Clinical Trials /

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

NCT03262935

Description:

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

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: SYD985.002
  • NCT ID: NCT03262935

Conditions

  • Metastatic Breast Cancer

Interventions

DrugSynonymsArms
(vic-)trastuzumab duocarmazineSYD985, Trastuzumab vc-seco-DUBA(vic-)trastuzumab duocarmazine
Physician's choiceLapatinib (Lap), Capecitabine (Cap), Trastuzumab (T), Vinorelbine (Vino), Eribulin (Eri)Physician's choice

Purpose

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

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.
    

Trial Arms

NameTypeDescriptionInterventions
(vic-)trastuzumab duocarmazineExperimentalSYD985, every 3 weeks (Q3W)
  • (vic-)trastuzumab duocarmazine
Physician's choiceActive ComparatorLap/Cap T/Cap T/Vino T/Eri
  • Physician's choice

Eligibility 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression Free Survival
Time Frame:Up to 2 years from baseline
Safety Issue:
Description: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

Measure:Overall Survival
Time Frame:2-year overall survival
Safety Issue:
Description:Overall survival is defined as the time from date of randomization to death due to any cause.
Measure:Objective Response Rate
Time Frame:Up to 2 years from baseline
Safety Issue:
Description: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.
Measure:Investigator assessed Progression Free Survival
Time Frame:Up to 2 years from baseline
Safety Issue:
Description: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.
Measure:Patient reported outcomes for health related quality of life
Time Frame:Up to 2 years
Safety Issue:
Description:Standard EORTC questionnaire

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Synthon Biopharmaceuticals BV

Last Updated

January 11, 2018