HER2-POSITIVE EARLY BREAST CANCER
Conditions
Brief summary
Average HCP time per patient per visit (per treatment cycle), measured for cycles 2-7 in the adjuvant setting, for the different administration route processes, time disaggregated per pre-specified task as well as per HCP (oncologist, nurse pharmacist and other): IV administration route process and SC administration route process include such tasks as: preparation times and administration times, Average patient time per visit (per treatment cycle), measured for cycles 2-7 in the adjuvant setting, for the different administration route processes: patient chair time (measured as time between sitting and rising from infusion chair) and treatment room time (measured as time between entrance and exit from the treatment room)
Detailed description
Average patient hospital time per visit (per treatment cycle), measured for cycles 2-7 in the adjuvant setting, for the different administration route processes measured as time between first entry and last exit from the hospital for their adjuvant treatment, Average quantity for each consumable used per patient visit (per treatment cycle), measured for cycles 2-7 in the adjuvant setting, per pre-specified task for the different administration route processes. Milligrams wasted from partly-used vials per patient visit (per treatment cycle), measured for cycles 2-7 in the adjuvant setting, To describe the safety and tolerability of PH FDC SC, P IV + H IV and P IV + H SC based on the following endpoints: o Incidence, nature and severity of all AEs, ≥ Grade 3 AEs, SAEs and cardiac AEs (including left ventricular ejection fraction [LVEF] events). o Incidence of premature withdrawal from study treatment. o Targeted vital signs and physical findings. o Targeted clinical laboratory test results.
Interventions
DRUGPerjeta 420 mg concentrate for solution for infusion
DRUGHerceptin 150 mg powder for concentrate for solution for infusion
Sponsors
Roche Farma S.A.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Average HCP time per patient per visit (per treatment cycle), measured for cycles 2-7 in the adjuvant setting, for the different administration route processes, time disaggregated per pre-specified task as well as per HCP (oncologist, nurse pharmacist and other): IV administration route process and SC administration route process include such tasks as: preparation times and administration times, Average patient time per visit (per treatment cycle), measured for cycles 2-7 in the adjuvant setting, for the different administration route processes: patient chair time (measured as time between sitting and rising from infusion chair) and treatment room time (measured as time between entrance and exit from the treatment room) | — |
Secondary
| Measure | Time frame |
|---|---|
| Average patient hospital time per visit (per treatment cycle), measured for cycles 2-7 in the adjuvant setting, for the different administration route processes measured as time between first entry and last exit from the hospital for their adjuvant treatment, Average quantity for each consumable used per patient visit (per treatment cycle), measured for cycles 2-7 in the adjuvant setting, per pre-specified task for the different administration route processes. Milligrams wasted from partly-used vials per patient visit (per treatment cycle), measured for cycles 2-7 in the adjuvant setting, To describe the safety and tolerability of PH FDC SC, P IV + H IV and P IV + H SC based on the following endpoints: o Incidence, nature and severity of all AEs, ≥ Grade 3 AEs, SAEs and cardiac AEs (including left ventricular ejection fraction [LVEF] events). o Incidence of premature withdrawal from study treatment. o Targeted vital signs and physical findings. o Targeted clinical laboratory test resul | — |
Countries
Spain
Outcome results
None listed