Status:
COMPLETED
SYD985 vs. Physician's Choice in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer
Lead Sponsor:
Byondis B.V.
Conditions:
Metastatic Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
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.
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 eith...
Eligibility Criteria
Inclusion
- Main
- 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
- 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.
Key Trial Info
Start Date :
December 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2022
Estimated Enrollment :
437 Patients enrolled
Trial Details
Trial ID
NCT03262935
Start Date
December 15 2017
End Date
June 30 2022
Last Update
October 19 2023
Active Locations (90)
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1
Southern Cancer Center
Mobile, Alabama, United States, 36608
2
Arizona Clinical Research Center
Tucson, Arizona, United States, 85715
3
Moores UCSD Cancer Center
San Diego, California, United States, 92093
4
Woodlands Medical Specialists
Pensacola, Florida, United States, 32503