This study will examine the safety and tolerability of ladiratuzumab vedotin (LV) in patients with metastatic breast cancer. LV will be given alone or in combination with trastuzumab.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
290
LV will be given into the vein (IV; intravenously)
Trastuzumab will be given by IV every 3 weeks at a dose of 6 mg/kg (the first dose will be 8 mg/kg)
Incidence of adverse events
An AE is any untoward medical occurrence in a patient or clinical investigational subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Time frame: Through 1 month following last dose; up to approximately 2 years
Incidence of laboratory abnormalities
To be summarized using descriptive statistics.
Time frame: Through 1 month following last dose; up to approximately 2 years
Incidence of dose-limiting toxicity (DLT)
Time frame: Through 3 weeks after first dose
Blood concentrations of LV and metabolites
Time frame: Through 3 weeks after dosing; up to approximately 2 years
Incidence of antitherapeutic antibodies
Time frame: Through 1 month following last dose; up to approximately 2 years
Objective response rate (ORR)
ORR is defined as the proportion of patients with complete response (CR) or partial response (PR) per RECIST v1.1.
Time frame: Through 1 month following last dose; up to approximately 2 years
Duration of response (DOR)
DOR is defined as the time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of tumor progression (clinical progression or progressive disease (PD) per RECIST v1.1).
Time frame: Up to approximately 3 years
Progression-free survival (PFS)
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Pinnacle Oncology Hematology
Scottsdale, Arizona, United States
UC San Diego / Moores Cancer Center
La Jolla, California, United States
Cedars Sinai Medical Center / Samuel Oschin Comprehensive Cancer Institute
Los Angeles, California, United States
University of California at San Francisco
San Francisco, California, United States
UCLA Medical Center / David Geffen School of Medicine
Santa Monica, California, United States
Rocky Mountain Cancer Centers - Aurora
Aurora, Colorado, United States
Poudre Valley Health System (PVHS)
Fort Collins, Colorado, United States
Yale Cancer Center
New Haven, Connecticut, United States
The Whittingham Cancer Center / Norwalk Hospital
Norwalk, Connecticut, United States
...and 28 more locations
PFS is defined as the time from start of study treatment to first documentation of tumor progression (clinical progression or PD per RECIST v1.1).
Time frame: Up to approximately 8 years
Overall survival (OS)
OS is defined as the time from start of study treatment to date of death due to any cause.
Time frame: Up to approximately 8 years
PFS relative to prior therapy
The PFS ratio is defined for each subject as the ratio of the current PFS and the PFS achieved on their most recent therapy where they experienced progression.
Time frame: Up to approximately 8 years