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Trastuzumab Deruxtecan (DS-8201a) Versus Investigator's Choice voor HER2-low borstkanker die zich heeft verspreid of niet chirurgisch kan worden verwijderd [DESTINY-Breast04]

1 september 2026 bijgewerkt door: Daiichi Sankyo

Een multicenter, gerandomiseerde, open-label, actief gecontroleerde fase 3-studie van DS-8201a, een anti-HER2-antilichaam-geneesmiddelconjugaat (ADC), versus behandeling naar keuze van de arts voor proefpersonen met HER2-lage, inoperabele en/of gemetastaseerde borstkanker

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

Studie Overzicht

Toestand

Voltooid

Conditie

Borstkanker

Interventie / Behandeling

Gedetailleerde beschrijving

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

Ingrijpend

Inschrijving (Werkelijk)

557

Fase

Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

België
- - Brussels, België, 1000
    - Institut Jules Bordet
  - Brussels, België, 1090
    - Universitair Ziekenhuis Brussel
  - Brussels, België, 1200
    - Cliniques Universitaires Saint-Luc
  - Leuven, België, 3000
    - UZ Leuven
  - Loverval, België, 6280
    - Grand Hôpital de Charleroi
  - Namur, België, 5000
    - CHU UCL Namur
  - Tournai, België, 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
China
- Anhui
  - Hefei, Anhui, China, 230001
    - Anhui Provincial Hospital
- Beijing Municipality
  - Beijing, Beijing Municipality, China, 100853
    - Chinese PLA General Hospital
  - Beijing, Beijing Municipality, China, 100021
    - Cancer Hospital Chinese Academy of Medical Sciences
- Fujian
  - Fuzhou, Fujian, China, 350025
    - Fuzhou General Hospital of Nanjing Military Area Command of Chinese PLA
- Guangdong
  - Guangzhou, Guangdong, China, 510120
    - Sun Yat-sen Memorial hospital, Sun Yat-sen University
- Heilongjiang
  - Harbin, Heilongjiang, China, 150081
    - Harbin Medical University Cancer Hospital
- Hubei
  - Wuhan, Hubei, China, 430079
    - Hubei Cancer Hospital
- Jiangsu
  - Nanjing, Jiangsu, China, 210008
    - The Affiliated Drum Tower Hospital of Nanjing University
- Jilin
  - Changchun, Jilin, China, 130000
    - The First Hospital of Jilin University
  - Changchun, Jilin, China, 130012
    - Jilin Cancer Hospital
- Liaoning
  - Shenyang, Liaoning, China, 110042
    - Liaoning Cancer Hospital & Institute
- Ningxia Hui
  - Yinchuan, Ningxia Hui, China, 750004
    - General Hospital of Ningxia Medical University
- Shandong
  - Linyi, Shandong, China, 276001
    - Linyi Cancer Hospital
- Shanghai Municipality
  - Shanghai, Shanghai Municipality, China, 200080
    - Shanghai General Hospital
  - Shanghai, Shanghai Municipality, China, 20032
    - Fudan University Shanghai Cancer Center
- Sichuan
  - Chengdu, Sichuan, China, 610041
    - West China Hospital, Sichuan University
- Zhejiang
  - Hangzhou, Zhejiang, China, 310022
    - Zhejiang Cancer Hospital
  - Hangzhou, Zhejiang, China, 310016
    - Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
Duitsland
- Baden-Wurttemberg
  - Heidelberg, Baden-Wurttemberg, Duitsland, 69120
    - Universitaetsklinikum Heidelberg
- Bavaria
  - Munich, Bavaria, Duitsland, 81377
    - Klinikum der Universitaet Muenchen - Campus Grosshardern
Frankrijk
- - Paris, Frankrijk, 75020
    - Hopital Tenon
  - Paris, Frankrijk, 75005
    - Institut Curie - site de Paris
- Bouches-du-Rhône
  - Marseille, Bouches-du-Rhône, Frankrijk, 13009
    - Institut Paoli Calmettes
- Calvados
  - Caen, Calvados, Frankrijk, 14076
    - Centre François Baclesse
- Cotes d'Armor
  - Plérin, Cotes d'Armor, Frankrijk, 22190
    - CARIO - Centre Armoricain de Radiothérapie, Imagerie médicale et Oncologie
- Finistere
  - Brest, Finistere, Frankrijk, 29609
    - CHU Brest - Hôpital Morvan
- Gironde
  - Bordeaux, Gironde, Frankrijk, 33076
    - Institut Bergonié
- Herault
  - Montpellier, Herault, Frankrijk, 34070
    - Clinique Clementville
  - Montpellier, Herault, Frankrijk, 34298
    - Institut Régional du Cancer de Montpellier
- Ille Et Vilaine
  - Rennes, Ille Et Vilaine, Frankrijk, 35042
    - CRLCC Eugene Marquis
- Loire Atlantique
  - Saint-Herblain, Loire Atlantique, Frankrijk, 44805
    - ICO - Site René Gauducheau
- Loiret
  - Le Puy-en-Velay, Loiret, Frankrijk, 43012
    - Centre Hospitalier Emile Roux
- Maine Et Loire
  - Angers, Maine Et Loire, Frankrijk, 49055
    - ICO - Site Paul Papin
- Nord
  - Valenciennes, Nord, Frankrijk, 59322
    - Centre Hospitalier Valenciennes
- Paris
  - Paris, Paris, Frankrijk, 75475
    - Hôpital Saint-Louis - Paris
- Sarthe
  - Le Mans, Sarthe, Frankrijk, 72015
    - Clinique Victor Hugo - Centre Jean Bernard
- Vaculuse
  - Avignon, Vaculuse, Frankrijk, 84918
    - Institut Sainte Catherine
- Val De Marne
  - Saint-Mandé, Val De Marne, Frankrijk, 94160
    - Hôpital d'Instruction des Armees Begin*
  - Villejuif, Val De Marne, Frankrijk, 94805
    - Institut Gustave Roussy
Griekenland
- - Athens, Griekenland, 15125
    - Athens Medical Center
  - Athens, Griekenland, 11528
    - General Hospital of Athens "Alexandra"
  - Athens, Griekenland, 14564
    - General Oncology Hospital of Kifissia " Agioi Anargyroi"
  - Heraklion, Griekenland, 71110
    - University General Hospital of Heraklion
  - Larissa, Griekenland, 41110
    - University General Hospital of Larissa
  - Thessaloniki, Griekenland, 54622
    - Bioclinic Thessaloniki
  - Thessaloniki, Griekenland, 54645
    - Euromedica General Clinic Thessaloniki
  - Thessaloniki, Griekenland, 56429
    - General Hospital Papageorgiou
  - Thessaloniki, Griekenland, 57001
    - Interbalkan Hospital of Thessaloniki
Hongarije
- - Budapest, Hongarije, 1097
    - Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet
  - Budapest, Hongarije, 1122
    - Orszagos Onkologiai Intezet
  - Debrecen, Hongarije, 4032
    - Debreceni Egyetem
  - Gyula, Hongarije, 5700
    - Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza
  - Nyíregyháza, Hongarije, 4400
    - SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz
  - Szolnok, Hongarije, 5004
    - Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet
Israël
- - Haifa, Israël, 3109601
    - Rambam Health Care Center
  - Jerusalem, Israël, 9103102
    - Shaare Zedek Medical Center
  - Jerusalem, Israël, 9112001
    - Hadassah University Hospital - Ein Kerem
  - Petah Tikva, Israël, 49100
    - Rabin Medical Center-Beilinson Campus
  - Ramat Gan, Israël, 52363
    - Chaim Sheba Medical Center
  - Rehovot, Israël, 7610001
    - Kaplan Medical Center
  - Safed, Israël, 13100
    - Ziv Medical Center
  - Tel Aviv, Israël, 6423906
    - Tel Aviv Sourasky Medical Center
Italië
- - Bologna, Italië, 40138
    - Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
  - Brescia, Italië, 25100
    - Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
  - Catania, Italië, 95125
    - Azienda Ospedaliera Univ. Policlinico Gaspare Rodolico
  - Catanzaro, Italië, 88100
    - Azienda Ospedaliero Universitaria Mater Domini-Campus Universitario
  - Milan, Italië, 20141
    - IEO Istituto Europeo di Oncologia
  - Naples, Italië, 80131
    - Istituto Nazionale Tumori Fondazione G. Pascale
  - Rimini, Italië, 47923
    - Ospedale degli Infermi
  - Roma, Italië, 00168
    - Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  - Roma, Italië, 00133
    - Azienda Ospedaliera Universitaria Policlinico Tor Vergata
- Lecce
  - Tricase, Lecce, Italië, 73039
    - Azienda Ospedaliera Card. G. Panico
- Milano
  - Monza, Milano, Italië, 20900
    - Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo)
  - Rozzano, Milano, Italië, 20089
    - Istituto Clinico Humanitas
- Verona
  - Negrar, Verona, Italië, 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
Oostenrijk
- - Innsbruck, Oostenrijk, 6020
    - Medizinische Universität Innsbruck
  - Linz, Oostenrijk, 4020
    - Kepler Universitätsklinikum
  - Salzburg, Oostenrijk, 5020
    - LKH - Universitätsklinikum der PMU Salzburg
  - Vienna, Oostenrijk, 1090
    - AKH - Medizinische Universität Wien (4305)
  - Wels, Oostenrijk, 4600
    - Klinikum Wels-Grieskirchen GmbH
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"
Spanje
- - Barcelona, Spanje, 08036
    - Hospital Clinic de Barcelona
  - Barcelona, Spanje, 08035
    - Hospital Universitari Vall d'Hebron
  - Barcelona, Spanje, 08023
    - Hospital Quironsalud Barcelona
  - Barcelona, Spanje, 08003
    - Hospital del Mar
  - Madrid, Spanje, 28034
    - Hospital Universitario Ramon y Cajal
  - Madrid, Spanje, 28040
    - Hospital Universitario Clinico San Carlos
  - Madrid, Spanje, 28034
    - Hospital Ruber Internacional
  - Madrid, Spanje, 28033
    - MD Anderson Cancer Centre
  - Málaga, Spanje, 29010
    - Hospital Clinico Universitario Virgen de la Victoria
  - Seville, Spanje, 41009
    - Hospital Universitario Virgen Macarena
  - Seville, Spanje, 41013
    - Hospital Universitario Virgen del Rocio
  - Valencia, Spanje, 46014
    - Hospital General Universitario de Valencia
  - Valencia, Spanje, 46009
    - Instituto Valenciano de Oncologia IVO
- Barcelona
  - L'Hospitalet de Llobregat, Barcelona, Spanje, 08908
    - ICO l'Hospitalet - Hospital Duran i Reynals
- Guipuzcoa
  - San Sebastián, Guipuzcoa, Spanje, 20014
    - Hospital Universitario Donostia
- La Coruña
  - A Coruña, La Coruña, Spanje, 15006
    - Complejo Hospitalario Universitario A Coruña
- Tenerife
  - San Cristóbal de La Laguna, Tenerife, Spanje, 38320
    - Hospital Universitario de Canarias
- Vizcaya
  - Bilbao, Vizcaya, Spanje, 48013
    - Hospital de Basurto
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
Verenigd Koninkrijk
- Cornwall
  - Truro, Cornwall, Verenigd Koninkrijk, TR1 3LJ
    - Royal Cornwall Hospital
- Greater London
  - London, Greater London, Verenigd Koninkrijk, NW3 2QG
    - Royal Free Hospital
  - London, Greater London, Verenigd Koninkrijk, EC1M 6BQ
    - Queen Mary University of London
  - London, Greater London, Verenigd Koninkrijk, NW1 2PG
    - University College London Hospitals
- Lothian Region
  - Edinburgh, Lothian Region, Verenigd Koninkrijk, EH4 2XU
    - Western General Hospital
- Nottinghamshire
  - Nottingham, Nottinghamshire, Verenigd Koninkrijk, NG5 1PB
    - Nottingham University Hospitals City Campus
- Surrey
  - Guildford, Surrey, Verenigd Koninkrijk, GU2 7XX
    - Royal Surrey County Hospital
Verenigde Staten
- Arizona
  - Chandler, Arizona, Verenigde Staten, 85224
    - Ironwood Cancer & Research Centers - Chandler II
  - Gilbert, Arizona, Verenigde Staten, 85234
    - Banner MD Anderson Cancer Center
  - Goodyear, Arizona, Verenigde Staten, 85338
    - Cancer Treatment Centers of America at Western Regional Medical Center
- California
  - Los Angeles, California, Verenigde Staten, 90095
    - UCLA School of Medicine
  - Palo Alto, California, Verenigde Staten, 94305
    - Stanford Cancer Institute
  - Redondo Beach, California, Verenigde Staten, 90277
    - Cancer Care Associates Medical Group, Inc. TORI
  - San Francisco, California, Verenigde Staten, 94158
    - University of California at San Francisco (PARENT)
- Connecticut
  - Norwich, Connecticut, Verenigde Staten, 06360
    - Eastern Connecticut Hematology/Oncology Assoc.
- Delaware
  - Newark, Delaware, Verenigde Staten, 19713
    - Christiana Care Health Services, Inc.
- Florida
  - Boca Raton, Florida, Verenigde Staten, 33426
    - Sylvester Comprehensive Cancer Center - Deerfield Beach
  - Fort Myers, Florida, Verenigde Staten, 33916
    - Florida Cancer Specialists (South Region)
  - Hollywood, Florida, Verenigde Staten, 33021
    - Memorial Healthcare System MRH Cancer Center
  - Orlando, Florida, Verenigde Staten, 32806
    - Orlando Health, Inc.
  - Tampa, Florida, Verenigde Staten, 33139
    - Moffitt Cancer Center -Tampa
- Georgia
  - Newnan, Georgia, Verenigde Staten, 30263
    - Cancer Treatment Centers of America-Georgia
- Illinois
  - Chicago, Illinois, Verenigde Staten, 60637
    - University of Chicago Medical Center
  - Zion, Illinois, Verenigde Staten, 60099
    - Cancer Treatment Centers of America
- Kansas
  - Wichita, Kansas, Verenigde Staten, 67214
    - Cancer Center of Kansas
- Louisiana
  - New Orleans, Louisiana, Verenigde Staten, 70115
    - Touro Infirmary
- Massachusetts
  - Boston, Massachusetts, Verenigde Staten, 02215
    - Dana-Farber Cancer Institute
- Michigan
  - Detroit, Michigan, Verenigde Staten, 48202
    - Henry Ford Hospital
- Missouri
  - Kansas City, Missouri, Verenigde Staten, 64111
    - Saint Luke's Hospital of Kansas City
- New Jersey
  - Livingston, New Jersey, Verenigde Staten, 07039
    - Saint Barnabas Medical Center
- New York
  - New York, New York, Verenigde Staten, 10016
    - New York University Medical Center
  - New York, New York, Verenigde Staten, 10065
    - Memorial Sloan Kettering Hospital
  - New York, New York, Verenigde Staten, 10065
    - Weill Cornell Medicine Breast Center
- Ohio
  - Cleveland, Ohio, Verenigde Staten, 44195
    - The Cleveland Clinic Foundation
- Oregon
  - Portland, Oregon, Verenigde Staten, 97239
    - Oregon Health & Science University
- Pennsylvania
  - Pittsburgh, Pennsylvania, Verenigde Staten, 15212
    - Allegheny General Hospital
  - Pittsburgh, Pennsylvania, Verenigde Staten, 15219
    - University of Pittsburgh Medical Center Health System
- South Carolina
  - Greenville, South Carolina, Verenigde Staten, 29601
    - St Francis Hospital
- Tennessee
  - Knoxville, Tennessee, Verenigde Staten, 37909
    - Brig Center for Cancer Care and Survivorship
  - Memphis, Tennessee, Verenigde Staten, 38120
    - Baptist Cancer Center
  - Nashville, Tennessee, Verenigde Staten, 37201
    - Tennessee Oncology - Skyline Satellite
- Texas
  - Dallas, Texas, Verenigde Staten, 75234
    - BloomTrials Clinical Research, LLC
  - Houston, Texas, Verenigde Staten, 77030
    - The Methodist Hospital Research Institute
  - Houston, Texas, Verenigde Staten, 77030
    - University of Texas M. D. Anderson Cancer Center - Investigational Cancer Therapeutics
- Virginia
  - Fairfax, Virginia, Verenigde Staten, 22031
    - Virginia Cancer Specialists
Zuid -Korea
- - Daegu, Zuid -Korea, 41404
    - Kyungpook National University Chilgok Hospital
  - Seoul, Zuid -Korea, 03080
    - Seoul National University Hospital
  - Seoul, Zuid -Korea, 05505
    - Asan Medical Center
  - Seoul, Zuid -Korea, 06351
    - Samsung Medical Center
  - Seoul, Zuid -Korea, 06591
    - The Catholic University of Korea, Seoul St. Mary's Hospital
  - Seoul, Zuid -Korea, 120-752
    - Severance Hospital, Yonsei University Health System
- Gyeonggi-do
  - Goyang-si, Gyeonggi-do, Zuid -Korea, 10408
    - National Cancer Center
  - Incheon, Gyeonggi-do, Zuid -Korea, 22332
    - Inha University Hospital
  - Seongnam-si, Gyeonggi-do, Zuid -Korea, 13620
    - Seoul National University Bundang Hospital
  - Suwon, Gyeonggi-do, Zuid -Korea, 16499
    - Ajou University Hospital
- North Chungcheong
  - Cheongju-si, North Chungcheong, Zuid -Korea, 361-711
    - Chungbuk National University Hospital
Zweden
- - Solna, Zweden, 17176
    - Karolinska universitetssjukhuset - Solna
  - Sundsvall, Zweden, 85186
    - Länssjukhuset Sundsvall-Härnösand
  - Uppsala, Zweden, 75185
    - Akademiska Sjukhuset
Zwitserland
- - Aarau, Zwitserland, 5000
    - Hirslanden Medical Center
  - Basel, Zwitserland, 4031
    - Universitaetsspital Basel
  - Chur, Zwitserland, 7000
    - Kantonsspital Graubuenden
  - Lausanne, Zwitserland, 1011
    - Centre Hospitalier Universitaire Vaudois
  - Sankt Gallen, Zwitserland, 9007
    - Kantonsspital St. Gallen
  - Winterthur, Zwitserland, 8401
    - Kantonsspital Winterthur
  - Zurich, Zwitserland, 8091
    - Universitaetsspital Zuerich

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Primair doel: Behandeling
Toewijzing: Gerandomiseerd
Interventioneel model: Parallelle opdracht
Masker: Geen (open label)

Aantal wapens

Wapens en interventies

Deelnemersgroep / Arm	Interventie / Behandeling
Experimenteel: Trastuzumab deruxtecan HER2-low, unresectable, and/or metastatic breast cancer participants previously treated with chemotherapy randomized to DS8201a	Geneesmiddel: Trastuzumab deruxtecan (DS-8201a) DS-8201a is a lyophilized powder reconstituted into a sterile aqueous solution (100 mg/5 mL) to be administered intravenously Andere namen: DS-8201a
Actieve vergelijker: 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	Geneesmiddel: Capecitabine Administered according to label, as one option for Physician's Choice (determined before randomization) Geneesmiddel: Eribulin Administered according to label, as one option for Physician's Choice (determined before randomization) Geneesmiddel: Gemcitabine Administered according to label, as one option for Physician's Choice (determined before randomization) Geneesmiddel: Paclitaxel Administered according to label, as one option for Physician's Choice (determined before randomization) Geneesmiddel: Nab-paclitaxel Administered according to label, as one option for Physician's Choice (determined before randomization)

Deelnemersgroep / Arm

Interventie / Behandeling

Experimenteel: Trastuzumab deruxtecan

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

Geneesmiddel: Trastuzumab deruxtecan (DS-8201a)

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

Andere namen:

DS-8201a

Actieve vergelijker: 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

Geneesmiddel: Capecitabine