A Phase II Study of T-DXd Plus SRT in HER2-positive Breast Cancer Brain Metastases

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

17

Participants

Timeline

Start Date

November 30, 2023

Primary Completion Date

June 30, 2024

Study Completion Date

July 31, 2026

Conditions
Breast CancerBrain MetastasesRadiotherapy
Interventions
DRUG

Combination use of SRT with T-DXd

"Radiation therapy SRT will be implemented according to investigator's clinical practice(based on brain metastases number and tumor volume). T-DXd(5.4mg/kg, once per 21 days, initiated within 2 weeks after SRT) will be provided to patients with confirmed HER2 positive breast cancer and brain metastasis until tumor progression, a severe adverse event deemed related to the study drug, or death. All dose adjustments should be based on the most severe toxicity level (CTCAE version 5.0) that occurred. Two doses are allowed to be reduced.~Dose Level 0: 5.4mg/kg Dose Level 1 :4.4mg/kg Dose Level 2: 3.2mg/kg"

Trial Locations (1)

Unknown

Fudan University Shanghai Cancer Center, Shanghai

All Listed Sponsors
lead

Fudan University

OTHER

NCT06088056 - A Phase II Study of T-DXd Plus SRT in HER2-positive Breast Cancer Brain Metastases | Biotech Hunter | Biotech Hunter