNBC. How to prolong the disease control time of patients with advanced TNBC without affecting the quality of life has become the focus of current research. 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. The results of this study will help explore the new treatment of small molecule anti-angiogenic drugs for TNBC maintenance therapy, and provide some new ideas for improving individualized treatment options for patients with advanced TNBC.

Conditions

• Triple-negative Breast Cancer

Interventions

Type	Name	Description
DRUG	Apatinib	apatinib 425mg qd po
DRUG	capecitabine	capecitabine 1000mg/m2 bid d1-d14

Timeline

• Start date: 2018-12-18
• Primary completion: 2020-12-01
• Completion: 2021-10-01
• First posted: 2018-12-14
• Last updated: 2018-12-14

Locations

1 site across 1 country: China