2
Indication details
- Combined Agent(s)
- ChT
- Control Arm
- Trastuzumab plus ChT
- FDA Therapeutic Indication
- Treatment of adult patients who have received two or more prior anti-HER2 regimes, at least one of which was for metastatic disease
- Tumour Sub-type
- Breast Cancer
- Tumour Stage
- Metastatic
- Tumour Sub-Group
- HER2+
- Trial Name
- SOPHIA
- NCT Number
- NCT02492711
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval December 2020
- EMA Approval
- Not EMA approved
Primary Outcome(s)
- Primary Outcome(s)
- PFS/OS (ITT)
- Evaluated Outcome
- PFS
- Form(s)
- Form 2b
Outcome Data
- PFS Control
- 4.9 months
- PFS Gain
- 0.9 months
- PFS HR
- 0.76 (0.59-0.98)
- OS Control
- 21.9 months
- OS Gain
- −0.3 months
- OS HR
- 0.95 (0.77-1.17) Not significant
Adjustments
- QoL Comment
-
QoL was not a prespecified endpoint
Score (after adjustments)
- Preliminary non-curative score
-
2
- Non-curative score
-
2
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 242
- Scorecard version
- 1
- Issue date
- 01.03.2021
- 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.