NCT07132749

NEPA in Patients With HER2-positive or HER2-low Advanced Breast Cancer Treated With T-DXd

A Prospective, Observational, Multicenter Cohort Study Evaluating the Efficacy and Safety of NEPA (Netupitant/Palonosetron) in Patients With HER2-positive or HER2-low Advanced Breast Cancer Treated With T-DXd

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Yeon Hee Park · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial is a prospective, observational, multicenter cohort study evaluating the efficacy and safety of NEPA (netupitant/palonosetron) in patients with HER2-positive or HER2-low advanced breast cancer treated with T-DXd

Detailed description

The observation period of this study is until the discontinuation after administration of T-Dxd or until 8 Cycle. * Acute phase: 0 -24 hours after T-DXd administration * Delayed phase: \>24-120 hours after T-DXd administration * Overall phase: 0-120 hours after T-DXd administration * Long-delayed phase: \>120-504 hours * Extended overall phase: 0-504 hours Primary objectives: to evaluate the efficacy and safety of NEPA for CINV prevention in advanced breast cancer patients receiving at least 2 cycles of T-DXd across all defined assessment periods (acute, delayed, overall, long-delayed, and extended overall phases).

Conditions

• Patients With HER2-positive Advanced Breast Cancer Treated With T-DXd
• Patients With HER2-low Advanced Breast Cancer Treated With T-DXd

Timeline

• Start date: 2025-08-12
• Primary completion: 2026-06-30
• Completion: 2026-09-30
• First posted: 2025-08-20
• Last updated: 2026-01-08

Locations

1 site across 1 country: South Korea