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
- Locally advanced or metastatic
- Combined Agent(s)
- Aromatase inhibitor
- Control Arm
- Placebo + aromatase inhibitor
- Treatment Setting
- First-line treatment of hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer
- Trial Name
- MONARCH 3
Primary Outcome(s)
- Primary Outcome(s)
- PFS
- Evaluated Outcome
- PFS
- Form(s)
- Form 2b
Outcome Data
- PFS Control
- 14.8 months
- PFS Gain
- 13.4 months
- PFS HR
- 0.54 (0.42-0.70)
- QoL Comment
- QoL not clinically significant
Final Score (after adjustments)
- Preliminary non-curative score
- 3
- Final non-curative Score
- 3
- Comment
- EMA (CHMP) July 2018 EC decision September 2018, not FDA approved
- Issue date
- 20.04.2020
- Release date
- 20.04.2020
- Last update
- 01.12.2022
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