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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

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