Phase I/II Study of Intrathecal/Ommaya T-DXd in HER2-Expressing Breast Cancer With Leptomeningeal/Brain Metastases

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

139

Participants

Timeline

Start Date

April 18, 2025

Primary Completion Date

August 30, 2026

Study Completion Date

February 28, 2027

Conditions
Breast Cancer
Interventions
DRUG

T-DXd

Evaluating safety and efficacy of intrathecal or ommaya reservoir administration of T-DXd in patients with HER2-expressing breast cancer with active leptomeningeal and/or brain metastases based on systemic therapy

Trial Locations (2)

200032

RECRUITING

Fudan University Shanghai Cancer Center, Shanghai

200043

RECRUITING

Fudan University Shanghai Cancer Cancer, Shanghai

All Listed Sponsors
lead

Fudan University

OTHER