4
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
- Advanced
- Combined Agent(s)
- Letrozole
- Control Arm
- Letrozole + placebo
- Treatment Setting
- First-line postmenopausal, hormone receptor-positive, HER2-negative advanced breast cancer
- Trial Name
- MONALEESA-2
Primary Outcome(s)
- Primary Outcome(s)
- PFS
- Evaluated Outcome
- OS
- Form(s)
- Form 2a
Outcome Data
- PFS Control
- 16 months
- PFS Gain
- 9.3 months
- PFS HR
- 0.57 (0.46-0.70)
- OS Control
- 51.4 months
- OS Gain
- 12.5 months
- OS HR
- 0.76 (0.63-0.93)
- QoL Comment
- No global QoL benefit observed
Final Score (after adjustments)
- Preliminary non-curative score
- 4
- Final non-curative Score
- 4
- Comment
- EMA approval June 2017 EC decision August 2017
FDA approval March 2017 - Issue date
- 11.12.2018
- Release date
- 11.12.2018
- Last update
- 09.05.2022
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