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RECRUITING

NCT05950945

PHASE3

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

Sponsor: Daiichi Sankyo

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

250

Start Date

2023-12-30

Completion Date

2027-10-01

Last Updated

2026-04-08

Healthy Volunteers

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

Inclusion Criteria: * Sign and date the main informed consent form * Must agree to provide a newly obtained or archival baseline biopsy from primary and/or metastatic lesion. * Pathologically documented Breast Cancer (BC) tumor * Is unresectable and/or metastatic. * Is hormone receptor-negative or hormone receptor-positive. * Must include percentage of positively stained cells to characterize if hormone receptor-positive or -negative. * Has confirmed HER2 IHC 1+ or IHC 2+/ISH- (HER2-low) status or HER2 IHC 0 status as determined according to ASCO CAP 2018 guidelines1 based on sample collected during Tissue Screening as described above. * Was never previously HER2-positive (IHC 3+ or IHC 2+/ISH+) on prior pathology testing (per ASCO CAP guidelines). * Was never previously treated with anti-HER2 therapy in the metastatic setting. * Has had at least one and up to two prior lines of therapy in the metastatic setting. * In participants with hormone receptor-positive HER2-low metastatic BC (Cohort 3): * Has recurrent disease \<2 years from the initiation of adjuvant ET OR * Has disease progression on CDK4/6 inhibitor-based regimen within 12 months of completion of adjuvant therapy with a CDK4/6 inhibitor OR * Has disease progression within the first 12 months of CDK4/6 in the first line metastatic setting * Presence of at least one measurable lesion based on computed tomography or magnetic resonance imaging. * Participants with brain metastases are allowed in the study. The brain lesion(s) should be small (\<2 cm), untreated, asymptomatic, not requiring urgent medical intervention, and are asymptomatic and clinically stable. * Has an Eastern Cooperative Oncology Group performance status of 0 or 1. * Has a minimum life expectancy of 12 weeks at Screening. * Has a left ventricular ejection fraction ≥50% within 28 days before enrollment. * Has adequate organ and bone marrow function within 28 days before enrollment. * Has adequate treatment washout period before enrollment. * Male and female subjects of reproductive/childbearing potential must agree to use a highly effective form of contraception. Exclusion Criteria: * Prior treatment with an antibody drug conjugate (ADC). * Uncontrolled or significant cardiovascular disease. * Has a corrected QT interval prolongation. * Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening. * Has spinal cord compression or clinically active central nervous system metastases. * Has multiple primary malignancies within 3 years, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, other solid tumors curatively treated, or contralateral BC. * Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients in the drug product. * Has a history of severe hypersensitivity reactions to other monoclonal antibodies. * Has an uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals. * Active primary immunodeficiency, known uncontrolled active human immunodeficiency virus (HIV) infection, or active hepatitis B or C infection. * Has history of receiving a live, attenuated vaccine (messenger RNA and replication-deficient adenoviral vaccines are not considered attenuated live vaccines) within 30 days prior to the first exposure to study drug. * Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to Grade ≤1 or baseline. * Is pregnant or breastfeeding or planning to become pregnant. * Lung-specific intercurrent clinically significant illnesses. * Any autoimmune, connective tissue, or inflammatory disorders. * Prior complete pneumonectomy.

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

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (86)