4
Indication details
- Combined Agent(s)
- Fulvestrant
- Control Arm
- Fulvestrant + placebo
- 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
- Locally advanced or metastatic
- Tumour Sub-Group
- HR+ HER2-
- Trial Name
- MONARCH 2
- NCT Number
- NCT02107703
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval September 2017
- EMA Approval
- EMA (CHMP) July 2018 EC decision September 2018
- Comment
- EMA approval (July 2018) includes both first- and second-line treatment
Primary Outcome(s)
- Primary Outcome(s)
- PFS
- Evaluated Outcome
- OS
- Form(s)
- Form 2a
Outcome Data
- PFS Control
- 9.3 months
- PFS Gain
- 7.1 months
- PFS HR
- 0.55 (0.45-0.68)
- OS Control
- 37.3 months
- OS Gain
- 9.4 months
- OS HR
- 0.76 (0.61-0.95)
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
- 160
- Scorecard version
- 1
- Issue date
- 20.04.2020
- 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.