SYD985 vs. Physician's Choice in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer
TULIP
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
1 other identifier
interventional
437
11 countries
90
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2017
Longer than P75 for phase_3
90 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 16, 2017
CompletedFirst Posted
Study publicly available on registry
August 25, 2017
CompletedStudy Start
First participant enrolled
December 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2022
CompletedResults Posted
Study results publicly available
October 19, 2023
CompletedOctober 19, 2023
June 1, 2023
3.3 years
August 16, 2017
June 30, 2023
September 28, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Progression Free Survival
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.
baseline until primary analysis data cut-off date of 31March2021
Secondary Outcomes (4)
Overall Survival
baseline until final Overall Survival analysis data cut-off date of 30June2022
Objective Response Rate
baseline until primary analysis data cut-off date of 31March2021
Investigator Assessed Progression Free Survival
baseline until primary analysis data cut-off date of 31March2021
Patient Reported Outcomes for Health Related Quality of Life
baseline until primary analysis data cut-off date of 31March2021
Study Arms (2)
(vic-)trastuzumab duocarmazine
EXPERIMENTALSYD985, every 3 weeks (Q3W)
Physician's choice
ACTIVE COMPARATOR1. Lap/Cap 2. T/Cap 3. T/Vino 4. T/Eri
Interventions
Intravenous SYD985, Q3W
See drug label
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Byondis B.V.lead
Study Sites (90)
Southern Cancer Center
Mobile, Alabama, 36608, United States
Arizona Clinical Research Center
Tucson, Arizona, 85715, United States
Moores UCSD Cancer Center
San Diego, California, 92093, United States
Woodlands Medical Specialists
Pensacola, Florida, 32503, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Cancer Center of Kansas
Wichita, Kansas, 67214, United States
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, 21144, United States
Greater Baltimore Medical Center
Baltimore, Maryland, 21204, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111, United States
FirstHealth Outpatient Cancer Center
Pinehurst, North Carolina, 28374, United States
Toledo Clinic Cancer Center
Toledo, Ohio, 43623, United States
Northwest Cancer Specialists
Portland, Oregon, 97213, United States
Magee-Womens Hospital of UPMS
Pittsburgh, Pennsylvania, 15213, United States
Texas Oncology PA (Texas Oncology-Dallas Presbyterian Hospital)
Dallas, Texas, 75231, United States
Texas Oncology- Baylor Charles A. Sammor
Dallas, Texas, 75246, United States
Texas Oncology - Denton South
Denton, Texas, 76210, United States
Texas Oncology-Memorial City
Houston, Texas, 77024, United States
Baylor College of Medicine
Houston, Texas, 77030-34011, United States
Texas Oncology-San Antonio Northeast
San Antonio, Texas, 78217, United States
Texas Oncology-Tyler
Tyler, Texas, 75702, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031, United States
Virginia Oncology Associates
Norfolk, Virginia, 23502, United States
Institut Jules Bordet
Brussels, 1000, Belgium
Cliniques Universitaires Saint-Luc
Brussels, 1200, Belgium
University Hospital Antwerp
Edegem, 2650, Belgium
UZ Gent
Ghent, 9000, Belgium
AZ Groeninge
Kortrijk, 8500, Belgium
UZ Leuven - campus Gasthuisberg
Leuven, 3000, Belgium
CHU Liege
Liège, B-4000, Belgium
Cross Cancer Institute
Edmonton, T6G 1Z2, Canada
BC Cancer Agency Centre for the Southern Interior
Kelowna, V1Y 5L3, Canada
McGill University Health Centre
Montreal, H4A 3JI, Canada
The Ottawa Hospital Cancer Center
Ottawa, K1H 8L6, Canada
Sealand University Hospital
Næstved, 4700, Denmark
Odense University Hospital
Odense, DK-5000, Denmark
Sønderborg sygehus
Sønderborg, 6400, Denmark
Institut de Cancerologie de l'ouest
Angers, 49055, France
Institut Bergonie
Bordeaux, 33076, France
CH Fleyrait
Bourg-en-Bresse, 01012, France
Centre Hospitalier Lyon Sud
Corbeil-Essonnes, 91100, France
Centre Georges francois leclerc
Dijon, 21079, France
Oscar Lambret
Lille, 59020, France
CHR Metz-Thionville
Metz, 57085, France
Hopital Prive du Confluent
Nantes, 44277, France
Hopital Saint Louis
Paris, 75475, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69310, France
Centre Henri Becquere
Rouen, 76038, France
Centre Paul Strauss
Strasbourg, 67065, France
IRCCS Istituto Oncologico
Bari, 70124, Italy
Policlinico S.Orsola-Malpighi
Bologna, 40183, Italy
Azienda Ospedaliera Garibaldi- Nesima
Catania, 95123, Italy
Azienda Ospedaliero - Universitaria Careggi
Florence, 50134, Italy
IRCCS Ospedale San Raffaele
Milan, 20132, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133, Italy
Istituto Europeo di Oncologia
Milan, 20141, Italy
University Hospital of Modena
Modena, 41124, Italy
Ospedale San Gerardo-Asst Monza
Monza, 20900, Italy
Istituto Oncologico Veneto Irccs
Padua, 35128, Italy
Nuovo Ospedale Santo Stefano
Prato, 59100, Italy
Istituto Nazionale dei Tumori Regina Elena
Roma, 144, Italy
Azienda Ospedaliera Sant'Andrea
Roma, 189, Italy
Casa Sollievo Della Sofferenza
San Giovanni Rotondo, 71013, Italy
Radboud University Medical Center
Nijmegen, Gelderland, 6251 GA, Netherlands
VU Medical Center
Amsterdam, North Holland, 1081 HV, Netherlands
University Medical Center Groningen
Groningen, 9700 VB, Netherlands
National University Cancer Institute
Singapore, 119228, Singapore
National Cancer Centre Singapore
Singapore, 169610, Singapore
Hospital General Universitario de Alicante
Alicante, 3010, Spain
Hospital Quironsalud
Barcelona, 08023, Spain
Hospital Universitari Vall d'Hebron Vall d' Hebron Institute of Oncology (VHIO)
Barcelona, 8035, Spain
Hospital Clinic de Barcelona
Barcelona, 8036, Spain
Institut Catala D'oncologia
Barcelona, 8908, Spain
Hospital Arnau de Vilanova
Lleida, 21598, Spain
Hospital General Universitario Gregorio Marañón
Madrid, 28009, Spain
IOB del Hospital Ruber Internacional
Madrid, 28045, Spain
Hospital HM Universitario Sanchinarro
Madrid, 28050, Spain
Hospital Clinico Universitario de Valencia
Valencia, 46010, Spain
Hospital Universitario Miguel Servet
Zaragoza, 50009, Spain
Gävle Sjukhus Onkologkliniken
Gävle, 80187, Sweden
Sahlgrenska University Hospital
Gothenburg, 413 45, Sweden
Karolina University Hospital
Stockholm, S-171 76, Sweden
Akademiska Hospital
Uppsala, 78551, Sweden
The Clatterbridge Cancer Centre NHS Foundation Trust
Bebington, CH63 4JY, United Kingdom
Velindre Cancer Centre VCC
Cardiff, CF14 2TL, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN, United Kingdom
The Royal Marsden NHS Foundation Trust
London, SW3 6JJ, United Kingdom
SCRI UK
London, W1G 6AD, United Kingdom
The Christie NHS Foundation
Manchester, M20 4GJ, United Kingdom
Oxford University NHS hospital
Oxford, OX3 7LE, United Kingdom
Related Publications (1)
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.
PMID: 39442070DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Development
- Organization
- Byondis B.V.
Study Officials
- STUDY DIRECTOR
Evelyn van den Tweel, PhD
Byondis B.V., The Netherlands
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 16, 2017
First Posted
August 25, 2017
Study Start
December 15, 2017
Primary Completion
March 31, 2021
Study Completion
June 30, 2022
Last Updated
October 19, 2023
Results First Posted
October 19, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will not share