Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT03734029
PHASE3

Trastuzumab Deruxtecan (DS-8201a) Versus Investigator's Choice for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04]

Sponsor: Daiichi Sankyo

View on ClinicalTrials.gov

Summary

This study will compare DS-8201a to physician choice standard treatment. Participants must have HER2-low breast cancer that has been treated before. Participants' cancer: * Cannot be removed by an operation * Has spread to other parts of the body

Official title: A Phase 3, Multicenter, Randomized, Open-label, Active Controlled Trial of DS-8201a, an Anti-HER2-antibody Drug Conjugate (ADC), Versus Treatment of Physician's Choice for HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

557

Start Date

2018-12-27

Completion Date

2026-08-01

Last Updated

2025-10-06

Healthy Volunteers

No

Conditions

Interventions

DRUG

Trastuzumab deruxtecan (DS-8201a)

DS-8201a is a lyophilized powder reconstituted into a sterile aqueous solution (100 mg/5 mL) to be administered intravenously

DRUG

Capecitabine

Administered according to label, as one option for Physician's Choice (determined before randomization)

DRUG

Eribulin

Administered according to label, as one option for Physician's Choice (determined before randomization)

DRUG

Gemcitabine

Administered according to label, as one option for Physician's Choice (determined before randomization)

DRUG

Paclitaxel

Administered according to label, as one option for Physician's Choice (determined before randomization)

DRUG

Nab-paclitaxel

Administered according to label, as one option for Physician's Choice (determined before randomization)

Locations (208)

Ironwood Cancer & Research Centers - Chandler II

Chandler, Arizona, United States

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

Cancer Treatment Centers of America at Western Regional Medical Center

Goodyear, Arizona, United States

UCLA School of Medicine

Los Angeles, California, United States

Stanford Cancer Institute

Palo Alto, California, United States

Cancer Care Associates Medical Group, Inc. TORI

Redondo Beach, California, United States

University of California at San Francisco (PARENT)

San Francisco, California, United States

Eastern Connecticut Hematology/Oncology Assoc.

Norwich, Connecticut, United States

Christiana Care Health Services, Inc.

Newark, Delaware, United States

Sylvester Comprehensive Cancer Center - Deerfield Beach

Boca Raton, Florida, United States

Florida Cancer Specialists (South Region)

Fort Myers, Florida, United States

Memorial Healthcare System MRH Cancer Center

Hollywood, Florida, United States

Orlando Health, Inc.

Orlando, Florida, United States

Moffitt Cancer Center -Tampa

Tampa, Florida, United States

Cancer Treatment Centers of America-Georgia

Newnan, Georgia, United States

University of Chicago Medical Center

Chicago, Illinois, United States

Cancer Treatment Centers of America

Zion, Illinois, United States

Cancer Center of Kansas

Wichita, Kansas, United States

Touro Infirmary

New Orleans, Louisiana, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Henry Ford Hospital

Detroit, Michigan, United States

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, United States

Saint Barnabas Medical Center

Livingston, New Jersey, United States

New York University Medical Center

New York, New York, United States

Memorial Sloan Kettering Hospital

New York, New York, United States

Weill Cornell Medicine Breast Center

New York, New York, United States

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

Oregon Health & Science University

Portland, Oregon, United States

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

University of Pittsburgh Medical Center Health System

Pittsburgh, Pennsylvania, United States

St Francis Hospital

Greenville, South Carolina, United States

Brig Center for Cancer Care and Survivorship

Knoxville, Tennessee, United States

Baptist Cancer Center

Memphis, Tennessee, United States

Tennessee Oncology - Skyline Satellite

Nashville, Tennessee, United States

BloomTrials Clinical Research, LLC

Dallas, Texas, United States

The Methodist Hospital Research Institute

Houston, Texas, United States

University of Texas M. D. Anderson Cancer Center - Investigational Cancer Therapeutics

Houston, Texas, United States

Virginia Cancer Specialists

Fairfax, Virginia, United States

Medizinische Universität Innsbruck

Innsbruck, Austria

Kepler Universitätsklinikum

Linz, Austria

LKH - Universitätsklinikum der PMU Salzburg

Salzburg, Austria

AKH - Medizinische Universität Wien (4305)

Vienna, Austria

Klinikum Wels-Grieskirchen GmbH

Wels, Austria

Institut Jules Bordet

Brussels, Belgium

Universitair Ziekenhuis Brussel

Brussels, Belgium

Cliniques Universitaires Saint-Luc

Brussels, Belgium

UZ Leuven

Leuven, Belgium

Grand Hôpital de Charleroi

Loverval, Belgium

CHU UCL Namur

Namur, Belgium

Centre Hospitalier Wallonie picarde - Site IMC

Tournai, Belgium

Tom Baker Cancer Center

Calgary, Alberta, Canada

Toronto Sunnybrook Hospital

Toronto, Ontario, Canada

McGill University - Dept. Oncology Clinical Research Program

Montreal, Quebec, Canada

Anhui Provincial Hospital

Hefei, Anhui, China

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Fuzhou General Hospital of Nanjing Military Area Command of Chinese PLA

Fuzhou, Fujian, China

Sun Yat-sen Memorial hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Hubei Cancer Hospital

Wuhan, Hubei, China

The Affiliated Drum Tower Hospital of Nanjing University

Nanjing, Jiangsu, China

The First Hospital of Jilin University

Changchun, Jilin, China

Jilin Cancer Hospital

Changchun, Jilin, China

Liaoning Cancer Hospital & Institute

Shenyang, Liaoning, China

General Hospital of Ningxia Medical University

Yinchuan, Ningxia Hui, China

Linyi Cancer Hospital

Linyi, Shandong, China

Shanghai General Hospital

Shanghai, Shanghai Municipality, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine

Hangzhou, Zhejiang, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Institut Paoli Calmettes

Marseille, Bouches-du-Rhône, France

Centre François Baclesse

Caen, Calvados, France

CARIO - Centre Armoricain de Radiothérapie, Imagerie médicale et Oncologie

Plérin, Cotes d'Armor, France

CHU Brest - Hôpital Morvan

Brest, Finistere, France

Institut Bergonié

Bordeaux, Gironde, France

Clinique Clementville

Montpellier, Herault, France

Institut Régional du Cancer de Montpellier

Montpellier, Herault, France

CRLCC Eugene Marquis

Rennes, Ille Et Vilaine, France

ICO - Site René Gauducheau

Saint-Herblain, Loire Atlantique, France

Centre Hospitalier Emile Roux

Le Puy-en-Velay, Loiret, France

ICO - Site Paul Papin

Angers, Maine Et Loire, France

Centre Hospitalier Valenciennes

Valenciennes, Nord, France

Hôpital Saint-Louis - Paris

Paris, Paris, France

Clinique Victor Hugo - Centre Jean Bernard

Le Mans, Sarthe, France

Institut Sainte Catherine

Avignon, Vaculuse, France

Hôpital d'Instruction des Armees Begin*

Saint-Mandé, Val De Marne, France

Institut Gustave Roussy

Villejuif, Val De Marne, France

Institut Curie - site de Paris

Paris, France

Hopital Tenon

Paris, France

Universitaetsklinikum Heidelberg

Heidelberg, Baden-Wurttemberg, Germany

Klinikum der Universitaet Muenchen - Campus Grosshardern

Munich, Bavaria, Germany

General Hospital of Athens "Alexandra"

Athens, Greece

General Oncology Hospital of Kifissia " Agioi Anargyroi"

Athens, Greece

Athens Medical Center

Athens, Greece

University General Hospital of Heraklion

Heraklion, Greece

University General Hospital of Larissa

Larissa, Greece

Bioclinic Thessaloniki

Thessaloniki, Greece

Euromedica General Clinic Thessaloniki

Thessaloniki, Greece

General Hospital Papageorgiou

Thessaloniki, Greece

Interbalkan Hospital of Thessaloniki

Thessaloniki, Greece

Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet

Budapest, Hungary

Orszagos Onkologiai Intezet

Budapest, Hungary

Debreceni Egyetem

Debrecen, Hungary

Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza

Gyula, Hungary

SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz

Nyíregyháza, Hungary

Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet

Szolnok, Hungary

Rambam Health Care Center

Haifa, Israel

Shaare Zedek Medical Center

Jerusalem, Israel

Hadassah University Hospital - Ein Kerem

Jerusalem, Israel

Rabin Medical Center-Beilinson Campus

Petah Tikva, Israel

Chaim Sheba Medical Center

Ramat Gan, Israel

Kaplan Medical Center

Rehovot, Israel

Ziv Medical Center

Safed, Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Azienda Ospedaliera Card. G. Panico

Tricase, Lecce, Italy

Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo)

Monza, Milano, Italy

Istituto Clinico Humanitas

Rozzano, Milano, Italy

Ospedale Sacro Cuore Don Calabria

Negrar, Verona, Italy

Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi

Bologna, Italy

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)

Brescia, Italy

Azienda Ospedaliera Univ. Policlinico Gaspare Rodolico

Catania, Italy

Azienda Ospedaliero Universitaria Mater Domini-Campus Universitario

Catanzaro, Italy

IEO Istituto Europeo di Oncologia

Milan, Italy

Istituto Nazionale Tumori Fondazione G. Pascale

Naples, Italy

Ospedale degli Infermi

Rimini, Italy

Azienda Ospedaliera Universitaria Policlinico Tor Vergata

Roma, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Italy

Aichi Cancer Center Hospital

Nagoya, Aichi-ken, Japan

National Cancer Center Hospital East

Kashiwa-shi, Chiba, Japan

NHO Shikoku Cancer Center

Matsuyama, Ehime, Japan

NHO Kyushu Cancer Center

Fukuoka, Fukuoka, Japan

Fukushima Medical University Hospital

Fukushima, Fukushima, Japan

Hiroshima City Hiroshima Citizens Hospital

Hiroshima, Hiroshima, Japan

NHO Hokkaido Cancer Center

Sapporo, Hokkaido, Japan

Hyogo College of Medicine Hospital

Nishinomiya-shi, Hyōgo, Japan

Hakuaikai Sagara Hospital

Kagoshima, Kagoshima-ken, Japan

Tokai University Hospital

Isehara, Kanagawa, Japan

Kanagawa Cancer Center

Yokohama, Kanagawa, Japan

NHO Osaka National Hospital

Osaka, Osaka, Japan

Kindai University Hospital

Onohigashi, Osakasayama-shi, Japan

Saitama Cancer Center

Kitaadachi-gun, Saitama, Japan

Shizuoka Cancer Center

Sunto-gun, Shizuoka, Japan

Cancer Institute Hospital of JFCR

Kōtoku, Tokyo-To, Japan

Toranomon Hospital

Minatoku, Tokyo-To, Japan

Showa University Hospital

Shinagawa-Ku, Tokyo-To, Japan

Hospital de Braga

Braga, Portugal

Centro Hospitalar do Alto do Ave, EPE

Guimarães, Portugal

Fundação Champalimaud

Lisbon, Portugal

Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria

Lisbon, Portugal

Unidade Local de Saúde de Matosinhos, EPE (Hospital Pedro Hispano)

Matosinhos Municipality, Portugal

Centro Hospitalar do Porto, E.P.E. - Hospital de Santo António

Porto, Portugal

Instituto Português de Oncologia do Porto Francisco Gentil, EPE

Porto, Portugal

Centro Hospitalar de Entre o Douro e Vouga, E.P.E - Hospital de São Sebastião

Santa Maria da Feira, Portugal

Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E

Vila Nova de Gaia, Portugal

Centro Hospitalar de Trás-os-Montes e Alto Douro, EPE

Vila Real, Portugal

FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"

Moscow, Russia

SBIH of Moscow City "Moscow City Oncology Hospital №62" of Moscow Healthcare Departement

Moscow, Russia

SBIH of Yaroslavl Region "Regional Clinical Oncological Hospital"

Yaroslavl, Russia

National Cancer Center

Goyang-si, Gyeonggi-do, South Korea

Inha University Hospital

Incheon, Gyeonggi-do, South Korea

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Ajou University Hospital

Suwon, Gyeonggi-do, South Korea

Chungbuk National University Hospital

Cheongju-si, North Chungcheong, South Korea

Kyungpook National University Chilgok Hospital

Daegu, South Korea

Seoul National University Hospital

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, South Korea

Severance Hospital, Yonsei University Health System

Seoul, South Korea

ICO l'Hospitalet - Hospital Duran i Reynals

L'Hospitalet de Llobregat, Barcelona, Spain

Hospital Universitario Donostia

San Sebastián, Guipuzcoa, Spain

Complejo Hospitalario Universitario A Coruña

A Coruña, La Coruña, Spain

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Tenerife, Spain

Hospital de Basurto

Bilbao, Vizcaya, Spain

Hospital del Mar

Barcelona, Spain

Hospital Quironsalud Barcelona

Barcelona, Spain

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Hospital Clinic de Barcelona

Barcelona, Spain

MD Anderson Cancer Centre

Madrid, Spain

Hospital Ruber Internacional

Madrid, Spain

Hospital Universitario Ramon y Cajal

Madrid, Spain

Hospital Universitario Clinico San Carlos

Madrid, Spain

Hospital Clinico Universitario Virgen de la Victoria

Málaga, Spain

Hospital Universitario Virgen Macarena

Seville, Spain

Hospital Universitario Virgen del Rocio

Seville, Spain

Instituto Valenciano de Oncologia IVO

Valencia, Spain

Hospital General Universitario de Valencia

Valencia, Spain

Karolinska universitetssjukhuset - Solna

Solna, Sweden

Länssjukhuset Sundsvall-Härnösand

Sundsvall, Sweden

Akademiska Sjukhuset

Uppsala, Sweden

Hirslanden Medical Center

Aarau, Switzerland

Universitaetsspital Basel

Basel, Switzerland

Kantonsspital Graubuenden

Chur, Switzerland

Centre Hospitalier Universitaire Vaudois

Lausanne, Switzerland

Kantonsspital St. Gallen

Sankt Gallen, Switzerland

Kantonsspital Winterthur

Winterthur, Switzerland

Universitaetsspital Zuerich

Zurich, Switzerland

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Royal Cornwall Hospital

Truro, Cornwall, United Kingdom

Queen Mary University of London

London, Greater London, United Kingdom

University College London Hospitals

London, Greater London, United Kingdom

Royal Free Hospital

London, Greater London, United Kingdom

Western General Hospital

Edinburgh, Lothian Region, United Kingdom

Nottingham University Hospitals City Campus

Nottingham, Nottinghamshire, United Kingdom

Royal Surrey County Hospital

Guildford, Surrey, United Kingdom