5
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)
- Endocrine therapy
- Control Arm
- Placebo + endocrine therapy
- Treatment Setting
- First-line premenopausal, hormone receptor-positive, HER2-negative advanced breast cancer
- Trial Name
- MONALEESA-7
Primary Outcome(s)
- Primary Outcome(s)
- PFS
- Evaluated Outcome
- OS
- Form(s)
- Form 2a
Outcome Data
- PFS Control
- 13.0 months
- PFS Gain
- 10.8 months
- PFS HR
- 0.55 (0.44-0.69)
- OS Control
- 40.9 months
- OS Gain
- 16 months (Calculated estimate of gain based on PE HR 0.71)
- OS HR
- 0.71 (0.54-0.95)
- QoL Comment
- Delayed deterioration of global QoL
- Toxicity Comment
- Serious adverse effects 18% vs 12%
Final Score (after adjustments)
- Preliminary non-curative score
- 4
- QoL adjustment
- 1+
- Final non-curative Score
- 5
- Issue date
- 20.04.2020
- Release date
- 20.04.2020
- Last update
- 09.05.2022
DFS, disease-free survival; DoR, duration of response; EFS, event-free survival; HR, hazard ratio; iDFS, invasive disease-free survival; ITT, intention to treat; ORR, overall response rate; OS, overall survival; pCR, pathologic complete response/remission; 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