Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Trastuzumab deruxtecan (DS-8201a) versus la elección del investigador para el cáncer de mama con bajo nivel de HER2 que se diseminó o no se puede extirpar quirúrgicamente [DESTINY-Breast04]

1 de septiembre de 2026 actualizado por: Daiichi Sankyo

Un ensayo de fase 3, multicéntrico, aleatorizado, abierto, con control activo de DS-8201a, un conjugado de fármaco (ADC) con anticuerpo anti-HER2, frente al tratamiento elegido por el médico para pacientes con cáncer de mama metastásico, no resecable o con HER2 bajo

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

Descripción general del estudio

Estado

Terminado

Condiciones

Cáncer de mama

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Actual)

557

Fase

Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

Alemania
- Baden-Wurttemberg
  - Heidelberg, Baden-Wurttemberg, Alemania, 69120
    - Universitaetsklinikum Heidelberg
- Bavaria
  - Munich, Bavaria, Alemania, 81377
    - Klinikum der Universitaet Muenchen - Campus Grosshardern
Austria
- - Innsbruck, Austria, 6020
    - Medizinische Universität Innsbruck
  - Linz, Austria, 4020
    - Kepler Universitätsklinikum
  - Salzburg, Austria, 5020
    - LKH - Universitätsklinikum der PMU Salzburg
  - Vienna, Austria, 1090
    - AKH - Medizinische Universität Wien (4305)
  - Wels, Austria, 4600
    - Klinikum Wels-Grieskirchen GmbH
Bélgica
- - Brussels, Bélgica, 1000
    - Institut Jules Bordet
  - Brussels, Bélgica, 1090
    - Universitair Ziekenhuis Brussel
  - Brussels, Bélgica, 1200
    - Cliniques Universitaires Saint-Luc
  - Leuven, Bélgica, 3000
    - UZ Leuven
  - Loverval, Bélgica, 6280
    - Grand Hôpital de Charleroi
  - Namur, Bélgica, 5000
    - CHU UCL Namur
  - Tournai, Bélgica, 7500
    - Centre Hospitalier Wallonie picarde - Site IMC
Canadá
- Alberta
  - Calgary, Alberta, Canadá, T2N4N2
    - Tom Baker Cancer Center
- Ontario
  - Toronto, Ontario, Canadá, M4N 3M5
    - Toronto Sunnybrook Hospital
- Quebec
  - Montreal, Quebec, Canadá, H2W 1S6
    - McGill University - Dept. Oncology Clinical Research Program
Corea del Sur
- - Daegu, Corea del Sur, 41404
    - Kyungpook National University Chilgok Hospital
  - Seoul, Corea del Sur, 03080
    - Seoul National University Hospital
  - Seoul, Corea del Sur, 05505
    - Asan Medical Center
  - Seoul, Corea del Sur, 06351
    - Samsung Medical Center
  - Seoul, Corea del Sur, 06591
    - The Catholic University of Korea, Seoul St. Mary's Hospital
  - Seoul, Corea del Sur, 120-752
    - Severance Hospital, Yonsei University Health System
- Gyeonggi-do
  - Goyang-si, Gyeonggi-do, Corea del Sur, 10408
    - National Cancer Center
  - Incheon, Gyeonggi-do, Corea del Sur, 22332
    - Inha University Hospital
  - Seongnam-si, Gyeonggi-do, Corea del Sur, 13620
    - Seoul National University Bundang Hospital
  - Suwon, Gyeonggi-do, Corea del Sur, 16499
    - Ajou University Hospital
- North Chungcheong
  - Cheongju-si, North Chungcheong, Corea del Sur, 361-711
    - Chungbuk National University Hospital
España
- - Barcelona, España, 08036
    - Hospital Clinic de Barcelona
  - Barcelona, España, 08035
    - Hospital Universitari Vall d'Hebron
  - Barcelona, España, 08023
    - Hospital Quironsalud Barcelona
  - Barcelona, España, 08003
    - Hospital del Mar
  - Madrid, España, 28034
    - Hospital Universitario Ramon y Cajal
  - Madrid, España, 28040
    - Hospital Universitario Clinico San Carlos
  - Madrid, España, 28034
    - Hospital Ruber Internacional
  - Madrid, España, 28033
    - MD Anderson Cancer Centre
  - Málaga, España, 29010
    - Hospital Clinico Universitario Virgen de la Victoria
  - Seville, España, 41009
    - Hospital Universitario Virgen Macarena
  - Seville, España, 41013
    - Hospital Universitario Virgen del Rocio
  - Valencia, España, 46014
    - Hospital General Universitario de Valencia
  - Valencia, España, 46009
    - Instituto Valenciano de Oncologia IVO
- Barcelona
  - L'Hospitalet de Llobregat, Barcelona, España, 08908
    - ICO l'Hospitalet - Hospital Duran i Reynals
- Guipuzcoa
  - San Sebastián, Guipuzcoa, España, 20014
    - Hospital Universitario Donostia
- La Coruña
  - A Coruña, La Coruña, España, 15006
    - Complejo Hospitalario Universitario A Coruña
- Tenerife
  - San Cristóbal de La Laguna, Tenerife, España, 38320
    - Hospital Universitario de Canarias
- Vizcaya
  - Bilbao, Vizcaya, España, 48013
    - Hospital de Basurto
Estados Unidos
- Arizona
  - Chandler, Arizona, Estados Unidos, 85224
    - Ironwood Cancer & Research Centers - Chandler II
  - Gilbert, Arizona, Estados Unidos, 85234
    - Banner MD Anderson Cancer Center
  - Goodyear, Arizona, Estados Unidos, 85338
    - Cancer Treatment Centers of America at Western Regional Medical Center
- California
  - Los Angeles, California, Estados Unidos, 90095
    - UCLA School of Medicine
  - Palo Alto, California, Estados Unidos, 94305
    - Stanford Cancer Institute
  - Redondo Beach, California, Estados Unidos, 90277
    - Cancer Care Associates Medical Group, Inc. TORI
  - San Francisco, California, Estados Unidos, 94158
    - University of California at San Francisco (PARENT)
- Connecticut
  - Norwich, Connecticut, Estados Unidos, 06360
    - Eastern Connecticut Hematology/Oncology Assoc.
- Delaware
  - Newark, Delaware, Estados Unidos, 19713
    - Christiana Care Health Services, Inc.
- Florida
  - Boca Raton, Florida, Estados Unidos, 33426
    - Sylvester Comprehensive Cancer Center - Deerfield Beach
  - Fort Myers, Florida, Estados Unidos, 33916
    - Florida Cancer Specialists (South Region)
  - Hollywood, Florida, Estados Unidos, 33021
    - Memorial Healthcare System MRH Cancer Center
  - Orlando, Florida, Estados Unidos, 32806
    - Orlando Health, Inc.
  - Tampa, Florida, Estados Unidos, 33139
    - Moffitt Cancer Center -Tampa
- Georgia
  - Newnan, Georgia, Estados Unidos, 30263
    - Cancer Treatment Centers of America-Georgia
- Illinois
  - Chicago, Illinois, Estados Unidos, 60637
    - University of Chicago Medical Center
  - Zion, Illinois, Estados Unidos, 60099
    - Cancer Treatment Centers of America
- Kansas
  - Wichita, Kansas, Estados Unidos, 67214
    - Cancer Center of Kansas
- Louisiana
  - New Orleans, Louisiana, Estados Unidos, 70115
    - Touro Infirmary
- Massachusetts
  - Boston, Massachusetts, Estados Unidos, 02215
    - Dana-Farber Cancer Institute
- Michigan
  - Detroit, Michigan, Estados Unidos, 48202
    - Henry Ford Hospital
- Missouri
  - Kansas City, Missouri, Estados Unidos, 64111
    - Saint Luke's Hospital of Kansas City
- New Jersey
  - Livingston, New Jersey, Estados Unidos, 07039
    - Saint Barnabas Medical Center
- New York
  - New York, New York, Estados Unidos, 10016
    - New York University Medical Center
  - New York, New York, Estados Unidos, 10065
    - Memorial Sloan Kettering Hospital
  - New York, New York, Estados Unidos, 10065
    - Weill Cornell Medicine Breast Center
- Ohio
  - Cleveland, Ohio, Estados Unidos, 44195
    - The Cleveland Clinic Foundation
- Oregon
  - Portland, Oregon, Estados Unidos, 97239
    - Oregon Health & Science University
- Pennsylvania
  - Pittsburgh, Pennsylvania, Estados Unidos, 15212
    - Allegheny General Hospital
  - Pittsburgh, Pennsylvania, Estados Unidos, 15219
    - University of Pittsburgh Medical Center Health System
- South Carolina
  - Greenville, South Carolina, Estados Unidos, 29601
    - St Francis Hospital
- Tennessee
  - Knoxville, Tennessee, Estados Unidos, 37909
    - Brig Center for Cancer Care and Survivorship
  - Memphis, Tennessee, Estados Unidos, 38120
    - Baptist Cancer Center
  - Nashville, Tennessee, Estados Unidos, 37201
    - Tennessee Oncology - Skyline Satellite
- Texas
  - Dallas, Texas, Estados Unidos, 75234
    - BloomTrials Clinical Research, LLC
  - Houston, Texas, Estados Unidos, 77030
    - The Methodist Hospital Research Institute
  - Houston, Texas, Estados Unidos, 77030
    - University of Texas M. D. Anderson Cancer Center - Investigational Cancer Therapeutics
- Virginia
  - Fairfax, Virginia, Estados Unidos, 22031
    - Virginia Cancer Specialists
Francia
- - Paris, Francia, 75020
    - Hopital Tenon
  - Paris, Francia, 75005
    - Institut Curie - site de Paris
- Bouches-du-Rhône
  - Marseille, Bouches-du-Rhône, Francia, 13009
    - Institut Paoli Calmettes
- Calvados
  - Caen, Calvados, Francia, 14076
    - Centre François Baclesse
- Cotes d'Armor
  - Plérin, Cotes d'Armor, Francia, 22190
    - CARIO - Centre Armoricain de Radiothérapie, Imagerie médicale et Oncologie
- Finistere
  - Brest, Finistere, Francia, 29609
    - CHU Brest - Hôpital Morvan
- Gironde
  - Bordeaux, Gironde, Francia, 33076
    - Institut Bergonié
- Herault
  - Montpellier, Herault, Francia, 34070
    - Clinique Clementville
  - Montpellier, Herault, Francia, 34298
    - Institut Régional du Cancer de Montpellier
- Ille Et Vilaine
  - Rennes, Ille Et Vilaine, Francia, 35042
    - CRLCC Eugene Marquis
- Loire Atlantique
  - Saint-Herblain, Loire Atlantique, Francia, 44805
    - ICO - Site René Gauducheau
- Loiret
  - Le Puy-en-Velay, Loiret, Francia, 43012
    - Centre Hospitalier Emile Roux
- Maine Et Loire
  - Angers, Maine Et Loire, Francia, 49055
    - ICO - Site Paul Papin
- Nord
  - Valenciennes, Nord, Francia, 59322
    - Centre Hospitalier Valenciennes
- Paris
  - Paris, Paris, Francia, 75475
    - Hôpital Saint-Louis - Paris
- Sarthe
  - Le Mans, Sarthe, Francia, 72015
    - Clinique Victor Hugo - Centre Jean Bernard
- Vaculuse
  - Avignon, Vaculuse, Francia, 84918
    - Institut Sainte Catherine
- Val De Marne
  - Saint-Mandé, Val De Marne, Francia, 94160
    - Hôpital d'Instruction des Armees Begin*
  - Villejuif, Val De Marne, Francia, 94805
    - Institut Gustave Roussy
Grecia
- - Athens, Grecia, 15125
    - Athens Medical Center
  - Athens, Grecia, 11528
    - General Hospital of Athens "Alexandra"
  - Athens, Grecia, 14564
    - General Oncology Hospital of Kifissia " Agioi Anargyroi"
  - Heraklion, Grecia, 71110
    - University General Hospital of Heraklion
  - Larissa, Grecia, 41110
    - University General Hospital of Larissa
  - Thessaloniki, Grecia, 54622
    - Bioclinic Thessaloniki
  - Thessaloniki, Grecia, 54645
    - Euromedica General Clinic Thessaloniki
  - Thessaloniki, Grecia, 56429
    - General Hospital Papageorgiou
  - Thessaloniki, Grecia, 57001
    - Interbalkan Hospital of Thessaloniki
Hungría
- - Budapest, Hungría, 1097
    - Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet
  - Budapest, Hungría, 1122
    - Orszagos Onkologiai Intezet
  - Debrecen, Hungría, 4032
    - Debreceni Egyetem
  - Gyula, Hungría, 5700
    - Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza
  - Nyíregyháza, Hungría, 4400
    - SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz
  - Szolnok, Hungría, 5004
    - Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet
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
Japón
- Aichi-ken
  - Nagoya, Aichi-ken, Japón, 464-8681
    - Aichi Cancer Center Hospital
- Chiba
  - Kashiwa-shi, Chiba, Japón, 277-8577
    - National Cancer Center Hospital East
- Ehime
  - Matsuyama, Ehime, Japón, 791-0280
    - NHO Shikoku Cancer Center
- Fukuoka
  - Fukuoka, Fukuoka, Japón, 811-1395
    - NHO Kyushu Cancer Center
- Fukushima
  - Fukushima, Fukushima, Japón, 960-1295
    - Fukushima Medical University Hospital
- Hiroshima
  - Hiroshima, Hiroshima, Japón, 730-8518
    - Hiroshima City Hiroshima Citizens Hospital
- Hokkaido
  - Sapporo, Hokkaido, Japón, 003-0804
    - NHO Hokkaido Cancer Center
- Hyōgo
  - Nishinomiya-shi, Hyōgo, Japón, 663-8501
    - Hyogo College of Medicine Hospital
- Kagoshima-ken
  - Kagoshima, Kagoshima-ken, Japón, 892-0833
    - Hakuaikai Sagara Hospital
- Kanagawa
  - Isehara, Kanagawa, Japón, 259-1193
    - Tokai University Hospital
  - Yokohama, Kanagawa, Japón, 241-8515
    - Kanagawa Cancer Center
- Osaka
  - Osaka, Osaka, Japón, 540-0006
    - NHO Osaka National Hospital
- Osakasayama-shi
  - Onohigashi, Osakasayama-shi, Japón, 589-8511
    - Kindai University Hospital
- Saitama
  - Kitaadachi-gun, Saitama, Japón, 362-0806
    - Saitama Cancer Center
- Shizuoka
  - Sunto-gun, Shizuoka, Japón, 411-8777
    - Shizuoka Cancer Center
- Tokyo-To
  - Kōtoku, Tokyo-To, Japón, 135-8550
    - Cancer Institute Hospital of JFCR
  - Minatoku, Tokyo-To, Japón, 105-8470
    - Toranomon Hospital
  - Shinagawa-Ku, Tokyo-To, Japón, 142-8666
    - Showa University Hospital
Porcelana
- Anhui
  - Hefei, Anhui, Porcelana, 230001
    - Anhui Provincial Hospital
- Beijing Municipality
  - Beijing, Beijing Municipality, Porcelana, 100853
    - Chinese PLA General Hospital
  - Beijing, Beijing Municipality, Porcelana, 100021
    - Cancer Hospital Chinese Academy of Medical Sciences
- Fujian
  - Fuzhou, Fujian, Porcelana, 350025
    - Fuzhou General Hospital of Nanjing Military Area Command of Chinese PLA
- Guangdong
  - Guangzhou, Guangdong, Porcelana, 510120
    - Sun Yat-sen Memorial hospital, Sun Yat-sen University
- Heilongjiang
  - Harbin, Heilongjiang, Porcelana, 150081
    - Harbin Medical University Cancer Hospital
- Hubei
  - Wuhan, Hubei, Porcelana, 430079
    - Hubei Cancer Hospital
- Jiangsu
  - Nanjing, Jiangsu, Porcelana, 210008
    - The Affiliated Drum Tower Hospital of Nanjing University
- Jilin
  - Changchun, Jilin, Porcelana, 130000
    - The First Hospital of Jilin University
  - Changchun, Jilin, Porcelana, 130012
    - Jilin Cancer Hospital
- Liaoning
  - Shenyang, Liaoning, Porcelana, 110042
    - Liaoning Cancer Hospital & Institute
- Ningxia Hui
  - Yinchuan, Ningxia Hui, Porcelana, 750004
    - General Hospital of Ningxia Medical University
- Shandong
  - Linyi, Shandong, Porcelana, 276001
    - Linyi Cancer Hospital
- Shanghai Municipality
  - Shanghai, Shanghai Municipality, Porcelana, 200080
    - Shanghai General Hospital
  - Shanghai, Shanghai Municipality, Porcelana, 20032
    - Fudan University Shanghai Cancer Center
- Sichuan
  - Chengdu, Sichuan, Porcelana, 610041
    - West China Hospital, Sichuan University
- Zhejiang
  - Hangzhou, Zhejiang, Porcelana, 310022
    - Zhejiang Cancer Hospital
  - Hangzhou, Zhejiang, Porcelana, 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
Reino Unido
- Cornwall
  - Truro, Cornwall, Reino Unido, TR1 3LJ
    - Royal Cornwall Hospital
- Greater London
  - London, Greater London, Reino Unido, NW3 2QG
    - Royal Free Hospital
  - London, Greater London, Reino Unido, EC1M 6BQ
    - Queen Mary University of London
  - London, Greater London, Reino Unido, NW1 2PG
    - University College London Hospitals
- Lothian Region
  - Edinburgh, Lothian Region, Reino Unido, EH4 2XU
    - Western General Hospital
- Nottinghamshire
  - Nottingham, Nottinghamshire, Reino Unido, NG5 1PB
    - Nottingham University Hospitals City Campus
- Surrey
  - Guildford, Surrey, Reino Unido, GU2 7XX
    - Royal Surrey County Hospital
Rusia
- - Moscow, Rusia, 115478
    - FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"
  - Moscow, Rusia, 143423
    - SBIH of Moscow City "Moscow City Oncology Hospital №62" of Moscow Healthcare Departement
  - Yaroslavl, Rusia, 150054
    - SBIH of Yaroslavl Region "Regional Clinical Oncological Hospital"
Suecia
- - Solna, Suecia, 17176
    - Karolinska universitetssjukhuset - Solna
  - Sundsvall, Suecia, 85186
    - Länssjukhuset Sundsvall-Härnösand
  - Uppsala, Suecia, 75185
    - Akademiska Sjukhuset
Suiza
- - Aarau, Suiza, 5000
    - Hirslanden Medical Center
  - Basel, Suiza, 4031
    - Universitaetsspital Basel
  - Chur, Suiza, 7000
    - Kantonsspital Graubuenden
  - Lausanne, Suiza, 1011
    - Centre Hospitalier Universitaire Vaudois
  - Sankt Gallen, Suiza, 9007
    - Kantonsspital St. Gallen
  - Winterthur, Suiza, 8401
    - Kantonsspital Winterthur
  - Zurich, Suiza, 8091
    - Universitaetsspital Zuerich
Taiwán
- - Kaohsiung City, Taiwán, 807
    - Kaohsiung Medical University Chung-Ho Memorial Hospital
  - Tainan, Taiwán, 704
    - National Cheng Kung University Hospital
  - Taipei, Taiwán, 100
    - National Taiwan University Hospital

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Propósito principal: Tratamiento
Asignación: Aleatorizado
Modelo Intervencionista: Asignación paralela
Enmascaramiento: Ninguno (etiqueta abierta)

Número de brazos

Armas e Intervenciones

Grupo de participantes/brazo	Intervención / Tratamiento
Experimental: Trastuzumab deruxtecan HER2-low, unresectable, and/or metastatic breast cancer participants previously treated with chemotherapy randomized to DS8201a	Droga: Trastuzumab deruxtecan (DS-8201a) DS-8201a is a lyophilized powder reconstituted into a sterile aqueous solution (100 mg/5 mL) to be administered intravenously Otros nombres: DS-8201a
Comparador activo: 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	Droga: Capecitabine Administered according to label, as one option for Physician's Choice (determined before randomization) Droga: Eribulin Administered according to label, as one option for Physician's Choice (determined before randomization) Droga: Gemcitabine Administered according to label, as one option for Physician's Choice (determined before randomization) Droga: Paclitaxel Administered according to label, as one option for Physician's Choice (determined before randomization) Droga: Nab-paclitaxel Administered according to label, as one option for Physician's Choice (determined before randomization)

Grupo de participantes/brazo

Intervención / Tratamiento

Experimental: Trastuzumab deruxtecan

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

Droga: Trastuzumab deruxtecan (DS-8201a)

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

Otros nombres:

DS-8201a

Comparador activo: 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

Droga: Capecitabine