4
Indication details
- Combined Agent(s)
- Trastuzumab
- Control Arm
- Lapatinib
- FDA Therapeutic Indication
- Treatment of patients with breast cancer, whose tumours overexpress HER2 (ErbB2) in combination with trastuzumab for patients with HR- metastatic disease that has progressed on prior trastuzumab therapy of therapies in combination with ChT
- Tumour Sub-type
- Breast Cancer
- Tumour Stage
- Metastatic
- Tumour Sub-Group
- HER2+ HR-
- Trial Name
- EGF104900
- NCT Number
- NCT00320385
- Trial Phase
- Phase III
Approval details
- FDA Approval
- Not FDA approved
- EMA Approval
- EMA approved June 2013
- Comment
- FDA not approved in combination with trastuzumab
Primary Outcome(s)
- Primary Outcome(s)
- PFS
- Evaluated Outcome
- OS
- Form(s)
- Form 2a
Outcome Data
- PFS Control
- 8.1 weeks
- PFS Gain
- 3.0 weeks
- PFS HR
- 0.74 (0.58-0.94)
- OS Control
- 9.5 months
- OS Gain
- 4.5 months
- OS HR
- 0.74 (0.57-0.97)
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
- 5
- Scorecard version
- 1
- Issue date
- 11.12.2018
- Last update
- 14.08.2023
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.