2
Indication details
- Control Arm
- Treatment of physician's choice
- Therapeutic Indication
- As monotherapy for the treatment of patients with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimens for advanced disease. Prior therapy should have included an anthracycline and taxane unless patients were not suitable for these treatments
- Tumour Sub-type
- Breast Cancer
- Tumour Stage
- Locally advanced or metastatic
- Trial Name
- EMBRACE
- NCT Number
- NCT00388726
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval November 2010
- EMA Approval
- EMA (CHMP) January 2011 EC decision March 2011
- Comment
- FDA approval is after >2 ChT regimes
Primary Outcome(s)
- Primary Outcome(s)
- OS
- Evaluated Outcome
- OS
- Form(s)
- Form 2a
Outcome Data
- OS Control
- 10.6 months
- OS Gain
- 2.5 months
- OS HR
- 0.81 (0.66-0.99)
Final Score (after adjustments)
- Preliminary non-curative score
-
2
- Final non-curative score
-
2
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 13
- 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: