4
Indication details
- Control Arm
- Lapatinib + capecitabine
- FDA Therapeutic Indication
- As a single agent for the treatment of adult patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Patients should have either received prior therapy for locally advanced or metastatic disease, or developed disease recurrence during or within six months of completing adjuvant therapy
- Tumour Sub-type
- Breast Cancer
- Tumour Stage
- Unresectable locally advanced or metastatic
- Tumour Sub-Group
- HER2+
- Trial Name
- EMILIA
- NCT Number
- NCT00829166
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval February 2013
- EMA Approval
- EMA (CHMP) September 2013 EC decision November 2013
Primary Outcome(s)
- Primary Outcome(s)
- PFS and OS
- Evaluated Outcome
- PFS
- Form(s)
- Form 2b
Outcome Data
- PFS Control
- 6.4 months
- PFS Gain
- 3.2 months
- PFS HR
- 0.65 (0.55-0.77)
- OS Control
- 25.1 months
- OS Gain
- 5.8 months
- OS HR
- 0.68 (0.55-0.85)
Adjustments
- QoL Comment
-
Delayed deterioration in global QoL
Score (after adjustments)
- Preliminary non-curative score
-
3
- Early stopping or crossover
- Score derived from form 2b criteria with an upgrade for early stopping based on OS advantage detected at interim analysis
- QoL adjustment
- 1+
- Non-curative score
-
4
- Comment
-
EMA (CHMP) September 2013 EC decision November 2013
FDA approval February 2013
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 3
- Scorecard version
- 1
- Issue date
- 11.12.2018
- Last update
- 02.03.2023
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.