SYD985 vs. Physician's Choice in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer
NCT ID: NCT03262935
Last Updated: 2023-10-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
437 participants
INTERVENTIONAL
2017-12-15
2022-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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(vic-)trastuzumab duocarmazine
SYD985, every 3 weeks (Q3W)
(vic-)trastuzumab duocarmazine
Intravenous SYD985, Q3W
Physician's choice
1. Lap/Cap
2. T/Cap
3. T/Vino
4. T/Eri
Physician's choice
See drug label
Interventions
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(vic-)trastuzumab duocarmazine
Intravenous SYD985, Q3W
Physician's choice
See drug label
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 for locally advanced or metastatic disease;
* HER2-positive tumor status;
* Patients must have measurable or non-measurable disease that is evaluable per RECIST 1.1;
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;
* Estimated life expectancy \> 12 weeks at randomization;
* Adequate organ function and blood cell counts.
Exclusion Criteria
* History of infusion-related reactions and/or hypersensitivity to trastuzumab, (ado-)trastuzumab emtansine;
* History of keratitis;
* Severe, uncontrolled systemic disease at screening;
* Left Ventricular Ejection Fraction (LVEF) \< 50%, or a history of clinically significant decrease in LVEF during previous treatment with trastuzumab or (ado-)trastuzumab emtansine;
* Cardiac troponin value above the Upper Limit of Normal (ULN);
* History of clinically significant cardiovascular disease;
* Untreated brain metastases, symptomatic brain metastases, brain metastases requiring steroids to manage symptoms, or treatment for brain metastases within 8 weeks prior to randomization;
* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.
18 Years
FEMALE
No
Sponsors
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Byondis B.V.
INDUSTRY
Responsible Party
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Principal Investigators
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Evelyn van den Tweel, PhD
Role: STUDY_DIRECTOR
Byondis B.V., The Netherlands
Locations
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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
Brussels, , Belgium
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
University Hospital Antwerp
Edegem, , Belgium
UZ Gent
Ghent, , Belgium
AZ Groeninge
Kortrijk, , Belgium
UZ Leuven - campus Gasthuisberg
Leuven, , Belgium
CHU Liege
Liège, , 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
Næstved, , 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-Bénite, , 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
Florence, , Italy
IRCCS Ospedale San Raffaele
Milan, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, , Italy
Istituto Europeo di Oncologia
Milan, , Italy
University Hospital of Modena
Modena, , Italy
Ospedale San Gerardo-Asst Monza
Monza, , Italy
Istituto Oncologico Veneto Irccs
Padua, , 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, North 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
Gothenburg, , 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
Countries
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References
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Turner N, Saura C, Aftimos P, van den Tweel E, Oesterholt M, Koper N, Colleoni M, Kaczmarek E, Punie K, Song X, Armstrong A, Bianchi G, Stradella A, Ladoire S, Lim JSJ, Quenel-Tueux N, Tan TJ, Escriva-de-Romani S, O'Shaughnessy J; TULIP Trial Investigators. Trastuzumab Duocarmazine in Pretreated Human Epidermal Growth Factor Receptor 2-Positive Advanced or Metastatic Breast Cancer: An Open-Label, Randomized, Phase III Trial (TULIP). J Clin Oncol. 2025 Feb 10;43(5):513-523. doi: 10.1200/JCO.24.00529. Epub 2024 Oct 23.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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SYD985.002
Identifier Type: -
Identifier Source: org_study_id
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