NCT05019690

Apatinib Combined with Albumin-Bound Paclitaxel for Treatment of Advanced Triple Negative Breast Cancer

Apatinib Mesylate Combined with Albumin-bound Paclitaxel for Second-line Treatment of Advanced Triple Negative Breast Cancer:a Single-arm,exploratory Clinical Study

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 29 (estimated)
• Sponsor: Fujian Cancer Hospital · Other Government
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a single-arm,exploratory clinical study, to evaluate the effectiveness and safety of apatinib mesylate combined with albumin-bound paclitaxel for second-line treatment of advanced triple negative breast cancer.

Detailed description

This is a exploratory, single-arm, open-label trial. The investigator's primary purpose is to explore that PFS and safety of apatinib combined with albumin-bound paclitaxel for treatment of advanced triple negative breast cancer. In treatment period, patients will be administrated apatinib plus albumin-bound paclitaxel, every 21 days for 1 cycle, until disease progression, toxicity intolerance, withdrawal of informed consent, patients judged must be terminated study termination. The imaging evaluation was performed according to the RECIST 1.1 criteria every 6 weeks.

Conditions

• Advanced Triple Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	Apatinib Mesylate	Subjects receive Apatinib orally, Dosage form: tablet, Strength: 250 mg/tablet,QD,Q3W
DRUG	Albumin-Bound Paclitaxel	Subjects receive Albumin-Bound Paclitaxel,ivgtt, Strength: 125 mg/m\^2,d1、7、15,Q3W

Timeline

• Start date: 2021-10-01
• Primary completion: 2024-12-01
• Completion: 2025-06-01
• First posted: 2021-08-25
• Last updated: 2024-09-19

Locations

1 site across 1 country: China