Trastuzumab Deruxtecan in First-line HER2-positive Locally Advanced/MBC Patients Resistant to Trastuzumab+Pertuzumab

PHASE2TerminatedINTERVENTIONAL
Enrollment

2

Participants

Timeline

Start Date

September 28, 2023

Primary Completion Date

July 17, 2025

Study Completion Date

July 17, 2025

Conditions
Locally Advanced Breast CancerMetastatic Breast Cancer
Interventions
DRUG

Trastuzumab deruxtecan

"All patients enrolled will be treated with trastuzumab deruxtecan (T-DXd) 5.4 mg/kg IV every 3 weeks (± 3 days).~The subject's weight at baseline will be used to calculate the initial dose. If during the course of treatment the subject's weight changes by ± 10% of the baseline weight, the subject's dose will be recalculated based on the subject's updated weight.~Patients will receive T-DXd until unacceptable toxicity, progressive disease (PD), informed consent withdrawal, or other discontinuation criterion is met."

Trial Locations (19)

10003

Hospital Universitario San Pedro de Alcántara, Cáceres

11407

Hospital Universitario de Jeréz De La Frontera, Cadiz

15006

Complejo Hospitalario Universitario A Coruña (CHUAC), A Coruña

18016

Hospital Universitario Clínico San Cecilio, Granada

23007

Hospital Universitario de Jaén, Jaén

25198

Hospital Universitario Arnau de Vilanova de Lleida, Lleida

28007

Hospital General Universitario Gregorio Marañón, Madrid

28034

Hospital Universitario Ramón y Cajal, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

28046

Hospital Universitario La Paz, Madrid

28222

Hospital Universitario Puerta de Hierro de Majadahonda, Majadahonda

28942

Hospital Universitario de Fuenlabrada, Fuenlabrada

39008

Hospital Universitario Marqués de Valdecilla, Santander

41013

Hospital Universitario Virgen del Rocío, Seville

48960

Hospital Galdakao-Usansolo, Galdakao

07120

Hospital Universitario Son Espases, Palma de Mallorca

03550

Hospital San Juan de Alicante, Alicante

06080

Hospital Universitario de Badajoz, Badajoz

08003

Hospital del Mar, Barcelona

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

AstraZeneca

INDUSTRY

lead

Spanish Breast Cancer Research Group

OTHER