DEBBRAH

OFFICIAL TITLE: A MULTICENTER, OPEN-LABEL, SINGLE-ARM, MULTICOHORT PHASE II CLINICAL TRIAL OF TRASTUZUMAB DERUXTECAN (DS-8201A) IN HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)- POSITIVE ADVANCED BREAST CANCER WITH BRAIN METASTASES AND/OR LEPTOMENINGEAL CARCINOMATOSIS – THE DEBBRAH STUDY.

PROJECT DETAILS

THIS IS A MULTICENTER, INTERNATIONAL, OPEN-LABEL, SINGLE-ARM, MULTICOHORT, TWO-STAGE OPTIMAL SIMON’S DESIGN, PHASE II CLINICAL TRIAL.

 

THE STUDY COHORTS ARE DIVIDED IN:

•    COHORT 1: HER2-POSITIVE BC WITH NON-PROGRESSING BM (AFTER WBRT AND/OR SRS AND OR SURGERY.);

 

•    COHORT 2: HER2-POSITIVE OR HER2-LOW BC WITH ASYMPTOMATIC UNTREATED BM;

 

•    COHORT 3: HER2-POSITIVE BC WITH PROGRESSING BMS AFTER LOCAL TREATMENT;

 

•    COHORT 4: HER2-LOW EXPRESSING BC WITH PROGRESSING BMS AFTER LOCAL TREATMENT;

 

•    COHORT 5: HER2-POSITIVE OR HER2-LOW EXPRESSING BC WITH LMC.

 

PRIMARY OBJECTIVE: COHORT 1

•    TO ASSESS EFFICACY -DEFINED AS 16 WEEKS PROGRESSION-FREE SURVIVAL (PFS)- OF TRASTUZUMAB DERUXTECAN (DS-8201A) IN PATIENTS WITH PRETREATED UNRESECTABLE LOCALLY ADVANCED OR METASTATIC HER2- POSITIVE BC WITH NON-PROGRESSING BM (AFTER WBRT AND/OR SRS AND OR SURGERY.).

 

COHORTS 2, 3, AND 4

•    TO ASSESS EFFICACY -DEFINED AS CNS ORR- OF TRASTUZUMAB DERUXTECAN (DS-8201A) IN PATIENTS WITH PRETREATED UNRESECTABLE LOCALLY ADVANCED OR METASTATIC BC: 1.

 

COHORT 5

•    TO ASSESS EFFICACY -DEFINED AS OS- OF TRASTUZUMAB DERUXTECAN (DS-8201A) IN PATIENTS WITH PRETREATED UNRESECTABLE LOCALLY ADVANCED OR METASTATIC HER2-POSITIVE OR HER2-LOW EXPRESSING BC WITH LMC.

DEBBRAH AT CLINICALTRIALS.GOV

TUMOR TYPE

PHASE

N

SITES

COUNTRY

STATUS

Brain Metastases

IIa

38

23

Spain, Portugal

Recruiting

DEBBRAH SITES

SPAIN

Hospital Clínico San Carlos

SPAIN

Hospital Son Llatzer

SPAIN

Hospital Universitario Doce de Octubre

SPAIN

Hospital del Mar

SPAIN

Hospital Universitario Insular de Gran Canaria

SPAIN

Institut Català d' Oncologia Badalona (ICO)

SPAIN

Hospital Quiron San Camilo- Ruber Juan Bravo

SPAIN

Hospital Universitario Ramón y Cajal

SPAIN

Institut Català d' Oncologia L'Hospitalet (ICO)

SPAIN

Hospital Universitario Miguel Servet

SPAIN

Instituto Oncológico Baselga - Hospital Quiron Salud Barcelona

SPAIN

Consorci Hospital General Universitari de València

SPAIN

Hospital Clínico Universitario de Valencia

SPAIN

Hospital Universitario Reina Sofía

SPAIN

Instituto Valenciano de Oncología (IVO)

SPAIN

Hospital Universitario Virgen del Rocío

SPAIN

MD Anderson Cancer Center Madrid

SPAIN

Hospital San Pedro de Alcántara

PORTUGAL

Hospital Da Luz Lisboa

PORTUGAL

Hospital Fernando da Fonseca

PORTUGAL

Hospital de Santa Maria - Centro Hospitalar Lisboa Norte

PORTUGAL

Instituto Portugues Oncologia de Porto (IPO)

PORTUGAL

Champalimaud Clinical Centre - Champalimaud Foundation