DS-8201a Versus T-DM1 for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane [DESTINY-Breast03]
- Conditions
- Breast Cancer
- Interventions
- Registration Number
- NCT03529110
- Lead Sponsor
- Daiichi Sankyo
- Brief Summary
This study is designed to compare the anti-tumor activity as well as the safety and efficacy of DS-8201a versus T-DM1 in HER2-positive, unresectable and/or metastatic breast cancer subjects previously treated with trastuzumab and taxane.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 524
-
Is the age of majority in their country
-
Has pathologically documented breast cancer that:
- is unresectable or metastatic
- has confirmed HER2-positive expression as determined according to American Society of Clinical Oncology - College of American Pathologists guidelines evaluated at a central laboratory
- was previously treated with trastuzumab and taxane in the advanced/metastatic setting or progressed within 6 months after neoadjuvant or adjuvant treatment involving a regimen including trastuzumab and taxane
-
Has documented radiologic progression (during or after most recent treatment or within 6 months after completing adjuvant therapy)
-
Is HER2 positive as confirmed by central laboratory assessment of most recent tumor tissue sample available. If archived tissue is not available, agrees to provide a fresh biopsy.
-
If of reproductive/childbearing potential, agrees to use a highly effective form of contraception or avoid intercourse during and upon completion of the study for 7 months after the last dose of DS-8201a (females); 4.5 months after last dose of DS-8201a (males) or 7 months after the last dose of T-DM1
-
Has adequate renal and hepatic function
-
Has previously been treated with an anti-HER2 antibody drug conjugate (ADC) in the metastatic setting. Prior treatment in the adjuvant/neo-adjuvant setting would be allowed if progression of disease did not occur within 12 months of end of adjuvant therapy
-
Has uncontrolled or significant cardiovascular disease
-
Has a history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening
-
Has spinal cord compression or clinically active central nervous system (CNS) metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms.
- Participants with clinically inactive brain metastases may be included in the study.
- Participants with treated brain metastases that are no longer symptomatic and who require no treatment with corticosteroids or anticonvulsants may be included in the study if they have recovered from the acute toxic effect of radiotherapy. A minimum of 2 weeks must have elapsed between the end of whole brain radiotherapy and study enrollment.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Trastuzumab deruxtecan (T-DXd) Trastuzumab deruxtecan (T-DXd) Participants with HER2-positive, unresectable and/or metastatic breast cancer participants previously treated with trastuzumab and taxane who received T-DXd as a sterile intravenous (IV) solution at a dose of 5.4 mg/kg every 3 weeks (Q3W). Ado-trastuzumab emtansine (T-DM1) Ado-trastuzumab emtansine (T-DM1) Participants with HER2-positive, unresectable and/or metastatic breast cancer participants previously treated with trastuzumab and taxane who received T-DM1 in accordance with the approved label.
- Primary Outcome Measures
Name Time Method Progression-Free Survival (PFS) Based on Blinded Independent Central Review (BICR) in Participants With HER2-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane Up to 33 months (data cut-off) Progression-free survival (PFS) by BICR was defined as the time from the date of enrollment to the earlier of the dates of the first objective documentation of disease progression (as per RECIST v1.1) or death due to any cause. Progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions.
- Secondary Outcome Measures
Name Time Method Overall Survival (OS) in Participants With HER2-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane Up to 33 months (data cut-off) Overall survival (OS) was defined as the time from the date of first dose of study drug to the date of death due to any cause.
Progression-Free Survival (PFS) Based on Investigator Assessment in Participants With HER2-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane Up to 33 months (data cut-off) Progression-free survival (PFS) by investigator assessment was defined as the time from the date of enrollment to the earlier of the dates of the first objective documentation of disease progression (as per RECIST v1.1) or death due to any cause. Progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions.
Percentage of Participants With Objective Response Rate (ORR) Based on BICR and Investigator Assessment in Participants With HER2-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane Up to 33 months (data cut-off) The Objective Response Rate (ORR) was defined as the percentage of participants who achieved a best overall response of confirmed Complete Response (CR) or Partial Response (PR), assessed by BICR and investigator assessment based on RECIST version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. Confirmed ORR is reported.
Duration of Response (DoR) Based on BICR and Investigator Assessment in Participants With HER2-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane Up to 33 months (data cut-off) Duration of Response (DoR) was defined as the time from the date of the first documentation of objective response (complete response \[CR\] or partial response \[PR\]) to the date of the first objective documentation of progressive disease (PD) or death due to any cause. DoR in participants with confirmed CR/PR based on BICR and investigator assessment is reported.
Trial Locations
- Locations (164)
Florida Cancer Specialists-Broadway
🇺🇸Fort Myers, Florida, United States
Piedmont Cancer Institute, PC
🇺🇸Atlanta, Georgia, United States
The Ohio State University
🇺🇸Columbus, Ohio, United States
NOB - Nucleo de Oncologia da Bahia
🇧🇷Salvador, Bahia, Brazil
Toronto Sunnybrook Hospital
🇨🇦Toronto, Ontario, Canada
Sharp Memorial Hospital
🇺🇸San Diego, California, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
University of Cincinnati Medical Center
🇺🇸Cincinnati, Ohio, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Millennium Oncology
🇺🇸Houston, Texas, United States
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
Tianjin Medical University Cancer Institute & Hospital
🇨🇳Tianjin, Tianjin, China
Zhejiang Cancer Hospital
🇨🇳Hangzhou, Zhejiang, China
University of Rochester
🇺🇸Rochester, New York, United States
National Cheng Kung University Hospital
🇨🇳Tainan, Taiwan
Azienda Ospedaliera Ospedali Riuniti Papardo-Piemonte
🇮🇹Messina, Italy
ICO - Site Paul Papin
🇫🇷Angers Cedex 2, Maine Et Loire, France
Centre Leon Berard
🇫🇷Lyon Cedex 08, Rhone, France
Institut Curie - site de Paris
🇫🇷Paris, France
Hôpital Saint-Louis
🇫🇷Paris, France
Institut Gustave Roussy
🇫🇷Villejuif cedex, Val De Marne, France
Centre Hospitalier Lyon Sud
🇫🇷Pierre Benite Cedex, Rhone, France
Shizuoka Cancer Center
🇯🇵Shizuoka, Japan
Queen Mary University of London
🇬🇧London, Greater London, United Kingdom
St. Mary's Hospital
🇨🇦Montréal, Quebec, Canada
CHRU Jean Minjoz
🇫🇷Besançon, Doubs, France
University of California San Francisco
🇺🇸San Francisco, California, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Vanderbilt Breast Center at One Hundred Oaks
🇺🇸Nashville, Tennessee, United States
Loyola University Health System
🇺🇸Maywood, Illinois, United States
Box Hill Hospital
🇦🇺Box Hill, Victoria, Australia
UCLA Hematology Oncology
🇺🇸Los Angeles, California, United States
Washington Cancer Institute
🇺🇸Washington, District of Columbia, United States
Florida Cancer Specialists NORTH
🇺🇸Saint Petersburg, Florida, United States
Dayton Physicians, LLC
🇺🇸Kettering, Ohio, United States
Seidman Cancer Center
🇺🇸Cleveland, Ohio, United States
UT Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Houston Methodist Hospital / Houston Methodist Cancer Center
🇺🇸Houston, Texas, United States
MultiCare Health System Institute for Research and Innovation
🇺🇸Auburn, Washington, United States
Princess Alexandra Hospital
🇦🇺Woolloongabba, Queensland, Australia
The Tweed Hospital
🇦🇺Tweed Heads, New South Wales, Australia
Universitair Ziekenhuis Antwerpen
🇧🇪Edegem, Belgium
St John of God Subiaco Hospital
🇦🇺Subiaco, Western Australia, Australia
Institut Jules-Bordet
🇧🇪Bruxelles, Belgium
Peter MacCallum Cancer
🇦🇺Melbourne, Victoria, Australia
Universitair Ziekenhuis Brussel
🇧🇪Bruxelles, Belgium
Peninsula and South Eastern Haematology & Oncology Group
🇦🇺Frankston, Victoria, Australia
AZ Sint-Lucas - Campus Sint-Lucas
🇧🇪Gent, Belgium
Universitaire Ziekenhuizen Leuven
🇧🇪Leuven, Belgium
CHU UCL Namur site de Sainte Elisabeth
🇧🇪Namur, Belgium
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
🇧🇷Santo André, Sao Paulo, Brazil
ICESP - Instituto do Cancer do Estado de São Paulo Octavio Frias de Oliveira
🇧🇷São Paulo, Sao Paulo, Brazil
Instituto Americas
🇧🇷Rio De Janeiro, Brazil
Clínica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária Ltda.
🇧🇷São Paulo, Sao Paulo, Brazil
Beijing Hospital
🇨🇳Beijing, Beijing, China
Liaoning Cancer Hospital & Institute
🇨🇳Shenyang, Liaoning, China
Cancer Hospital Chinese Academy of Medical Sciences
🇨🇳Beijing, Beijing, China
The First Hospital of Jilin University
🇨🇳Chang chun, Jilin, China
Sun Yat-sen University, Cancer Center
🇨🇳Guangzhou, Guangdong, China
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, Shanghai, China
West China Hospital, Sichuan University
🇨🇳Chengdu, Sichuan, China
Sir Run Run Shaw Hospital Xiasha Branch, Zhejiang University, School of Medicine
🇨🇳Hangzhou, Zhejiang, China
Centre Paul Strauss
🇫🇷Strasbourg Cedex, Bas Rhin, France
Hôpital Nord - CHU Marseille
🇫🇷Marseille Cedex 20, Bouches-du-Rhone, France
Centre Georges François Leclerc
🇫🇷Dijon cedex, Côte-d'Or, France
ICM Val d'Aurelle
🇫🇷Montpellier, Herault, France
CRLCC Eugene Marquis
🇫🇷Rennes cedex, Ille Et Vilaine, France
Centre de cancerologie les Dentellieres
🇫🇷Valenciennes, Nord, France
Institut Sainte Catherine
🇫🇷Avignon Cedex 9, Vaculuse, France
Hopital Tenon
🇫🇷Paris, France
Hôpital d'Instruction des Armees Begin
🇫🇷Saint-Mandé, Val De Marne, France
Universitaetsklinikum Erlangen
🇩🇪Erlangen, Bayern, Germany
Rotkreuzklinikum Muenchen gGmbH
🇩🇪Muenchen, Bayern, Germany
Universitaetsklinikum Duesseldorf AoeR
🇩🇪Düsseldorf, Nordrhein Westfalen, Germany
The Chinese
🇭🇰Hong Kong, Hong Kong
Haematologisch-Onkologische Schwerpunktpraxis
🇩🇪Troisdorf, Nordrhein Westfalen, Germany
Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo), U.O Oncologia Medica
🇮🇹Monza, Milano, Italy
Istituto Nazionale per la Ricerca sul Cancro di Genova
🇮🇹Genova, Italy
A.O.U. Policlinico di Modena
🇮🇹Modena, Italy
Istituto Nazionale Tumori Fondazione G. Pascale
🇮🇹Napoli, Italy
Azienda Ospedaliera Città della Salute e della Scienza di Torino
🇮🇹Torino, Italy
NHO Kyushu Cancer Center
🇯🇵Fukuoka, Japan
Azienda Ospedaliero Universitaria di Parma
🇮🇹Parma, Italy
Aichi Cancer Center Hospital
🇯🇵Aichi, Japan
Fondazione IRCCS Policlinico San Matteo
🇮🇹Pavia, Italy
NHO Shikoku Cancer Center
🇯🇵Ehime, Japan
NHO Hokkaido Cancer Center
🇯🇵Hokkaido, Japan
Hiroshima City Hiroshima Citizens Hospital
🇯🇵Hiroshima, Japan
Kanagawa Cancer Center
🇯🇵Kanagawa, Japan
Niigata Cancer Center
🇯🇵Niigata, Japan
Showa University Hospital
🇯🇵Tokyo, Japan
NHO Osaka National Hospital
🇯🇵Osaka, Japan
ICO l'Hospitalet - Hospital Duran i Reynals
🇪🇸L'Hospitalet De Llobregat, Barcelona, Spain
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Hospital Infanta Cristina
🇪🇸Badajoz, Spain
Hospital Universitario de Canarias
🇪🇸San Cristobal de la Laguna, Tenerife, Spain
Hospital General Universitario Gregorio Maranon
🇪🇸Madrid, Spain
MD Anderson Cancer Centre
🇪🇸Madrid, Spain
Hospital Universitario Virgen del Rocio
🇪🇸Sevilla, Spain
Sarah Cannon Research Institute UK
🇬🇧London, Greater London, United Kingdom
Innovative Clinical Research Institute
🇺🇸Whittier, California, United States
North Shore Hematology Oncology Associates, PC
🇺🇸East Setauket, New York, United States
Tennessee Oncology- St Thomas Location
🇺🇸Nashville, Tennessee, United States
The University of Texas Health Science Center at Tyler
🇺🇸Tyler, Texas, United States
Hospital Nossa Senhora da Conceição
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Tom Baker Cancer Centre
🇨🇦Calgary, Alberta, Canada
A. C. Camargo Cancer Center
🇧🇷São Paulo, Brazil
Harbin Medical University Cancer Hospital
🇨🇳Harbin, Heilongjiang, China
CARIO - Centre Armoricain de Radiothérapie, Imagerie médicale et Oncologie
🇫🇷Plérin, Cotes d'Armor, France
Centre René Huguenin
🇫🇷Saint-Cloud, Hauts De Seine, France
Clinique Victor Hugo - Centre Jean Bernard
🇫🇷Le Mans, Cedex 02, Sarthe, France
ICO - Site René Gauducheau
🇫🇷Saint-Herblain, Loire Atlantique, France
Ospedale San Raffaele
🇮🇹Milano, Italy
Klinikum rechts der Isar der TU Muenchen
🇩🇪Muenchen, Bayern, Germany
Universitaetsklinikum Schleswig-Holstein - Campus Luebeck
🇩🇪Luebeck, Schleswig Holstein, Germany
Marienhospital Bottrop gGmbH
🇩🇪Bottrop, Rheinland Pfalz, Germany
Istituto Clinico Humanitas
🇮🇹Rozzano, Milano, Italy
Azienda Ospedaliera Universitaria Arcispedale Sant'Anna
🇮🇹Cona, Ferrara, Italy
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)
🇮🇹Bergamo, Italy
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
🇮🇹Bologna, Italy
Azienda Ospealiera della Provincia di Lecco
🇮🇹Lecco, Italy
IEO Istituto Europeo di Oncologia
🇮🇹Milano, Italy
Center Hospital of the National Center for Global Health and Medicine
🇯🇵Shinjuku-Ku, Tokyo-To, Japan
Kumamoto University Hospital
🇯🇵Kumamoto, Japan
Okayama University Hospital
🇯🇵Okayama, Japan
Osaka International Cancer Institute
🇯🇵Osaka, Japan
National Cancer Center Hospital
🇯🇵Tokyo, Japan
Saitama Cancer Center
🇯🇵Saitama, Japan
The Cancer Institute Hospital of JFCR
🇯🇵Tokyo, Japan
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital, Yonsei University
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Complejo Hospitalario Universitario A Coruña
🇪🇸A Coruña, La Coruña, Spain
Complejo Hospitalario Universitario de Santiago
🇪🇸Santiago De Compostela, La Coruña, Spain
Hospital Universitario Virgen Macarena
🇪🇸Sevilla, Sevill, Spain
Hospital Universitario Puerta de Hierro Majadahonda
🇪🇸Majadahonda, Madrid, Spain
IOB-Institute of Oncology
🇪🇸Barcelona, Spain
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital Clinic de Barcelona
🇪🇸Barcelona, Spain
Hospital Universitario Ramon y Cajal
🇪🇸Madrid, Spain
Hospital Universitario Clinico San Carlos
🇪🇸Madrid, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Hospital Clinico Universitario Virgen de la Victoria
🇪🇸Málaga, Spain
China Medical University Hospital
🇨🇳Taichung, Taiwan
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
Koo Foundation, Sun Yat-Sen Cancer Center
🇨🇳Taipei, Taiwan
Aberdeen Royal Infirmary
🇬🇧Aberdeen, Grampian Region, United Kingdom
University College London Hospitals
🇬🇧London, Greater London, United Kingdom
The Christie Hospital
🇬🇧Manchester, Greater Manchester, United Kingdom
Nottingham University Hospitals City Campus
🇬🇧Nottingham, Nottinghamshire, United Kingdom
Western General Hospital
🇬🇧Edinburgh, Lothian Region, United Kingdom
Royal Surrey County Hospital
🇬🇧Guildford, Surrey, United Kingdom
Magee-Womens Hospital of UPMC
🇺🇸Pittsburgh, Pennsylvania, United States
Norton Cancer Institute
🇺🇸Louisville, Kentucky, United States
Wake Forest University Baptist Medical Center
🇺🇸Winston-Salem, North Carolina, United States
Centre François Baclesse
🇫🇷Caen Cedex 05, Calvados, France
Institut Bergonié
🇫🇷Bordeaux cedex, Gironde, France
IRCCS Centro di Riferimento Oncologico
🇮🇹Aviano, Pordenone, Italy
Royal Devon and Exeter Hospital (Wonford)
🇬🇧Exeter, Devon, United Kingdom
Catarina Pesquisa Clinica
🇧🇷Itajaí, Santa Catarina, Brazil
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Guy's Hospital
🇬🇧London, Greater London, United Kingdom
The University of Hong Kong
🇭🇰Shatin, Hong Kong