NCT06718933

Study of SHR-A1811 Combined With Pyrotinib and Bevacizumab in Advanced Breast Cancer With Brain Metastasis

A Prospective, Single-arm, Exploratory, Phase Ib/II Study of SHR-A1811 Combined With Pyrotinib and Bevacizumab in Advanced Breast Cancer With Brain Metastasis.

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 74 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In phase Ib, our study is aimed to evaluate the safety and tolerance of SHR-A1811 combined with pyrotinib in breast cancer with brain metastasis, and confirm the recommended phase 2 dose combined with preliminary results of efficacy. In phase II, our study is aimed to evaluate the efficacy and safety of SHR-A1811 combined with pyrotinib and bevacizumab at RP2D in breast cancer with brain metastasis.

Conditions

• Breast Cancer Metastatic
• Breast Cancer Brain Metastases

Interventions

Type	Name	Description
DRUG	SHR-A1811	ADC
DRUG	Bevacizumab	bevacizumab biosimilar
DRUG	Pyrotinib	anti-HER2 inhibitor

Timeline

• Start date: 2025-01-08
• Primary completion: 2026-08-31
• Completion: 2027-02-28
• First posted: 2024-12-05
• Last updated: 2025-02-06

Locations

1 site across 1 country: China