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Metastatic Breast CancerPhase 3TULIPNCT03262935

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

A Phase 3 study testing (vic-)trastuzumab duocarmazine and Physician's choice in people with Metastatic Breast Cancer, run by Byondis B.V. at 90 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Metastatic Breast Cancer
What is being tested?
(vic-)trastuzumab duocarmazine and Physician's choice
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
437 participants
Where
90 sitesin 11 countries
Study dates
15 Dec 2017to 30 Jun 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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.

Trial locations and contacts

90 sites in 11 countries.

90 sites in 11 countries

United States23 sites

  • University of Maryland Greenebaum Cancer Center

    Baltimore, Maryland, 21144

  • Greater Baltimore Medical Center

    Baltimore, Maryland, 21204

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Texas Oncology PA (Texas Oncology-Dallas Presbyterian Hospital)

    Dallas, Texas, 75231

  • Texas Oncology- Baylor Charles A. Sammor

    Dallas, Texas, 75246

  • Texas Oncology - Denton South

    Denton, Texas, 76210

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Virginia Cancer Specialists, PC

    Fairfax, Virginia, 22031

  • Texas Oncology-Memorial City

    Houston, Texas, 77024

  • Baylor College of Medicine

    Houston, Texas, 77030-34011

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111

  • Southern Cancer Center

    Mobile, Alabama, 36608

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • Woodlands Medical Specialists

    Pensacola, Florida, 32503

  • FirstHealth Outpatient Cancer Center

    Pinehurst, North Carolina, 28374

  • Magee-Womens Hospital of UPMS

    Pittsburgh, Pennsylvania, 15213

  • Northwest Cancer Specialists

    Portland, Oregon, 97213

  • Texas Oncology-San Antonio Northeast

    San Antonio, Texas, 78217

  • Moores UCSD Cancer Center

    San Diego, California, 92093

  • Toledo Clinic Cancer Center

    Toledo, Ohio, 43623

  • Arizona Clinical Research Center

    Tucson, Arizona, 85715

  • Texas Oncology-Tyler

    Tyler, Texas, 75702

  • Cancer Center of Kansas

    Wichita, Kansas, 67214

Other trials in United States

Italy14 sites

  • IRCCS Istituto Oncologico

    Bari, 70124

  • Policlinico S.Orsola-Malpighi

    Bologna, 40183

  • Azienda Ospedaliera Garibaldi- Nesima

    Catania, 95123

  • Azienda Ospedaliero - Universitaria Careggi

    Florence, 50134

  • IRCCS Ospedale San Raffaele

    Milan, 20132

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133

  • Istituto Europeo di Oncologia

    Milan, 20141

  • University Hospital of Modena

    Modena, 41124

  • Ospedale San Gerardo-Asst Monza

    Monza, 20900

  • Istituto Oncologico Veneto Irccs

    Padova, 35128

  • Nuovo Ospedale Santo Stefano

    Prato, 59100

  • Istituto Nazionale dei Tumori Regina Elena

    Roma, 144

  • Azienda Ospedaliera Sant'Andrea

    Roma, 189

  • Casa Sollievo Della Sofferenza

    San Giovanni Rotondo, 71013

Other trials in Italy

France12 sites

  • Institut de Cancerologie de l'ouest

    Angers, 49055

  • Institut Bergonie

    Bordeaux, 33076

  • CH Fleyrait

    Bourg-en-Bresse, 01012

  • Centre Hospitalier Lyon Sud

    Corbeil-Essonnes, 91100

  • Centre Georges francois leclerc

    Dijon, 21079

  • Oscar Lambret

    Lille, 59020

  • CHR Metz-Thionville

    Metz, 57085

  • Hopital Prive du Confluent

    Nantes, 44277

  • Hopital Saint Louis

    Paris, 75475

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69310

  • Centre Henri Becquere

    Rouen, 76038

  • Centre Paul Strauss

    Strasbourg, 67065

Other trials in France

Spain11 sites

  • Hospital General Universitario de Alicante

    Alicante, 3010

  • Hospital Quironsalud

    Barcelona, 08023

  • Hospital Universitari Vall d'Hebron Vall d' Hebron Institute of Oncology (VHIO)

    Barcelona, 8035

  • Hospital Clinic de Barcelona

    Barcelona, 8036

  • Institut Catala D'oncologia

    Barcelona, 8908

  • Hospital Arnau de Vilanova

    Lleida, 21598

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28009

  • IOB del Hospital Ruber Internacional

    Madrid, 28045

  • Hospital HM Universitario Sanchinarro

    Madrid, 28050

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

Other trials in Spain

Belgium7 sites

  • Institut Jules Bordet

    Brussels, 1000

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • University Hospital Antwerp

    Edegem, 2650

  • UZ Gent

    Ghent, 9000

  • AZ Groeninge

    Kortrijk, 8500

  • UZ Leuven - campus Gasthuisberg

    Leuven, 3000

  • CHU Liege

    Liège, B-4000

Other trials in Belgium

United Kingdom7 sites

  • The Clatterbridge Cancer Centre NHS Foundation Trust

    Bebington, CH63 4JY

  • Velindre Cancer Centre VCC

    Cardiff, CF14 2TL

  • Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN

  • The Royal Marsden NHS Foundation Trust

    London, SW3 6JJ

  • SCRI UK

    London, W1G 6AD

  • The Christie NHS Foundation

    Manchester, M20 4GJ

  • Oxford University NHS hospital

    Oxford, OX3 7LE

Other trials in United Kingdom

Canada4 sites

  • Cross Cancer Institute

    Edmonton, T6G 1Z2

  • BC Cancer Agency Centre for the Southern Interior

    Kelowna, V1Y 5L3

  • McGill University Health Centre

    Montreal, H4A 3JI

  • The Ottawa Hospital Cancer Center

    Ottawa, K1H 8L6

Other trials in Canada

Sweden4 sites

  • Gävle Sjukhus Onkologkliniken

    Gävle, 80187

  • Sahlgrenska University Hospital

    Gothenburg, 413 45

  • Karolina University Hospital

    Stockholm, S-171 76

  • Akademiska Hospital

    Uppsala, 78551

Other trials in Sweden

Denmark3 sites

  • Sealand University Hospital

    Næstved, 4700

  • Odense University Hospital

    Odense, DK-5000

  • Sønderborg sygehus

    Sønderborg, 6400

Other trials in Denmark

Netherlands3 sites

  • VU Medical Center

    Amsterdam, North Holland, 1081 HV

  • University Medical Center Groningen

    Groningen, 9700 VB

  • Radboud University Medical Center

    Nijmegen, Gelderland, 6251 GA

Other trials in Netherlands

Singapore2 sites

  • National University Cancer Institute

    Singapore, 119228

  • National Cancer Centre Singapore

    Singapore, 169610

Other trials in Singapore

About this study

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

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

Read the 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.

Being tested
(vic-)trastuzumab duocarmazine, Physician's choice
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • (vic-)trastuzumab duocarmazineDrug

    Also called SYD985, Trastuzumab vc-seco-DUBA

    Intravenous SYD985, Q3W

  • Physician's choiceDrug

    Also called Lapatinib (Lap), Capecitabine (Cap), Trastuzumab (T), Vinorelbine (Vino)

    See drug label

Study groups in NCT03262935
Study groupRoleWhat they receive
(vic-)trastuzumab duocarmazineExperimentalSYD985, every 3 weeks (Q3W)
Receives: Drug: (vic-)trastuzumab duocarmazine
Physician's choiceActive comparator1. Lap/Cap 2. T/Cap 3. T/Vino 4. T/Eri
Receives: Drug: Physician's choice

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: baseline until primary analysis data cut-off date of 31March2021

Secondary outcomes (4)

  1. Overall Survival

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

    Measured: baseline until final Overall Survival analysis data cut-off date of 30June2022

  2. Objective Response Rate

    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.

    Measured: baseline until primary analysis data cut-off date of 31March2021

  3. Investigator Assessed 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 investigator assessment according to RECIST v1.1 or death due to any cause, whichever occurred earlier.

    Measured: baseline until primary analysis data cut-off date of 31March2021

  4. Patient Reported Outcomes for Health Related Quality of Life

    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.

    Measured: baseline until primary analysis data cut-off date of 31March2021

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Aug 2017
  2. Study start15 Dec 2017
  3. Primary completion31 Mar 2021
  4. Study completion30 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
437 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03262935
Sponsor's protocol ID
SYD985.002
Acronym
TULIP
Status last verified
Jun 2023
First submitted
16 Aug 2017
Last updated
19 Oct 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 39442070

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing (vic-)trastuzumab duocarmazine and Physician's choice in people with Metastatic Breast Cancer, run by Byondis B.V. at 90 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 90 sites in United States, Italy, France, Spain, Belgium and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (time frame: baseline until primary analysis data cut-off date of 31March2021). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03262935, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2023.

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