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Trastuzumab Deruxtecan (DS-8201a) Versus Investigator's Choice pour le cancer du sein HER2-low qui s'est propagé ou ne peut pas être retiré chirurgicalement [DESTINY-Breast04]

1 septembre 2026 mis à jour par: Daiichi Sankyo

Un essai contrôlé actif de phase 3, multicentrique, randomisé, ouvert, du DS-8201a, un conjugué médicamenteux anti-HER2-anticorps (ADC), par rapport au traitement de choix du médecin pour les sujets atteints d'un cancer du sein à faible HER2, non résécable et/ou métastatique

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

Aperçu de l'étude

Statut

Complété

Les conditions

Cancer du sein

Intervention / Traitement

Description détaillée

This is a randomized, 2-arm, Phase 3, open-label, multicenter study to compare the safety and efficacy of trastuzumab deruxtecan versus the physician's choice (2:1) in HER2-low, unresectable and/or metastatic breast cancer participants.

The Sponsor proposes to define a new HER2-low population in this trial including tumors with IHC 1+ and IHC 2+/ISH- HER2 expression.

Type d'étude

Interventionnel

Inscription (Réel)

557

Phase

Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

Allemagne
- Baden-Wurttemberg
  - Heidelberg, Baden-Wurttemberg, Allemagne, 69120
    - Universitaetsklinikum Heidelberg
- Bavaria
  - Munich, Bavaria, Allemagne, 81377
    - Klinikum der Universitaet Muenchen - Campus Grosshardern
Belgique
- - Brussels, Belgique, 1000
    - Institut Jules Bordet
  - Brussels, Belgique, 1090
    - Universitair Ziekenhuis Brussel
  - Brussels, Belgique, 1200
    - Cliniques Universitaires Saint-Luc
  - Leuven, Belgique, 3000
    - UZ Leuven
  - Loverval, Belgique, 6280
    - Grand Hôpital de Charleroi
  - Namur, Belgique, 5000
    - CHU UCL Namur
  - Tournai, Belgique, 7500
    - Centre Hospitalier Wallonie picarde - Site IMC
Canada
- Alberta
  - Calgary, Alberta, Canada, T2N4N2
    - Tom Baker Cancer Center
- Ontario
  - Toronto, Ontario, Canada, M4N 3M5
    - Toronto Sunnybrook Hospital
- Quebec
  - Montreal, Quebec, Canada, H2W 1S6
    - McGill University - Dept. Oncology Clinical Research Program
Chine
- Anhui
  - Hefei, Anhui, Chine, 230001
    - Anhui Provincial Hospital
- Beijing Municipality
  - Beijing, Beijing Municipality, Chine, 100853
    - Chinese PLA General Hospital
  - Beijing, Beijing Municipality, Chine, 100021
    - Cancer Hospital Chinese Academy of Medical Sciences
- Fujian
  - Fuzhou, Fujian, Chine, 350025
    - Fuzhou General Hospital of Nanjing Military Area Command of Chinese PLA
- Guangdong
  - Guangzhou, Guangdong, Chine, 510120
    - Sun Yat-sen Memorial hospital, Sun Yat-sen University
- Heilongjiang
  - Harbin, Heilongjiang, Chine, 150081
    - Harbin Medical University Cancer Hospital
- Hubei
  - Wuhan, Hubei, Chine, 430079
    - Hubei Cancer Hospital
- Jiangsu
  - Nanjing, Jiangsu, Chine, 210008
    - The Affiliated Drum Tower Hospital of Nanjing University
- Jilin
  - Changchun, Jilin, Chine, 130000
    - The First Hospital of Jilin University
  - Changchun, Jilin, Chine, 130012
    - Jilin Cancer Hospital
- Liaoning
  - Shenyang, Liaoning, Chine, 110042
    - Liaoning Cancer Hospital & Institute
- Ningxia Hui
  - Yinchuan, Ningxia Hui, Chine, 750004
    - General Hospital of Ningxia Medical University
- Shandong
  - Linyi, Shandong, Chine, 276001
    - Linyi Cancer Hospital
- Shanghai Municipality
  - Shanghai, Shanghai Municipality, Chine, 200080
    - Shanghai General Hospital
  - Shanghai, Shanghai Municipality, Chine, 20032
    - Fudan University Shanghai Cancer Center
- Sichuan
  - Chengdu, Sichuan, Chine, 610041
    - West China Hospital, Sichuan University
- Zhejiang
  - Hangzhou, Zhejiang, Chine, 310022
    - Zhejiang Cancer Hospital
  - Hangzhou, Zhejiang, Chine, 310016
    - Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
Corée du Sud
- - Daegu, Corée du Sud, 41404
    - Kyungpook National University Chilgok Hospital
  - Seoul, Corée du Sud, 03080
    - Seoul National University Hospital
  - Seoul, Corée du Sud, 05505
    - Asan Medical Center
  - Seoul, Corée du Sud, 06351
    - Samsung Medical Center
  - Seoul, Corée du Sud, 06591
    - The Catholic University of Korea, Seoul St. Mary's Hospital
  - Seoul, Corée du Sud, 120-752
    - Severance Hospital, Yonsei University Health System
- Gyeonggi-do
  - Goyang-si, Gyeonggi-do, Corée du Sud, 10408
    - National Cancer Center
  - Incheon, Gyeonggi-do, Corée du Sud, 22332
    - Inha University Hospital
  - Seongnam-si, Gyeonggi-do, Corée du Sud, 13620
    - Seoul National University Bundang Hospital
  - Suwon, Gyeonggi-do, Corée du Sud, 16499
    - Ajou University Hospital
- North Chungcheong
  - Cheongju-si, North Chungcheong, Corée du Sud, 361-711
    - Chungbuk National University Hospital
Espagne
- - Barcelona, Espagne, 08036
    - Hospital Clinic de Barcelona
  - Barcelona, Espagne, 08035
    - Hospital Universitari Vall d'Hebron
  - Barcelona, Espagne, 08023
    - Hospital Quironsalud Barcelona
  - Barcelona, Espagne, 08003
    - Hospital del Mar
  - Madrid, Espagne, 28034
    - Hospital Universitario Ramon y Cajal
  - Madrid, Espagne, 28040
    - Hospital Universitario Clinico San Carlos
  - Madrid, Espagne, 28034
    - Hospital Ruber Internacional
  - Madrid, Espagne, 28033
    - MD Anderson Cancer Centre
  - Málaga, Espagne, 29010
    - Hospital Clinico Universitario Virgen de la Victoria
  - Seville, Espagne, 41009
    - Hospital Universitario Virgen Macarena
  - Seville, Espagne, 41013
    - Hospital Universitario Virgen del Rocio
  - Valencia, Espagne, 46014
    - Hospital General Universitario de Valencia
  - Valencia, Espagne, 46009
    - Instituto Valenciano de Oncologia IVO
- Barcelona
  - L'Hospitalet de Llobregat, Barcelona, Espagne, 08908
    - ICO l'Hospitalet - Hospital Duran i Reynals
- Guipuzcoa
  - San Sebastián, Guipuzcoa, Espagne, 20014
    - Hospital Universitario Donostia
- La Coruña
  - A Coruña, La Coruña, Espagne, 15006
    - Complejo Hospitalario Universitario A Coruña
- Tenerife
  - San Cristóbal de La Laguna, Tenerife, Espagne, 38320
    - Hospital Universitario de Canarias
- Vizcaya
  - Bilbao, Vizcaya, Espagne, 48013
    - Hospital de Basurto
France
- - Paris, France, 75020
    - Hopital Tenon
  - Paris, France, 75005
    - Institut Curie - site de Paris
- Bouches-du-Rhône
  - Marseille, Bouches-du-Rhône, France, 13009
    - Institut Paoli Calmettes
- Calvados
  - Caen, Calvados, France, 14076
    - Centre François Baclesse
- Cotes d'Armor
  - Plérin, Cotes d'Armor, France, 22190
    - CARIO - Centre Armoricain de Radiothérapie, Imagerie médicale et Oncologie
- Finistere
  - Brest, Finistere, France, 29609
    - CHU Brest - Hôpital Morvan
- Gironde
  - Bordeaux, Gironde, France, 33076
    - Institut Bergonié
- Herault
  - Montpellier, Herault, France, 34070
    - Clinique Clementville
  - Montpellier, Herault, France, 34298
    - Institut Régional du Cancer de Montpellier
- Ille Et Vilaine
  - Rennes, Ille Et Vilaine, France, 35042
    - CRLCC Eugene Marquis
- Loire Atlantique
  - Saint-Herblain, Loire Atlantique, France, 44805
    - ICO - Site René Gauducheau
- Loiret
  - Le Puy-en-Velay, Loiret, France, 43012
    - Centre Hospitalier Emile Roux
- Maine Et Loire
  - Angers, Maine Et Loire, France, 49055
    - ICO - Site Paul Papin
- Nord
  - Valenciennes, Nord, France, 59322
    - Centre Hospitalier Valenciennes
- Paris
  - Paris, Paris, France, 75475
    - Hôpital Saint-Louis - Paris
- Sarthe
  - Le Mans, Sarthe, France, 72015
    - Clinique Victor Hugo - Centre Jean Bernard
- Vaculuse
  - Avignon, Vaculuse, France, 84918
    - Institut Sainte Catherine
- Val De Marne
  - Saint-Mandé, Val De Marne, France, 94160
    - Hôpital d'Instruction des Armees Begin*
  - Villejuif, Val De Marne, France, 94805
    - Institut Gustave Roussy
Grèce
- - Athens, Grèce, 15125
    - Athens Medical Center
  - Athens, Grèce, 11528
    - General Hospital of Athens "Alexandra"
  - Athens, Grèce, 14564
    - General Oncology Hospital of Kifissia " Agioi Anargyroi"
  - Heraklion, Grèce, 71110
    - University General Hospital of Heraklion
  - Larissa, Grèce, 41110
    - University General Hospital of Larissa
  - Thessaloniki, Grèce, 54622
    - Bioclinic Thessaloniki
  - Thessaloniki, Grèce, 54645
    - Euromedica General Clinic Thessaloniki
  - Thessaloniki, Grèce, 56429
    - General Hospital Papageorgiou
  - Thessaloniki, Grèce, 57001
    - Interbalkan Hospital of Thessaloniki
Hongrie
- - Budapest, Hongrie, 1097
    - Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet
  - Budapest, Hongrie, 1122
    - Orszagos Onkologiai Intezet
  - Debrecen, Hongrie, 4032
    - Debreceni Egyetem
  - Gyula, Hongrie, 5700
    - Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza
  - Nyíregyháza, Hongrie, 4400
    - SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz
  - Szolnok, Hongrie, 5004
    - Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet
Israël
- - Haifa, Israël, 3109601
    - Rambam Health Care Center
  - Jerusalem, Israël, 9103102
    - Shaare Zedek Medical Center
  - Jerusalem, Israël, 9112001
    - Hadassah University Hospital - Ein Kerem
  - Petah Tikva, Israël, 49100
    - Rabin Medical Center-Beilinson Campus
  - Ramat Gan, Israël, 52363
    - Chaim Sheba Medical Center
  - Rehovot, Israël, 7610001
    - Kaplan Medical Center
  - Safed, Israël, 13100
    - Ziv Medical Center
  - Tel Aviv, Israël, 6423906
    - Tel Aviv Sourasky Medical Center
Italie
- - Bologna, Italie, 40138
    - Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
  - Brescia, Italie, 25100
    - Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
  - Catania, Italie, 95125
    - Azienda Ospedaliera Univ. Policlinico Gaspare Rodolico
  - Catanzaro, Italie, 88100
    - Azienda Ospedaliero Universitaria Mater Domini-Campus Universitario
  - Milan, Italie, 20141
    - IEO Istituto Europeo di Oncologia
  - Naples, Italie, 80131
    - Istituto Nazionale Tumori Fondazione G. Pascale
  - Rimini, Italie, 47923
    - Ospedale degli Infermi
  - Roma, Italie, 00168
    - Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  - Roma, Italie, 00133
    - Azienda Ospedaliera Universitaria Policlinico Tor Vergata
- Lecce
  - Tricase, Lecce, Italie, 73039
    - Azienda Ospedaliera Card. G. Panico
- Milano
  - Monza, Milano, Italie, 20900
    - Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo)
  - Rozzano, Milano, Italie, 20089
    - Istituto Clinico Humanitas
- Verona
  - Negrar, Verona, Italie, 37024
    - Ospedale Sacro Cuore Don Calabria
Japon
- Aichi-ken
  - Nagoya, Aichi-ken, Japon, 464-8681
    - Aichi Cancer Center Hospital
- Chiba
  - Kashiwa-shi, Chiba, Japon, 277-8577
    - National Cancer Center Hospital East
- Ehime
  - Matsuyama, Ehime, Japon, 791-0280
    - NHO Shikoku Cancer Center
- Fukuoka
  - Fukuoka, Fukuoka, Japon, 811-1395
    - NHO Kyushu Cancer Center
- Fukushima
  - Fukushima, Fukushima, Japon, 960-1295
    - Fukushima Medical University Hospital
- Hiroshima
  - Hiroshima, Hiroshima, Japon, 730-8518
    - Hiroshima City Hiroshima Citizens Hospital
- Hokkaido
  - Sapporo, Hokkaido, Japon, 003-0804
    - NHO Hokkaido Cancer Center
- Hyōgo
  - Nishinomiya-shi, Hyōgo, Japon, 663-8501
    - Hyogo College of Medicine Hospital
- Kagoshima-ken
  - Kagoshima, Kagoshima-ken, Japon, 892-0833
    - Hakuaikai Sagara Hospital
- Kanagawa
  - Isehara, Kanagawa, Japon, 259-1193
    - Tokai University Hospital
  - Yokohama, Kanagawa, Japon, 241-8515
    - Kanagawa Cancer Center
- Osaka
  - Osaka, Osaka, Japon, 540-0006
    - NHO Osaka National Hospital
- Osakasayama-shi
  - Onohigashi, Osakasayama-shi, Japon, 589-8511
    - Kindai University Hospital
- Saitama
  - Kitaadachi-gun, Saitama, Japon, 362-0806
    - Saitama Cancer Center
- Shizuoka
  - Sunto-gun, Shizuoka, Japon, 411-8777
    - Shizuoka Cancer Center
- Tokyo-To
  - Kōtoku, Tokyo-To, Japon, 135-8550
    - Cancer Institute Hospital of JFCR
  - Minatoku, Tokyo-To, Japon, 105-8470
    - Toranomon Hospital
  - Shinagawa-Ku, Tokyo-To, Japon, 142-8666
    - Showa University Hospital
L'Autriche
- - Innsbruck, L'Autriche, 6020
    - Medizinische Universität Innsbruck
  - Linz, L'Autriche, 4020
    - Kepler Universitätsklinikum
  - Salzburg, L'Autriche, 5020
    - LKH - Universitätsklinikum der PMU Salzburg
  - Vienna, L'Autriche, 1090
    - AKH - Medizinische Universität Wien (4305)
  - Wels, L'Autriche, 4600
    - Klinikum Wels-Grieskirchen GmbH
Le Portugal
- - Braga, Le Portugal, 4710-243
    - Hospital de Braga
  - Guimarães, Le Portugal, 4835-044
    - Centro Hospitalar do Alto do Ave, EPE
  - Lisbon, Le Portugal, 1649-035
    - Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria
  - Lisbon, Le Portugal, 1400-038
    - Fundação Champalimaud
  - Matosinhos Municipality, Le Portugal, 4464-509
    - Unidade Local de Saúde de Matosinhos, EPE (Hospital Pedro Hispano)
  - Porto, Le Portugal, 4200-072
    - Instituto Português de Oncologia do Porto Francisco Gentil, EPE
  - Porto, Le Portugal, 4099-001
    - Centro Hospitalar do Porto, E.P.E. - Hospital de Santo António
  - Santa Maria da Feira, Le Portugal, 4520-211
    - Centro Hospitalar de Entre o Douro e Vouga, E.P.E - Hospital de São Sebastião
  - Vila Nova de Gaia, Le Portugal, 4434-502
    - Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E
  - Vila Real, Le Portugal, 5000-508
    - Centro Hospitalar de Trás-os-Montes e Alto Douro, EPE
Royaume-Uni
- Cornwall
  - Truro, Cornwall, Royaume-Uni, TR1 3LJ
    - Royal Cornwall Hospital
- Greater London
  - London, Greater London, Royaume-Uni, NW3 2QG
    - Royal Free Hospital
  - London, Greater London, Royaume-Uni, EC1M 6BQ
    - Queen Mary University of London
  - London, Greater London, Royaume-Uni, NW1 2PG
    - University College London Hospitals
- Lothian Region
  - Edinburgh, Lothian Region, Royaume-Uni, EH4 2XU
    - Western General Hospital
- Nottinghamshire
  - Nottingham, Nottinghamshire, Royaume-Uni, NG5 1PB
    - Nottingham University Hospitals City Campus
- Surrey
  - Guildford, Surrey, Royaume-Uni, GU2 7XX
    - Royal Surrey County Hospital
Russie
- - Moscow, Russie, 115478
    - FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"
  - Moscow, Russie, 143423
    - SBIH of Moscow City "Moscow City Oncology Hospital №62" of Moscow Healthcare Departement
  - Yaroslavl, Russie, 150054
    - SBIH of Yaroslavl Region "Regional Clinical Oncological Hospital"
Suisse
- - Aarau, Suisse, 5000
    - Hirslanden Medical Center
  - Basel, Suisse, 4031
    - Universitaetsspital Basel
  - Chur, Suisse, 7000
    - Kantonsspital Graubuenden
  - Lausanne, Suisse, 1011
    - Centre Hospitalier Universitaire Vaudois
  - Sankt Gallen, Suisse, 9007
    - Kantonsspital St. Gallen
  - Winterthur, Suisse, 8401
    - Kantonsspital Winterthur
  - Zurich, Suisse, 8091
    - Universitaetsspital Zuerich
Suède
- - Solna, Suède, 17176
    - Karolinska universitetssjukhuset - Solna
  - Sundsvall, Suède, 85186
    - Länssjukhuset Sundsvall-Härnösand
  - Uppsala, Suède, 75185
    - Akademiska Sjukhuset
Taïwan
- - Kaohsiung City, Taïwan, 807
    - Kaohsiung Medical University Chung-Ho Memorial Hospital
  - Tainan, Taïwan, 704
    - National Cheng Kung University Hospital
  - Taipei, Taïwan, 100
    - National Taiwan University Hospital
États-Unis
- Arizona
  - Chandler, Arizona, États-Unis, 85224
    - Ironwood Cancer & Research Centers - Chandler II
  - Gilbert, Arizona, États-Unis, 85234
    - Banner MD Anderson Cancer Center
  - Goodyear, Arizona, États-Unis, 85338
    - Cancer Treatment Centers of America at Western Regional Medical Center
- California
  - Los Angeles, California, États-Unis, 90095
    - UCLA School of Medicine
  - Palo Alto, California, États-Unis, 94305
    - Stanford Cancer Institute
  - Redondo Beach, California, États-Unis, 90277
    - Cancer Care Associates Medical Group, Inc. TORI
  - San Francisco, California, États-Unis, 94158
    - University of California at San Francisco (PARENT)
- Connecticut
  - Norwich, Connecticut, États-Unis, 06360
    - Eastern Connecticut Hematology/Oncology Assoc.
- Delaware
  - Newark, Delaware, États-Unis, 19713
    - Christiana Care Health Services, Inc.
- Florida
  - Boca Raton, Florida, États-Unis, 33426
    - Sylvester Comprehensive Cancer Center - Deerfield Beach
  - Fort Myers, Florida, États-Unis, 33916
    - Florida Cancer Specialists (South Region)
  - Hollywood, Florida, États-Unis, 33021
    - Memorial Healthcare System MRH Cancer Center
  - Orlando, Florida, États-Unis, 32806
    - Orlando Health, Inc.
  - Tampa, Florida, États-Unis, 33139
    - Moffitt Cancer Center -Tampa
- Georgia
  - Newnan, Georgia, États-Unis, 30263
    - Cancer Treatment Centers of America-Georgia
- Illinois
  - Chicago, Illinois, États-Unis, 60637
    - University of Chicago Medical Center
  - Zion, Illinois, États-Unis, 60099
    - Cancer Treatment Centers of America
- Kansas
  - Wichita, Kansas, États-Unis, 67214
    - Cancer Center of Kansas
- Louisiana
  - New Orleans, Louisiana, États-Unis, 70115
    - Touro Infirmary
- Massachusetts
  - Boston, Massachusetts, États-Unis, 02215
    - Dana-Farber Cancer Institute
- Michigan
  - Detroit, Michigan, États-Unis, 48202
    - Henry Ford Hospital
- Missouri
  - Kansas City, Missouri, États-Unis, 64111
    - Saint Luke's Hospital of Kansas City
- New Jersey
  - Livingston, New Jersey, États-Unis, 07039
    - Saint Barnabas Medical Center
- New York
  - New York, New York, États-Unis, 10016
    - New York University Medical Center
  - New York, New York, États-Unis, 10065
    - Memorial Sloan Kettering Hospital
  - New York, New York, États-Unis, 10065
    - Weill Cornell Medicine Breast Center
- Ohio
  - Cleveland, Ohio, États-Unis, 44195
    - The Cleveland Clinic Foundation
- Oregon
  - Portland, Oregon, États-Unis, 97239
    - Oregon Health & Science University
- Pennsylvania
  - Pittsburgh, Pennsylvania, États-Unis, 15212
    - Allegheny General Hospital
  - Pittsburgh, Pennsylvania, États-Unis, 15219
    - University of Pittsburgh Medical Center Health System
- South Carolina
  - Greenville, South Carolina, États-Unis, 29601
    - St Francis Hospital
- Tennessee
  - Knoxville, Tennessee, États-Unis, 37909
    - Brig Center for Cancer Care and Survivorship
  - Memphis, Tennessee, États-Unis, 38120
    - Baptist Cancer Center
  - Nashville, Tennessee, États-Unis, 37201
    - Tennessee Oncology - Skyline Satellite
- Texas
  - Dallas, Texas, États-Unis, 75234
    - BloomTrials Clinical Research, LLC
  - Houston, Texas, États-Unis, 77030
    - The Methodist Hospital Research Institute
  - Houston, Texas, États-Unis, 77030
    - University of Texas M. D. Anderson Cancer Center - Investigational Cancer Therapeutics
- Virginia
  - Fairfax, Virginia, États-Unis, 22031
    - Virginia Cancer Specialists

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

Is the age of majority in their country
Has pathologically documented breast cancer that:
1. Is unresectable or metastatic
2. Has low-HER2 expression defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested)
3. Is HR-positive or HR-negative
4. Has progressed on, and would no longer benefit from, endocrine therapy
5. Has been treated with 1 to 2 prior lines of chemotherapy/adjuvant in the recurrent or metastatic setting
6. Was never previously HER2-positive (ICH 3+ or ISH+) on prior pathology testing (per American Society of Clinical Oncology-College of American Pathologists [ASCO-CAP] guidelines)
Has documented radiologic progression (during or after most recent treatment)
Has adequate archival tumor samples available or is wiling to provide fresh biopsies prior to randomization for:
1. assessment of HER2 status
2. assessment of post-treatment status
Has at least 1 measurable lesion per Response Evaluation Criteria In Solid Tumors 1.1
Has protocol-defined adequate cardiac, bone marrow, renal, hepatic and blood clotting functions
Male and female participants of reproductive/childbearing potential, agrees to follow instructions for method(s) of contraception and agrees to avoid preserving ova or sperm for at least 4.5 months after treatment (or longer, per locally approved labels)

Exclusion Criteria:

Is ineligible for all options in the physician's choice arm
Has breast cancer ever assessed with high-HER2 expression
Has previously been treated with any anti-HER2 therapy, including an antibody drug conjugate
Has uncontrolled or significant cardiovascular disease
Has spinal cord compression or clinically active central nervous system metastases
Has 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 any medical history or condition that per protocol or in the opinion of the investigator is inappropriate for the study

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Objectif principal: Traitement
Répartition: Randomisé
Modèle interventionnel: Affectation parallèle
Masquage: Aucun (étiquette ouverte)

Nombre de bras

Armes et Interventions

Groupe de participants / Bras	Intervention / Traitement
Expérimental: Trastuzumab deruxtecan HER2-low, unresectable, and/or metastatic breast cancer participants previously treated with chemotherapy randomized to DS8201a	Médicament: Trastuzumab deruxtecan (DS-8201a) DS-8201a is a lyophilized powder reconstituted into a sterile aqueous solution (100 mg/5 mL) to be administered intravenously Autres noms: DS-8201a
Comparateur actif: Physician's Choice HER2-low, unresectable, and/or metastatic breast cancer participants previously treated with chemotherapy randomized to Physician's choice from the following options: Capecitabine Eribulin Gemcitabine Paclitaxel Nab-paclitaxel	Médicament: Capecitabine Administered according to label, as one option for Physician's Choice (determined before randomization) Médicament: Eribulin Administered according to label, as one option for Physician's Choice (determined before randomization) Médicament: Gemcitabine Administered according to label, as one option for Physician's Choice (determined before randomization) Médicament: Paclitaxel Administered according to label, as one option for Physician's Choice (determined before randomization) Médicament: Nab-paclitaxel Administered according to label, as one option for Physician's Choice (determined before randomization)

Groupe de participants / Bras

Intervention / Traitement

Expérimental: Trastuzumab deruxtecan

HER2-low, unresectable, and/or metastatic breast cancer participants previously treated with chemotherapy randomized to DS8201a

Médicament: Trastuzumab deruxtecan (DS-8201a)

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

Autres noms:

DS-8201a

Comparateur actif: Physician's Choice

HER2-low, unresectable, and/or metastatic breast cancer participants previously treated with chemotherapy randomized to Physician's choice from the following options:

Capecitabine
Eribulin
Gemcitabine
Paclitaxel
Nab-paclitaxel

Médicament: Capecitabine