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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
HR+ HER2- node-positive Ki-67 score ≥20%
Tumour stage
Adjuvant
Combined Agent(s)
Standard endocrine therapy (aromatase inhibitors and/or antiestrogens with or without ovarian suppression)
Control Arm
Standard endocrine therapy
Treatment Setting
In combination with endocrine therapy is indicated for the adjuvant treatment of adult patients with hormone receptor positive, HER2- negative, node positive early breast cancer at high risk of recurrence and a Ki-67 score >20% In pre or perimenopausal women, aromatase inhibitor endocrine therapy should be combined with a luteinising hormone-releasing hormone agonist.
Trial Name
monarchE

Primary Outcome(s)

Primary Outcome(s)
iDFS
Evaluated Outcome
iDFS
Form(s)
Form 1

Outcome Data

DFS Control
3-year: 79.0%
DFS Gain
3-year: 7.1%
DFS HR
0.63 (0.49-0.80)

Final Score (after adjustments)

Final curative score
A
Comment
FDA approval October 2021
Issue date
10.12.2021
Release date
10.12.2021
Last update
03.02.2023

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, radiogrpahic 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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