2
Indication details
- Combined Agent(s)
- Aromatase inhibitor
- Control Arm
- Placebo + aromatase inhibitor
- Therapeutic Indication
- EMA: First-line treatment of hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer. FDA: Abemaciclib in combination with an aromatase inhibitor as initial endocrine-based therapy for postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer
- Tumour Sub-type
- Breast Cancer
- Tumour Stage
- Locally advanced or metastatic
- Tumour Sub-Group
- HR+, HER2-
- Trial Name
- MONARCH 3
- NCT Number
- NCT02246621
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval February 2018
- EMA Approval
- EMA (CHMP) July 2018 EC decision September 2018
- Comment
- FDA approval (Feb 2018) is for first-line treatment only
Primary Outcome(s)
- Primary Outcome(s)
- PFS. OS as secondary endpoint (ITT)
- Evaluated Outcome
- PFS
- Form(s)
- Form 2b
Outcome Data
- PFS Control
- 14.8 months
- PFS Gain
- 14.2 months
- PFS HR
- 0.54 (0.43-0.67)
- OS Control
- 53.7 months
- OS Gain
- 13.1 months
- OS HR
- 0.80 (0.64-1.02) p=0.0664 NS
Adjustments
- QoL Comment
-
No QoL benefit
- Toxicity Comment
-
>10% increment in discontinuation due to AEs
Score (after adjustments)
- Preliminary non-curative score
-
3
- Only improved PFS mature data shows no OS advantage and no improved QoL
- 1-
- Non-curative score
-
2
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 159
- Scorecard version
- 1
- Issue date
- 20.04.2020
- Last update
- 04.12.2024
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.