3
Indication details
- Combined Agent(s)
- Capecitabine
- Control Arm
- Capecitabine
- 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 approved
- EMA Approval
- EMA approved
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
- 16.2 months
- OS Gain
- 2.6 months
- OS HR
- 0.87 (0.70-1.08) Not significant (mature)
Adjustments
- QoL Comment
-
QoL data pending
Final Score (after adjustments)
- Preliminary non-curative score
-
3
- Final non-curative score
-
3
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 10
- Scorecard version
- 1
- Issue date
- 11.12.2018
- Last update
- 14.08.2023
Legend
Information about symbols, abbrevations and color codes
- 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
Red = negative / deterioration
Green = positive / improvement
Red = negative / deterioration
Green = positive / improvement
Red = negative / deterioration
Green = positive / improvement
* Other adjustments include: