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C
ESMO-MCBS v1.1
Scorecard version: 1

Indication details

Tumour Type
Breast Cancer
Tumour Sub-type
Breast Cancer
Tumour Sub-Group
HER2+
Tumour stage
Early
Combined Agent(s)
Trastuzumab + docetaxel
Control Arm
Trastuzumab + docetaxel (Randomised phase II study)
Treatment Setting
Neo-adjuvant HER2 overexpressed invasive ductal breast
Trial Name
Neo Sphere

Primary Outcome(s)

Primary Outcome(s)
pCR
Evaluated Outcome
pCR
Form(s)
Form 1

Outcome Data

PFS HR
NS
pCR Gain
46% vs 29%

Final Score (after adjustments)

Final curative score
C
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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