RecruitingPhase 3NCT05950945

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

A Phase 3b, Multicenter, Global, Interventional, Open-label Study of Trastuzumab Deruxtecan (T-DXd), an Anti-HER2-Antibody Drug Conjugate (ADC), in Subjects Who Have Unresectable and/or Metastatic HER2-low or HER2 Immunohistochemistry (IHC) 0 Breast Cancer (DESTINY-Breast15)


Sponsor

Daiichi Sankyo

Enrollment

250 participants

Start Date

Dec 30, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This study will evaluate the safety and efficacy of trastuzumab deruxtecan (T-DXd) in participants with human epidermal growth factor receptor 2 (HER2)-low or HER2 immunohistochemistry (IHC) 0 (who are both hormone receptor \[HR\]-negative and HR-positive) unresectable and/or metastatic breast cancer.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called trastuzumab deruxtecan (T-DXd) in people with metastatic breast cancer that is hormone receptor-negative or hormone receptor-positive but with low or no HER2 expression. This drug is an antibody-drug conjugate — it attaches to cancer cells and delivers a toxic payload directly to them. **You may be eligible if...** - You have confirmed metastatic breast cancer with low HER2 expression (IHC 1+, IHC 2+/ISH negative) or no HER2 expression (IHC 0) - You have had 1 to 2 prior lines of therapy in the metastatic setting - Your overall health is good (ECOG 0-1) with a life expectancy of at least 12 weeks - Your heart function (ejection fraction ≥50%) and organ function are adequate - You have at least one measurable tumor - You have never been treated with an antibody-drug conjugate (ADC) before **You may NOT be eligible if...** - You have a history of serious lung disease, interstitial lung disease, or pneumonitis requiring steroids - You have active spinal cord compression or uncontrolled brain metastases - You have had another cancer in the past 3 years - You are pregnant, breastfeeding, or planning to become pregnant - You have an active autoimmune or connective tissue disorder Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTrastuzumab 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


Locations(86)

Mount Sinai Medical Center

Miami Beach, Florida, United States

USF College of Medicine

Tampa, Florida, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Beth Israel Lahey Health

Burlington, Massachusetts, United States

Overlook Medical Center

Summit, New Jersey, United States

Mater Hospital Sydney

North Sydney, New South Wales, Australia

Monash Medical Centre Moorabbin

East Bentleigh, Victoria, Australia

GenesisCare St Andrews Hospital

Adelaide, Australia

Fiona Stanley Hospital

Murdoch, Australia

Institut Jules Bordet

Anderlecht, Belgium

GZA Ziekenhuizen

Antwerp, Belgium

Universitair Ziekenhuis Brussel

Brussels, Belgium

Cliniques Universitaires Saint-Luc

Brussels, Belgium

UZ Leuven

Leuven, Belgium

Centre Hospitalier Universitaire de Liege Sart-Tilman

Liège, Belgium

GZA Ziekenhuizen

Wilrijk, Belgium

Centro de Oncologia - Unidade Brasília - Hospital Sírio Libanês

Brasília, Brazil

CIONC-Centro Integrado de Oncologia de Curitiba

Curitiba, Brazil

Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer

Curitiba, Brazil

CEPON - Centro de Pesquisas Oncológicas de Santa Catarina

Florianópolis, Brazil

Oncosite - Centro de Pesquisa Clinica e Oncologia

Ijuí, Brazil

Fundação Doutor Amaral Carvalho

Jaú, Brazil

Instituto de Cancer de Londrina

Londrina, Brazil

Hospital das Clínicas FMRP-USP

Riberão Preto, Brazil

Hospital Nossa Senhora da Conceicao

Rio Grande, Brazil

Ensino e Terapia de Inovação Clínica AMO-ETICA

Salvador, Brazil

Catarina Pesquisa Clinica

Santa Catarina, Brazil

CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia

Santo André, Brazil

Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto

São José do Rio Preto, Brazil

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

São Paulo, Brazil

Clínica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária Ltda

São Paulo, Brazil

Beijing Hospital

Beijing, China

307 Hospital of PLA

Beijing, China

Fujian Cancer Hospital

Fujian, China

Sun Yat sen University Cancer Center

Guangzhou, China

Zhejiang Cancer Hospital

Hangzhou, China

Anhui Provincial Cancer Hospital

Hefei, China

Shandong Cancer Hospital

Jinan, China

Yunnan Cancer Hospital

Kunming, China

Nanchang People's Hospital

Nanchang, China

Jiangxi Cancer Hospital

Nanchang, China

The Affiliated Hospital of Qingdao University

Qingdao, China

Fudan University Shanghai Cancer Center

Shanghai, China

Henan Cancer Hospital

Zhengzhou, China

Cork University Hospital

Cork, Ireland

St Vincent's University Hospital

Dublin, Ireland

St James Hospital

Dublin, Ireland

Beaumont Hospital

Dublin, Ireland

Galway University Hospital

Galway, Ireland

Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari

Bari, Italy

Azienda Ospedaliera Universitaria Policlinico Sant Orsola Malpighi IRCCS

Bologna, Italy

Istituto Nazionale per la Ricerca sul Cancro di Genova

Genova, Italy

Ospedale San Raffaele

Milan, Italy

Humanitas Istituto Clinico Catanese

Misterbianco, Italy

Istituto Nazionale Tumori Fondazione G Pascale

Naples, Italy

IOV - Istituto Oncologico Veneto IRCCS

Padova, Italy

Nuovo Ospedale di Prato

Prato, Italy

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

Rome, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, Italy

Ospedale Santa Chiara

Trento, Italy

Amsterdam UMC, Locatie VUMC

Amsterdam, Netherlands

Amphia Ziekenhuis Molengracht

Breda, Netherlands

Medisch Centrum Leeuwarden

Leeuwarden, Netherlands

Alrijne Ziekenhuis Leiden

Leiden, Netherlands

Maastricht University Medical Center

Maastricht, Netherlands

Haga Ziekenhuis

The Hague, Netherlands

Elisabeth TweeSteden Ziekenhuis

Tilburg, Netherlands

Bernhoven Uden

Uden, Netherlands

Hospital de Braga

Braga, Portugal

Instituto Português de Oncologia de Lisboa Francisco Gentil, EPE

Lisbon, Portugal

Fundação Champalimaud

Lisbon, Portugal

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

Lisbon, Portugal

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

ICO l'Hospitalet - Hospital Duran i Reynals

Barcelona, Spain

Hospital Universitario Donostia

Donostia / San Sebastian, Spain

Hospital Universitario Virgen de las Nieves

Granada, Spain

Complejo Hospitalario Universitario Insular Materno-Infantil

Las Palmas de Gran Canaria, Spain

Hospital Beata Maria Ana

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Spain

Hospital General Universitario Morales Meseguer

Murcia, Spain

Clinica Universidad de Navarra

Pamplona, Spain

Complejo Hospitalario Universitario de Santiago

Santiago de Compostela, Spain

Hospital Universitario Virgen Macarena

Seville, Spain

Hospital Clinico Universitario de Valencia

Valencia, Spain

Hospital Arnau de Vilanova de Valencia

Valencia, Spain

View Full Details on ClinicalTrials.gov

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NCT05950945


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