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4
ESMO-MCBS v1.1
Scorecard version: 1

Indication details

Tumour Type
Breast Cancer
Tumour Sub-type
Breast Cancer
Tumour Sub-Group
HER2+
Tumour stage
Unresectable locally advanced or metastatic
Control Arm
Lapatinib + capecitabine
Treatment Setting
HER2-positive, unresectable locally advanced or metastatic breast cancer who previously received trastuzumab and a taxane (extensive crossover)
Trial Name
EMILIA

Primary Outcome(s)

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

Outcome Data

PFS Control
6.4 months
PFS Gain
3.2 months
PFS HR
0.65 (0.55-0.77)
OS Control
25.1 months
OS Gain
5.8 months
OS HR
0.68 (0.55-0.85)
QoL Comment
Delayed deterioration in global QoL

Final Score (after adjustments)

Preliminary non-curative score
3
Final non-curative Score
4
Early stopping or crossover
1+
Comment
Score derived from form 2b criteria with an upgrade for early stopping based on OS advantage detected at interim analysis. 
Issue date
11.12.2018
Release date
11.12.2018
Last update
09.05.2022

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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