HER2+ early breast cancer
Conditions
Brief summary
pCR rate after neoadjuvant treatment, defined as ypTis/ypN0, to be compared between all T-DXd treated patients versus standard-of- care (PAC+T+P or PAC/DOC+Carbo+T+P) (pooled across cohorts) Hypotheses: H0: pCR T-DXd = pCR standard-of-care H1: pCR T-DXd ≠ pCR standard-of-care, 3-year distant disease-free survival (dDFS, according to STEEP 2.0 criteria) in T-DXd treated patients (pooled across cohorts) H0: 3-year dDFS rate in the T-DXd group < 92.0% H1: 3-year dDFS rate in the T-DXd group ≥ 92.0%
Detailed description
Clinical response after 6, 12, and 18 weeks of treatment by treatment and cohort, 3-year dDFS in patients with pCR after neoadjuvant treatment without further chemotherapy, pCR rates after different treatment durations (12 versus 18 weeks) to be compared by treatment in pooled cohorts, interaction between treatment arm and risk cohort, pCR rates in T-DXd12 weeks versus PAC+T+P in cohort 1, pCR rates in T-DXd18 weeks versus PAC/DOC+Carbo+T+P in cohort 2, STEEP 2.0 survival endpoints: - Invasive disease-free survival (IDFS) - Overall survival (OS) - Local recurrence-free survival (LRFS) - Breast cancer-free survival (BCFS) - Distant recurrence-free interval (DRFI) To be compared across T-DXd cohorts versus standard-of-care in pooled cohorts, Change of health-related quality of life between baseline and after 1 year
Interventions
DRUGTRASTUZUMAB DERUXTECAN
Sponsors
WSG Westdeutsche Studiengruppe GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pCR rate after neoadjuvant treatment, defined as ypTis/ypN0, to be compared between all T-DXd treated patients versus standard-of- care (PAC+T+P or PAC/DOC+Carbo+T+P) (pooled across cohorts) Hypotheses: H0: pCR T-DXd = pCR standard-of-care H1: pCR T-DXd ≠ pCR standard-of-care, 3-year distant disease-free survival (dDFS, according to STEEP 2.0 criteria) in T-DXd treated patients (pooled across cohorts) H0: 3-year dDFS rate in the T-DXd group < 92.0% H1: 3-year dDFS rate in the T-DXd group ≥ 92.0% | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical response after 6, 12, and 18 weeks of treatment by treatment and cohort, 3-year dDFS in patients with pCR after neoadjuvant treatment without further chemotherapy, pCR rates after different treatment durations (12 versus 18 weeks) to be compared by treatment in pooled cohorts, interaction between treatment arm and risk cohort, pCR rates in T-DXd12 weeks versus PAC+T+P in cohort 1, pCR rates in T-DXd18 weeks versus PAC/DOC+Carbo+T+P in cohort 2, STEEP 2.0 survival endpoints: - Invasive disease-free survival (IDFS) - Overall survival (OS) - Local recurrence-free survival (LRFS) - Breast cancer-free survival (BCFS) - Distant recurrence-free interval (DRFI) To be compared across T-DXd cohorts versus standard-of-care in pooled cohorts, Change of health-related quality of life between baseline and after 1 year | — |
Countries
Germany
Outcome results
None listed