NCT05244993

AK105 Plus Anlotinib Hydrochloride Combined With Albumin Paclitaxel as a First-line Therapy in Patients With Advanced Triple-negative Breast Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Liaoning Cancer Hospital & Institute · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This trial used a multicentre, single-arm design in which patients were treated with AK105 plus Anlotinib Hydrochloride combined with albumin paclitaxel. Patients included in this trial were advanced breast cancer with hormone receptor negative and Her2 negative. The primary endpoint is ORR, and the secondary endpoint is DCR, PFS, OS and safety.

Conditions

• Breast Neoplasm Female

Interventions

Type	Name	Description
DRUG	AK105	AK105: 100mg per bottle, 200mg IV Day 1, cycled every 21 days
DRUG	Anlotinib hydrochloride	Anlotinib Hydrochloride: 12mg per capsule, 12 mg PO once daily on Days 1-14, cycled every 21 days
DRUG	Albumin Paclitaxel	Albumin paclitaxel: 100mg per bottle, 125mg/m2 IV Days 1, 8, cycled every 21 days

Timeline

• Start date: 2022-07-01
• Primary completion: 2024-03-01
• Completion: 2024-03-01
• First posted: 2022-02-17
• Last updated: 2022-07-12