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)
- Lapatinib
- Control Arm
- Lapatinib
- Treatment Setting
- 3rd line metastatic
- Trial Name
- EGF104900
Primary Outcome(s)
- Primary Outcome(s)
- PFS
- Evaluated Outcome
- OS
- Form(s)
- Form 2a
Outcome Data
- PFS Control
- 2 months
- PFS Gain
- 1 month
- PFS HR
- 0.73 (0.57-0.93)
- OS Control
- 9.5 months
- OS Gain
- 4.5 months
- OS HR
- 0.74 (0.57-0.97)
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