A
ESMO-MCBS v1.1
Scorecard version: 1
Indication details
- Tumour Type
- Breast Cancer
- Tumour Sub-type
- Early Breast Cancer
- Tumour Sub-Group
- HER2+
- Tumour stage
- Adjuvant
- Control Arm
- Trastuzumab
- Treatment Setting
- Adjuvant treatment of patients with HER2-positive early breast cancer who have residual invasive disease in the breast and/or lymph nodes after neoadjuvant taxane-based and HER2-targeted therapy
- Trial Name
- KATHERINE
Primary Outcome(s)
- Primary Outcome(s)
- iDFS
- Evaluated Outcome
- iDFS
- Form(s)
- Form 1
Outcome Data
- DFS Control
- 3-year: 77.0%
- DFS Gain
- 3-year: 11.3%
- DFS HR
- 050 (0.39-0.64)
Final Score (after adjustments)
- Final curative score
- A
- Comment
- EMA (CHMP) November 2019 EC decision January 2021
FDA approval May 2019 - Issue date
- 13.05.2022
- Release date
- 13.05.2022
ChT; chemotherapy; DFS, disease-free survival; DoR, duration of response; EFS, event-free survival; FFS, failure-free survival; HR, hazard ratio; HRD, homologus recombination deficiency; HRP, homologous recombination proficient; iDFS, invasive disease-free survival; ITT, intention to treat; MFS, metastasis-free survival; NS, not significant; ORR, overall response rate; OS, overall survival; pCR, pathologic complete response.remission; PE, point estimate; PFS, progression-free survival; QoL, quality of life; RFS, relapse-free survival; RR, response rate; rPFS, radiographic progression-free survival; SD, stable disease; SSA, somatostatin analogue; SSTR, somatostatin receptor; TKI, tyrosine kinase inhibitor, TTP, time to progression; WT, wild type