3
Indication details
- Control Arm
- Single arm
- FDA Therapeutic Indication
- Hormone receptor-positive, HER2-negative advanced or metastatic breast cancer with disease progression following ET and prior ChT in the metastatic setting
- Tumour Sub-type
- Breast Cancer
- Tumour Stage
- Advanced or metastatic
- Tumour Sub-Group
- HR+ HER2-
- Trial Name
- MONARCH 1
- NCT Number
- NCT02102490
- Trial Phase
- Phase II
Approval details
- FDA Approval
- FDA approval September 2017
- EMA Approval
- Not EMA approved
Primary Outcome(s)
- Primary Outcome(s)
- ORR
- Evaluated Outcome
- PFS
- Form(s)
- Form 3
Outcome Data
- PFS Control
- 6.0 months
- ORR
- 19.70%
- DoR
- 8.6 months
Score (after adjustments)
- Preliminary non-curative score
-
3
- Non-curative score
-
3
Scorecard details
- Scorecard ID
- 364
- Scorecard version
- 1
- Issue date
- 01.12.2022
- 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.