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Trastuzumab Deruxtecan (DS-8201a) 与研究者对已扩散或无法手术切除的 HER2-low 乳腺癌的选择 [DESTINY-Breast04]

2026年9月1日更新者：Daiichi Sankyo

抗 HER2 抗体药物偶联物 (ADC) DS-8201a 的第 3 期、多中心、随机、开放标签、主动对照试验，与医生选择的 HER2 低、不可切除和/或转移性乳腺癌受试者的治疗相比

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

研究概览

地位

完全的

条件

乳腺癌

干预/治疗

详细说明

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.

研究类型

介入性

注册 (实际的)

557

阶段

第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

主要用途：治疗
分配：随机化
介入模型：并行分配
屏蔽：无（打开标签）

手臂数量

武器和干预

参与者组/臂	干预/治疗
实验性的：Trastuzumab deruxtecan HER2-low, unresectable, and/or metastatic breast cancer participants previously treated with chemotherapy randomized to DS8201a	药品：Trastuzumab deruxtecan (DS-8201a) DS-8201a is a lyophilized powder reconstituted into a sterile aqueous solution (100 mg/5 mL) to be administered intravenously 其他名称： DS-8201a
有源比较器：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	药品：Capecitabine Administered according to label, as one option for Physician's Choice (determined before randomization) 药品：Eribulin Administered according to label, as one option for Physician's Choice (determined before randomization) 药品：Gemcitabine Administered according to label, as one option for Physician's Choice (determined before randomization) 药品：Paclitaxel Administered according to label, as one option for Physician's Choice (determined before randomization) 药品：Nab-paclitaxel Administered according to label, as one option for Physician's Choice (determined before randomization)

参与者组/臂

干预/治疗

实验性的：Trastuzumab deruxtecan

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

药品：Trastuzumab deruxtecan (DS-8201a)

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

其他名称：

DS-8201a

有源比较器：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

药品：Capecitabine