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Trastuzumab Deruxtecan (DS-8201a) Versus Investigator's Choice for HER2-lav brystkræft, der har spredt sig eller ikke kan fjernes kirurgisk [DESTINY-Breast04]

1. september 2026 opdateret af: Daiichi Sankyo

Et fase 3, multicenter, randomiseret, åbent, aktivt kontrolleret forsøg med DS-8201a, et anti-HER2-antistof-lægemiddelkonjugat (ADC), versus behandling efter lægens valg til patienter med HER2-lav, uoperable og/eller metastaserende brystkræft

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

Studieoversigt

Status

Afsluttet

Betingelser

Brystkræft

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

557

Fase

Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Behandling
Tildeling: Randomiseret
Interventionel model: Parallel tildeling
Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm Deltagergruppe / Arm En gruppe eller undergruppe af deltagere i et klinisk forsøg, der modtager en specifik intervention/behandling eller ingen intervention i henhold til forsøgets protokol.	Intervention / Behandling Intervention / Behandling En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.
Eksperimentel: Trastuzumab deruxtecan HER2-low, unresectable, and/or metastatic breast cancer participants previously treated with chemotherapy randomized to DS8201a	Medicin: Trastuzumab deruxtecan (DS-8201a) DS-8201a is a lyophilized powder reconstituted into a sterile aqueous solution (100 mg/5 mL) to be administered intravenously Andre navne: DS-8201a
Aktiv komparator: 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	Medicin: Capecitabine Administered according to label, as one option for Physician's Choice (determined before randomization) Medicin: Eribulin Administered according to label, as one option for Physician's Choice (determined before randomization) Medicin: Gemcitabine Administered according to label, as one option for Physician's Choice (determined before randomization) Medicin: Paclitaxel Administered according to label, as one option for Physician's Choice (determined before randomization) Medicin: Nab-paclitaxel Administered according to label, as one option for Physician's Choice (determined before randomization)

Deltagergruppe / Arm

Intervention / Behandling

Eksperimentel: Trastuzumab deruxtecan

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

Medicin: Trastuzumab deruxtecan (DS-8201a)

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

Andre navne:

DS-8201a

Aktiv komparator: 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

Medicin: Capecitabine