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3
ESMO-MCBS v1.1
Scorecard version: 1

Indication details

Tumour Type
Breast Cancer
Tumour Sub-type
Breast Cancer
Tumour Sub-Group
HR+ HER2-
Tumour stage
Locally advanced or metastatic
Combined Agent(s)
Aromatase inhibitor
Control Arm
Placebo + aromatase inhibitor
Treatment Setting
First-line treatment of hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer
Trial Name
MONARCH 3

Primary Outcome(s)

Primary Outcome(s)
PFS
Evaluated Outcome
PFS
Form(s)
Form 2b

Outcome Data

PFS Control
14.8 months
PFS Gain
13.4 months
PFS HR
0.54 (0.42-0.70)
QoL Comment
QoL not clinically significant

Final Score (after adjustments)

Preliminary non-curative score
3
Final non-curative Score
3
Comment
EMA (CHMP) July 2018 EC decision September 2018, not FDA approved
Issue date
20.04.2020
Release date
20.04.2020
Last update
01.12.2022

ChT; chemotherapy; DFS, disease-free survival; DoR, duration of response; EFS, event-free survival; FFS, failure-free survival; HR, hazard ratio; iDFS, invasive disease-free survival; ITT, intention to treat; MFS, metastasis-free survival; 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; SD, stable disease; SSA, somatostatin analogue; SSTR, somatostatin receptor; TKI, tyrosine kinase inhibitor, TTP, time to progression

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