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T-DXd Therapy for HER2-low Breast Cancer Patients With Brain Metastases

NCT06048718 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2026-05-08

No results posted yet for this study

Summary

TUXEDO-4 is an international, multicentric, single arm, phase II study aiming to gather additional solid evidence of Trastuzumab-Deruxtecan (T-DXd) activity in patients with Human Epidermal Growth Factor Receptor 2 (HER2)-low breast cancer with active brain metastases.

This study will analyze the efficacy of T-DXd as determined by overall response rate (ORR) at any timepoint as judged by best CNS response according to RANO-BM criteria.

Conditions

Interventions

DRUG

Trastuzumab-Deruxtecan (T-DXd)

Trastuzumab-deruxtecan is a human HER2-directed antibody-drug conjugate (ADC) composed of humanized anti-HER2 immunoglobulin G1 (IgG1) monoclonal antibody (mAb) with the same amino acid sequence as trastuzumab, covalently linked to the membrane-permeable topoisomerase I inhibitor payload, DXd, an exatecan derivative, via a stable tetrapeptide-based linker, selectively cleaved within tumor cells.

Sponsors & Collaborators

Principal Investigators

  • Maximilian Marhold, MD, PhD, PD · Medical University of Vienna, Vienna General Hospital, Vienna, Austria

  • Matthias Preusser, MD, Prof · Medical University of Vienna, Vienna General Hospital, Vienna, Austria

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-05
Primary Completion
2026-11-30
Completion
2026-11-30

Countries

  • Austria
  • Spain

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06048718 on ClinicalTrials.gov