Clinical trial NCT03734029: Trastuzumab Deruxtecan (DS-8201a) Versus Investigator's Choice for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04]
Official title: A Phase 3, Multicenter, Randomized, Open-label, Active Controlled Trial of DS-8201a, an Anti-HER2-antibody Drug Conjugate (ADC), Versus Treatment of Physician's Choice for HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Breast Cancer
Keywords: Anti-HER2-Antibody Drug Conjugate (ADC)
Unresectable or Metastatic
Human epidermal growth factor receptor 2 (HER2)-low
DESTINY - Breast 04
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
Collaborators: name: Daiichi Sankyo Co., Ltd.
name: AstraZeneca
First posted: 2018-11-07
Enrollment: 557
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel model, randomized at a 2:1 ratio
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Progression-free Survival (PFS) Based on Blinded Independent Central Review (BICR) in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer
timeFrame: From the date of randomization to the earliest date of the first objective documentation of radiographic disease progression or death due to any cause, up to approximately 3 years
Secondary outcomes:
measure: Progression-free Survival (PFS) Based on Blinded Independent Central Review (BICR) in Participants With HER2-low Breast Cancer (All Patients) Regardless of Hormone Receptor Status
timeFrame: From the date of randomization to the earliest date of the first objective documentation of radiographic disease progression or death due to any cause, up to approximately 3 years
measure: Progression-free Survival Based on Investigator Assessment in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer
timeFrame: From the date of randomization to the earliest date of the first objective documentation of radiographic disease progression or death due to any cause, up to approximately 3 years
measure: Progression-free Survival Based on Investigator Assessment in Participants With HER2-low Breast Cancer (All Patients)
timeFrame: From the date of randomization to the earliest date of the first objective documentation of radiographic disease progression or death due to any cause, up to approximately 3 years
measure: Overall Survival (OS) in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer
timeFrame: From the date of randomization up to the date of death due to any cause, up to approximately 3 years
measure: Number of Overall Survival Events (Deaths)
timeFrame: From the date of randomization up to the date of death due to any cause, up to approximately 3 years
measure: Overall Survival (OS) in All Patients
timeFrame: From the date of randomization up to the date of death due to any cause, up to approximately 3 years
measure: Best Overall Response and Confirmed Objective Response Rate (ORR) in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer
timeFrame: From screening and every 6 weeks up to withdrawal of subject consent, progressive disease (PD), or unacceptable toxicity, up to approximately 3 years
measure: Best Overall Response and Confirmed Objective Response Rate (ORR) in Participants With HER2-low Breast Cancer (All Patients)
timeFrame: From screening and every 6 weeks up to withdrawal of subject consent, progressive disease (PD), or unacceptable toxicity, up to approximately 3 years
measure: Duration of Response in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer
timeFrame: From the date of the first documented objective response (CR or PR) to the first documented disease progression or death, whichever occurs first, up to approximately 3 years
measure: Duration of Response in Participants With HER2-low Breast Cancer (All Patients)
timeFrame: From the date of the first documented objective response (CR or PR) to the first documented disease progression or death, whichever occurs first, up to approximately 3 years
Other outcomes:
measure: All-Cause Mortality
timeFrame: From the date of randomization up to the date of death due to any cause, up to approximately 3 years
Locations:
city: Chandler
country: United States
facility: Ironwood Cancer & Research Centers - Chandler II
state: Arizona
city: Gilbert
country: United States
facility: Banner MD Anderson Cancer Center
state: Arizona
city: Goodyear
country: United States
facility: Cancer Treatment Centers of America at Western Regional Medical Center
state: Arizona
city: Los Angeles
country: United States
facility: UCLA School of Medicine
state: California
city: Palo Alto
country: United States
facility: Stanford Cancer Institute
state: California
city: Redondo Beach
country: United States
facility: Cancer Care Associates Medical Group, Inc. TORI
state: California
city: San Francisco
country: United States
facility: University of California at San Francisco (PARENT)
state: California
city: Norwich
country: United States
facility: Eastern Connecticut Hematology/Oncology Assoc.
state: Connecticut
city: Newark
country: United States
facility: Christiana Care Health Services, Inc.
state: Delaware
city: Boca Raton
country: United States
facility: Sylvester Comprehensive Cancer Center - Deerfield Beach
state: Florida
city: Fort Myers
country: United States
facility: Florida Cancer Specialists (South Region)
state: Florida
city: Hollywood
country: United States
facility: Memorial Healthcare System MRH Cancer Center
state: Florida
city: Orlando
country: United States
facility: Orlando Health, Inc.
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center -Tampa
state: Florida
city: Newnan
country: United States
facility: Cancer Treatment Centers of America-Georgia
state: Georgia
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Zion
country: United States
facility: Cancer Treatment Centers of America
state: Illinois
city: Wichita
country: United States
facility: Cancer Center of Kansas
state: Kansas
city: New Orleans
country: United States
facility: Touro Infirmary
state: Louisiana
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Kansas City
country: United States
facility: Saint Luke's Hospital of Kansas City
state: Missouri
city: Livingston
country: United States
facility: Saint Barnabas Medical Center
state: New Jersey
city: New York
country: United States
facility: New York University Medical Center
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Hospital
state: New York
city: New York
country: United States
facility: Weill Cornell Medicine Breast Center
state: New York
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center Health System
state: Pennsylvania
city: Greenville
country: United States
facility: St Francis Hospital
state: South Carolina
city: Knoxville
country: United States
facility: Brig Center for Cancer Care and Survivorship
state: Tennessee
city: Memphis
country: United States
facility: Baptist Cancer Center
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology - Skyline Satellite
state: Tennessee
city: Dallas
country: United States
facility: BloomTrials Clinical Research, LLC
state: Texas
city: Houston
country: United States
facility: The Methodist Hospital Research Institute
state: Texas
city: Houston
country: United States
facility: University of Texas M. D. Anderson Cancer Center - Investigational Cancer Therapeutics
state: Texas
city: Fairfax
country: United States
facility: Virginia Cancer Specialists
state: Virginia
city: Innsbruck
country: Austria
facility: Medizinische Universität Innsbruck
city: Linz
country: Austria
facility: Kepler Universitätsklinikum
city: Salzburg
country: Austria
facility: LKH - Universitätsklinikum der PMU Salzburg
city: Vienna
country: Austria
facility: AKH - Medizinische Universität Wien (4305)
city: Wels
country: Austria
facility: Klinikum Wels-Grieskirchen GmbH
city: Bruxelles
country: Belgium
facility: Institut Jules Bordet
city: Bruxelles
country: Belgium
facility: Universitair Ziekenhuis Brussel
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Leuven
country: Belgium
facility: UZ Leuven
city: Loverval
country: Belgium
facility: Grand Hôpital de Charleroi
city: Namur
country: Belgium
facility: CHU UCL Namur
city: Tournai
country: Belgium
facility: Centre Hospitalier Wallonie picarde - Site IMC
city: Calgary
country: Canada
facility: Tom Baker Cancer Center
state: Alberta
city: Toronto
country: Canada
facility: Toronto Sunnybrook Hospital
state: Ontario
city: Montréal
country: Canada
facility: McGill University - Dept. Oncology Clinical Research Program
state: Quebec
city: Hefei
country: China
facility: Anhui Provincial Hospital
state: Anhui
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences
state: Beijing
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
city: Fuzhou
country: China
facility: Fuzhou General Hospital of Nanjing Military Area Command of Chinese PLA
state: Fujian
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial hospital, Sun Yat-sen University
state: Guangdong
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
city: Wuhan
country: China
facility: Hubei Cancer Hospital
state: Hubei
city: Nanjing
country: China
facility: The Affiliated Drum Tower Hospital of Nanjing University
state: Jiangsu
city: Chang chun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Chang chun
country: China
facility: Jilin Cancer Hospital
state: Jilin
city: Shenyang
country: China
facility: Liaoning Cancer Hospital & Institute
state: Liaoning
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
state: Ningxia
city: Linyi
country: China
facility: Linyi Cancer Hospital
state: Shandong
city: Shanghai
country: China
facility: Shanghai General Hospital
state: Shanghai
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
city: Marseille cedex 9
country: France
facility: Institut Paoli Calmettes
state: Bouches-du-Rhône
city: Caen
country: France
facility: Centre François Baclesse
state: Calvados
city: Plérin
country: France
facility: CARIO - Centre Armoricain de Radiothérapie, Imagerie médicale et Oncologie
state: Cotes d'Armor
city: Brest Cedex
country: France
facility: CHU Brest - Hôpital Morvan
state: Finistere
city: Bordeaux cedex
country: France
facility: Institut Bergonié
state: Gironde
city: Montpellier
country: France
facility: Clinique Clementville
state: Herault
city: Montpellier
country: France
facility: Institut Régional du Cancer de Montpellier
state: Herault
city: Rennes-cedex
country: France
facility: CRLCC Eugene Marquis
state: Ille Et Vilaine
city: Saint-Herblain
country: France
facility: ICO - Site René Gauducheau
state: Loire Atlantique
city: Le Puy-en-Velay
country: France
facility: Centre Hospitalier Emile Roux
state: Loiret
city: Angers Cedex 2
country: France
facility: ICO - Site Paul Papin
state: Maine Et Loire
city: Valenciennes
country: France
facility: Centre Hospitalier Valenciennes
state: Nord
city: Paris Cedex 10
country: France
facility: Hôpital Saint-Louis - Paris
state: Paris
city: Le Mans Cedex 02
country: France
facility: Clinique Victor Hugo - Centre Jean Bernard
state: Sarthe
city: Avignon Cedex 9
country: France
facility: Institut Sainte Catherine
state: Vaculuse
city: Saint Mande
country: France
facility: Hôpital d'Instruction des Armees Begin*
state: Val De Marne
city: Villejuif cedex
country: France
facility: Institut Gustave Roussy
state: Val De Marne
city: Paris
country: France
facility: Institut Curie - site de Paris
city: Paris
country: France
facility: Hopital Tenon
city: Heidelberg
country: Germany
facility: Universitaetsklinikum Heidelberg
state: Baden Wuerttemberg
city: Munich
country: Germany
facility: Klinikum der Universitaet Muenchen - Campus Grosshardern
state: Bayern
city: Athens
country: Greece
facility: General Hospital of Athens "Alexandra"
city: Athens
country: Greece
facility: General Oncology Hospital of Kifissia " Agioi Anargyroi"
city: Athens
country: Greece
facility: Athens Medical Center
city: Heraklion
country: Greece
facility: University General Hospital of Heraklion
city: Larissa
country: Greece
facility: University General Hospital of Larissa
city: Thessaloníki
country: Greece
facility: Bioclinic Thessaloniki
city: Thessaloníki
country: Greece
facility: Euromedica General Clinic Thessaloniki
city: Thessaloníki
country: Greece
facility: General Hospital Papageorgiou
city: Thessaloníki
country: Greece
facility: Interbalkan Hospital of Thessaloniki
city: Budapest
country: Hungary
facility: Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet
city: Budapest
country: Hungary
facility: Orszagos Onkologiai Intezet
city: Debrecen
country: Hungary
facility: Debreceni Egyetem
city: Gyula
country: Hungary
facility: Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza
city: Nyiregyhaza
country: Hungary
facility: SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz
city: Szolnok
country: Hungary
facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet
city: Haifa
country: Israel
facility: Rambam Health Care Center
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Jerusalem
country: Israel
facility: Hadassah University Hospital - Ein Kerem
city: Petah tikva
country: Israel
facility: Rabin Medical Center-Beilinson Campus
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center
city: Rechovot
country: Israel
facility: Kaplan Medical Center
city: Safed
country: Israel
facility: Ziv Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Tricase
country: Italy
facility: Azienda Ospedaliera Card. G. Panico
state: Lecce
city: Monza
country: Italy
facility: Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo)
state: Milano
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Milano
city: Negrar
country: Italy
facility: Ospedale Sacro Cuore Don Calabria
state: Verona
city: Bologna
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
city: Brescia
country: Italy
facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
city: Catania
country: Italy
facility: Azienda Ospedaliera Univ. Policlinico Gaspare Rodolico
city: Catanzaro
country: Italy
facility: Azienda Ospedaliero Universitaria Mater Domini-Campus Universitario
city: Milano
country: Italy
facility: IEO Istituto Europeo di Oncologia
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori Fondazione G. Pascale
city: Rimini
country: Italy
facility: Ospedale degli Infermi
city: Roma
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
city: Nagoya
country: Japan
facility: Aichi Cancer Center Hospital
state: Aichi-Ken
city: Kashiwa-shi
country: Japan
facility: National Cancer Center Hospital East
state: Chiba-Ken
city: Matsuyama-shi
country: Japan
facility: NHO Shikoku Cancer Center
state: Ehime-Ken
city: Fukuoka-shi
country: Japan
facility: NHO Kyushu Cancer Center
state: Fukuoka-Ken
city: Fukushima
country: Japan
facility: Fukushima Medical University Hospital
state: Fukushima-Ken
city: Hiroshima-shi
country: Japan
facility: Hiroshima City Hiroshima Citizens Hospital
state: Hiroshima-Ken
city: Sapporo-shi
country: Japan
facility: NHO Hokkaido Cancer Center
state: Hokkaido
city: Nishinomiya-shi
country: Japan
facility: Hyogo College of Medicine Hospital
state: Hyogo-Ken
city: Kagoshima
country: Japan
facility: Hakuaikai Sagara Hospital
state: Kagoshima-Ken
city: Isehara
country: Japan
facility: Tokai University Hospital
state: Kanagawa-Ken
city: Yokohama
country: Japan
facility: Kanagawa Cancer Center
state: Kanagawa
city: Osaka-shi
country: Japan
facility: NHO Osaka National Hospital
state: Osaka-Fu
city: Onohigashi
country: Japan
facility: Kindai University Hospital
state: Osakasayama-shi
city: Kitaadachi-gun
country: Japan
facility: Saitama Cancer Center
state: Saitama-Ken
city: Sunto-gun
country: Japan
facility: Shizuoka Cancer Center
state: Shizuoka-Ken
city: Koto-Ku
country: Japan
facility: Cancer Institute Hospital of JFCR
state: Tokyo-To
city: Minato-Ku
country: Japan
facility: Toranomon Hospital
state: Tokyo-To
city: Shinagawa-Ku
country: Japan
facility: Showa University Hospital
state: Tokyo-To
city: Cheongju-si
country: Korea, Republic of
facility: Chungbuk National University Hospital
state: Chungcheongbuk-do
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi-do
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
state: Gyeonggi-do
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Braga
country: Portugal
facility: Hospital de Braga
city: Guimarães
country: Portugal
facility: Centro Hospitalar do Alto do Ave, EPE
city: Lisboa
country: Portugal
facility: Fundação Champalimaud
city: Lisboa
country: Portugal
facility: Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria
city: Matosinhos
country: Portugal
facility: Unidade Local de Saúde de Matosinhos, EPE (Hospital Pedro Hispano)
city: Porto
country: Portugal
facility: Centro Hospitalar do Porto, E.P.E. - Hospital de Santo António
city: Porto
country: Portugal
facility: Instituto Português de Oncologia do Porto Francisco Gentil, EPE
city: Santa Maria Da Feira
country: Portugal
facility: Centro Hospitalar de Entre o Douro e Vouga, E.P.E - Hospital de São Sebastião
city: Vila Nova De Gaia
country: Portugal
facility: Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E
city: Vila Real
country: Portugal
facility: Centro Hospitalar de Trás-os-Montes e Alto Douro, EPE
city: Moscow
country: Russian Federation
facility: FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"
city: Moscow
country: Russian Federation
facility: SBIH of Moscow City "Moscow City Oncology Hospital №62" of Moscow Healthcare Departement
city: Yaroslavl
country: Russian Federation
facility: SBIH of Yaroslavl Region "Regional Clinical Oncological Hospital"
city: L'Hospitalet De Llobregat
country: Spain
facility: ICO l'Hospitalet - Hospital Duran i Reynals
state: Barcelona
city: San Sebastián
country: Spain
facility: Hospital Universitario Donostia
state: Guipuzcoa
city: A Coruña
country: Spain
facility: Complejo Hospitalario Universitario A Coruña
state: La Coruña
city: San Cristobal de la Laguna
country: Spain
facility: Hospital Universitario de Canarias
state: Tenerife
city: Bilbao
country: Spain
facility: Hospital de Basurto
state: Vizcaya
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Quironsalud Barcelona
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Madrid
country: Spain
facility: MD Anderson Cancer Centre
city: Madrid
country: Spain
facility: Hospital Ruber Internacional
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario Clinico San Carlos
city: Málaga
country: Spain
facility: Hospital Clinico Universitario Virgen de la Victoria
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Valencia
country: Spain
facility: Instituto Valenciano de Oncologia IVO
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia
city: Solna
country: Sweden
facility: Karolinska universitetssjukhuset - Solna
city: Sundsvall
country: Sweden
facility: Länssjukhuset Sundsvall-Härnösand
city: Uppsala
country: Sweden
facility: Akademiska Sjukhuset
city: Aarau
country: Switzerland
facility: Hirslanden Medical Center
city: Basel
country: Switzerland
facility: Universitaetsspital Basel
city: Chur
country: Switzerland
facility: Kantonsspital Graubuenden
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
city: Saint Gallen
country: Switzerland
facility: Kantonsspital St. Gallen
city: Winterthur
country: Switzerland
facility: Kantonsspital Winterthur
city: Zürich
country: Switzerland
facility: Universitaetsspital Zuerich
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospital
state: Cornwall
city: London
country: United Kingdom
facility: Queen Mary University of London
state: Greater London
city: London
country: United Kingdom
facility: University College London Hospitals
state: Greater London
city: London
country: United Kingdom
facility: Royal Free Hospital
state: Greater London
city: Edinburgh
country: United Kingdom
facility: Western General Hospital
state: Lothian Region
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals City Campus
state: Nottinghamshire
city: Guildford
country: United Kingdom
facility: Royal Surrey County Hospital
state: Surrey
Study officials:
affiliation: Daiichi Sankyo
name: Global Clinical Leader
role: STUDY_DIRECTOR
References:
citation: Modi S, Jacot W, Yamashita T, Sohn J, Vidal M, Tokunaga E, Tsurutani J, Ueno NT, Prat A, Chae YS, Lee KS, Niikura N, Park YH, Xu B, Wang X, Gil-Gil M, Li W, Pierga JY, Im SA, Moore HCF, Rugo HS, Yerushalmi R, Zagouri F, Gombos A, Kim SB, Liu Q, Luo T, Saura C, Schmid P, Sun T, Gambhire D, Yung L, Wang Y, Singh J, Vitazka P, Meinhardt G, Harbeck N, Cameron DA; DESTINY-Breast04 Trial Investigators. Trastuzumab Deruxtecan in Previously Treated HER2-Low Advanced Breast Cancer. N Engl J Med. 2022 Jul 7;387(1):9-20. doi: 10.1056/NEJMoa2203690. Epub 2022 Jun 5.