NCT06475443

Efficacy of Pyrotinib Plus Capecitabine in HER2-positive MBC With Active Brain Metastases That Have Failed ADCs

The Efficacy and Safety of Pyrotinib Plus Capecitabine in Human Epidermal Growth Factor Receptor 2-positive Breast Cancer Patients With Active Brain Metastases That Have Failed Antibody-drug Conjugate(ADC): a Prospective, Single Arm, Trial

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Henan Cancer Hospital · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of pyrotinib plus capecitabine in HER2-positive breast cancer patients with active brain metastases that have failed ADCs

Detailed description

To evaluate the efficacy and safety of pyrotinib plus capecitabine in Human Epidermal Growth Factor Receptor 2（HER2）-positive breast cancer patients with active brain metastases that have failed Antibody Drug Conjugates（Fam-trastuzumab deruxtecan-nxki\[T-DXd\] or A1811), had received no local radiotherapy previously and have at least one measurable brain lesion according to response assessment in neuro-oncology (RANO)criteria.

Conditions

• Metastatic Breast Cancer in the Brain

Interventions

Type	Name	Description
DRUG	pyrotinib plus capecitabine	oral

Timeline

• Start date: 2024-06-15
• Primary completion: 2026-06-30
• Completion: 2027-01-31
• First posted: 2024-06-26
• Last updated: 2024-06-26