DS-8201a in Pre-treated HER2 Breast Cancer That Cannot be Surgically Removed or Has Spread [DESTINY-Breast02]

NCT03523585 | Completed Phase 3 Results DMC FDA Drug

• 4 other identifiers: DS8201-A-U3012018-000221-31184017DESTINY-Breast02
• Study Type: interventional
• Target: 608
• Locations: 15 countries
• Sites: 227

Brief Summary

This study will compare DS 8201a to standard treatment. Participants must have HER2 breast cancer that has been treated before. Their cancer:

• cannot be removed by an operation
• has spread to other parts of the body

Conditions

Breast Cancer

Keywords

Breast Cancer; Metastatic breast cancer; DS 8201a; DESTINY - Breast 02

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS) Based on Blinded Independent Central Review (BICR) in Participants With HER2-positive, Unresectable and/or Metastatic Breast Cancer Participants Previously Treated With Trastuzumab Emtansine

  Progression-free survival (PFS) by BICR was defined as the time from the date of randomization to the earlier of the dates of the first objective documentation of disease progression (as per RECIST v1.1) or death due to any cause.

  Baseline up to 46 months postdose

Secondary Outcomes (4)

• Overall Survival (OS) in Participants With HER2-positive, Unresectable and/or Metastatic Breast Cancer Participants Previously Treated With Trastuzumab Emtansine

  Baseline up to 46 months postdose

• Percentage of Participants With Objective Response Rate (ORR) in Participants With HER2-positive, Unresectable and/or Metastatic Breast Cancer Participants Previously Treated With Trastuzumab Emtansine

  Baseline up to 46 months postdose

• Duration of Response (DoR) Based on BICR in Participants With HER2-positive, Unresectable and/or Metastatic Breast Cancer Participants Previously Treated With Trastuzumab Emtansine

  Baseline up to 46 months postdose

• Progression-Free Survival (PFS) Based on Investigator Assessment in Participants With HER2-positive, Unresectable and/or Metastatic Breast Cancer Participants Previously Treated With Trastuzumab Emtansine

  Up to 46 months

Study Arms (3)

Trastuzumab deruxtecan (DS-8201a)

EXPERIMENTAL

HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), randomized to treatment with DS-8201a

Drug: Trastuzumab deruxtecan

Trastuzumab+capecitabine

ACTIVE COMPARATOR

HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), randomized to investigator's choice treatment with Trastuzumab/capecitabine

Drug: Capecitabine; Drug: Trastuzumab

Lapatinib+capecitabine

ACTIVE COMPARATOR

HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), randomized to investigator's choice treatment with Lapatinib/capecitabine

Drug: Capecitabine; Drug: Lapatinib

Interventions

Lapatinib DRUG

Investigator's choice Standard of Care when combined with capecitabine

Also known as: Investigator's Choice Comparative Therapy

Lapatinib+capecitabine

Trastuzumab DRUG

Investigator's choice Standard of Care when combined with capecitabine

Also known as: Investigator's Choice Comparative Therapy

Trastuzumab+capecitabine

Trastuzumab deruxtecan DRUG

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

Also known as: DS-8201a, T-DXd

Trastuzumab deruxtecan (DS-8201a)

Capecitabine DRUG

Investigator's choice Standard of Care when combined with trastuzumab or lapatinib

Also known as: Investigator's Choice Comparative Therapy

Lapatinib+capecitabine; Trastuzumab+capecitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is the age of majority in their country
• Has pathologically documented breast cancer that:
• is unresectable or metastatic
• has confirmed HER2-positive expression as determined according to American Society of Clinical Oncology - College of American Pathologists guidelines evaluated at a central laboratory
• was previously treated with ado-trastuzumab emtansine (T-DM1)
• Has documented radiologic progression (during or after most recent treatment or within 6 months after completing adjuvant therapy)
• Is HER2 positive as confirmed by central laboratory assessment of most recent tumor tissue sample available. If archived tissue is not available, agrees to provide a fresh biopsy.
• Male and female participants of reproductive/childbearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and for at least:
• months after the last dose of DS-8201a (females); 4.5 months after last dose of DS-8201a (males)
• months after the last dose of lapatinib/capecitabine for female participants (3 months for male participants)
• months after the last dose of trastuzumab/capecitabine
• Has adequate hematopoietic, renal and hepatic functions

You may not qualify if:

• Has previously participated in an antibody drug conjugate study sponsored by Daiichi Sankyo. Prior treatment in the adjuvant/neo-adjuvant setting would be allowed if progression of disease did not occur within 12 months of end of adjuvant therapy
• Has had prior treatment with capecitabine
• Has uncontrolled or significant cardiovascular disease
• Has a history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening
• Has active central nervous system (CNS) metastases

Sponsors & Collaborators

• AstraZeneca: collaborator
• Daiichi Sankyo: lead
• Daiichi Sankyo Co., Ltd.: collaborator

Study Sites (227)

Ironwood Cancer Research Centers

Chandler, Arizona, 85224, United States

Location

UCLA Hematology Oncology - Main Site

Los Angeles, California, 90095, United States

Location

Pacific Cancer Care

Monterey, California, 93940, United States

Location

Sharp Memorial Hospital

San Diego, California, 92123, United States

Location

Innovative Clinical Research Institute

Whittier, California, 90603, United States

Location

Smilow Cancer Hospital at Yale New Haven

New Haven, Connecticut, 06510, United States

Location

Washington Cancer Institute

Washington D.C., District of Columbia, 20010, United States

Location

Florida Cancer Specialists-Broadway

Fort Myers, Florida, 33901, United States

Location

Piedmont Cancer Institute, PC

Atlanta, Georgia, 30318, United States

Location

Kapiolani Medical Center for Women and Children/Univ of HI

Honolulu, Hawaii, 96826, United States

Location

Loyola University Health System

Maywood, Illinois, 60153, United States

Location

Community Hospital

Munster, Indiana, 46321, United States

Location

Norton Cancer Institute

Louisville, Kentucky, 40207, United States

Location

Maine Center for Cancer Medicine

Scarborough, Maine, 04074, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Cornell-Beshore Cancer Institute

Joplin, Missouri, 64804, United States

Location

Saint Luke's Cancer Institute

Kansas City, Missouri, 64111, United States

Location

Health Midwest Ventures Group, Inc d/b/a HCA MidAmerica Division, LLC

Kansas City, Missouri, 64132, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

North Shore Hematology Oncology Associates, PC

East Setauket, New York, 11733, United States

Location

Memorial Sloan-Kettering Cancer Center (MSKCC) - New York

New York, New York, 10065, United States

Location

University of Cincinnati Medical Center

Cincinnati, Ohio, 45267, United States

Location

Cleveland Clinic Main Campus

Cleveland, Ohio, 44195, United States

Location

The Ohio State University

Columbus, Ohio, 43235, United States

Location

Dayton Physicians, LLC

Kettering, Ohio, 45409, United States

Location

Abramson Cancer Center

Philadelphia, Pennsylvania, 19104, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

UPMC Cancer Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Tennessee Oncology, PLLC Chattanooga

Chattanooga, Tennessee, 37404, United States

Location

The West Clinic

Germantown, Tennessee, 38138, United States

Location

SCRI - Tennessee Oncology

Nashville, Tennessee, 37203, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

The Methodist Hospital Research Institute

Houston, Texas, 77030, United States

Location

The University of Texas Health Science Center at Tyler

Tyler, Texas, 75708, United States

Location

Community Cancer Trials of Utah

Ogden, Utah, 84405, United States

Location

Virginia Cancer Specialists, PC

Fairfax, Virginia, 22031, United States

Location

MultiCare Health System Institute for Research and Innovation

Tacoma, Washington, 98405, United States

Location

St Vincent's Hospital Sydney

Darlinghurst, New South Wales, 2010, Australia

Location

Liverpool Hospital

Liverpool, New South Wales, 2170, Australia

Location

Macquarie University Hospital

Sydney, New South Wales, 2109, Australia

Location

The Tweed Hospital

Tweed Heads, New South Wales, 2485, Australia

Location

Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

Location

Ashford Cancer Centre Research

Kurralta Park, South Australia, 5037, Australia

Location

Box Hill Hospital

Box Hill, Victoria, 3128, Australia

Location

Frankston Hospital

Frankston, Victoria, 3199, Australia

Location

Peninsula and South Eastern Haematology & Oncology Group

Frankston, Victoria, 3199, Australia

Location

Austin Health

Heidelberg, Victoria, 3084, Australia

Location

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3000, Australia

Location

Sunshine Hospital

Saint Albans, Victoria, 3021, Australia

Location

South West Oncology

Warrnambool, Victoria, 3280, Australia

Location

Ballarat Oncology & Haematology Service

Wendouree, Victoria, 3355, Australia

Location

St John of God Subiaco Hospital

Subiaco, Western Australia, 6008, Australia

Location

Calvary North Adelaide Hospital

Bruce, 2614, Australia

Location

Universitair Ziekenhuis Brussel

Brussels, 1090, Belgium

Location

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

AZ Maria Middelares

Ghent, 9000, Belgium

Location

Az Groeninge

Kortrijk, 8500, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

CHU UCL Namur site de Sainte Elisabeth

Namur, 5000, Belgium

Location

Pronutrir

Fortaleza, Ceará, 60810-180, Brazil

Location

NOB - Núcleo de Oncologia da Bahia

Salvador, Estado de Bahia, 40170-110, Brazil

Location

AMO - Assistência Multidisciplinar em Oncologia

Salvador, Estado de Bahia, 41950-640, Brazil

Location

Oncobio Servicos de Saude

Nova Lima, Minas Gerais, 34000, Brazil

Location

HGB - Hospital Giovanni Battista - Mãe de Deus Center

Porto Alegre, Rio Grande do Sul, 90110-270, Brazil

Location

CliniOnco - Tratamento Integrado do Câncer

Porto Alegre, Rio Grande do Sul, 90430-090, Brazil

Location

Escosteguy Barrios, Carlos Henrique

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Location

Hospital Nossa Senhora da Conceição

Porto Alegre, Rio Grande do Sul, 91350-200, Brazil

Location

Clínica de Neoplasias Litoral Ltda.

Itajaí, Santa Catarina, 88301-220, Brazil

Location

CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia

Santo André, São Paulo, 09060-650, Brazil

Location

IBCC - Instituto Brasileiro de Controle do Câncer

São Paulo, São Paulo, 03102-002, Brazil

Location

COI - Clínicas Oncológicas Integradas

Rio de Janeiro, 22793-080, Brazil

Location

Sociedade Beneficiente de Senhoras Hospital Sírio Libanês

São Paulo, 01308, Brazil

Location

A. C. Camargo Cancer Center

São Paulo, 01509-900, Brazil

Location

Fakultni nemocnice Brno

Brno, 625 00, Czechia

Location

Fakultni nemocnice Olomouc

Olomouc, 775 20, Czechia

Location

Fakultni nemocnice v Motole

Prague, 150 06, Czechia

Location

Nemocnice Na Bulovce

Prague, 180 81, Czechia

Location

Hôpital Nord - CHU Marseille

Marseille, Bouches-du-Rhône, 13915, France

Location

Centre François Baclesse

Caen, Calvados, 14076, France

Location

CARIO - Centre Armoricain de Radiothérapie, Imagerie médicale et Oncologie

Plérin, Cotes d'Armor, 22190, France

Location

Centre Georges François Leclerc

Dijon, Côte-d'Or, 21079, France

Location

CHU Besançon - Hôpital Jean Minjoz

Besançon, Doubs, 25030, France

Location

CHU Brest - Hôpital Morvan

Brest, Finistere, 29609, France

Location

Hôpital Privé d'Antony

Antony, Hauts De Seine, 92160, France

Location

Centre René Huguenin

Saint-Cloud, Hauts De Seine, 92110, France

Location

Clinique Clementville

Montpellier, Herault, 34070, France

Location

Institut Régional du Cancer de Montpellier

Montpellier, Herault, 34298, France

Location

CRLCC Eugene Marquis

Rennes, Ille Et Vilaine, 35042, France

Location

Centre Oscar Lambret

Lille, Nord, 59020, France

Location

Centre de cancerologie les Dentellieres

Valenciennes, Nord, 59300, France

Location

Institut Curie - site de Paris

Paris, Paris, 75005, France

Location

Centre Hospitalier de la côte Basque

Bayonne, Pyrenees Atlantiques, 64109, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, Rhone, 69495, France

Location

Clinique Victor Hugo - Centre Jean Bernard

Le Mans, Sarthe, 72015, France

Location

Centre Henri Becquerel

Rouen, Seine Maritime, 76038, France

Location

Institut Sainte Catherine

Avignon, Vaculuse, 84918, France

Location

Institut Gustave Roussy

Villejuif, Val De Marne, 94805, France

Location

Institut Régional du Cancer de Montpellier

Montpellier, 34298, France

Location

Institut Curie - site de Paris

Paris, 75005, France

Location

Hopital Tenon

Paris, 75020, France

Location

Klinikum rechts der Isar der TU Muenchen

Munich, Bavaria, 81675, Germany

Location

Marienhospital Bottrop gGmbH

Bottrop, Rhineland-Palatinate, 46236, Germany

Location

Universitaetsklinikum Schleswig-Holstein - Campus Luebeck

Lübeck, Schleswig-Holstein, 23538, Germany

Location

Helios-Kliniken Berlin-Buch

Berlin, 13125, Germany

Location

Kliniken Koeln

Cologne, 51067, Germany

Location

Universitaetsklinikum Duesseldorf AoeR

Düsseldorf, 40225, Germany

Location

Universitaetsklinikum Erlangen

Erlangen, 91054, Germany

Location

Universitaetsklinikum Leipzig AoeR

Leipzig, 04103, Germany

Location

Klinikum der Universitaet Muenchen - Campus Grosshardern

Munich, 81377, Germany

Location

Universitaetsklinikum Muenster

Müenster, 48149, Germany

Location

Haematologisch-Onkologische Schwerpunktpraxis

Troisdorf, 53840, Germany

Location

251 General Air Force Hospital

Athens, 11525, Greece

Location

General Hospital of Athens "Alexandra"

Athens, 11528, Greece

Location

General Oncology Hospital of Kifissia " Agioi Anargyroi"

Athens, 14564, Greece

Location

University General Hospital of Heraklion

Heraklion, 71110, Greece

Location

Euromedica General Clinic Thessaloniki

Thessaloniki, 54645, Greece

Location

Rambam Health Care Center

Haifa, 3109601, Israel

Location

Shaare Zedek Medical Center

Jerusalem, 9103102, Israel

Location

Hadassah University Hospital - Ein Kerem

Jerusalem, 9112001, Israel

Location

Sapir Medical Center, Meir Hospital

Kfar Saba, 4428164, Israel

Location

Rabin Medical Center-Beilinson Campus

Petah Tikva, 49100, Israel

Location

Chaim Sheba Medical Center

Ramat Gan, 52363, Israel

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, 6423906, Israel

Location

Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo)

Monza, Milano, 20900, Italy

Location

IRCCS Centro di Riferimento Oncologico

Aviano, Pordenone, 33081, Italy

Location

Ospedale Sacro Cuore Don Calabria

Negrar, Verona, 37024, Italy

Location

Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)

Bergamo, 24127, Italy

Location

Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi

Bologna, 40138, Italy

Location

Azienda Ospedaliera Universitaria Arcispedale Sant'Anna

Cona, 44124, Italy

Location

Istituto Nazionale per la Ricerca sul Cancro di Genova

Genova, 16132, Italy

Location

Azienda Ospealiera della Provincia di Lecco

Lecco, 23900, Italy

Location

Azienda Ospedaliera Ospedali Riuniti Papardo-Piemonte

Messina, 98158, Italy

Location

Ospedale San Raffaele

Milan, 20132, Italy

Location

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, 20133, Italy

Location

IEO Istituto Europeo di Oncologia

Milan, 20141, Italy

Location

A.O.U. Policlinico di Modena

Modena, 41124, Italy

Location

Istituto Nazionale Tumori Fondazione G. Pascale

Naples, 80131, Italy

Location

IOV - Istituto Oncologico Veneto IRCCS

Padua, 35128, Italy

Location

Azienda Ospedaliero Universitaria di Parma

Parma, 43100, Italy

Location

Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

Location

Azienda Ospedaliero Universitaria Pisana

Pisa, 56126, Italy

Location

Azienda Ospedaliera Città della Salute e della Scienza di Torino

Torino, 10126, Italy

Location

Fukushima Medical University Hospital

Fukushima, Fukushima, 960-1295, Japan

Location

Kindai University Hospital

Osakasayama-shi, Osaka, 589-8511, Japan

Location

Kindai University Hospital

Ōsakasayama-shi, Osaka, 589-8511, Japan

Location

National Cancer Center Hospital

Chūōku, Tokyo-To, 104-0045, Japan

Location

NHO Shikoku Cancer Center

Ehime, 791-0280, Japan

Location

NHO Kyushu Cancer Center

Fukuoka, 811-1395, Japan

Location

Hiroshima City Hiroshima Citizens Hospital

Hiroshima, 730-8518, Japan

Location

NHO Hokkaido Cancer Center

Hokkaido, 003-0804, Japan

Location

Hyōgo College of Medicine Hospital

Hyōgo, 663-8501, Japan

Location

St. Marianna University School of Medicine Hospital

Kanagawa, 216-8511, Japan

Location

Kanagawa Cancer Center

Kanagawa, 241-8515, Japan

Location

Kyoto University Hospital

Kyoto, 606-8507, Japan

Location

Tohoku University Hospital

Miyagi, 980-8574, Japan

Location

Aichi Cancer Center Hospital

Nagoya, 464-8681, Japan

Location

Niigata Cancer Center Hospital

Niigata, 951-8566, Japan

Location

Okayama University Hospital

Okayama, 700-8558, Japan

Location

NHO Osaka National Hospital

Osaka, 540-0006, Japan

Location

Osaka International Cancer Institute

Osaka, 541-8567, Japan

Location

Saitama Cancer Center

Saitama, 362-0806, Japan

Location

Shizuoka Cancer Center

Shizuoka, 411-8777, Japan

Location

Toranomon Hospital

Tokyo, 105-8470, Japan

Location

The Cancer Institute Hospital of JFCR

Tokyo, 135-8550, Japan

Location

Tokyo Medical University Hospital

Tokyo, 160-0023, Japan

Location

Inha University Hospital

Incheon, Gyeonggi-do, 22332, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

The Catholic University of Korea, St. Vincent's Hospital

Suwon, Gyeonggi-do, 16247, South Korea

Location

Ajou University Hospital

Suwon, Gyeonggi-do, 16499, South Korea

Location

Chungbuk National University Hospital

Cheongju-si, North Chungcheong, 28644, South Korea

Location

Kyungpook National University Chilgok Hospital

Daegu, 41404, South Korea

Location

National Cancer Center

Goyang-si, 10408, South Korea

Location

Korea University Anam Hospital

Seoul, 02841, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Severance Hospital, Yonsei University

Seoul, 03772, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

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

Seoul, 06591, South Korea

Location

ICO Badalona - Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

ICO l'Hospitalet - Hospital Duran i Reynals

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

Location

Hospital de Especialidades de Jerez de la Frontera

Jerez de la Frontera, Cádiz, 11407, Spain

Location

Complejo Hospitalario Universitario A Coruña

A Coruña, La Coruña, 15006, Spain

Location

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Tenerife, 38320, Spain

Location

Hospital Infanta Cristina

Badajoz, 06007, Spain

Location

Hospital Quironsalud Barcelona

Barcelona, 08023, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hospital del Mar

Barcelona, 8003, Spain

Location

Hospital Universitari Arnau de Vilanova

Lleida, 25198, Spain

Location

Hospital General Universitario Gregorio Marañon

Madrid, 28007, Spain

Location

MD Anderson Cancer Centre

Madrid, 28033, Spain

Location

Hospital Universitario Clinico San Carlos

Madrid, 28040, Spain

Location

Hospital Clinico Universitario Virgen de la Victoria

Málaga, 29010, Spain

Location

Hospital Universitario de Salamanca

Salamanca, 37370, Spain

Location

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

Location

Hospital Universitario Virgen del Rocio

Seville, 41013, Spain

Location

Instituto Valenciano de Oncologia IVO

Valencia, 46009, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

Location

Acibadem Adana Hospital

Adana, 01130, Turkey (Türkiye)

Location

Adana Numune Training and Research Hospital

Adana, 01370, Turkey (Türkiye)

Location

Ankara Yildirim Beyazit Uni. Med. Fac.Ankara City Hospital

Ankara, 6800, Turkey (Türkiye)

Location

Akdeniz University Medical Faculty

Antalya, 07058, Turkey (Türkiye)

Location

Uludag University Medical Faculty

Bursa, 16059, Turkey (Türkiye)

Location

Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty

Istanbul, 34098, Turkey (Türkiye)

Location

Bakirkoy Dr. Sadi Konuk Teaching and Research Hospital

Istanbul, 34147, Turkey (Türkiye)

Location

Medipol University Medical Faculty

Istanbul, 34214, Turkey (Türkiye)

Location

Medical Park Goztepe Hospital

Istanbul, 34732, Turkey (Türkiye)

Location

Istanbul Medeniyet Uni Goztepe Training & Research Hospital

Istanbul, 34854, Turkey (Türkiye)

Location

Kartal Lutfi Kirdar Research and Training Hospital

Istanbul, 34890, Turkey (Türkiye)

Location

Izmir Medicalpark Hospital

Izmir, 35530, Turkey (Türkiye)

Location

Konya Necmettin Erbakan University Meram Faculty of Medicine

Konya, 42080, Turkey (Türkiye)

Location

Sakarya Traning and Research Hospital

Sakarya, 54187, Turkey (Türkiye)

Location

Medical Park Samsun Hastanesi

Samsun, 55200, Turkey (Türkiye)

Location

Namik Kemal University

Tekirdağ, 59100, Turkey (Türkiye)

Location

Royal Cornwall Hospital

Truro, Cornwall, TR1 3LJ, United Kingdom

Location

Royal Devon and Exeter Hospital (Wonford)

Exeter, Devon, EX2 5DW, United Kingdom

Location

Derriford Hospital

Plymouth, Devon, PL6 8BQ, United Kingdom

Location

Aberdeen Royal Infirmary

Aberdeen, Grampian Region, AB25 2ZB, United Kingdom

Location

Queen Mary University of London

London, Greater London, EC1M 6BQ, United Kingdom

Location

University College London Hospitals

London, Greater London, NW1 2PG, United Kingdom

Location

Sarah Cannon Research Institute UK

London, Greater London, W1G 6AD, United Kingdom

Location

Western General Hospital

Edinburgh, Lothian Region, EH4 2XU, United Kingdom

Location

Nottingham University Hospitals City Campus

Nottingham, Nottinghamshire, NG5 1PB, United Kingdom

Location

Related Publications (2)

• Andre F, Hee Park Y, Kim SB, Takano T, Im SA, Borges G, Lima JP, Aksoy S, Gavila Gregori J, De Laurentiis M, Bianchini G, Roylance R, Miyoshi Y, Armstrong A, Sinha R, Ruiz Borrego M, Lim E, Ettl J, Yerushalmi R, Zagouri F, Duhoux FP, Fehm T, Gambhire D, Cathcart J, Wu C, Chu C, Egorov A, Krop I. Trastuzumab deruxtecan versus treatment of physician's choice in patients with HER2-positive metastatic breast cancer (DESTINY-Breast02): a randomised, open-label, multicentre, phase 3 trial. Lancet. 2023 May 27;401(10390):1773-1785. doi: 10.1016/S0140-6736(23)00725-0. Epub 2023 Apr 20.

  PMID: 37086745 RESULT

• Fehm T, Cottone F, Dunton K, Andre F, Krop I, Park YH, De Laurentiis M, Miyoshi Y, Armstrong A, Borrego MR, Yerushalmi R, Duhoux FP, Takano T, Lu W, Egorov A, Kim SB. Trastuzumab deruxtecan versus treatment of physician's choice in patients with HER2-positive metastatic breast cancer (DESTINY-Breast02): patient-reported outcomes from a randomised, open-label, multicentre, phase 3 trial. Lancet Oncol. 2024 May;25(5):614-625. doi: 10.1016/S1470-2045(24)00128-1.

  PMID: 38697155 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

trastuzumab deruxtecan; Capecitabine; Lapatinib; Trastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Contact for Clinical Trial Information
• Organization: Daiichi Sankyo

CTRinfo@dsi.com

1-908-992-6400

Study Officials

• Global Team Leader

  Daiichi Sankyo

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2018
• First Posted: May 14, 2018
• Study Start: August 1, 2018
• Primary Completion: June 30, 2022
• Study Completion: December 23, 2025
• Last Updated: February 27, 2026
• Results First Posted: June 26, 2023

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Completed studies that has reached a global end or completion with all data set collected and analyzed, and for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
• Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents on completed clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.

Locations

KR (13); AU (16); GB (9); GR (5); US (41); TU (16); BR (14); IL (7); ES (20); FR (23); CZ (4); BE (6); JP (23); IT (19); DE (11)