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 : October 10, 2019
|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)|
|Estimated Enrollment :||345 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|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||May 2021|
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
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
|Contact: Evelyn van den Tweel, PhD||+31 24 372 firstname.lastname@example.org|
|Contact: Mayke Oesterholt, MSc||+31 24 372 email@example.com|
|Study Director:||Evelyn van den Tweel, PhD||Synthon Biopharmaceuticals BV, The Netherlands|