
TUXEDO-4
OFFICIAL TITLE: PHASE II STUDY OF TRASTUZUMAB-DERUXTECAN (T-DXD; DS-8201A) IN HER2-LOW BREAST CANCER PATIENTS PRESENTING WITH NEWLY DIAGNOSED OR PROGRESSING BRAIN METASTASES.

Breast cancer with brain metastases
II
27
12
Spain, Austria
Set-up
CLINICAL TRIAL DETAILS
THE PRIMARY OBJECTIVE IS TO ASSESS THE OVERALL RESPONSE RATE (ORR) ACCORDING TO RANO-BM CRITERIA. THE STUDY WILL ALSO ASSESS THE ORR ACCORDING TO RECIST V.1.1 FOR EXTRACRANIAL AND OVERALL LESIONS, THE BICOMPARTMENTAL BENEFIT RATE (SUM OF THE COMPLETE RESPONSE, PARTIAL RESPONSE AND STABLE DISEASE RATES), DURATION OF RESPONSE, TIME TO RESPONSE, BEST PERCENTAGE CHANGE IN TUMOR BURDEN, PROGRESSION FREE SURVIVAL, OVERALL SURVIVAL, SAFETY, QUALITY OF LIFE, AND NEUROCOGNITIVE AND NEUROLOGICAL FUNCTION.
TUXEDO-4 AT CLINICALTRIALS.GOV
TUMOR TYPE
PHASE
N
SITES
COUNTRY
STATUS
TUXEDO-4 SITES


SPAIN
Vall d’Hebron Instituto de Oncología

SPAIN
Hospital Beata María Ana

SPAIN
Hospital Universitario Clínico San Cecilio de Granada

SPAIN
Hospital Universitario Reina Sofía

SPAIN
Hospital Universitari Dexeus

SPAIN
Hospital Clínico Universitario de Valencia

SPAIN
Hospital Universitario Basurto

SPAIN
Hospital Universitario Ramón y Cajal

SPAIN
Hospital Universitario Virgen del Rocío

SPAIN
Hospital Universitario San Juan Alicante

AUSTRIA
Medical University of Vienna

AUSTRIA
Salzburg Cancer research Institute-Center for Clinical Cancer and Immunology Trials (SCRI-CCCIT)