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
Last Update Posted : May 25, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Metastatic Breast Cancer||Drug: (vic-)trastuzumab duocarmazine Drug: Physician's choice||Phase 3|
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)|
|Actual Enrollment :||436 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Primary Completion Date :||July 1, 2021|
|Actual Study Completion Date :||August 24, 2022|
Experimental: (vic-)trastuzumab duocarmazine
SYD985, every 3 weeks (Q3W)
Drug: (vic-)trastuzumab duocarmazine
Intravenous SYD985, Q3W
Active Comparator: Physician's choice
Drug: Physician's choice
See drug label
- 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.
- 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.
- 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.
- 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.
- Patient reported outcomes for health related quality of life [ Time Frame: Up to 2 years ]Standard EORTC questionnaire
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.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|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.
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
|Study Director:||Evelyn van den Tweel, PhD||Byondis B.V., The Netherlands|
|Responsible Party:||Byondis B.V.|
|Other Study ID Numbers:||
|First Posted:||August 25, 2017 Key Record Dates|
|Last Update Posted:||May 25, 2023|
|Last Verified:||May 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
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