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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
Locally recurrent unresectable or metastatic
Combined Agent(s)
Trastuzumab + docetaxel
Control Arm
Trastuzumab + docetaxel + placebo
Treatment Setting
HER2-positive locally recurrent unresectable or metastatic breast cancer with no prior anti-HER2 therapy or ChT for metastatic disease
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
16.3 months
OS HR
0.69 (0.58-0.82)
QoL Comment
No improvement in global QoL

Final Score (after adjustments)

Preliminary non-curative score
4
Final non-curative Score
4
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; 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; SD, stable disease; SSA, somatostatin analogue; SSTR, somatostatin receptor; TKI, tyrosine kinase inhibitor, TTP, time to progression; WT, wild type

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