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5
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
Advanced
Combined Agent(s)
Endocrine therapy
Control Arm
Placebo + endocrine therapy
Treatment Setting
1st line premenopausal HR+, HER2-
Trial Name
MONALEESA-7

Primary Outcome(s)

Primary Outcome(s)
PFS
Evaluated Outcome
OS
Form(s)
Form 2a

Outcome Data

PFS Control
13.0 months
PFS Gain
10.8 months
PFS HR
0.55 (0.44-0.69)
OS Control
40.9 months
OS Gain
16 months (Calculated estimate of gain based on PE HR 0.71)
OS HR
0.71 (0.54-0.95)
QoL Comment
Delayed deterioration
Toxicity Comment
Serious adverse effects 18% vs 12%

Final Score (after adjustments)

Preliminary non-curative score
4
QoL adjustment
1+
Final non-curative Score
5
Issue date
20.04.2020
Release date
20.04.2020
Last update
21.08.2020

DFS, disease-free survival; DoR, duration of response; EFS, event-free survival; HR, hazard ratio; iDFS, invasive disease-free survival; ITT, intention to treat; ORR, overall response rate; OS, overall survival; pCR, pathologic complete response/remission; 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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