NCT06140576

The Efficacy and Safety of Lenvatinib Combined With Sindilimab and Nab-paclitaxel in the First-line Treatment for Recurrent and Metastatic Triple Negative Breast Cancer: a Phase Ib/IIa Clinical Trial.

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 58 (estimated)
• Sponsor: Zhejiang Cancer Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The treatment regimen of lenvatinib combined with PD1 antibody has brought earth shaking changes to the immunotherapy of various "cold tumors". This is a phase Ib/IIa clinical trial to investigate the efficacy and safety of Lenvatinib combined with Sindilimab and Nab-paclitaxel in the first-line treatment for recurrent and metastatic triple negative breast cancer.

Detailed description

In recent years, the research on immunotherapy in triple negative breast cancer has been carried out in full swing, but the results are inconsistent. Lenvatinib is an oral multi kinase inhibitor with main targets including VEGFR1-3, FGFR1-4, and PDGFR-α, KIT and RET. It inhibits the FGFR4 signaling pathway, and downregulate the expression of PD-L1 in tumor cells, thereby regulating the tumor immune microenvironment. The treatment regimen of lenvatinib combined with PD1 antibody has brought earth shaking changes to the immunotherapy of various "cold tumors". This is a phase Ib/IIa clinical trial to investigate the efficacy and safety of Lenvatinib combined with Sindilimab and Nab-paclitaxel in the first-line treatment for recurrent and metastatic triple negative breast cancer.

Conditions

• Breast Neoplasms

Interventions

Type	Name	Description
DRUG	Sindilimab	Sindilimab, 200mg, Intravenous，every three weeks
DRUG	Nab-paclitaxel	Nab-paclitaxel，125mg/m\^2, d1,8, every three weeks
DRUG	Lenvatinib	Lenvatinib 8mg, 12mg, 16mg everyday

Timeline

• Start date: 2023-11-30
• Primary completion: 2025-12-31
• Completion: 2026-12-31
• First posted: 2023-11-20
• Last updated: 2023-11-20

Locations

1 site across 1 country: China