SYD985 vs. Physician's Choice in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer (TULIP)

September 28, 2023 updated by: Byondis B.V.

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

The purpose of this study is to demonstrate that SYD985 [(vic-)trastuzumab duocarmazine] is superior to physician's choice in prolonging progression free survival.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

437

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussel, Belgium, 1000
        • Institut Jules Bordet
      • Bruxelles, Belgium, 1200
        • Cliniques Universitaires Saint-Luc
      • Edegem, Belgium, 2650
        • University Hospital Antwerp
      • Gent, Belgium, 9000
        • UZ Gent
      • Kortrijk, Belgium, 8500
        • Az Groeninge
      • Leuven, Belgium, 3000
        • UZ Leuven - Campus Gasthuisberg
      • Liege, Belgium, B-4000
        • CHU Liège
  • Canada
      • Edmonton, Canada, T6G 1Z2
        • Cross Cancer Institute
      • Kelowna, Canada, V1Y 5L3
        • BC Cancer Agency Centre for the Southern Interior
      • Montreal, Canada, H4A 3JI
        • McGill University Health Centre
      • Ottawa, Canada, K1H 8L6
        • The Ottawa Hospital Cancer Center
  • Denmark
      • Naestved, Denmark, 4700
        • Sealand University Hospital
      • Odense, Denmark, DK-5000
        • Odense University Hospital
      • Sønderborg, Denmark, 6400
        • Sønderborg Sygehus
  • France
      • Angers, France, 49055
        • Institut de Cancérologie de l'Ouest
      • Bordeaux, France, 33076
        • Institut Bergonié
      • Bourg-en-Bresse, France, 01012
        • CH Fleyrait
      • Corbeil-Essonnes, France, 91100
        • Centre Hospitalier Lyon Sud
      • Dijon, France, 21079
        • Centre Georges Francois Leclerc
      • Lille, France, 59020
        • Oscar Lambret
      • Metz, France, 57085
        • CHR Metz-Thionville
      • Nantes, France, 44277
        • Hôpital Privé du Confluent
      • Paris, France, 75475
        • Hopital Saint Louis
      • Pierre-Benite, France, 69310
        • Centre Hospitalier Lyon Sud
      • Rouen, France, 76038
        • Centre Henri Becquere
      • Strasbourg, France, 67065
        • Centre Paul Strauss
  • Italy
      • Bari, Italy, 70124
        • IRCCS Istituto Oncologico
      • Bologna, Italy, 40183
        • Policlinico S.Orsola-Malpighi
      • Catania, Italy, 95123
        • Azienda Ospedaliera Garibaldi- Nesima
      • Firenze, Italy, 50134
        • Azienda Ospedaliero - Universitaria Careggi
      • Milano, Italy, 20133
        • Fondazione Irccs Istituto Nazionale Dei Tumori
      • Milano, Italy, 20132
        • IRCCS Ospedale San Raffaele
      • Milano, Italy, 20141
        • Istituto Europeo di Oncologia
      • Modena, Italy, 41124
        • University Hospital of Modena
      • Monza, Italy, 20900
        • Ospedale San Gerardo-ASST Monza
      • Padova, Italy, 35128
        • Istituto Oncologico Veneto IRCCS
      • Prato, Italy, 59100
        • Nuovo Ospedale Santo Stefano
      • Roma, Italy, 144
        • Istituto Nazionale dei Tumori Regina Elena
      • Roma, Italy, 189
        • Azienda Ospedaliera Sant'Andrea
      • San Giovanni Rotondo, Italy, 71013
        • Casa Sollievo della Sofferenza
  • Netherlands
      • Groningen, Netherlands, 9700 VB
        • University Medical Center Groningen
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6251 GA
        • Radboud University Medical Center
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands, 1081 HV
        • VU Medical Center
  • Singapore
      • Singapore, Singapore, 169610
        • National Cancer Centre Singapore
      • Singapore, Singapore, 119228
        • National University Cancer Institute
  • Spain
      • Alicante, Spain, 3010
        • Hospital General Universitario de Alicante
      • Barcelona, Spain, 8036
        • Hospital Clinic de Barcelona
      • Barcelona, Spain, 8908
        • Institut Catala d'Oncologia
      • Barcelona, Spain, 08023
        • Hospital Quironsalud
      • Barcelona, Spain, 8035
        • Hospital Universitari Vall d'Hebron Vall d' Hebron Institute of Oncology (VHIO)
      • Lleida, Spain, 21598
        • Hospital Arnau de Vilanova
      • Madrid, Spain, 28009
        • Hospital General Universitario Gregorio Marañon
      • Madrid, Spain, 28050
        • Hospital HM Universitario Sanchinarro
      • Madrid, Spain, 28045
        • IOB del Hospital Ruber Internacional
      • Valencia, Spain, 46010
        • Hospital Clinico Universitario de Valencia
      • Zaragoza, Spain, 50009
        • Hospital Universitario Miguel Servet
  • Sweden
      • Gävle, Sweden, 80187
        • Gävle Sjukhus Onkologkliniken
      • Göteborg, Sweden, 413 45
        • Sahlgrenska University Hospital
      • Stockholm, Sweden, S-171 76
        • Karolina University Hospital
      • Uppsala, Sweden, 78551
        • Akademiska hospital
  • United Kingdom
      • Bebington, United Kingdom, CH63 4JY
        • The Clatterbridge Cancer Centre NHS Foundation Trust
      • Cardiff, United Kingdom, CF14 2TL
        • Velindre Cancer Centre VCC
      • Glasgow, United Kingdom, G12 0YN
        • Beatson West of Scotland Cancer Centre
      • London, United Kingdom, SW3 6JJ
        • The Royal Marsden NHS Foundation Trust
      • London, United Kingdom, W1G 6AD
        • SCRI UK
      • Manchester, United Kingdom, M20 4GJ
        • The Christie NHS Foundation
      • Oxford, United Kingdom, OX3 7LE
        • Oxford University NHS hospital
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
        • Southern Cancer Center
    • Arizona
      • Tucson, Arizona, United States, 85715
        • Arizona Clinical Research Center
    • California
      • San Diego, California, United States, 92093
        • Moores UCSD Cancer Center
    • Florida
      • Pensacola, Florida, United States, 32503
        • Woodlands Medical Specialists
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Cancer Center of Kansas
    • Maryland
      • Baltimore, Maryland, United States, 21204
        • Greater Baltimore Medical Center
      • Baltimore, Maryland, United States, 21144
        • University of Maryland Greenebaum Cancer Center
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Saint Luke'S Hospital of Kansas City
    • North Carolina
      • Pinehurst, North Carolina, United States, 28374
        • FirstHealth Outpatient Cancer Center
    • Ohio
      • Toledo, Ohio, United States, 43623
        • Toledo Clinic Cancer Center
    • Oregon
      • Portland, Oregon, United States, 97213
        • Northwest Cancer Specialists
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Magee-Womens Hospital of UPMS
    • Texas
      • Dallas, Texas, United States, 75231
        • Texas Oncology PA (Texas Oncology-Dallas Presbyterian Hospital)
      • Dallas, Texas, United States, 75246
        • Texas Oncology- Baylor Charles A. Sammor
      • Denton, Texas, United States, 76210
        • Texas Oncology - Denton South
      • Houston, Texas, United States, 77024
        • Texas Oncology-Memorial City
      • Houston, Texas, United States, 77030-34011
        • Baylor College of Medicine
      • San Antonio, Texas, United States, 78217
        • Texas Oncology-San Antonio Northeast
      • Tyler, Texas, United States, 75702
        • Texas Oncology-Tyler
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Virginia Cancer Specialists, PC
      • Norfolk, Virginia, United States, 23502
        • Virginia Oncology Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Main Inclusion Criteria:

  • 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 Exclusion Criteria:

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: (vic-)trastuzumab duocarmazine
SYD985, every 3 weeks (Q3W)
Drug: (vic-)trastuzumab duocarmazine
Intravenous SYD985, Q3W
Other Names:
  • SYD985
  • Trastuzumab vc-seco-DUBA
Active Comparator: Physician's choice
  1. Lap/Cap
  2. T/Cap
  3. T/Vino
  4. T/Eri
Drug: Physician's choice
See drug label
Other Names:
  • Lapatinib (Lap)
  • Capecitabine (Cap)
  • Trastuzumab (T)
  • Vinorelbine (Vino)
  • Eribulin (Eri)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival
Time Frame: 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.
baseline until primary analysis data cut-off date of 31March2021

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: 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.
baseline until final Overall Survival analysis data cut-off date of 30June2022
Objective Response Rate
Time Frame: 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.
baseline until primary analysis data cut-off date of 31March2021
Investigator Assessed Progression Free Survival
Time Frame: 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.
baseline until primary analysis data cut-off date of 31March2021
Patient Reported Outcomes for Health Related Quality of Life
Time Frame: 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.
baseline until primary analysis data cut-off date of 31March2021

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Byondis B.V.

Investigators

  • Study Director: Evelyn van den Tweel, PhD, Byondis B.V., The Netherlands

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2017

Primary Completion (Actual)

March 31, 2021

Study Completion (Actual)

June 30, 2022

Study Registration Dates

First Submitted

August 16, 2017

First Submitted That Met QC Criteria

August 23, 2017

First Posted (Actual)

August 25, 2017

Study Record Updates

Last Update Posted (Actual)

October 19, 2023

Last Update Submitted That Met QC Criteria

September 28, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYD985.002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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