Spots Global Cancer Trial Database for SYD985 vs. Physician's Choice in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer
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Trial Identification
Brief Title: SYD985 vs. Physician's Choice in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer
Official Title: A Multi-centre, Open-label, Randomized Clinical Trial Comparing the Efficacy and Safety of the Antibody-drug Conjugate SYD985 to Physician's Choice in Patients With HER2-positive Unresectable Locally Advanced or Metastatic Breast Cancer
Study ID: NCT03262935
Conditions
Study Description
Brief Summary: The purpose of this study is to demonstrate that SYD985 \[(vic-)trastuzumab duocarmazine\] is superior to physician's choice in prolonging progression free survival.
Detailed Description: This study is designed as a randomized, active-controlled, superiority study in patients with unresectable locally advanced or metastatic HER2-positive breast cancer. The patients should have had either progression during or after at least two HER2-targeting treatment regimens for locally advanced or metastatic disease or progression during or after (ado-)trastuzumab emtansine treatment. Eligible patients will be randomly assigned (2:1) to receive SYD985 or physician's choice treatment until disease progression, unacceptable toxicity or study termination by the Sponsor. During treatment, patients will have to visit the clinical site to assess efficacy, quality of life (QoL), and safety using standardized criteria.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Southern Cancer Center, Mobile, Alabama, United States
Arizona Clinical Research Center, Tucson, Arizona, United States
Moores UCSD Cancer Center, San Diego, California, United States
Woodlands Medical Specialists, Pensacola, Florida, United States
Rush University Medical Center, Chicago, Illinois, United States
Cancer Center of Kansas, Wichita, Kansas, United States
University of Maryland Greenebaum Cancer Center, Baltimore, Maryland, United States
Greater Baltimore Medical Center, Baltimore, Maryland, United States
Henry Ford Hospital, Detroit, Michigan, United States
Saint Luke's Hospital of Kansas City, Kansas City, Missouri, United States
FirstHealth Outpatient Cancer Center, Pinehurst, North Carolina, United States
Toledo Clinic Cancer Center, Toledo, Ohio, United States
Northwest Cancer Specialists, Portland, Oregon, United States
Magee-Womens Hospital of UPMS, Pittsburgh, Pennsylvania, United States
Texas Oncology PA (Texas Oncology-Dallas Presbyterian Hospital), Dallas, Texas, United States
Texas Oncology- Baylor Charles A. Sammor, Dallas, Texas, United States
Texas Oncology - Denton South, Denton, Texas, United States
Texas Oncology-Memorial City, Houston, Texas, United States
Baylor College of Medicine, Houston, Texas, United States
Texas Oncology-San Antonio Northeast, San Antonio, Texas, United States
Texas Oncology-Tyler, Tyler, Texas, United States
Virginia Cancer Specialists, PC, Fairfax, Virginia, United States
Virginia Oncology Associates, Norfolk, Virginia, United States
Institut Jules Bordet, Brussel, , Belgium
Cliniques Universitaires Saint-Luc, Bruxelles, , Belgium
University Hospital Antwerp, Edegem, , Belgium
UZ Gent, Gent, , Belgium
AZ Groeninge, Kortrijk, , Belgium
UZ Leuven - campus Gasthuisberg, Leuven, , Belgium
CHU Liege, Liege, , Belgium
Cross Cancer Institute, Edmonton, , Canada
BC Cancer Agency Centre for the Southern Interior, Kelowna, , Canada
McGill University Health Centre, Montreal, , Canada
The Ottawa Hospital Cancer Center, Ottawa, , Canada
Sealand University Hospital, Naestved, , Denmark
Odense University Hospital, Odense, , Denmark
Sønderborg sygehus, Sønderborg, , Denmark
Institut de Cancerologie de l'ouest, Angers, , France
Institut Bergonie, Bordeaux, , France
CH Fleyrait, Bourg-en-Bresse, , France
Centre Hospitalier Lyon Sud, Corbeil-Essonnes, , France
Centre Georges francois leclerc, Dijon, , France
Oscar Lambret, Lille, , France
CHR Metz-Thionville, Metz, , France
Hopital Prive du Confluent, Nantes, , France
Hopital Saint Louis, Paris, , France
Centre Hospitalier Lyon Sud, Pierre-Benite, , France
Centre Henri Becquere, Rouen, , France
Centre Paul Strauss, Strasbourg, , France
IRCCS Istituto Oncologico, Bari, , Italy
Policlinico S.Orsola-Malpighi, Bologna, , Italy
Azienda Ospedaliera Garibaldi- Nesima, Catania, , Italy
Azienda Ospedaliero - Universitaria Careggi, Firenze, , Italy
IRCCS Ospedale San Raffaele, Milano, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, , Italy
Istituto Europeo di Oncologia, Milano, , Italy
University Hospital of Modena, Modena, , Italy
Ospedale San Gerardo-Asst Monza, Monza, , Italy
Istituto Oncologico Veneto Irccs, Padova, , Italy
Nuovo Ospedale Santo Stefano, Prato, , Italy
Istituto Nazionale dei Tumori Regina Elena, Roma, , Italy
Azienda Ospedaliera Sant'Andrea, Roma, , Italy
Casa Sollievo Della Sofferenza, San Giovanni Rotondo, , Italy
Radboud University Medical Center, Nijmegen, Gelderland, Netherlands
VU Medical Center, Amsterdam, Noord-Holland, Netherlands
University Medical Center Groningen, Groningen, , Netherlands
National University Cancer Institute, Singapore, , Singapore
National Cancer Centre Singapore, Singapore, , Singapore
Hospital General Universitario de Alicante, Alicante, , Spain
Hospital Quironsalud, Barcelona, , Spain
Hospital Universitari Vall d'Hebron Vall d' Hebron Institute of Oncology (VHIO), Barcelona, , Spain
Hospital Clinic de Barcelona, Barcelona, , Spain
Institut Catala D'oncologia, Barcelona, , Spain
Hospital Arnau de Vilanova, Lleida, , Spain
Hospital General Universitario Gregorio Marañón, Madrid, , Spain
IOB del Hospital Ruber Internacional, Madrid, , Spain
Hospital HM Universitario Sanchinarro, Madrid, , Spain
Hospital Clinico Universitario de Valencia, Valencia, , Spain
Hospital Universitario Miguel Servet, Zaragoza, , Spain
Gävle Sjukhus Onkologkliniken, Gävle, , Sweden
Sahlgrenska University Hospital, Göteborg, , Sweden
Karolina University Hospital, Stockholm, , Sweden
Akademiska Hospital, Uppsala, , Sweden
The Clatterbridge Cancer Centre NHS Foundation Trust, Bebington, , United Kingdom
Velindre Cancer Centre VCC, Cardiff, , United Kingdom
Beatson West of Scotland Cancer Centre, Glasgow, , United Kingdom
The Royal Marsden NHS Foundation Trust, London, , United Kingdom
SCRI UK, London, , United Kingdom
The Christie NHS Foundation, Manchester, , United Kingdom
Oxford University NHS hospital, Oxford, , United Kingdom
Contact Details
Name: Evelyn van den Tweel, PhD
Affiliation: Byondis B.V., The Netherlands
Role: STUDY_DIRECTOR
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