This clinical trial is a prospective, observational, multicenter cohort study evaluating the efficacy and safety of NEPA (netupitant/palonosetron) in patients with HER2-positive or HER2-low advanced breast cancer treated with T-DXd
The observation period of this study is until the discontinuation after administration of T-Dxd or until 8 Cycle. * Acute phase: 0 -24 hours after T-DXd administration * Delayed phase: \>24-120 hours after T-DXd administration * Overall phase: 0-120 hours after T-DXd administration * Long-delayed phase: \>120-504 hours * Extended overall phase: 0-504 hours Primary objectives: to evaluate the efficacy and safety of NEPA for CINV prevention in advanced breast cancer patients receiving at least 2 cycles of T-DXd across all defined assessment periods (acute, delayed, overall, long-delayed, and extended overall phases).
Study Type
OBSERVATIONAL
Enrollment
100
Samsung Medical Center
Seoul, Gangnam-gu, South Korea
Complete response (CR: no emesis and no rescue medication)
CR during the long-delayed phase(\>120-504 hours)
Time frame: At the end of first Cycle 2 of T-DXd (each cycle is 28 days), assessed up to 6 weeks
Complete response (CR: no emesis and no rescue medication)
CR during the acute phase (0-24 hours), delayed phase (\>24-120 hours), overall phase (0-120 hours), extended overall phase (0-504 hours)
Time frame: At the end of first Cycle 2 of T-DXd (each cycle is 28 days), assessed up to 6 weeks
Complete control (CC: no emesis, no rescue medication and no or mild nausea)
CC during the acute phase (0-24 hours), delayed phase (\>24-120 hours), overall phase (0-120 hours), long-delayed phase (\>120-504 hours), and extended overall phase (0-504 hours)
Time frame: At the end of first Cycle 2 of T-DXd (each cycle is 28 days), assessed up to 6 weeks
Total control (TC: no emesis, no rescue medication and no nausea)
TC during the acute phase (0-24 hours), delayed phase (\>24-120 hours), overall phase (0-120 hours), long-delayed phase (\>120-504 hours), and extended overall phase (0-504 hours)
Time frame: At the end of first Cycle 2 of T-DXd (each cycle is 28 day), assessed up to 6 weeks
No significant nausea (NSN: defined as no or mild nausea)
NSN during the acute phase (0-24 hours), delayed phase (\>24-120 hours), overall phase (0-120 hours), long-delayed phase (\>120-504 hours), and extended overall phase (0-504 hours
Time frame: At the end of first Cycle 2 of T-DXd (each cycle is 28 day), assessed up to 6 weeks
No nausea
No nausea during the acute phase (0-24 hours), delayed phase (\>24-120 hours), overall phase (0-120 hours), long-delayed phase (\>120-504 hours), and extended overall phase (0-504 hours)
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Time frame: At the end of first Cycle 2 of T-DXd (each cycle is 28 day), assessed up to 6 weeks
CR rate
Daily CR rate
Time frame: At the end of first Cycle 2 of T-DXd (each cycle is 28 days), assessed up to 6 weeks
NSN rate
Daily NSN rate
Time frame: At the end of first Cycle 2 of T-DXd (each cycle is 28 days), assessed up to 6 weeks
no nausea rate
Daily no nausea rate
Time frame: At the end of first Cycle 2 of T-DXd (each cycle is 28 days), assessed up to 6 weeks
Proportion of patients who receive rescue medications
Proportion of patients who receive rescue medications
Time frame: At the end of first Cycle 2 of T-DXd (each cycle is 28 days), assessed up to 6 weeks
Proportion of patients undergoing T-DXd dose delay
Proportion of patients undergoing T-DXd dose delay due to nausea and/or vomiting
Time frame: At the end of first documented progression or first Cycle 8 of T-DXd (each cycle is 28 days), assessed up to 24 weeks
Proportion of patients requiring permanent discontinuation
Proportion of patients requiring permanent discontinuation of T-DXd due to nausea and/or vomiting
Time frame: At the end of first documented progression or first Cycle 8 of T-DXd (each cycle is 28 days), assessed up to 24 weeks
Health-related quality of life (EQ-5D-5L)
1. Range of EQ-5D index Minimum-Maximum Range: approx.-0.28 to -0/17 \~ 1,000 2. Range of EQ VASMinimum-Maximum Range: 0\~100 \*The higher to score, the better the health status.
Time frame: At the end of first documented progression or first Cycle 8 of T-DXd (each cycle is 28 days), assessed up to 24 weeks
FACIT Fatigue
Proportion of patients experiencing fatigue and severity of fatigue (FACIT Fatigue) (1) Range of FACIT Fatigue scale Minimum-Maximum Range 0\~52 \*Higher score indicate less fatigue and better health status.
Time frame: At the end of first documented progression or first Cycle 8 of T-DXd (each cycle is 28 days), assessed up to 24 weeks
CTCAE v5.0
Safety evaluated according to CTCAE v5.0, higher scores mean a worse outcome
Time frame: At the end of first documented progression or first Cycle 8 of T-DXd (each cycle is 28 days), assessed up to 24 weeks
Daily rescue medication rate
Daily rescue medication rate
Time frame: At the end of first Cycle 2 of T-DXd (each cycle is 28 days), assessed up to 6 weeks
Duration of rescue medication
Duration of rescue medication
Time frame: At the end of first Cycle 2 of T-DXd (each cycle is 28 days), assessed up to 6 weeks