NCT04914390

A Phase Ⅱ Study of Anlotinib Combined With Tislelizumab and AT in the Neoadjuvant Treatment of Triple-negative Breast Cancer

A Prospective, Open, Single-arm, Phase Ⅱ Clinical Study of Anlotinib Combined With Tislelizumab and AT in the Neoadjuvant Treatment of Triple-negative Breast Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Sichuan Provincial People's Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, single-arm and open-label phase II study, evaluating the efficacy and safety of anlotinib combined with tislelizumab and AT regimen as neoadjuvant treatment for triple-negative breast cancer. Participants will undergo/receive PDL1 testing after enrollment. All patients will be receive 6 cycles of low-dose anlotinib combined with tislelizumab and AT（Doxorubicin or Epirubicin+albumin-bound paclitaxel）regimen, followed by surgery.

Conditions

• Triple-negative Breast Cancer

Interventions

Type	Name	Description
DRUG	AT regimen	Doxorubin 60mg/㎡ d1 or Epirubicin 75mg/㎡ d1 and Nab-paclitaxel 260mg/㎡ d1 of Cycles 1-6 (Q3W) of the neoadjuvant phase of the study; IV injection.
DRUG	Tislelizumab	200mg on d1 of Cycles 1-6 (Q3W) of the neoadjuvant phase of the study; IV injection.
DRUG	Anlotinib	8mg on d1-14 of Cycles 1-5 (Q3W) of the neoadjuvant phase of the study; po. Arotinib is a small molecule multi-target TKI, which exerts its effect by inhibiting angiogenesis, a critical component of tumour growth and metastasis.

Timeline

• Start date: 2023-09-15
• Primary completion: 2025-03-31
• Completion: 2025-09-30
• First posted: 2021-06-04
• Last updated: 2024-01-22

Locations

1 site across 1 country: China