4
Indication details
- Combined Agent(s)
- Letrozole
- Control Arm
- Letrozole + placebo
- FDA Therapeutic Indication
- Treatment of women with hormone receptor-positive, HER2-negative locally advanced or MBC as initial endocrine-based therapy, or in women who have received prior ET
- Tumour Sub-type
- Breast Cancer
- Tumour Stage
- Advanced
- Tumour Sub-Group
- HR+ HER2-
- Trial Name
- MONALEESA-2
- NCT Number
- NCT01958021
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval March 2017
- EMA Approval
- EMA approval June 2017 EC decision August 2017
- Comment
- FDA approval (March 2017) is specifically for first-line treatment only
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)
Adjustments
- QoL Comment
-
No QoL benefit
Score (after adjustments)
- Preliminary non-curative score
-
4
- Non-curative score
-
4
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 9
- Scorecard version
- 1
- Issue date
- 11.12.2018
- Last update
- 25.04.2024
Legend
Information about symbols, abbrevations and color codes
Red = negative
Green = positive
Grey = neutral
?
Grey + ? = neutral with pending data
- DFS
- Disease-Free Survival
- DoR
- Duration of Response
- EFS
- Event-Free Survival
- HR
- Hazard Ratio
- NEB
- No evaluable benefit
- NI
- Non-inferiority Study
- ORR
- Overall Response Rate
- OS
- Overall Surival
- pCR
- Pathological Complete Response/Remission
- PFS
- Progression-Free Survival
- QoL
- Quality of Life
- RFS
- Relapse-Free Survival
- RR
- Response Rate
QoL adjustments
Other adjustments*
Serious and disabling adverse effects
Red = negative / deterioration
Green = positive / improvement
QoL adjustments
Red = negative / deterioration
Green = positive / improvement
Other adjustments*
Red = negative / deterioration
Green = positive / improvement
Serious and disabling adverse effects
Red = negative / deterioration
Green = positive / improvement
* Other adjustments include:
- Long-term plateau in the survival curve
- Long-term plateau in the PFS curve
- Early stopping or crossover
- Only improved PFS mature data shows no OS advantage and no improved Qol.