NCT04405505

A Study of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsule Versus Paclitaxel for Injection (Albumin Bound) in Subjects With Triple Negative Breast Cancer (TNBC)

A Randomized, Positive Parallel Controlled, Multicenter Phase III Study of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsule Versus Paclitaxel for Injection (Albumin Bound) in Subjects With Triple Negative Breast Cancer (TNBC)

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 332 (estimated)
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a randomized, positive parallel controlled, multicentre phase III clinical trial to evaluate the efficacy and safety of TQB2450 combined with anlotinib versus paclitaxel for injection (albumin bound) in subjects with advanced triple negative breast cancer.

Conditions

• Triple Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	TQB2450	TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors.
DRUG	Anlotinib	a multi-target receptor tyrosine kinase inhibitor.
DRUG	Paclitaxel for Injection (albumin bound)	a anti-microtubule drug.

Timeline

• Start date: 2020-06-01
• Primary completion: 2022-07-01
• Completion: 2022-07-01
• First posted: 2020-05-28
• Last updated: 2020-05-28

Locations

30 sites across 1 country: China