Phase II Study of daTopotamab-derUXtecan (Dato-DXd; DS-1026a) in triple-negative brEast cancer patients with newly Diagnosed or prOgressing brain metastases

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-518819-19-00

Acronym

Tuxedo-2

Enrollment

Registered

2024-12-10

Start date

2023-05-23

Completion date

Unknown

Last updated

2026-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

triple negative breast cancer

Brief summary

intracranial response rate at any timepoint as judged by best response during the study period (response measured according to RANO-BM criteria)

Detailed description

extracranial response rate (response measured according to RECIST 1.1), bicompartmental clinical benefit rate (CBR; CR+PR+SD ≥6 months; intracranial CBR measured by RANO-BM; extracranial CBR measured by RECIST 1.1), progression-free survival, overall survival

Interventions

DRUGDatopotamab deruxtecan

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
intracranial response rate at any timepoint as judged by best response during the study period (response measured according to RANO-BM criteria)	—

Secondary

Measure	Time frame
extracranial response rate (response measured according to RECIST 1.1), bicompartmental clinical benefit rate (CBR; CR+PR+SD ≥6 months; intracranial CBR measured by RANO-BM; extracranial CBR measured by RECIST 1.1), progression-free survival, overall survival	—

Countries

Austria, Ireland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026