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NOT YET RECRUITING
NCT06088056
PHASE2

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

Sponsor: Fudan University

View on ClinicalTrials.gov

Summary

This research study will evaluate the efficacy and safety of stereotactic radiotherapy (SRT) combined with Trastuzumab-Deruxtecan (T-DXd; DS-8201a) in HER2-positive Breast Cancer Patients with newly diagnosed or progressing Brain Metastases.

Official title: A Phase II Study of T-DXd Plus Stereotactic Radiotherapy(SRT) in HER2-positive Breast Cancer Brain Metastases

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

17

Start Date

2023-11

Completion Date

2026-07

Last Updated

2023-10-18

Healthy Volunteers

No

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

Locations (1)

Fudan University Shanghai Cancer Center

Shanghai, China