NCT04582968

Pyrotinib Combined With Brain Radiotherapy in Breast Cancer Patients With Brain Metastases

A Phase Ib/II Pilot Study of Pyrotinib Plus Capecitabine Combined With Brain Radiotherapy in HER2 Positive Breast Cancer Patients With Brain Metastases

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 39 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Brain metastases occur in 30-50% of patients with metastatic HER2-positive breast cancer. Pyrotinib is an irreversible pan-ErbB receptor tyrosine kinase inhibitor (TKI) with activity against epidermal growth factor receptor (EGFR)/HER1, HER2, and HER4. This study consists of two parts. In a phase Ib part, investigators will explore the safety and tolerance of Pyrotinib Plus Capecitabine combined with brain radiotherapy. After completing the phase Ib part, investigators will review the data and decide whether this patient is included in before the start of a phase II part. In the phase II part, investigators will evaluate the efficacy of Pyrotinib Plus Capecitabine combined with brain radiotherapy in patients with HER2 positive breast cancer patients with brain metastases.

Conditions

• Breast Cancer
• Brain Metastases
• HER2-positive Breast Cancer

Interventions

Type	Name	Description
OTHER	Pyrotinib Plus Capecitabine combined with brain radiotherapy	Drug combined with radiation

Timeline

• Start date: 2020-01-02
• Primary completion: 2022-08-12
• Completion: 2023-08-12
• First posted: 2020-10-12
• Last updated: 2023-01-18

Locations

1 site across 1 country: China