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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 : Recruiting
First Posted : August 25, 2017
Last Update Posted : December 6, 2018
Sponsor:
Information provided by (Responsible Party):
Synthon Biopharmaceuticals BV

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 345 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 : November 30, 2017
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

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

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)




Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Up to 2 years ]
    Standard EORTC questionnaire



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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.

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


Contacts
Contact: Evelyn van den Tweel, PhD +31 24 372 7700 clinicaltrials@synthon.com
Contact: Mayke Oesterholt, MSc +31 24 372 7700 clinicaltrials@synthon.com

  Show 69 Study Locations
Sponsors and Collaborators
Synthon Biopharmaceuticals BV
Investigators
Study Director: Evelyn van den Tweel, PhD Synthon Biopharmaceuticals BV, The Netherlands

Responsible Party: Synthon Biopharmaceuticals BV
ClinicalTrials.gov Identifier: NCT03262935     History of Changes
Other Study ID Numbers: SYD985.002
First Posted: August 25, 2017    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Trastuzumab
Antineoplastic Agents