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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
Metastatic
Combined Agent(s)
Trastuzumab + docetaxel
Control Arm
Trastuzumab + docetaxel + placebo
Treatment Setting
1st line metastatic
Trial Name
CLEOPATRA

Primary Outcome(s)

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

Outcome Data

PFS Control
12.4 months
PFS Gain
6.3 months
PFS HR
0.62 (0.52-0.75)
OS Control
40.8 months
OS Gain
15.7 months
OS HR
0.68 (0.56-0.84)
QoL Comment
No improvement

Final Score (after adjustments)

Preliminary non-curative score
4
Final non-curative Score
4
Issue date
11.12.2018
Release date
11.12.2018

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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