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A
ESMO-MCBS v1.1
Scorecard version: 1

Indication details

Tumour Type
Breast Cancer
Tumour Sub-type
Breast Cancer
Tumour Sub-Group
HER2+
Tumour stage
Adjuvant
Combined Agent(s)
Standard adjuvant ChT + 1 year of treatment with trastuzumab
Control Arm
Placebo + standard adjuvant ChT + 1 year of treatment with trastuzumab
Treatment Setting
Adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence
Trial Name
APHINITY

Primary Outcome(s)

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

Outcome Data

OS Control
94%
OS Gain
1%
OS HR
NS in the second interim
DFS Control
6-year: 88.10%
DFS Gain
6-year: 2.90%
DFS HR
0.76 (0.64-0.91) in the ITT population
Toxicity Comment
Increased grade 3 diarrhoea (9.8% vs 3.7%)

Final Score (after adjustments)

Final curative score
A
Comment
Node positive show 4.5% IDFS gain 83.4 vs 87.9% at 6 years 0.72 (0.59-0.82)

EMA (CHMP) April 2018 EC decision June 2018
FDA regular approval December 2017
Release date
05.06.2019
Last update
13.05.2022

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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