Trastuzumab Deruxtecan (T-DXd) in Patients Who Have Hormone Receptor-negative and Hormone Receptor-positive HER2-low or HER2 IHC 0 Metastatic Breast Cancer

PHASE3RecruitingINTERVENTIONAL
Enrollment

250

Participants

Timeline

Start Date

December 30, 2023

Primary Completion Date

October 1, 2027

Study Completion Date

October 1, 2027

Conditions
Breast Cancer
Interventions
DRUG

Trastuzumab Deruxtecan

Intravenous administration, 5.4 mg/kg on Day 1 of each 21-day cycle until radiographic disease progression as assessed by the investigator, unacceptable toxicity, other discontinuation criteria are met, or 2 years after first dose of study drug

Trial Locations (84)

1070

RECRUITING

Institut Jules Bordet, Anderlecht

1090

RECRUITING

Universitair Ziekenhuis Brussel, Brussels

1200

RECRUITING

Cliniques Universitaires Saint-Luc, Brussels

2065

RECRUITING

Mater Hospital Sydney, North Sydney

2334

RECRUITING

Alrijne Ziekenhuis Leiden, Leiden

2610

RECRUITING

GZA Ziekenhuizen, Antwerp

RECRUITING

GZA Ziekenhuizen, Wilrijk

3000

RECRUITING

UZ Leuven, Leuven

3165

RECRUITING

Monash Medical Centre Moorabbin, East Bentleigh

4000

RECRUITING

Centre Hospitalier Universitaire de Liege Sart-Tilman, Liège

5406

RECRUITING

Bernhoven Uden, Uden

6150

RECRUITING

Fiona Stanley Hospital, Murdoch

15706

RECRUITING

Complejo Hospitalario Universitario de Santiago, Santiago de Compostela

16132

RECRUITING

Istituto Nazionale per la Ricerca sul Cancro di Genova, Genova

18014

RECRUITING

Hospital Universitario Virgen de las Nieves, Granada

20014

RECRUITING

Hospital Universitario Donostia, Donostia / San Sebastian

20132

RECRUITING

Ospedale San Raffaele, Milan

28007

RECRUITING

Hospital Beata Maria Ana, Madrid

28041

RECRUITING

Hospital Universitario 12 de Octubre, Madrid

28222

RECRUITING

Hospital Universitario Puerta de Hierro Majadahonda, Majadahonda

30008

RECRUITING

Hospital General Universitario Morales Meseguer, Murcia

31008

RECRUITING

Clinica Universidad de Navarra, Pamplona

33140

TERMINATED

Mount Sinai Medical Center, Miami Beach

33602

RECRUITING

USF College of Medicine, Tampa

35016

RECRUITING

Complejo Hospitalario Universitario Insular Materno-Infantil, Las Palmas de Gran Canaria

35128

RECRUITING

IOV - Istituto Oncologico Veneto IRCCS, Padua

38123

RECRUITING

Ospedale Santa Chiara, Trento

40138

RECRUITING

Azienda Ospedaliera Universitaria Policlinico Sant Orsola Malpighi IRCCS, Bologna

41009

RECRUITING

Hospital Universitario Virgen Macarena, Seville

46010

RECRUITING

Hospital Clinico Universitario de Valencia, Valencia

46015

RECRUITING

Hospital Arnau de Vilanova de Valencia, Valencia

59100

RECRUITING

Nuovo Ospedale di Prato, Prato

70124

RECRUITING

Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari, Bari

80131

RECRUITING

Istituto Nazionale Tumori Fondazione G Pascale, Naples

95045

RECRUITING

Humanitas Istituto Clinico Catanese, Misterbianco

100006

RECRUITING

Beijing Hospital, Beijing

100161

RECRUITING

307 Hospital of PLA, Beijing

200032

RECRUITING

Fudan University Shanghai Cancer Center, Shanghai

230031

RECRUITING

Anhui Provincial Cancer Hospital, Hefei

250117

RECRUITING

Shandong Cancer Hospital, Jinan

266000

RECRUITING

The Affiliated Hospital of Qingdao University, Qingdao

310022

RECRUITING

Zhejiang Cancer Hospital, Hangzhou

330006

RECRUITING

Nanchang People's Hospital, Nanchang

330029

RECRUITING

Jiangxi Cancer Hospital, Nanchang

350011

RECRUITING

Fujian Cancer Hospital, Fujian

450008

RECRUITING

Henan Cancer Hospital, Zhengzhou

510060

RECRUITING

Sun Yat sen University Cancer Center, Guangzhou

650107

RECRUITING

Yunnan Cancer Hospital, Kunming

02215

RECRUITING

Dana-Farber Cancer Institute, Boston

01805

RECRUITING

Beth Israel Lahey Health, Burlington

07901

RECRUITING

Overlook Medical Center, Summit

71635-610

RECRUITING

Centro de Oncologia - Unidade Brasília - Hospital Sírio Libanês, Brasília

80810-050

RECRUITING

CIONC-Centro Integrado de Oncologia de Curitiba, Curitiba

81520-060

RECRUITING

Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer, Curitiba

88034-000

RECRUITING

CEPON - Centro de Pesquisas Oncológicas de Santa Catarina, Florianópolis

98700-000

RECRUITING

Oncosite - Centro de Pesquisa Clinica e Oncologia, Ijuí

17.210 - 080

RECRUITING

Fundação Doutor Amaral Carvalho, Jaú

86015-520

RECRUITING

Instituto de Cancer de Londrina, Londrina

14015-010

RECRUITING

Hospital das Clínicas FMRP-USP, Riberão Preto

88701-160

RECRUITING

Hospital Nossa Senhora da Conceicao, Rio Grande

41810-570

RECRUITING

Ensino e Terapia de Inovação Clínica AMO-ETICA, Salvador

88301-220

RECRUITING

Catarina Pesquisa Clinica, Santa Catarina

09060-650

RECRUITING

CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia, Santo André

15090-000

RECRUITING

Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto, São José do Rio Preto

01246-000

RECRUITING

ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira, São Paulo

01317-001

RECRUITING

Clínica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária Ltda, São Paulo

T12 EC8P

RECRUITING

Cork University Hospital, Cork

D04 T6F4

RECRUITING

St Vincent's University Hospital, Dublin

D08 NHY1

RECRUITING

St James Hospital, Dublin

Dublin 9

RECRUITING

Beaumont Hospital, Dublin

H91 YR71

RECRUITING

Galway University Hospital, Galway

00161

RECRUITING

Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza, Rome

00168

RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome

1081 HV

RECRUITING

Amsterdam UMC, Locatie VUMC, Amsterdam

4818 CK

RECRUITING

Amphia Ziekenhuis Molengracht, Breda

8934 AD

RECRUITING

Medisch Centrum Leeuwarden, Leeuwarden

6229 HX

RECRUITING

Maastricht University Medical Center, Maastricht

2545 AA

RECRUITING

Haga Ziekenhuis, The Hague

5022 GC

RECRUITING

Elisabeth TweeSteden Ziekenhuis, Tilburg

4710-243

RECRUITING

Hospital de Braga, Braga

1099-023

RECRUITING

Instituto Português de Oncologia de Lisboa Francisco Gentil, EPE, Lisbon

1649-028

RECRUITING

Centro Hospitalar de Lisboa Norte E P E Hospital de Santa Maria, Lisbon

08025

RECRUITING

Hospital de la Santa Creu i Sant Pau, Barcelona

08908

RECRUITING

ICO l'Hospitalet - Hospital Duran i Reynals, Barcelona

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

AstraZeneca

INDUSTRY

lead

Daiichi Sankyo

INDUSTRY