SYD985 vs. Physician's Choice in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer
- Conditions
- Metastatic Breast Cancer
- Interventions
- Drug: (vic-)trastuzumab duocarmazineDrug: Physician's choice
- Registration Number
- NCT03262935
- Lead Sponsor
- Byondis B.V.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 437
- Female patients with histologically-confirmed, unresectable locally advanced or metastatic breast cancer;
- 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.
Main
- Current or previous use of a prohibited medication as listed in the protocol;
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description (vic-)trastuzumab duocarmazine (vic-)trastuzumab duocarmazine SYD985, every 3 weeks (Q3W) Physician's choice Physician's choice 1. Lap/Cap 2. T/Cap 3. T/Vino 4. T/Eri
- Primary Outcome Measures
Name Time Method Progression Free Survival baseline until primary analysis data cut-off date of 31March2021 Progression-free survival is defined as the time from the date of randomization to the date of first documented disease progression by central assessment according to Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 or death due to any cause, whichever occurred earlier.
- Secondary Outcome Measures
Name Time Method Investigator Assessed Progression Free Survival baseline until primary analysis data cut-off date of 31March2021 Progression-free survival is defined as the time from the date of randomization to the date of first documented disease progression by investigator assessment according to RECIST v1.1 or death due to any cause, whichever occurred earlier.
Patient Reported Outcomes for Health Related Quality of Life baseline until primary analysis data cut-off date of 31March2021 Change in the global health status/Quality of Life (QoL) scale score of the European Organization for Research and Treatment for Cancer (EORTC) Quality of Life Questionnaire C30 from baseline (cycle 1). The raw score (1 to 7) has been transformed to a score ranging from 0 to 100. A higher score means a better outcome: hence a positive change from baseline means an improvement in global health status/Quality of Life and a negative change from baseline means a worsening of global health status/Quality of Life.
Overall Survival baseline until final Overall Survival analysis data cut-off date of 30June2022 Overall survival is defined as the time from date of randomization to death due to any cause.
Objective Response Rate baseline until primary analysis data cut-off date of 31March2021 Objective Response Rate is defined as the proportion of patients with a centrally assessed best overall response of complete response or partial response according to RECIST v1.1.
Trial Locations
- Locations (89)
CHU Liege
🇧🇪Liege, Belgium
Velindre Cancer Centre VCC
🇬🇧Cardiff, United Kingdom
The Royal Marsden NHS Foundation Trust
🇬🇧London, United Kingdom
Institut de Cancerologie de l'ouest
🇫🇷Angers, France
UZ Gent
🇧🇪Gent, Belgium
Centre Georges francois leclerc
🇫🇷Dijon, France
Centre Paul Strauss
🇫🇷Strasbourg, France
Beatson West of Scotland Cancer Centre
🇬🇧Glasgow, United Kingdom
The Ottawa Hospital Cancer Center
🇨🇦Ottawa, Canada
Karolina University Hospital
🇸🇪Stockholm, Sweden
Hospital General Universitario Gregorio Marañón
🇪🇸Madrid, Spain
Centre Hospitalier Lyon Sud
🇫🇷Pierre-Benite, France
SCRI UK
🇬🇧London, United Kingdom
Hospital General Universitario de Alicante
🇪🇸Alicante, Spain
The Clatterbridge Cancer Centre NHS Foundation Trust
🇬🇧Bebington, United Kingdom
Hospital Universitario Miguel Servet
🇪🇸Zaragoza, Spain
Southern Cancer Center
🇺🇸Mobile, Alabama, United States
Saint Luke's Hospital of Kansas City
🇺🇸Kansas City, Missouri, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
FirstHealth Outpatient Cancer Center
🇺🇸Pinehurst, North Carolina, United States
Magee-Womens Hospital of UPMS
🇺🇸Pittsburgh, Pennsylvania, United States
Toledo Clinic Cancer Center
🇺🇸Toledo, Ohio, 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-Memorial City
🇺🇸Houston, Texas, United States
Texas Oncology - Denton South
🇺🇸Denton, 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
Cancer Center of Kansas
🇺🇸Wichita, Kansas, United States
IRCCS Ospedale San Raffaele
🇮🇹Milano, Italy
Cliniques Universitaires Saint-Luc
🇧🇪Bruxelles, Belgium
University Hospital Antwerp
🇧🇪Edegem, Belgium
UZ Leuven - campus Gasthuisberg
🇧🇪Leuven, Belgium
Istituto Europeo di Oncologia
🇮🇹Milano, 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
Casa Sollievo Della Sofferenza
🇮🇹San Giovanni Rotondo, Italy
VU Medical Center
🇳🇱Amsterdam, Noord-Holland, Netherlands
National University Cancer Institute
🇸🇬Singapore, Singapore
Hospital Quironsalud
🇪🇸Barcelona, Spain
Hospital Universitari Vall d'Hebron Vall d' Hebron Institute of Oncology (VHIO)
🇪🇸Barcelona, Spain
Institut Catala D'oncologia
🇪🇸Barcelona, Spain
Hospital Clinic de Barcelona
🇪🇸Barcelona, Spain
Hospital Arnau de Vilanova
🇪🇸Lleida, Spain
IOB del Hospital Ruber Internacional
🇪🇸Madrid, Spain
Gävle Sjukhus Onkologkliniken
🇸🇪Gävle, Sweden
Hospital HM Universitario Sanchinarro
🇪🇸Madrid, Spain
Hospital Clinico Universitario de Valencia
🇪🇸Valencia, Spain
Sahlgrenska University Hospital
🇸🇪Göteborg, Sweden
Akademiska Hospital
🇸🇪Uppsala, Sweden
Sealand University Hospital
🇩🇰Naestved, Denmark
Odense University Hospital
🇩🇰Odense, Denmark
Sønderborg sygehus
🇩🇰Sønderborg, Denmark
The Christie NHS Foundation
🇬🇧Manchester, United Kingdom
Oxford University NHS hospital
🇬🇧Oxford, United Kingdom
Moores UCSD Cancer Center
🇺🇸San Diego, California, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Texas Oncology-San Antonio Northeast
🇺🇸San Antonio, Texas, United States
Northwest Cancer Specialists
🇺🇸Portland, Oregon, United States
Institut Jules Bordet
🇧🇪Brussel, Belgium
AZ Groeninge
🇧🇪Kortrijk, Belgium
CH Fleyrait
🇫🇷Bourg-en-Bresse, France
University of Maryland Greenebaum Cancer Center
🇺🇸Baltimore, Maryland, United States
Cross Cancer Institute
🇨🇦Edmonton, Canada
Institut Bergonie
🇫🇷Bordeaux, France
CHR Metz-Thionville
🇫🇷Metz, France
University Medical Center Groningen
🇳🇱Groningen, Netherlands
Radboud University Medical Center
🇳🇱Nijmegen, Gelderland, Netherlands
Policlinico S.Orsola-Malpighi
🇮🇹Bologna, Italy
Azienda Ospedaliero - Universitaria Careggi
🇮🇹Firenze, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
🇮🇹Milano, Italy
University Hospital of Modena
🇮🇹Modena, Italy
Hopital Saint Louis
🇫🇷Paris, France
Oscar Lambret
🇫🇷Lille, France
IRCCS Istituto Oncologico
🇮🇹Bari, Italy
Azienda Ospedaliera Garibaldi- Nesima
🇮🇹Catania, Italy
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Woodlands Medical Specialists
🇺🇸Pensacola, Florida, United States
Greater Baltimore Medical Center
🇺🇸Baltimore, Maryland, United States
BC Cancer Agency Centre for the Southern Interior
🇨🇦Kelowna, Canada
McGill University Health Centre
🇨🇦Montreal, Canada
Hopital Prive du Confluent
🇫🇷Nantes, France
Centre Henri Becquere
🇫🇷Rouen, France
National Cancer Centre Singapore
🇸🇬Singapore, Singapore
Azienda Ospedaliera Sant'Andrea
🇮🇹Roma, Italy
Arizona Clinical Research Center
🇺🇸Tucson, Arizona, United States
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