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