3
ESMO-MCBS v1.1
Scorecard version: 1
Indication details
- Tumour Type
- Breast Cancer
- Tumour Sub-type
- Breast Cancer
- Tumour Sub-Group
- HR+ HER2-
- Tumour stage
- Metastatic
- Combined Agent(s)
- Letrozole
- Control Arm
- Letrozole (Randomised phase II study)
- Treatment Setting
- 1st line metastatic HR+ HER2-
- Trial Name
- PALOMA-1/TRIO-18
Primary Outcome(s)
- Primary Outcome(s)
- PFS
- Evaluated Outcome
- PFS
- Form(s)
- Form 2b
Outcome Data
- PFS Control
- 10.2 months
- PFS Gain
- 10 months
- PFS HR
- 0.49 (0.32-0.75)
- OS Control
- 33.3 months
- OS Gain
- 4.2 months
- OS HR
- Not significant
Final Score (after adjustments)
- Preliminary non-curative score
- 3
- Final non-curative Score
- 3
- 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