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Trastuzumab Deruxtecan (DS-8201a) versus etterforskerens valg for HER2-lav brystkreft som har spredt seg eller ikke kan fjernes kirurgisk [DESTINY-Breast04]

1. september 2026 oppdatert av: Daiichi Sankyo

En fase 3, multisenter, randomisert, åpen, aktiv kontrollert utprøving av DS-8201a, et anti-HER2-antistoffkonjugat (ADC), versus behandling av legens valg for pasienter med HER2-lav, uoperabel og/eller metastatisk brystkreft

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

Studieoversikt

Status

Fullført

Forhold

Brystkreft

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

557

Fase

Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

Belgia
- - Brussels, Belgia, 1000
    - Institut Jules Bordet
  - Brussels, Belgia, 1090
    - Universitair Ziekenhuis Brussel
  - Brussels, Belgia, 1200
    - Cliniques Universitaires Saint-Luc
  - Leuven, Belgia, 3000
    - UZ Leuven
  - Loverval, Belgia, 6280
    - Grand Hôpital de Charleroi
  - Namur, Belgia, 5000
    - CHU UCL Namur
  - Tournai, Belgia, 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
Forente stater
- Arizona
  - Chandler, Arizona, Forente stater, 85224
    - Ironwood Cancer & Research Centers - Chandler II
  - Gilbert, Arizona, Forente stater, 85234
    - Banner MD Anderson Cancer Center
  - Goodyear, Arizona, Forente stater, 85338
    - Cancer Treatment Centers of America at Western Regional Medical Center
- California
  - Los Angeles, California, Forente stater, 90095
    - UCLA School of Medicine
  - Palo Alto, California, Forente stater, 94305
    - Stanford Cancer Institute
  - Redondo Beach, California, Forente stater, 90277
    - Cancer Care Associates Medical Group, Inc. TORI
  - San Francisco, California, Forente stater, 94158
    - University of California at San Francisco (PARENT)
- Connecticut
  - Norwich, Connecticut, Forente stater, 06360
    - Eastern Connecticut Hematology/Oncology Assoc.
- Delaware
  - Newark, Delaware, Forente stater, 19713
    - Christiana Care Health Services, Inc.
- Florida
  - Boca Raton, Florida, Forente stater, 33426
    - Sylvester Comprehensive Cancer Center - Deerfield Beach
  - Fort Myers, Florida, Forente stater, 33916
    - Florida Cancer Specialists (South Region)
  - Hollywood, Florida, Forente stater, 33021
    - Memorial Healthcare System MRH Cancer Center
  - Orlando, Florida, Forente stater, 32806
    - Orlando Health, Inc.
  - Tampa, Florida, Forente stater, 33139
    - Moffitt Cancer Center -Tampa
- Georgia
  - Newnan, Georgia, Forente stater, 30263
    - Cancer Treatment Centers of America-Georgia
- Illinois
  - Chicago, Illinois, Forente stater, 60637
    - University of Chicago Medical Center
  - Zion, Illinois, Forente stater, 60099
    - Cancer Treatment Centers of America
- Kansas
  - Wichita, Kansas, Forente stater, 67214
    - Cancer Center of Kansas
- Louisiana
  - New Orleans, Louisiana, Forente stater, 70115
    - Touro Infirmary
- Massachusetts
  - Boston, Massachusetts, Forente stater, 02215
    - Dana-Farber Cancer Institute
- Michigan
  - Detroit, Michigan, Forente stater, 48202
    - Henry Ford Hospital
- Missouri
  - Kansas City, Missouri, Forente stater, 64111
    - Saint Luke's Hospital of Kansas City
- New Jersey
  - Livingston, New Jersey, Forente stater, 07039
    - Saint Barnabas Medical Center
- New York
  - New York, New York, Forente stater, 10016
    - New York University Medical Center
  - New York, New York, Forente stater, 10065
    - Memorial Sloan Kettering Hospital
  - New York, New York, Forente stater, 10065
    - Weill Cornell Medicine Breast Center
- Ohio
  - Cleveland, Ohio, Forente stater, 44195
    - The Cleveland Clinic Foundation
- Oregon
  - Portland, Oregon, Forente stater, 97239
    - Oregon Health & Science University
- Pennsylvania
  - Pittsburgh, Pennsylvania, Forente stater, 15212
    - Allegheny General Hospital
  - Pittsburgh, Pennsylvania, Forente stater, 15219
    - University of Pittsburgh Medical Center Health System
- South Carolina
  - Greenville, South Carolina, Forente stater, 29601
    - St Francis Hospital
- Tennessee
  - Knoxville, Tennessee, Forente stater, 37909
    - Brig Center for Cancer Care and Survivorship
  - Memphis, Tennessee, Forente stater, 38120
    - Baptist Cancer Center
  - Nashville, Tennessee, Forente stater, 37201
    - Tennessee Oncology - Skyline Satellite
- Texas
  - Dallas, Texas, Forente stater, 75234
    - BloomTrials Clinical Research, LLC
  - Houston, Texas, Forente stater, 77030
    - The Methodist Hospital Research Institute
  - Houston, Texas, Forente stater, 77030
    - University of Texas M. D. Anderson Cancer Center - Investigational Cancer Therapeutics
- Virginia
  - Fairfax, Virginia, Forente stater, 22031
    - Virginia Cancer Specialists
Frankrike
- - Paris, Frankrike, 75020
    - Hopital Tenon
  - Paris, Frankrike, 75005
    - Institut Curie - site de Paris
- Bouches-du-Rhône
  - Marseille, Bouches-du-Rhône, Frankrike, 13009
    - Institut Paoli Calmettes
- Calvados
  - Caen, Calvados, Frankrike, 14076
    - Centre François Baclesse
- Cotes d'Armor
  - Plérin, Cotes d'Armor, Frankrike, 22190
    - CARIO - Centre Armoricain de Radiothérapie, Imagerie médicale et Oncologie
- Finistere
  - Brest, Finistere, Frankrike, 29609
    - CHU Brest - Hôpital Morvan
- Gironde
  - Bordeaux, Gironde, Frankrike, 33076
    - Institut Bergonié
- Herault
  - Montpellier, Herault, Frankrike, 34070
    - Clinique Clementville
  - Montpellier, Herault, Frankrike, 34298
    - Institut Régional du Cancer de Montpellier
- Ille Et Vilaine
  - Rennes, Ille Et Vilaine, Frankrike, 35042
    - CRLCC Eugene Marquis
- Loire Atlantique
  - Saint-Herblain, Loire Atlantique, Frankrike, 44805
    - ICO - Site René Gauducheau
- Loiret
  - Le Puy-en-Velay, Loiret, Frankrike, 43012
    - Centre Hospitalier Emile Roux
- Maine Et Loire
  - Angers, Maine Et Loire, Frankrike, 49055
    - ICO - Site Paul Papin
- Nord
  - Valenciennes, Nord, Frankrike, 59322
    - Centre Hospitalier Valenciennes
- Paris
  - Paris, Paris, Frankrike, 75475
    - Hôpital Saint-Louis - Paris
- Sarthe
  - Le Mans, Sarthe, Frankrike, 72015
    - Clinique Victor Hugo - Centre Jean Bernard
- Vaculuse
  - Avignon, Vaculuse, Frankrike, 84918
    - Institut Sainte Catherine
- Val De Marne
  - Saint-Mandé, Val De Marne, Frankrike, 94160
    - Hôpital d'Instruction des Armees Begin*
  - Villejuif, Val De Marne, Frankrike, 94805
    - Institut Gustave Roussy
Hellas
- - Athens, Hellas, 15125
    - Athens Medical Center
  - Athens, Hellas, 11528
    - General Hospital of Athens "Alexandra"
  - Athens, Hellas, 14564
    - General Oncology Hospital of Kifissia " Agioi Anargyroi"
  - Heraklion, Hellas, 71110
    - University General Hospital of Heraklion
  - Larissa, Hellas, 41110
    - University General Hospital of Larissa
  - Thessaloniki, Hellas, 54622
    - Bioclinic Thessaloniki
  - Thessaloniki, Hellas, 54645
    - Euromedica General Clinic Thessaloniki
  - Thessaloniki, Hellas, 56429
    - General Hospital Papageorgiou
  - Thessaloniki, Hellas, 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
Italia
- - Bologna, Italia, 40138
    - Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
  - Brescia, Italia, 25100
    - Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
  - Catania, Italia, 95125
    - Azienda Ospedaliera Univ. Policlinico Gaspare Rodolico
  - Catanzaro, Italia, 88100
    - Azienda Ospedaliero Universitaria Mater Domini-Campus Universitario
  - Milan, Italia, 20141
    - IEO Istituto Europeo di Oncologia
  - Naples, Italia, 80131
    - Istituto Nazionale Tumori Fondazione G. Pascale
  - Rimini, Italia, 47923
    - Ospedale degli Infermi
  - Roma, Italia, 00168
    - Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  - Roma, Italia, 00133
    - Azienda Ospedaliera Universitaria Policlinico Tor Vergata
- Lecce
  - Tricase, Lecce, Italia, 73039
    - Azienda Ospedaliera Card. G. Panico
- Milano
  - Monza, Milano, Italia, 20900
    - Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo)
  - Rozzano, Milano, Italia, 20089
    - Istituto Clinico Humanitas
- Verona
  - Negrar, Verona, Italia, 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
Russland
- - Moscow, Russland, 115478
    - FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"
  - Moscow, Russland, 143423
    - SBIH of Moscow City "Moscow City Oncology Hospital №62" of Moscow Healthcare Departement
  - Yaroslavl, Russland, 150054
    - SBIH of Yaroslavl Region "Regional Clinical Oncological Hospital"
Spania
- - Barcelona, Spania, 08036
    - Hospital Clinic de Barcelona
  - Barcelona, Spania, 08035
    - Hospital Universitari Vall d'Hebron
  - Barcelona, Spania, 08023
    - Hospital Quironsalud Barcelona
  - Barcelona, Spania, 08003
    - Hospital del Mar
  - Madrid, Spania, 28034
    - Hospital Universitario Ramon y Cajal
  - Madrid, Spania, 28040
    - Hospital Universitario Clinico San Carlos
  - Madrid, Spania, 28034
    - Hospital Ruber Internacional
  - Madrid, Spania, 28033
    - MD Anderson Cancer Centre
  - Málaga, Spania, 29010
    - Hospital Clinico Universitario Virgen de la Victoria
  - Seville, Spania, 41009
    - Hospital Universitario Virgen Macarena
  - Seville, Spania, 41013
    - Hospital Universitario Virgen del Rocio
  - Valencia, Spania, 46014
    - Hospital General Universitario de Valencia
  - Valencia, Spania, 46009
    - Instituto Valenciano de Oncologia IVO
- Barcelona
  - L'Hospitalet de Llobregat, Barcelona, Spania, 08908
    - ICO l'Hospitalet - Hospital Duran i Reynals
- Guipuzcoa
  - San Sebastián, Guipuzcoa, Spania, 20014
    - Hospital Universitario Donostia
- La Coruña
  - A Coruña, La Coruña, Spania, 15006
    - Complejo Hospitalario Universitario A Coruña
- Tenerife
  - San Cristóbal de La Laguna, Tenerife, Spania, 38320
    - Hospital Universitario de Canarias
- Vizcaya
  - Bilbao, Vizcaya, Spania, 48013
    - Hospital de Basurto
Storbritannia
- Cornwall
  - Truro, Cornwall, Storbritannia, TR1 3LJ
    - Royal Cornwall Hospital
- Greater London
  - London, Greater London, Storbritannia, NW3 2QG
    - Royal Free Hospital
  - London, Greater London, Storbritannia, EC1M 6BQ
    - Queen Mary University of London
  - London, Greater London, Storbritannia, NW1 2PG
    - University College London Hospitals
- Lothian Region
  - Edinburgh, Lothian Region, Storbritannia, EH4 2XU
    - Western General Hospital
- Nottinghamshire
  - Nottingham, Nottinghamshire, Storbritannia, NG5 1PB
    - Nottingham University Hospitals City Campus
- Surrey
  - Guildford, Surrey, Storbritannia, GU2 7XX
    - Royal Surrey County Hospital
Sveits
- - Aarau, Sveits, 5000
    - Hirslanden Medical Center
  - Basel, Sveits, 4031
    - Universitaetsspital Basel
  - Chur, Sveits, 7000
    - Kantonsspital Graubuenden
  - Lausanne, Sveits, 1011
    - Centre Hospitalier Universitaire Vaudois
  - Sankt Gallen, Sveits, 9007
    - Kantonsspital St. Gallen
  - Winterthur, Sveits, 8401
    - Kantonsspital Winterthur
  - Zurich, Sveits, 8091
    - Universitaetsspital Zuerich
Sverige
- - Solna, Sverige, 17176
    - Karolinska universitetssjukhuset - Solna
  - Sundsvall, Sverige, 85186
    - Länssjukhuset Sundsvall-Härnösand
  - Uppsala, Sverige, 75185
    - Akademiska Sjukhuset
Sør -Korea
- - Daegu, Sør -Korea, 41404
    - Kyungpook National University Chilgok Hospital
  - Seoul, Sør -Korea, 03080
    - Seoul National University Hospital
  - Seoul, Sør -Korea, 05505
    - Asan Medical Center
  - Seoul, Sør -Korea, 06351
    - Samsung Medical Center
  - Seoul, Sør -Korea, 06591
    - The Catholic University of Korea, Seoul St. Mary's Hospital
  - Seoul, Sør -Korea, 120-752
    - Severance Hospital, Yonsei University Health System
- Gyeonggi-do
  - Goyang-si, Gyeonggi-do, Sør -Korea, 10408
    - National Cancer Center
  - Incheon, Gyeonggi-do, Sør -Korea, 22332
    - Inha University Hospital
  - Seongnam-si, Gyeonggi-do, Sør -Korea, 13620
    - Seoul National University Bundang Hospital
  - Suwon, Gyeonggi-do, Sør -Korea, 16499
    - Ajou University Hospital
- North Chungcheong
  - Cheongju-si, North Chungcheong, Sør -Korea, 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
Østerrike
- - Innsbruck, Østerrike, 6020
    - Medizinische Universität Innsbruck
  - Linz, Østerrike, 4020
    - Kepler Universitätsklinikum
  - Salzburg, Østerrike, 5020
    - LKH - Universitätsklinikum der PMU Salzburg
  - Vienna, Østerrike, 1090
    - AKH - Medizinische Universität Wien (4305)
  - Wels, Østerrike, 4600
    - Klinikum Wels-Grieskirchen GmbH

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Primært formål: Behandling
Tildeling: Randomisert
Intervensjonsmodell: Parallell tildeling
Masking: Ingen (Open Label)

Antall våpen

Våpen og intervensjoner

Deltakergruppe / Arm	Intervensjon / Behandling
Eksperimentell: Trastuzumab deruxtecan HER2-low, unresectable, and/or metastatic breast cancer participants previously treated with chemotherapy randomized to DS8201a	Legemiddel: 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 navn: 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	Legemiddel: Capecitabine Administered according to label, as one option for Physician's Choice (determined before randomization) Legemiddel: Eribulin Administered according to label, as one option for Physician's Choice (determined before randomization) Legemiddel: Gemcitabine Administered according to label, as one option for Physician's Choice (determined before randomization) Legemiddel: Paclitaxel Administered according to label, as one option for Physician's Choice (determined before randomization) Legemiddel: Nab-paclitaxel Administered according to label, as one option for Physician's Choice (determined before randomization)

Deltakergruppe / Arm

Intervensjon / Behandling

Eksperimentell: Trastuzumab deruxtecan

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

Legemiddel: 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 navn:

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

Legemiddel: Capecitabine