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

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ClinicalTrials.gov Identifier: NCT03262935
Recruitment Status : Completed
First Posted : August 25, 2017
Results First Posted : October 19, 2023
Last Update Posted : October 19, 2023
Sponsor:
Information provided by (Responsible Party):
Byondis B.V.

Study Description
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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
Metastatic Breast Cancer 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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 437 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 : December 15, 2017
Actual Primary Completion Date : March 31, 2021
Actual Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Trastuzumab

Arms and Interventions
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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)


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03262935


Locations
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Sponsors and Collaborators
Byondis B.V.
Investigators
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Study Director: Evelyn van den Tweel, PhD Byondis B.V., The Netherlands
  Study Documents (Full-Text)

Documents provided by Byondis B.V.:
Study Protocol  [PDF] January 18, 2021
Statistical Analysis Plan  [PDF] April 29, 2021

More Information
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Responsible Party: Byondis B.V.
ClinicalTrials.gov Identifier: NCT03262935    
Other Study ID Numbers: SYD985.002
First Posted: August 25, 2017    Key Record Dates
Results First Posted: October 19, 2023
Last Update Posted: October 19, 2023
Last Verified: June 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Capecitabine
Trastuzumab
Vinorelbine
Lapatinib
Antimetabolites, Antineoplastic
Antimetabolites
 Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Immunological
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Tyrosine Kinase Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors