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

Sponsor
Byondis B.V. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03262935
Collaborator
(none)
436
Enrollment
90
Locations
2
Arms
58
Anticipated Duration (Months)
4.8
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: (vic-)trastuzumab duocarmazine
  • Drug: Physician's choice
 Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
436 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Nov 30, 2017
Actual Primary Completion Date :
Jul 1, 2021
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

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

    Lap/Cap T/Cap T/Vino T/Eri

    Drug: Physician's choice
    See drug label
    Other Names:
  • Lapatinib (Lap)
  • Capecitabine (Cap)
  • Trastuzumab (T)
  • Vinorelbine (Vino)
  • Eribulin (Eri)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Progression Free Survival [Up to 2 years from baseline]

      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

    1. Overall Survival [2-year overall survival]

      Overall survival is defined as the time from date of randomization to death due to any cause.

    2. Objective Response Rate [Up to 2 years from baseline]

      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.

    3. Investigator assessed Progression Free Survival [Up to 2 years from baseline]

      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.

    4. Patient reported outcomes for health related quality of life [Up to 2 years]

      Standard EORTC questionnaire

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Southern Cancer Center Mobile Alabama United States 36608
    2 Arizona Clinical Research Center Tucson Arizona United States 85715
    3 Moores UCSD Cancer Center San Diego California United States 92093
    4 Woodlands Medical Specialists Pensacola Florida United States 32503
    5 Rush University Medical Center Chicago Illinois United States 60612
    6 Cancer Center of Kansas Wichita Kansas United States 67214
    7 University of Maryland Greenebaum Cancer Center Baltimore Maryland United States 21144
    8 Greater Baltimore Medical Center Baltimore Maryland United States 21204
    9 Henry Ford Hospital Detroit Michigan United States 48202
    10 Saint Luke's Hospital of Kansas City Kansas City Missouri United States 64111
    11 FirstHealth Outpatient Cancer Center Pinehurst North Carolina United States 28374
    12 Toledo Clinic Cancer Center Toledo Ohio United States 43623
    13 Northwest Cancer Specialists Portland Oregon United States 97213
    14 Magee-Womens Hospital of UPMS Pittsburgh Pennsylvania United States 15213
    15 Texas Oncology PA (Texas Oncology-Dallas Presbyterian Hospital) Dallas Texas United States 75231
    16 Texas Oncology- Baylor Charles A. Sammor Dallas Texas United States 75246
    17 Texas Oncology - Denton South Denton Texas United States 76210
    18 Texas Oncology-Memorial City Houston Texas United States 77024
    19 Baylor College of Medicine Houston Texas United States 77030-34011
    20 Texas Oncology-San Antonio Northeast San Antonio Texas United States 78217
    21 Texas Oncology-Tyler Tyler Texas United States 75702
    22 Virginia Cancer Specialists, PC Fairfax Virginia United States 22031
    23 Virginia Oncology Associates Norfolk Virginia United States 23502
    24 Institut Jules Bordet Brussel Belgium 1000
    25 Cliniques Universitaires Saint-Luc Bruxelles Belgium 1200
    26 University Hospital Antwerp Edegem Belgium 2650
    27 UZ Gent Gent Belgium 9000
    28 AZ Groeninge Kortrijk Belgium 8500
    29 UZ Leuven - campus Gasthuisberg Leuven Belgium 3000
    30 CHU Liege Liege Belgium B-4000
    31 Cross Cancer Institute Edmonton Canada T6G 1Z2
    32 BC Cancer Agency Centre for the Southern Interior Kelowna Canada V1Y 5L3
    33 McGill University Health Centre Montreal Canada H4A 3JI
    34 The Ottawa Hospital Cancer Center Ottawa Canada K1H 8L6
    35 Sealand University Hospital Naestved Denmark 4700
    36 Odense University Hospita Odense Denmark DK-5000
    37 Sønderborg sygehus Sønderborg Denmark 6400
    38 Institut de Cancerologie de l'ouest Angers France 49055
    39 Institut Bergonie Bordeaux France 33076
    40 CH Fleyrait Bourg-en-Bresse France 01012
    41 Centre Hospitalier Lyon Sud Corbeil-Essonnes France 91100
    42 Centre Georges francois leclerc Dijon France 21079
    43 Oscar Lambret Lille France 59020
    44 CHR Metz-Thionville Metz France 57085
    45 Hopital Prive du Confluent Nantes France 44277
    46 Hopital Saint Louis Paris France 75475
    47 Centre Hospitalier Lyon Sud Pierre-Benite France 69310
    48 Centre Henri Becquere Rouen France 76038
    49 Centre Paul Strauss Strasbourg France 67065
    50 IRCCS Istituto Oncologico Bari Italy 70124
    51 Policlinico S.Orsola-Malpighi Bologna Italy 40183
    52 Azienda Ospedaliera Garibaldi- Nesima Catania Italy 95123
    53 Azienda Ospedaliero - Universitaria Careggi Firenze Italy 50134
    54 IRCCS Ospedale San Raffaele Milano Italy 20132
    55 Fondazione IRCCS Istituto Nazionale dei Tumori Milano Italy 20133
    56 Istituto Europeo di Oncologia Milano Italy 20141
    57 University Hospital of Modena Modena Italy 41124
    58 Ospedale San Gerardo-Asst Monza Monza Italy 20900
    59 Istituto Oncologico Veneto Irccs Padova Italy 35128
    60 Nuovo Ospedale Santo Stefano Prato Italy 59100
    61 Istituto Nazionale dei Tumori Regina Elena Roma Italy 144
    62 Azienda Ospedaliera Sant'Andrea Roma Italy 189
    63 Casa Sollievo Della Sofferenza San Giovanni Rotondo Italy 71013
    64 Radboud University Medical Center Nijmegen Gelderland Netherlands 6251 GA
    65 VU Medical Center Amsterdam Noord-Holland Netherlands 1081 HV
    66 University Medical Center Groningen Groningen Netherlands 9700 VB
    67 National University Cancer Institute Singapore Singapore 119228
    68 National Cancer Centre Singapore Singapore Singapore 169610
    69 Hospital General Universitario de Alicante Alicante Spain 3010
    70 Hospital Quironsalud Barcelona Spain 08023
    71 Hospital Universitari Vall d'Hebron Vall d' Hebron Institute of Oncology (VHIO) Barcelona Spain 8035
    72 Hospital Clinic de Barcelona Barcelona Spain 8036
    73 Institut Catala D'oncologia Barcelona Spain 8908
    74 Hospital Arnau de Vilanova Lleida Spain 21598
    75 Hospital General Universitario Gregorio Marañón Madrid Spain 28009
    76 IOB del Hospital Ruber Internacional Madrid Spain 28045
    77 Hospital HM Universitario Sanchinarro Madrid Spain 28050
    78 Hospital Clinico Universitario de Valencia Valencia Spain 46010
    79 Hospital Universitario Miguel Servet Zaragoza Spain 50009
    80 Gävle Sjukhus Onkologkliniken Gävle Sweden 80187
    81 Sahlgrenska University Hospital Göteborg Sweden 413 45
    82 Karolina University Hospital Stockholm Sweden S-171 76
    83 Akademiska Hospital Uppsala Sweden 78551
    84 The Clatterbridge Cancer Centre NHS Foundation Trust Bebington United Kingdom CH63 4JY
    85 Velindre Cancer Centre VCC Cardiff United Kingdom CF14 2TL
    86 Beatson West of Scotland Cancer Centre Glasgow United Kingdom G12 0YN
    87 The Royal Marsden NHS Foundation Trust London United Kingdom SW3 6JJ
    88 SCRI UK London United Kingdom W1G 6AD
    89 The Christie NHS Foundation Manchester United Kingdom M20 4GJ
    90 Oxford University NHS hospital Oxford United Kingdom OX3 7LE

    Sponsors and Collaborators

    • Byondis B.V.

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Byondis B.V.
    ClinicalTrials.gov Identifier:
    NCT03262935
    Other Study ID Numbers:
    • SYD985.002
    First Posted:
    Aug 25, 2017
    Last Update Posted:
    Aug 4, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Breast Neoplasms
    Capecitabine
    Trastuzumab
    Vinorelbine
    Lapatinib

    Study Results

    No Results Posted as of Aug 4, 2022