Breast Cancer Clinical Trial

Trastuzumab Deruxtecan (DS-8201a) Versus Investigator’s Choice for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04]

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

View Full Description

Full 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Is the age of majority in their country

Has pathologically documented breast cancer that:

Is unresectable or metastatic
Has low-HER2 expression defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested)
Is HR-positive or HR-negative
Has progressed on, and would no longer benefit from, endocrine therapy
Has been treated with 1 to 2 prior lines of chemotherapy/adjuvant in the recurrent or metastatic setting
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:

assessment of HER2 status
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

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

557

Study ID:

NCT03734029

Recruitment Status:

Active, not recruiting

Sponsor:

Daiichi Sankyo

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There are 202 Locations for this study

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Ironwood Cancer & Research Centers - Chandler II
Chandler Arizona, 85224, United States
Banner MD Anderson Cancer Center
Gilbert Arizona, 85234, United States
Cancer Treatment Centers of America at Western Regional Medical Center
Goodyear Arizona, 85338, United States
UCLA School of Medicine
Los Angeles California, 90095, United States
Stanford Cancer Institute
Palo Alto California, 94305, United States
Cancer Care Associates Medical Group, Inc. TORI
Redondo Beach California, 90277, United States
University of California at San Francisco (PARENT)
San Francisco California, 94158, United States
Eastern Connecticut Hematology/Oncology Assoc.
Norwich Connecticut, 06360, United States
Christiana Care Health Services, Inc.
Newark Delaware, 19713, United States
Sylvester Comprehensive Cancer Center - Deerfield Beach
Boca Raton Florida, 33426, United States
Florida Cancer Specialists (South Region)
Fort Myers Florida, 33916, United States
Memorial Healthcare System MRH Cancer Center
Hollywood Florida, 33021, United States
Orlando Health, Inc.
Orlando Florida, 32806, United States
Moffitt Cancer Center -Tampa
Tampa Florida, 33139, United States
Cancer Treatment Centers of America-Georgia
Newnan Georgia, 30263, United States
University of Chicago Medical Center
Chicago Illinois, 60637, United States
Cancer Treatment Centers of America
Zion Illinois, 60099, United States
Cancer Center of Kansas
Wichita Kansas, 67214, United States
Touro Infirmary
New Orleans Louisiana, 70115, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States
Henry Ford Hospital
Detroit Michigan, 48202, United States
Saint Luke's Hospital of Kansas City
Kansas City Missouri, 64111, United States
Saint Barnabas Medical Center
Livingston New Jersey, 07039, United States
New York University Medical Center
New York New York, 10016, United States
Memorial Sloan Kettering Hospital
New York New York, 10065, United States
Weill Cornell Medicine Breast Center
New York New York, 10065, United States
The Cleveland Clinic Foundation
Cleveland Ohio, 44195, United States
Oregon Health & Science University
Portland Oregon, 97239, United States
Allegheny General Hospital
Pittsburgh Pennsylvania, 15212, United States
University of Pittsburgh Medical Center Health System
Pittsburgh Pennsylvania, 15219, United States
St Francis Hospital
Greenville South Carolina, 29601, United States
Brig Center for Cancer Care and Survivorship
Knoxville Tennessee, 37909, United States
Baptist Cancer Center
Memphis Tennessee, 38120, United States
Tennessee Oncology - Skyline Satellite
Nashville Tennessee, 37201, United States
BloomTrials Clinical Research, LLC
Dallas Texas, 75234, United States
The Methodist Hospital Research Institute
Houston Texas, 77030, United States
University of Texas M. D. Anderson Cancer Center - Investigational Cancer Therapeutics
Houston Texas, 77030, United States
Virginia Cancer Specialists
Fairfax Virginia, 22031, United States
Medizinische Universität Innsbruck
Innsbruck , 6020, Austria
Kepler Universitätsklinikum
Linz , 4020, Austria
LKH - Universitätsklinikum der PMU Salzburg
Salzburg , 5020, Austria
AKH - Medizinische Universität Wien (4305)
Vienna , 1090, Austria
Klinikum Wels-Grieskirchen GmbH
Wels , 4600, Austria
Institut Jules Bordet
Bruxelles , 1000, Belgium
Universitair Ziekenhuis Brussel
Bruxelles , 1090, Belgium
Cliniques Universitaires Saint-Luc
Bruxelles , 1200, Belgium
UZ Leuven
Leuven , 3000, Belgium
Grand Hôpital de Charleroi
Loverval , 6280, Belgium
CHU UCL Namur
Namur , 5000, Belgium
Centre Hospitalier Wallonie picarde - Site IMC
Tournai , 7500, Belgium
Tom Baker Cancer Center
Calgary Alberta, T2N4N, Canada
Toronto Sunnybrook Hospital
Toronto Ontario, M4N 3, Canada
McGill University - Dept. Oncology Clinical Research Program
Montréal Quebec, H2W 1, Canada
Anhui Provincial Hospital
Hefei Anhui, 23000, China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing Beijing, 10002, China
Chinese PLA General Hospital
Beijing Beijing, 10085, China
Fuzhou General Hospital of Nanjing Military Area Command of Chinese PLA
Fuzhou Fujian, 35002, China
Sun Yat-sen Memorial hospital, Sun Yat-sen University
Guangzhou Guangdong, 51012, China
Harbin Medical University Cancer Hospital
Harbin Heilongjiang, 15008, China
Hubei Cancer Hospital
Wuhan Hubei, 43007, China
The Affiliated Drum Tower Hospital of Nanjing University
Nanjing Jiangsu, 21000, China
The First Hospital of Jilin University
Chang chun Jilin, 13000, China
Jilin Cancer Hospital
Chang chun Jilin, 13001, China
Liaoning Cancer Hospital & Institute
Shenyang Liaoning, 11004, China
General Hospital of Ningxia Medical University
Yinchuan Ningxia, 75000, China
Linyi Cancer Hospital
Linyi Shandong, 27600, China
Shanghai General Hospital
Shanghai Shanghai, 20008, China
Fudan University Shanghai Cancer Center
Shanghai Shanghai, 20032, China
West China Hospital, Sichuan University
Chengdu Sichuan, 61004, China
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
Hangzhou Zhejiang, 31001, China
Zhejiang Cancer Hospital
Hangzhou Zhejiang, 31002, China
Institut Paoli Calmettes
Marseille cedex 9 Bouches-du-Rhône, 13009, France
Centre François Baclesse
Caen Calvados, 14076, France
CARIO - Centre Armoricain de Radiothérapie, Imagerie médicale et Oncologie
Plérin Cotes d'Armor, 22190, France
CHU Brest - Hôpital Morvan
Brest Cedex Finistere, 29609, France
Institut Bergonié
Bordeaux cedex Gironde, 33076, France
Clinique Clementville
Montpellier Herault, 34070, France
Institut Régional du Cancer de Montpellier
Montpellier Herault, 34298, France
CRLCC Eugene Marquis
Rennes-cedex Ille Et Vilaine, 35042, France
ICO - Site René Gauducheau
Saint-Herblain Loire Atlantique, 44805, France
Centre Hospitalier Emile Roux
Le Puy-en-Velay Loiret, 43012, France
ICO - Site Paul Papin
Angers Cedex 2 Maine Et Loire, 49055, France
Centre Hospitalier Valenciennes
Valenciennes Nord, 59322, France
Hôpital Saint-Louis - Paris
Paris Cedex 10 Paris, 75475, France
Clinique Victor Hugo - Centre Jean Bernard
Le Mans Cedex 02 Sarthe, 72015, France
Institut Sainte Catherine
Avignon Cedex 9 Vaculuse, 84918, France
Hôpital d'Instruction des Armees Begin*
Saint Mande Val De Marne, 94160, France
Institut Gustave Roussy
Villejuif cedex Val De Marne, 94805, France
Institut Curie - site de Paris
Paris , 75005, France
Hopital Tenon
Paris , 75020, France
Universitaetsklinikum Heidelberg
Heidelberg Baden Wuerttemberg, 69120, Germany
Klinikum der Universitaet Muenchen - Campus Grosshardern
Munich Bayern, 81377, Germany
General Hospital of Athens "Alexandra"
Athens , 11528, Greece
General Oncology Hospital of Kifissia " Agioi Anargyroi"
Athens , 14564, Greece
Athens Medical Center
Athens , 15125, Greece
University General Hospital of Heraklion
Heraklion , 71110, Greece
University General Hospital of Larissa
Larissa , 41110, Greece
Bioclinic Thessaloniki
Thessaloníki , 54622, Greece
Euromedica General Clinic Thessaloniki
Thessaloníki , 54645, Greece
General Hospital Papageorgiou
Thessaloníki , 56429, Greece
Interbalkan Hospital of Thessaloniki
Thessaloníki , 57001, Greece
Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet
Budapest , 1097, Hungary
Orszagos Onkologiai Intezet
Budapest , 1122, Hungary
Debreceni Egyetem
Debrecen , 4032, Hungary
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza
Gyula , 5700, Hungary
SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz
Nyiregyhaza , 4400, Hungary
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet
Szolnok , 5004, Hungary
Rambam Health Care Center
Haifa , 31096, Israel
Shaare Zedek Medical Center
Jerusalem , 91031, Israel
Hadassah University Hospital - Ein Kerem
Jerusalem , 91120, Israel
Rabin Medical Center-Beilinson Campus
Petah tikva , 49100, Israel
Chaim Sheba Medical Center
Ramat Gan , 52363, Israel
Kaplan Medical Center
Rechovot , 76100, Israel
Ziv Medical Center
Safed , 13100, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv , 64239, Israel
Azienda Ospedaliera Card. G. Panico
Tricase Lecce, 73039, Italy
Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo)
Monza Milano, 20900, Italy
Istituto Clinico Humanitas
Rozzano Milano, 20089, Italy
Ospedale Sacro Cuore Don Calabria
Negrar Verona, 37024, Italy
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
Bologna , 40138, Italy
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
Brescia , 25100, Italy
Azienda Ospedaliera Univ. Policlinico Gaspare Rodolico
Catania , 95125, Italy
Azienda Ospedaliero Universitaria Mater Domini-Campus Universitario
Catanzaro , 88100, Italy
IEO Istituto Europeo di Oncologia
Milano , 20141, Italy
Istituto Nazionale Tumori Fondazione G. Pascale
Napoli , 80131, Italy
Ospedale degli Infermi
Rimini , 47923, Italy
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
Roma , 00133, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma , 00168, Italy
Aichi Cancer Center Hospital
Nagoya Aichi-Ken, 464-8, Japan
National Cancer Center Hospital East
Kashiwa-shi Chiba-Ken, 277-8, Japan
NHO Shikoku Cancer Center
Matsuyama-shi Ehime-Ken, 791-0, Japan
NHO Kyushu Cancer Center
Fukuoka-shi Fukuoka-Ken, 811-1, Japan
Fukushima Medical University Hospital
Fukushima Fukushima-Ken, 960-1, Japan
Hiroshima City Hiroshima Citizens Hospital
Hiroshima-shi Hiroshima-Ken, 730-8, Japan
NHO Hokkaido Cancer Center
Sapporo-shi Hokkaido, 003-0, Japan
Hyogo College of Medicine Hospital
Nishinomiya-shi Hyogo-Ken, 663-8, Japan
Hakuaikai Sagara Hospital
Kagoshima Kagoshima-Ken, 892-0, Japan
Tokai University Hospital
Isehara Kanagawa-Ken, 259-1, Japan
Kanagawa Cancer Center
Yokohama Kanagawa, 241-8, Japan
NHO Osaka National Hospital
Osaka-shi Osaka-Fu, 540-0, Japan
Kindai University Hospital
Onohigashi Osakasayama-shi, 589-8, Japan
Saitama Cancer Center
Kitaadachi-gun Saitama-Ken, 362-0, Japan
Shizuoka Cancer Center
Sunto-gun Shizuoka-Ken, 411-8, Japan
Cancer Institute Hospital of JFCR
Koto-Ku Tokyo-To, 135-8, Japan
Toranomon Hospital
Minato-Ku Tokyo-To, 105-8, Japan
Showa University Hospital
Shinagawa-Ku Tokyo-To, 142-8, Japan
Chungbuk National University Hospital
Cheongju-si Chungcheongbuk-do, 361-7, Korea, Republic of
National Cancer Center
Goyang-si Gyeonggi-do, 10408, Korea, Republic of
Inha University Hospital
Incheon Gyeonggi-do, 22332, Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si Gyeonggi-do, 13620, Korea, Republic of
Ajou University Hospital
Suwon Gyeonggi-do, 16499, Korea, Republic of
Kyungpook National University Chilgok Hospital
Daegu , 41404, Korea, Republic of
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Asan Medical Center
Seoul , 05505, Korea, Republic of
Samsung Medical Center
Seoul , 06351, Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul , 06591, Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul , 120-7, Korea, Republic of
Hospital de Braga
Braga , 4710-, Portugal
Centro Hospitalar do Alto do Ave, EPE
Guimarães , 4835-, Portugal
Fundação Champalimaud
Lisboa , 1400-, Portugal
Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria
Lisboa , 1649-, Portugal
Unidade Local de Saúde de Matosinhos, EPE (Hospital Pedro Hispano)
Matosinhos , 4464-, Portugal
Centro Hospitalar do Porto, E.P.E. - Hospital de Santo António
Porto , 4099-, Portugal
Instituto Português de Oncologia do Porto Francisco Gentil, EPE
Porto , 4200-, Portugal
Centro Hospitalar de Entre o Douro e Vouga, E.P.E - Hospital de São Sebastião
Santa Maria Da Feira , 4520-, Portugal
Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E
Vila Nova De Gaia , 4434-, Portugal
Centro Hospitalar de Trás-os-Montes e Alto Douro, EPE
Vila Real , 5000-, Portugal
FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"
Moscow , 11547, Russian Federation
SBIH of Moscow City "Moscow City Oncology Hospital №62" of Moscow Healthcare Departement
Moscow , 14342, Russian Federation
SBIH of Yaroslavl Region "Regional Clinical Oncological Hospital"
Yaroslavl , 15005, Russian Federation
ICO l'Hospitalet - Hospital Duran i Reynals
L'Hospitalet De Llobregat Barcelona, 08908, Spain
Hospital Universitario Donostia
San Sebastián Guipuzcoa, 20014, Spain
Complejo Hospitalario Universitario A Coruña
A Coruña La Coruña, 15006, Spain
Hospital Universitario de Canarias
San Cristobal de la Laguna Tenerife, 38320, Spain
Hospital de Basurto
Bilbao Vizcaya, 48013, Spain
Hospital del Mar
Barcelona , 08003, Spain
Hospital Quironsalud Barcelona
Barcelona , 08023, Spain
Hospital Universitari Vall d'Hebron
Barcelona , 08035, Spain
Hospital Clinic de Barcelona
Barcelona , 08036, Spain
MD Anderson Cancer Centre
Madrid , 28033, Spain
Hospital Ruber Internacional
Madrid , 28034, Spain
Hospital Universitario Ramon y Cajal
Madrid , 28034, Spain
Hospital Universitario Clinico San Carlos
Madrid , 28040, Spain
Hospital Clinico Universitario Virgen de la Victoria
Málaga , 29010, Spain
Hospital Universitario Virgen Macarena
Sevilla , 41009, Spain
Hospital Universitario Virgen del Rocio
Sevilla , 41013, Spain
Instituto Valenciano de Oncologia IVO
Valencia , 46009, Spain
Hospital General Universitario de Valencia
Valencia , 46014, Spain
Karolinska universitetssjukhuset - Solna
Solna , 17176, Sweden
Länssjukhuset Sundsvall-Härnösand
Sundsvall , 85186, Sweden
Akademiska Sjukhuset
Uppsala , 75185, Sweden
Hirslanden Medical Center
Aarau , 5000, Switzerland
Universitaetsspital Basel
Basel , 4031, Switzerland
Kantonsspital Graubuenden
Chur , 7000, Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne , 1011, Switzerland
Kantonsspital St. Gallen
Saint Gallen , 9007, Switzerland
Kantonsspital Winterthur
Winterthur , 8401, Switzerland
Universitaetsspital Zuerich
Zürich , 8091, Switzerland
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung , 807, Taiwan
National Cheng Kung University Hospital
Tainan , 704, Taiwan
National Taiwan University Hospital
Taipei , 100, Taiwan
Royal Cornwall Hospital
Truro Cornwall, TR1 3, United Kingdom
Queen Mary University of London
London Greater London, EC1M , United Kingdom
University College London Hospitals
London Greater London, NW1 2, United Kingdom
Royal Free Hospital
London Greater London, NW3 2, United Kingdom
Western General Hospital
Edinburgh Lothian Region, EH4 2, United Kingdom
Nottingham University Hospitals City Campus
Nottingham Nottinghamshire, NG5 1, United Kingdom
Royal Surrey County Hospital
Guildford Surrey, GU2 7, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

557

Study ID:

NCT03734029

Recruitment Status:

Active, not recruiting

Sponsor:


Daiichi Sankyo

How clear is this clinincal trial information?

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