2
Indication details
- Combined Agent(s)
- Capecitabine
- Control Arm
- Capecitabine
- FDA Therapeutic Indication
- Treatment of patients with breast cancer, whose tumours overexpress HER2 (ErbB2) in combination with capecitabine for patients with advanced or metastatic disease with progression following prior therapy, which must have included anthracyclines and taxanes and therapy with trastuzumab in the metastatic setting
- Tumour Sub-type
- Breast Cancer
- Tumour Stage
- Advanced or metastatic
- Tumour Sub-Group
- HER2+
- Trial Name
- EGF100151
- NCT Number
- NCT00078572
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval March 2007
- EMA Approval
- EMA approved April 2008
Primary Outcome(s)
- Primary Outcome(s)
- PFS (TTP)
- Evaluated Outcome
- PFS (TTP)
- Form(s)
- Form 2b
Outcome Data
- PFS Control
- 4.3 months
- PFS Gain
- 1.9 months
- PFS HR
- 0.57 (0.43-0.77)
- OS Control
- 14.9 months
- OS Gain
- 2.4 months
- OS HR
- 0.87 (0.70-1.08) Not significant (mature)
Adjustments
- QoL Comment
-
No QoL benefit
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
- Comment
-
Only improved PFS mature data shows no OS advantage and no improved QoL
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 10
- Scorecard version
- 1
- Issue date
- 11.12.2018
- 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.