DS-8201a for trEatment of aBc, BRain Mets, And Her2[+] Disease

PHASE2CompletedINTERVENTIONAL
Enrollment

41

Participants

Timeline

Start Date

May 25, 2020

Primary Completion Date

September 30, 2021

Study Completion Date

April 4, 2023

Conditions
Advanced Breast CancerHER2-positive Breast CancerBrain MetastasesLeptomeningeal Metastasis
Interventions
DRUG

Trastuzumab deruxtecan

"After having confirmed eligibility and entered into the clinical trial, patients will be treated with trastuzumab deruxtecan (DS-8201a) at 5.4 mg/Kg administered as an intravenous (IV) infusion on Day of 21-day cycle (Q3W), initially for at least 90 minutes, then, if there is no infusion-related reaction, for a minimum of 30 minutes.~In patients with hormone receptor (HR)-positive status (estrogen receptor \[ER\] and/or progesterone receptor \[PgR\]) administration of endocrine therapy is not allowed.~In patients allocated in study cohort 5, administration of intrathecal therapy is not allowed"

Trial Locations (16)

46009

Fundación Instituto Valenciano de Oncología (IVO), Valencia

Unknown

Champalimaud Center for the Unknown, Lisbon

Instituto Português de Oncologia do Porto Francisco Gentil, EPE (IPO Porto), Porto

Institut Català d'Oncologica ICO Badalona, Badalona

Hospital del Mar, Barcelona

Institut Oncologic Baselga-Hospital Quiron Salud Barcelona, Barcelona

Hospital Universitario Reina Sofia, Córdoba

Institut Catala d'Oncologia ICO Hospitalet, L'Hospitalet de Llobregat

Hospital Clínico San Carlos, Madrid

Hospital Universitario 12 de Octubre, Madrid

Hospital Universitario Ramon y Cajal, Madrid

IOB- Complejo Hospitalario Ruber Juan Bravo, Madrid

Hospital Universitario Virgen del Rocio, Seville

Hospital Clinico Universitario de Valencia, Valencia

Hospital Universitario Migue Servet, Zaragoza

08028

Hospital Universitari Dexeus, Barcelona

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Daiichi Sankyo

INDUSTRY

lead

MedSIR

OTHER