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Trastuzumab Deruxtecan(DS-8201a) 대 전이되었거나 외과적으로 제거할 수 없는 HER2-낮은 유방암에 대한 연구자의 선택 [DESTINY-Breast04]

2026년 9월 1일 업데이트: Daiichi Sankyo

DS-8201a, 항 HER2-항체 약물 접합체(ADC)의 3상, 다기관, 무작위, 공개, 능동 제어 시험, HER2가 낮고 절제 불가능 및/또는 전이성 유방암 피험자를 위한 의사의 선택 치료 비교

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

연구 개요

상태

완전한

정황

유방암

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (실제)

557

단계

3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

그리스
- - Athens, 그리스, 15125
    - Athens Medical Center
  - Athens, 그리스, 11528
    - General Hospital of Athens "Alexandra"
  - Athens, 그리스, 14564
    - General Oncology Hospital of Kifissia " Agioi Anargyroi"
  - Heraklion, 그리스, 71110
    - University General Hospital of Heraklion
  - Larissa, 그리스, 41110
    - University General Hospital of Larissa
  - Thessaloniki, 그리스, 54622
    - Bioclinic Thessaloniki
  - Thessaloniki, 그리스, 54645
    - Euromedica General Clinic Thessaloniki
  - Thessaloniki, 그리스, 56429
    - General Hospital Papageorgiou
  - Thessaloniki, 그리스, 57001
    - Interbalkan Hospital of Thessaloniki
대만
- - Kaohsiung City, 대만, 807
    - Kaohsiung Medical University Chung-Ho Memorial Hospital
  - Tainan, 대만, 704
    - National Cheng Kung University Hospital
  - Taipei, 대만, 100
    - National Taiwan University Hospital
대한민국
- - Daegu, 대한민국, 41404
    - Kyungpook National University Chilgok Hospital
  - Seoul, 대한민국, 03080
    - Seoul National University Hospital
  - Seoul, 대한민국, 05505
    - Asan Medical Center
  - Seoul, 대한민국, 06351
    - Samsung Medical Center
  - Seoul, 대한민국, 06591
    - The Catholic University of Korea, Seoul St. Mary's Hospital
  - Seoul, 대한민국, 120-752
    - Severance Hospital, Yonsei University Health System
- Gyeonggi-do
  - Goyang-si, Gyeonggi-do, 대한민국, 10408
    - National Cancer Center
  - Incheon, Gyeonggi-do, 대한민국, 22332
    - Inha University Hospital
  - Seongnam-si, Gyeonggi-do, 대한민국, 13620
    - Seoul National University Bundang Hospital
  - Suwon, Gyeonggi-do, 대한민국, 16499
    - Ajou University Hospital
- North Chungcheong
  - Cheongju-si, North Chungcheong, 대한민국, 361-711
    - Chungbuk National University Hospital
독일
- Baden-Wurttemberg
  - Heidelberg, Baden-Wurttemberg, 독일, 69120
    - Universitaetsklinikum Heidelberg
- Bavaria
  - Munich, Bavaria, 독일, 81377
    - Klinikum der Universitaet Muenchen - Campus Grosshardern
러시아 제국
- - Moscow, 러시아 제국, 115478
    - FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"
  - Moscow, 러시아 제국, 143423
    - SBIH of Moscow City "Moscow City Oncology Hospital №62" of Moscow Healthcare Departement
  - Yaroslavl, 러시아 제국, 150054
    - SBIH of Yaroslavl Region "Regional Clinical Oncological Hospital"
미국
- Arizona
  - Chandler, Arizona, 미국, 85224
    - Ironwood Cancer & Research Centers - Chandler II
  - Gilbert, Arizona, 미국, 85234
    - Banner MD Anderson Cancer Center
  - Goodyear, Arizona, 미국, 85338
    - Cancer Treatment Centers of America at Western Regional Medical Center
- California
  - Los Angeles, California, 미국, 90095
    - UCLA School of Medicine
  - Palo Alto, California, 미국, 94305
    - Stanford Cancer Institute
  - Redondo Beach, California, 미국, 90277
    - Cancer Care Associates Medical Group, Inc. TORI
  - San Francisco, California, 미국, 94158
    - University of California at San Francisco (PARENT)
- Connecticut
  - Norwich, Connecticut, 미국, 06360
    - Eastern Connecticut Hematology/Oncology Assoc.
- Delaware
  - Newark, Delaware, 미국, 19713
    - Christiana Care Health Services, Inc.
- Florida
  - Boca Raton, Florida, 미국, 33426
    - Sylvester Comprehensive Cancer Center - Deerfield Beach
  - Fort Myers, Florida, 미국, 33916
    - Florida Cancer Specialists (South Region)
  - Hollywood, Florida, 미국, 33021
    - Memorial Healthcare System MRH Cancer Center
  - Orlando, Florida, 미국, 32806
    - Orlando Health, Inc.
  - Tampa, Florida, 미국, 33139
    - Moffitt Cancer Center -Tampa
- Georgia
  - Newnan, Georgia, 미국, 30263
    - Cancer Treatment Centers of America-Georgia
- Illinois
  - Chicago, Illinois, 미국, 60637
    - University of Chicago Medical Center
  - Zion, Illinois, 미국, 60099
    - Cancer Treatment Centers of America
- Kansas
  - Wichita, Kansas, 미국, 67214
    - Cancer Center of Kansas
- Louisiana
  - New Orleans, Louisiana, 미국, 70115
    - Touro Infirmary
- Massachusetts
  - Boston, Massachusetts, 미국, 02215
    - Dana-Farber Cancer Institute
- Michigan
  - Detroit, Michigan, 미국, 48202
    - Henry Ford Hospital
- Missouri
  - Kansas City, Missouri, 미국, 64111
    - Saint Luke's Hospital of Kansas City
- New Jersey
  - Livingston, New Jersey, 미국, 07039
    - Saint Barnabas Medical Center
- New York
  - New York, New York, 미국, 10016
    - New York University Medical Center
  - New York, New York, 미국, 10065
    - Memorial Sloan Kettering Hospital
  - New York, New York, 미국, 10065
    - Weill Cornell Medicine Breast Center
- Ohio
  - Cleveland, Ohio, 미국, 44195
    - The Cleveland Clinic Foundation
- Oregon
  - Portland, Oregon, 미국, 97239
    - Oregon Health & Science University
- Pennsylvania
  - Pittsburgh, Pennsylvania, 미국, 15212
    - Allegheny General Hospital
  - Pittsburgh, Pennsylvania, 미국, 15219
    - University of Pittsburgh Medical Center Health System
- South Carolina
  - Greenville, South Carolina, 미국, 29601
    - St Francis Hospital
- Tennessee
  - Knoxville, Tennessee, 미국, 37909
    - Brig Center for Cancer Care and Survivorship
  - Memphis, Tennessee, 미국, 38120
    - Baptist Cancer Center
  - Nashville, Tennessee, 미국, 37201
    - Tennessee Oncology - Skyline Satellite
- Texas
  - Dallas, Texas, 미국, 75234
    - BloomTrials Clinical Research, LLC
  - Houston, Texas, 미국, 77030
    - The Methodist Hospital Research Institute
  - Houston, Texas, 미국, 77030
    - University of Texas M. D. Anderson Cancer Center - Investigational Cancer Therapeutics
- Virginia
  - Fairfax, Virginia, 미국, 22031
    - Virginia Cancer Specialists
벨기에
- - Brussels, 벨기에, 1000
    - Institut Jules Bordet
  - Brussels, 벨기에, 1090
    - Universitair Ziekenhuis Brussel
  - Brussels, 벨기에, 1200
    - Cliniques Universitaires Saint-Luc
  - Leuven, 벨기에, 3000
    - UZ Leuven
  - Loverval, 벨기에, 6280
    - Grand Hôpital de Charleroi
  - Namur, 벨기에, 5000
    - CHU UCL Namur
  - Tournai, 벨기에, 7500
    - Centre Hospitalier Wallonie picarde - Site IMC
스웨덴
- - Solna, 스웨덴, 17176
    - Karolinska universitetssjukhuset - Solna
  - Sundsvall, 스웨덴, 85186
    - Länssjukhuset Sundsvall-Härnösand
  - Uppsala, 스웨덴, 75185
    - Akademiska Sjukhuset
스위스
- - Aarau, 스위스, 5000
    - Hirslanden Medical Center
  - Basel, 스위스, 4031
    - Universitaetsspital Basel
  - Chur, 스위스, 7000
    - Kantonsspital Graubuenden
  - Lausanne, 스위스, 1011
    - Centre Hospitalier Universitaire Vaudois
  - Sankt Gallen, 스위스, 9007
    - Kantonsspital St. Gallen
  - Winterthur, 스위스, 8401
    - Kantonsspital Winterthur
  - Zurich, 스위스, 8091
    - Universitaetsspital Zuerich
스페인
- - Barcelona, 스페인, 08036
    - Hospital Clinic de Barcelona
  - Barcelona, 스페인, 08035
    - Hospital Universitari Vall d'Hebron
  - Barcelona, 스페인, 08023
    - Hospital Quironsalud Barcelona
  - Barcelona, 스페인, 08003
    - Hospital del Mar
  - Madrid, 스페인, 28034
    - Hospital Universitario Ramon y Cajal
  - Madrid, 스페인, 28040
    - Hospital Universitario Clinico San Carlos
  - Madrid, 스페인, 28034
    - Hospital Ruber Internacional
  - Madrid, 스페인, 28033
    - MD Anderson Cancer Centre
  - Málaga, 스페인, 29010
    - Hospital Clinico Universitario Virgen de la Victoria
  - Seville, 스페인, 41009
    - Hospital Universitario Virgen Macarena
  - Seville, 스페인, 41013
    - Hospital Universitario Virgen del Rocio
  - Valencia, 스페인, 46014
    - Hospital General Universitario de Valencia
  - Valencia, 스페인, 46009
    - Instituto Valenciano de Oncologia IVO
- Barcelona
  - L'Hospitalet de Llobregat, Barcelona, 스페인, 08908
    - ICO l'Hospitalet - Hospital Duran i Reynals
- Guipuzcoa
  - San Sebastián, Guipuzcoa, 스페인, 20014
    - Hospital Universitario Donostia
- La Coruña
  - A Coruña, La Coruña, 스페인, 15006
    - Complejo Hospitalario Universitario A Coruña
- Tenerife
  - San Cristóbal de La Laguna, Tenerife, 스페인, 38320
    - Hospital Universitario de Canarias
- Vizcaya
  - Bilbao, Vizcaya, 스페인, 48013
    - Hospital de Basurto
영국
- Cornwall
  - Truro, Cornwall, 영국, TR1 3LJ
    - Royal Cornwall Hospital
- Greater London
  - London, Greater London, 영국, NW3 2QG
    - Royal Free Hospital
  - London, Greater London, 영국, EC1M 6BQ
    - Queen Mary University of London
  - London, Greater London, 영국, NW1 2PG
    - University College London Hospitals
- Lothian Region
  - Edinburgh, Lothian Region, 영국, EH4 2XU
    - Western General Hospital
- Nottinghamshire
  - Nottingham, Nottinghamshire, 영국, NG5 1PB
    - Nottingham University Hospitals City Campus
- Surrey
  - Guildford, Surrey, 영국, GU2 7XX
    - Royal Surrey County Hospital
오스트리아
- - Innsbruck, 오스트리아, 6020
    - Medizinische Universität Innsbruck
  - Linz, 오스트리아, 4020
    - Kepler Universitätsklinikum
  - Salzburg, 오스트리아, 5020
    - LKH - Universitätsklinikum der PMU Salzburg
  - Vienna, 오스트리아, 1090
    - AKH - Medizinische Universität Wien (4305)
  - Wels, 오스트리아, 4600
    - Klinikum Wels-Grieskirchen GmbH
이스라엘
- - Haifa, 이스라엘, 3109601
    - Rambam Health Care Center
  - Jerusalem, 이스라엘, 9103102
    - Shaare Zedek Medical Center
  - Jerusalem, 이스라엘, 9112001
    - Hadassah University Hospital - Ein Kerem
  - Petah Tikva, 이스라엘, 49100
    - Rabin Medical Center-Beilinson Campus
  - Ramat Gan, 이스라엘, 52363
    - Chaim Sheba Medical Center
  - Rehovot, 이스라엘, 7610001
    - Kaplan Medical Center
  - Safed, 이스라엘, 13100
    - Ziv Medical Center
  - Tel Aviv, 이스라엘, 6423906
    - Tel Aviv Sourasky Medical Center
이탈리아
- - Bologna, 이탈리아, 40138
    - Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
  - Brescia, 이탈리아, 25100
    - Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
  - Catania, 이탈리아, 95125
    - Azienda Ospedaliera Univ. Policlinico Gaspare Rodolico
  - Catanzaro, 이탈리아, 88100
    - Azienda Ospedaliero Universitaria Mater Domini-Campus Universitario
  - Milan, 이탈리아, 20141
    - IEO Istituto Europeo di Oncologia
  - Naples, 이탈리아, 80131
    - Istituto Nazionale Tumori Fondazione G. Pascale
  - Rimini, 이탈리아, 47923
    - Ospedale degli Infermi
  - Roma, 이탈리아, 00168
    - Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  - Roma, 이탈리아, 00133
    - Azienda Ospedaliera Universitaria Policlinico Tor Vergata
- Lecce
  - Tricase, Lecce, 이탈리아, 73039
    - Azienda Ospedaliera Card. G. Panico
- Milano
  - Monza, Milano, 이탈리아, 20900
    - Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo)
  - Rozzano, Milano, 이탈리아, 20089
    - Istituto Clinico Humanitas
- Verona
  - Negrar, Verona, 이탈리아, 37024
    - Ospedale Sacro Cuore Don Calabria
일본
- Aichi-ken
  - Nagoya, Aichi-ken, 일본, 464-8681
    - Aichi Cancer Center Hospital
- Chiba
  - Kashiwa-shi, Chiba, 일본, 277-8577
    - National Cancer Center Hospital East
- Ehime
  - Matsuyama, Ehime, 일본, 791-0280
    - NHO Shikoku Cancer Center
- Fukuoka
  - Fukuoka, Fukuoka, 일본, 811-1395
    - NHO Kyushu Cancer Center
- Fukushima
  - Fukushima, Fukushima, 일본, 960-1295
    - Fukushima Medical University Hospital
- Hiroshima
  - Hiroshima, Hiroshima, 일본, 730-8518
    - Hiroshima City Hiroshima Citizens Hospital
- Hokkaido
  - Sapporo, Hokkaido, 일본, 003-0804
    - NHO Hokkaido Cancer Center
- Hyōgo
  - Nishinomiya-shi, Hyōgo, 일본, 663-8501
    - Hyogo College of Medicine Hospital
- Kagoshima-ken
  - Kagoshima, Kagoshima-ken, 일본, 892-0833
    - Hakuaikai Sagara Hospital
- Kanagawa
  - Isehara, Kanagawa, 일본, 259-1193
    - Tokai University Hospital
  - Yokohama, Kanagawa, 일본, 241-8515
    - Kanagawa Cancer Center
- Osaka
  - Osaka, Osaka, 일본, 540-0006
    - NHO Osaka National Hospital
- Osakasayama-shi
  - Onohigashi, Osakasayama-shi, 일본, 589-8511
    - Kindai University Hospital
- Saitama
  - Kitaadachi-gun, Saitama, 일본, 362-0806
    - Saitama Cancer Center
- Shizuoka
  - Sunto-gun, Shizuoka, 일본, 411-8777
    - Shizuoka Cancer Center
- Tokyo-To
  - Kōtoku, Tokyo-To, 일본, 135-8550
    - Cancer Institute Hospital of JFCR
  - Minatoku, Tokyo-To, 일본, 105-8470
    - Toranomon Hospital
  - Shinagawa-Ku, Tokyo-To, 일본, 142-8666
    - Showa University Hospital
중국
- Anhui
  - Hefei, Anhui, 중국, 230001
    - Anhui Provincial Hospital
- Beijing Municipality
  - Beijing, Beijing Municipality, 중국, 100853
    - Chinese PLA General Hospital
  - Beijing, Beijing Municipality, 중국, 100021
    - Cancer Hospital Chinese Academy of Medical Sciences
- Fujian
  - Fuzhou, Fujian, 중국, 350025
    - Fuzhou General Hospital of Nanjing Military Area Command of Chinese PLA
- Guangdong
  - Guangzhou, Guangdong, 중국, 510120
    - Sun Yat-sen Memorial hospital, Sun Yat-sen University
- Heilongjiang
  - Harbin, Heilongjiang, 중국, 150081
    - Harbin Medical University Cancer Hospital
- Hubei
  - Wuhan, Hubei, 중국, 430079
    - Hubei Cancer Hospital
- Jiangsu
  - Nanjing, Jiangsu, 중국, 210008
    - The Affiliated Drum Tower Hospital of Nanjing University
- Jilin
  - Changchun, Jilin, 중국, 130000
    - The First Hospital of Jilin University
  - Changchun, Jilin, 중국, 130012
    - Jilin Cancer Hospital
- Liaoning
  - Shenyang, Liaoning, 중국, 110042
    - Liaoning Cancer Hospital & Institute
- Ningxia Hui
  - Yinchuan, Ningxia Hui, 중국, 750004
    - General Hospital of Ningxia Medical University
- Shandong
  - Linyi, Shandong, 중국, 276001
    - Linyi Cancer Hospital
- Shanghai Municipality
  - Shanghai, Shanghai Municipality, 중국, 200080
    - Shanghai General Hospital
  - Shanghai, Shanghai Municipality, 중국, 20032
    - Fudan University Shanghai Cancer Center
- Sichuan
  - Chengdu, Sichuan, 중국, 610041
    - West China Hospital, Sichuan University
- Zhejiang
  - Hangzhou, Zhejiang, 중국, 310022
    - Zhejiang Cancer Hospital
  - Hangzhou, Zhejiang, 중국, 310016
    - Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
캐나다
- Alberta
  - Calgary, Alberta, 캐나다, T2N4N2
    - Tom Baker Cancer Center
- Ontario
  - Toronto, Ontario, 캐나다, M4N 3M5
    - Toronto Sunnybrook Hospital
- Quebec
  - Montreal, Quebec, 캐나다, H2W 1S6
    - McGill University - Dept. Oncology Clinical Research Program
포르투갈
- - Braga, 포르투갈, 4710-243
    - Hospital de Braga
  - Guimarães, 포르투갈, 4835-044
    - Centro Hospitalar do Alto do Ave, EPE
  - Lisbon, 포르투갈, 1649-035
    - Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria
  - Lisbon, 포르투갈, 1400-038
    - Fundação Champalimaud
  - Matosinhos Municipality, 포르투갈, 4464-509
    - Unidade Local de Saúde de Matosinhos, EPE (Hospital Pedro Hispano)
  - Porto, 포르투갈, 4200-072
    - Instituto Português de Oncologia do Porto Francisco Gentil, EPE
  - Porto, 포르투갈, 4099-001
    - Centro Hospitalar do Porto, E.P.E. - Hospital de Santo António
  - Santa Maria da Feira, 포르투갈, 4520-211
    - Centro Hospitalar de Entre o Douro e Vouga, E.P.E - Hospital de São Sebastião
  - Vila Nova de Gaia, 포르투갈, 4434-502
    - Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E
  - Vila Real, 포르투갈, 5000-508
    - Centro Hospitalar de Trás-os-Montes e Alto Douro, EPE
프랑스
- - Paris, 프랑스, 75020
    - Hopital Tenon
  - Paris, 프랑스, 75005
    - Institut Curie - site de Paris
- Bouches-du-Rhône
  - Marseille, Bouches-du-Rhône, 프랑스, 13009
    - Institut Paoli Calmettes
- Calvados
  - Caen, Calvados, 프랑스, 14076
    - Centre François Baclesse
- Cotes d'Armor
  - Plérin, Cotes d'Armor, 프랑스, 22190
    - CARIO - Centre Armoricain de Radiothérapie, Imagerie médicale et Oncologie
- Finistere
  - Brest, Finistere, 프랑스, 29609
    - CHU Brest - Hôpital Morvan
- Gironde
  - Bordeaux, Gironde, 프랑스, 33076
    - Institut Bergonié
- Herault
  - Montpellier, Herault, 프랑스, 34070
    - Clinique Clementville
  - Montpellier, Herault, 프랑스, 34298
    - Institut Régional du Cancer de Montpellier
- Ille Et Vilaine
  - Rennes, Ille Et Vilaine, 프랑스, 35042
    - CRLCC Eugene Marquis
- Loire Atlantique
  - Saint-Herblain, Loire Atlantique, 프랑스, 44805
    - ICO - Site René Gauducheau
- Loiret
  - Le Puy-en-Velay, Loiret, 프랑스, 43012
    - Centre Hospitalier Emile Roux
- Maine Et Loire
  - Angers, Maine Et Loire, 프랑스, 49055
    - ICO - Site Paul Papin
- Nord
  - Valenciennes, Nord, 프랑스, 59322
    - Centre Hospitalier Valenciennes
- Paris
  - Paris, Paris, 프랑스, 75475
    - Hôpital Saint-Louis - Paris
- Sarthe
  - Le Mans, Sarthe, 프랑스, 72015
    - Clinique Victor Hugo - Centre Jean Bernard
- Vaculuse
  - Avignon, Vaculuse, 프랑스, 84918
    - Institut Sainte Catherine
- Val De Marne
  - Saint-Mandé, Val De Marne, 프랑스, 94160
    - Hôpital d'Instruction des Armees Begin*
  - Villejuif, Val De Marne, 프랑스, 94805
    - Institut Gustave Roussy
헝가리
- - Budapest, 헝가리, 1097
    - Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet
  - Budapest, 헝가리, 1122
    - Orszagos Onkologiai Intezet
  - Debrecen, 헝가리, 4032
    - Debreceni Egyetem
  - Gyula, 헝가리, 5700
    - Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza
  - Nyíregyháza, 헝가리, 4400
    - SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz
  - Szolnok, 헝가리, 5004
    - Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

주 목적: 치료
할당: 무작위
중재 모델: 병렬 할당
마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔 참가자 그룹 / 팔 시험 프로토콜에 따라 특정 중재/치료를 받거나 중재를 받지 않는 임상 시험 참가자 그룹 또는 하위 그룹입니다.	개입 / 치료 개입 / 치료 임상 연구의 초점이 되는 프로세스 또는 작업입니다. 개입에는 약물, 의료 기기, 절차, 백신 및 조사 중이거나 이미 사용 가능한 기타 제품이 포함됩니다. 개입에는 교육이나 식이요법 및 운동 수정과 같은 비침습적 접근법도 포함될 수 있습니다.
실험적: Trastuzumab deruxtecan HER2-low, unresectable, and/or metastatic breast cancer participants previously treated with chemotherapy randomized to DS8201a	의약품: Trastuzumab deruxtecan (DS-8201a) DS-8201a is a lyophilized powder reconstituted into a sterile aqueous solution (100 mg/5 mL) to be administered intravenously 다른 이름들: DS-8201a
활성 비교기: 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	의약품: Capecitabine Administered according to label, as one option for Physician's Choice (determined before randomization) 의약품: Eribulin Administered according to label, as one option for Physician's Choice (determined before randomization) 의약품: Gemcitabine Administered according to label, as one option for Physician's Choice (determined before randomization) 의약품: Paclitaxel Administered according to label, as one option for Physician's Choice (determined before randomization) 의약품: Nab-paclitaxel Administered according to label, as one option for Physician's Choice (determined before randomization)

참가자 그룹 / 팔

개입 / 치료

실험적: Trastuzumab deruxtecan

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

의약품: Trastuzumab deruxtecan (DS-8201a)

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

다른 이름들:

DS-8201a

활성 비교기: 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

의약품: Capecitabine