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Trastuzumab Deruxtecan (DS-8201a) rispetto alla scelta dello sperimentatore per il carcinoma mammario a basso contenuto di HER2 che si è diffuso o non può essere rimosso chirurgicamente [DESTINY-Breast04]

1 settembre 2026 aggiornato da: Daiichi Sankyo

Uno studio di fase 3, multicentrico, randomizzato, in aperto, con controllo attivo di DS-8201a, un farmaco coniugato anti-HER2-anticorpo (ADC), rispetto al trattamento scelto dal medico per soggetti affetti da carcinoma mammario a basso contenuto di HER2, non resecabile e/o metastatico

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

Panoramica dello studio

Stato

Completato

Condizioni

Cancro al seno

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Effettivo)

557

Fase

Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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
Belgio
- - Brussels, Belgio, 1000
    - Institut Jules Bordet
  - Brussels, Belgio, 1090
    - Universitair Ziekenhuis Brussel
  - Brussels, Belgio, 1200
    - Cliniques Universitaires Saint-Luc
  - Leuven, Belgio, 3000
    - UZ Leuven
  - Loverval, Belgio, 6280
    - Grand Hôpital de Charleroi
  - Namur, Belgio, 5000
    - CHU UCL Namur
  - Tournai, Belgio, 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
Cina
- Anhui
  - Hefei, Anhui, Cina, 230001
    - Anhui Provincial Hospital
- Beijing Municipality
  - Beijing, Beijing Municipality, Cina, 100853
    - Chinese PLA General Hospital
  - Beijing, Beijing Municipality, Cina, 100021
    - Cancer Hospital Chinese Academy of Medical Sciences
- Fujian
  - Fuzhou, Fujian, Cina, 350025
    - Fuzhou General Hospital of Nanjing Military Area Command of Chinese PLA
- Guangdong
  - Guangzhou, Guangdong, Cina, 510120
    - Sun Yat-sen Memorial hospital, Sun Yat-sen University
- Heilongjiang
  - Harbin, Heilongjiang, Cina, 150081
    - Harbin Medical University Cancer Hospital
- Hubei
  - Wuhan, Hubei, Cina, 430079
    - Hubei Cancer Hospital
- Jiangsu
  - Nanjing, Jiangsu, Cina, 210008
    - The Affiliated Drum Tower Hospital of Nanjing University
- Jilin
  - Changchun, Jilin, Cina, 130000
    - The First Hospital of Jilin University
  - Changchun, Jilin, Cina, 130012
    - Jilin Cancer Hospital
- Liaoning
  - Shenyang, Liaoning, Cina, 110042
    - Liaoning Cancer Hospital & Institute
- Ningxia Hui
  - Yinchuan, Ningxia Hui, Cina, 750004
    - General Hospital of Ningxia Medical University
- Shandong
  - Linyi, Shandong, Cina, 276001
    - Linyi Cancer Hospital
- Shanghai Municipality
  - Shanghai, Shanghai Municipality, Cina, 200080
    - Shanghai General Hospital
  - Shanghai, Shanghai Municipality, Cina, 20032
    - Fudan University Shanghai Cancer Center
- Sichuan
  - Chengdu, Sichuan, Cina, 610041
    - West China Hospital, Sichuan University
- Zhejiang
  - Hangzhou, Zhejiang, Cina, 310022
    - Zhejiang Cancer Hospital
  - Hangzhou, Zhejiang, Cina, 310016
    - Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
Corea del Sud
- - Daegu, Corea del Sud, 41404
    - Kyungpook National University Chilgok Hospital
  - Seoul, Corea del Sud, 03080
    - Seoul National University Hospital
  - Seoul, Corea del Sud, 05505
    - Asan Medical Center
  - Seoul, Corea del Sud, 06351
    - Samsung Medical Center
  - Seoul, Corea del Sud, 06591
    - The Catholic University of Korea, Seoul St. Mary's Hospital
  - Seoul, Corea del Sud, 120-752
    - Severance Hospital, Yonsei University Health System
- Gyeonggi-do
  - Goyang-si, Gyeonggi-do, Corea del Sud, 10408
    - National Cancer Center
  - Incheon, Gyeonggi-do, Corea del Sud, 22332
    - Inha University Hospital
  - Seongnam-si, Gyeonggi-do, Corea del Sud, 13620
    - Seoul National University Bundang Hospital
  - Suwon, Gyeonggi-do, Corea del Sud, 16499
    - Ajou University Hospital
- North Chungcheong
  - Cheongju-si, North Chungcheong, Corea del Sud, 361-711
    - Chungbuk National University Hospital
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
Germania
- Baden-Wurttemberg
  - Heidelberg, Baden-Wurttemberg, Germania, 69120
    - Universitaetsklinikum Heidelberg
- Bavaria
  - Munich, Bavaria, Germania, 81377
    - Klinikum der Universitaet Muenchen - Campus Grosshardern
Giappone
- Aichi-ken
  - Nagoya, Aichi-ken, Giappone, 464-8681
    - Aichi Cancer Center Hospital
- Chiba
  - Kashiwa-shi, Chiba, Giappone, 277-8577
    - National Cancer Center Hospital East
- Ehime
  - Matsuyama, Ehime, Giappone, 791-0280
    - NHO Shikoku Cancer Center
- Fukuoka
  - Fukuoka, Fukuoka, Giappone, 811-1395
    - NHO Kyushu Cancer Center
- Fukushima
  - Fukushima, Fukushima, Giappone, 960-1295
    - Fukushima Medical University Hospital
- Hiroshima
  - Hiroshima, Hiroshima, Giappone, 730-8518
    - Hiroshima City Hiroshima Citizens Hospital
- Hokkaido
  - Sapporo, Hokkaido, Giappone, 003-0804
    - NHO Hokkaido Cancer Center
- Hyōgo
  - Nishinomiya-shi, Hyōgo, Giappone, 663-8501
    - Hyogo College of Medicine Hospital
- Kagoshima-ken
  - Kagoshima, Kagoshima-ken, Giappone, 892-0833
    - Hakuaikai Sagara Hospital
- Kanagawa
  - Isehara, Kanagawa, Giappone, 259-1193
    - Tokai University Hospital
  - Yokohama, Kanagawa, Giappone, 241-8515
    - Kanagawa Cancer Center
- Osaka
  - Osaka, Osaka, Giappone, 540-0006
    - NHO Osaka National Hospital
- Osakasayama-shi
  - Onohigashi, Osakasayama-shi, Giappone, 589-8511
    - Kindai University Hospital
- Saitama
  - Kitaadachi-gun, Saitama, Giappone, 362-0806
    - Saitama Cancer Center
- Shizuoka
  - Sunto-gun, Shizuoka, Giappone, 411-8777
    - Shizuoka Cancer Center
- Tokyo-To
  - Kōtoku, Tokyo-To, Giappone, 135-8550
    - Cancer Institute Hospital of JFCR
  - Minatoku, Tokyo-To, Giappone, 105-8470
    - Toranomon Hospital
  - Shinagawa-Ku, Tokyo-To, Giappone, 142-8666
    - Showa University Hospital
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
Israele
- - Haifa, Israele, 3109601
    - Rambam Health Care Center
  - Jerusalem, Israele, 9103102
    - Shaare Zedek Medical Center
  - Jerusalem, Israele, 9112001
    - Hadassah University Hospital - Ein Kerem
  - Petah Tikva, Israele, 49100
    - Rabin Medical Center-Beilinson Campus
  - Ramat Gan, Israele, 52363
    - Chaim Sheba Medical Center
  - Rehovot, Israele, 7610001
    - Kaplan Medical Center
  - Safed, Israele, 13100
    - Ziv Medical Center
  - Tel Aviv, Israele, 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
Portogallo
- - Braga, Portogallo, 4710-243
    - Hospital de Braga
  - Guimarães, Portogallo, 4835-044
    - Centro Hospitalar do Alto do Ave, EPE
  - Lisbon, Portogallo, 1649-035
    - Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria
  - Lisbon, Portogallo, 1400-038
    - Fundação Champalimaud
  - Matosinhos Municipality, Portogallo, 4464-509
    - Unidade Local de Saúde de Matosinhos, EPE (Hospital Pedro Hispano)
  - Porto, Portogallo, 4200-072
    - Instituto Português de Oncologia do Porto Francisco Gentil, EPE
  - Porto, Portogallo, 4099-001
    - Centro Hospitalar do Porto, E.P.E. - Hospital de Santo António
  - Santa Maria da Feira, Portogallo, 4520-211
    - Centro Hospitalar de Entre o Douro e Vouga, E.P.E - Hospital de São Sebastião
  - Vila Nova de Gaia, Portogallo, 4434-502
    - Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E
  - Vila Real, Portogallo, 5000-508
    - Centro Hospitalar de Trás-os-Montes e Alto Douro, EPE
Regno Unito
- Cornwall
  - Truro, Cornwall, Regno Unito, TR1 3LJ
    - Royal Cornwall Hospital
- Greater London
  - London, Greater London, Regno Unito, NW3 2QG
    - Royal Free Hospital
  - London, Greater London, Regno Unito, EC1M 6BQ
    - Queen Mary University of London
  - London, Greater London, Regno Unito, NW1 2PG
    - University College London Hospitals
- Lothian Region
  - Edinburgh, Lothian Region, Regno Unito, EH4 2XU
    - Western General Hospital
- Nottinghamshire
  - Nottingham, Nottinghamshire, Regno Unito, NG5 1PB
    - Nottingham University Hospitals City Campus
- Surrey
  - Guildford, Surrey, Regno Unito, GU2 7XX
    - Royal Surrey County Hospital
Russia
- - Moscow, Russia, 115478
    - FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"
  - Moscow, Russia, 143423
    - SBIH of Moscow City "Moscow City Oncology Hospital №62" of Moscow Healthcare Departement
  - Yaroslavl, Russia, 150054
    - SBIH of Yaroslavl Region "Regional Clinical Oncological Hospital"
Spagna
- - Barcelona, Spagna, 08036
    - Hospital Clinic de Barcelona
  - Barcelona, Spagna, 08035
    - Hospital Universitari Vall d'Hebron
  - Barcelona, Spagna, 08023
    - Hospital Quironsalud Barcelona
  - Barcelona, Spagna, 08003
    - Hospital del Mar
  - Madrid, Spagna, 28034
    - Hospital Universitario Ramon y Cajal
  - Madrid, Spagna, 28040
    - Hospital Universitario Clinico San Carlos
  - Madrid, Spagna, 28034
    - Hospital Ruber Internacional
  - Madrid, Spagna, 28033
    - MD Anderson Cancer Centre
  - Málaga, Spagna, 29010
    - Hospital Clinico Universitario Virgen de la Victoria
  - Seville, Spagna, 41009
    - Hospital Universitario Virgen Macarena
  - Seville, Spagna, 41013
    - Hospital Universitario Virgen del Rocio
  - Valencia, Spagna, 46014
    - Hospital General Universitario de Valencia
  - Valencia, Spagna, 46009
    - Instituto Valenciano de Oncologia IVO
- Barcelona
  - L'Hospitalet de Llobregat, Barcelona, Spagna, 08908
    - ICO l'Hospitalet - Hospital Duran i Reynals
- Guipuzcoa
  - San Sebastián, Guipuzcoa, Spagna, 20014
    - Hospital Universitario Donostia
- La Coruña
  - A Coruña, La Coruña, Spagna, 15006
    - Complejo Hospitalario Universitario A Coruña
- Tenerife
  - San Cristóbal de La Laguna, Tenerife, Spagna, 38320
    - Hospital Universitario de Canarias
- Vizcaya
  - Bilbao, Vizcaya, Spagna, 48013
    - Hospital de Basurto
Stati Uniti
- Arizona
  - Chandler, Arizona, Stati Uniti, 85224
    - Ironwood Cancer & Research Centers - Chandler II
  - Gilbert, Arizona, Stati Uniti, 85234
    - Banner MD Anderson Cancer Center
  - Goodyear, Arizona, Stati Uniti, 85338
    - Cancer Treatment Centers of America at Western Regional Medical Center
- California
  - Los Angeles, California, Stati Uniti, 90095
    - UCLA School of Medicine
  - Palo Alto, California, Stati Uniti, 94305
    - Stanford Cancer Institute
  - Redondo Beach, California, Stati Uniti, 90277
    - Cancer Care Associates Medical Group, Inc. TORI
  - San Francisco, California, Stati Uniti, 94158
    - University of California at San Francisco (PARENT)
- Connecticut
  - Norwich, Connecticut, Stati Uniti, 06360
    - Eastern Connecticut Hematology/Oncology Assoc.
- Delaware
  - Newark, Delaware, Stati Uniti, 19713
    - Christiana Care Health Services, Inc.
- Florida
  - Boca Raton, Florida, Stati Uniti, 33426
    - Sylvester Comprehensive Cancer Center - Deerfield Beach
  - Fort Myers, Florida, Stati Uniti, 33916
    - Florida Cancer Specialists (South Region)
  - Hollywood, Florida, Stati Uniti, 33021
    - Memorial Healthcare System MRH Cancer Center
  - Orlando, Florida, Stati Uniti, 32806
    - Orlando Health, Inc.
  - Tampa, Florida, Stati Uniti, 33139
    - Moffitt Cancer Center -Tampa
- Georgia
  - Newnan, Georgia, Stati Uniti, 30263
    - Cancer Treatment Centers of America-Georgia
- Illinois
  - Chicago, Illinois, Stati Uniti, 60637
    - University of Chicago Medical Center
  - Zion, Illinois, Stati Uniti, 60099
    - Cancer Treatment Centers of America
- Kansas
  - Wichita, Kansas, Stati Uniti, 67214
    - Cancer Center of Kansas
- Louisiana
  - New Orleans, Louisiana, Stati Uniti, 70115
    - Touro Infirmary
- Massachusetts
  - Boston, Massachusetts, Stati Uniti, 02215
    - Dana-Farber Cancer Institute
- Michigan
  - Detroit, Michigan, Stati Uniti, 48202
    - Henry Ford Hospital
- Missouri
  - Kansas City, Missouri, Stati Uniti, 64111
    - Saint Luke's Hospital of Kansas City
- New Jersey
  - Livingston, New Jersey, Stati Uniti, 07039
    - Saint Barnabas Medical Center
- New York
  - New York, New York, Stati Uniti, 10016
    - New York University Medical Center
  - New York, New York, Stati Uniti, 10065
    - Memorial Sloan Kettering Hospital
  - New York, New York, Stati Uniti, 10065
    - Weill Cornell Medicine Breast Center
- Ohio
  - Cleveland, Ohio, Stati Uniti, 44195
    - The Cleveland Clinic Foundation
- Oregon
  - Portland, Oregon, Stati Uniti, 97239
    - Oregon Health & Science University
- Pennsylvania
  - Pittsburgh, Pennsylvania, Stati Uniti, 15212
    - Allegheny General Hospital
  - Pittsburgh, Pennsylvania, Stati Uniti, 15219
    - University of Pittsburgh Medical Center Health System
- South Carolina
  - Greenville, South Carolina, Stati Uniti, 29601
    - St Francis Hospital
- Tennessee
  - Knoxville, Tennessee, Stati Uniti, 37909
    - Brig Center for Cancer Care and Survivorship
  - Memphis, Tennessee, Stati Uniti, 38120
    - Baptist Cancer Center
  - Nashville, Tennessee, Stati Uniti, 37201
    - Tennessee Oncology - Skyline Satellite
- Texas
  - Dallas, Texas, Stati Uniti, 75234
    - BloomTrials Clinical Research, LLC
  - Houston, Texas, Stati Uniti, 77030
    - The Methodist Hospital Research Institute
  - Houston, Texas, Stati Uniti, 77030
    - University of Texas M. D. Anderson Cancer Center - Investigational Cancer Therapeutics
- Virginia
  - Fairfax, Virginia, Stati Uniti, 22031
    - Virginia Cancer Specialists
Svezia
- - Solna, Svezia, 17176
    - Karolinska universitetssjukhuset - Solna
  - Sundsvall, Svezia, 85186
    - Länssjukhuset Sundsvall-Härnösand
  - Uppsala, Svezia, 75185
    - Akademiska Sjukhuset
Svizzera
- - Aarau, Svizzera, 5000
    - Hirslanden Medical Center
  - Basel, Svizzera, 4031
    - Universitaetsspital Basel
  - Chur, Svizzera, 7000
    - Kantonsspital Graubuenden
  - Lausanne, Svizzera, 1011
    - Centre Hospitalier Universitaire Vaudois
  - Sankt Gallen, Svizzera, 9007
    - Kantonsspital St. Gallen
  - Winterthur, Svizzera, 8401
    - Kantonsspital Winterthur
  - Zurich, Svizzera, 8091
    - Universitaetsspital Zuerich
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
Ungheria
- - Budapest, Ungheria, 1097
    - Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet
  - Budapest, Ungheria, 1122
    - Orszagos Onkologiai Intezet
  - Debrecen, Ungheria, 4032
    - Debreceni Egyetem
  - Gyula, Ungheria, 5700
    - Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza
  - Nyíregyháza, Ungheria, 4400
    - SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz
  - Szolnok, Ungheria, 5004
    - Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Scopo principale: Trattamento
Assegnazione: Randomizzato
Modello interventistico: Assegnazione parallela
Mascheramento: Nessuno (etichetta aperta)

Numero di armi

Armi e interventi

Gruppo di partecipanti / Arm	Intervento / Trattamento
Sperimentale: 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 Altri nomi: DS-8201a
Comparatore attivo: 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)

Gruppo di partecipanti / Arm

Intervento / Trattamento

Sperimentale: 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

Altri nomi:

DS-8201a

Comparatore attivo: 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