The purpose of this study is to demonstrate that SYD985 \[(vic-)trastuzumab duocarmazine\] is superior to physician's choice in prolonging progression free survival.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
437
Intravenous SYD985, Q3W
See drug label
Progression Free Survival
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.
Time frame: baseline until primary analysis data cut-off date of 31March2021
Overall Survival
Overall survival is defined as the time from date of randomization to death due to any cause.
Time frame: baseline until final Overall Survival analysis data cut-off date of 30June2022
Objective Response Rate
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.
Time frame: baseline until primary analysis data cut-off date of 31March2021
Investigator Assessed Progression Free Survival
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.
Time frame: baseline until primary analysis data cut-off date of 31March2021
Patient Reported Outcomes for Health Related Quality of Life
Change in the global health status/Quality of Life (QoL) scale score of the European Organization for Research and Treatment for Cancer (EORTC) Quality of Life Questionnaire C30 from baseline (cycle 1). The raw score (1 to 7) has been transformed to a score ranging from 0 to 100. A higher score means a better outcome: hence a positive change from baseline means an improvement in global health status/Quality of Life and a negative change from baseline means a worsening of global health status/Quality of Life.
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Southern Cancer Center
Mobile, Alabama, United States
Arizona Clinical Research Center
Tucson, Arizona, United States
Moores UCSD Cancer Center
San Diego, California, United States
Woodlands Medical Specialists
Pensacola, Florida, United States
Rush University Medical Center
Chicago, Illinois, United States
Cancer Center of Kansas
Wichita, Kansas, United States
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, United States
Greater Baltimore Medical Center
Baltimore, Maryland, United States
Henry Ford Hospital
Detroit, Michigan, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States
...and 80 more locations
Time frame: baseline until primary analysis data cut-off date of 31March2021