NCT05042791

A Study of Pyrotinib Plus Capecitabine Combined With SRT in HER2+ MBC With Brain Metastases

SRT Versus WBRT Combined With Pyrrotinib and Capecitabine in the Treatment of HER2-positive Advanced Breast Cancer Patients With Brain Metastases: A Randomized Controlled, Prospective Clinical Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 362 (estimated)
• Sponsor: Jiangxi Provincial Cancer Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the efficacy and safety of SRT combined with pyrotinib and capecitabine in the treatment of patients with HER2-positive advanced breast cancer patients with brain metastases.

Detailed description

Brain metastases occur in 30-50% of patients with metastatic HER2-positive breast cancer. In the case of multiple brain metastases, radiation therapy is the preferred therapeutic approaches. However, the side effects of WBRT for long-lived patients are also obvious, such as irreversible decline in cognitive function and decline in memory function. WBRT can also cause extensive hair loss and extensive white matter lesions on imaging. Pyrotinib as an oral tyrosine kinase inhibitor has good efficacy and safety in patients with breast cancer brain metastases. Therefore, in order to reduce the impact of WBRT on the cognitive function, a phase II clinical study of SRT versus WBRT combined with pyrotinib and capecitabine in the treatment of MBC with brain metastases was carried out to explore the efficacy and safety of radiotherapy de-escalation therapy.

Conditions

• HER2-positive Metastatic Breast Cancer

Interventions

Type	Name	Description
COMBINATION_PRODUCT	radiation combined with pyrotinib and capecitabine	This study selects different radiation (SRT or WBRT) combined with pyrotinib and capecitabine to treat HER2-positive advanced breast cancer patients with brain metastases

Timeline

• Start date: 2022-03-01
• Primary completion: 2025-09-30
• Completion: 2025-09-30
• First posted: 2021-09-13
• Last updated: 2024-02-09

Locations

1 site across 1 country: China