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
- Early
- Combined Agent(s)
- Standard adjuvant chemotherapy + 1 year of treatment with trastuzumab
- Control Arm
- Placebo + standard adjuvant chemotherapy + 1 year of treatment with trastuzumab
- Treatment Setting
- Adjuvant early HER2+
- 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
- 88.10%
- DFS Gain
- 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)
- Release date
- 05.06.2019
- Last update
- 29.03.2021
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