3
Indication details
- Control Arm
- Standard chemotherapy
- Therapeutic Indication
- Treatment of patients with germline BRCA1/2 mutations, who have HER2-negative locally advanced or MBC who have been previously treated with an anthracycline and/or a taxane in the (neo)adjuvant, locally advanced or metastatic setting unless unsuitable for these treatments
- Tumour Sub-type
- Breast Cancer
- Tumour Stage
- Advanced
- Tumour Sub-Group
- HER2- g-BrCa+ve
- Trial Name
- EMBRACA
- NCT Number
- NCT01945775
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval
- EMA Approval
- EMA (CHMP) April 2019 EC decision June 2019
Primary Outcome(s)
- Primary Outcome(s)
- PFS
- Evaluated Outcome
- PFS
- Form(s)
- Form 2b
Outcome Data
- PFS Control
- 5.6 months
- PFS Gain
- 3 months
- PFS HR
- 0.54 (0.41-0.71)
- OS Control
- 19.5 months
- OS Gain
- −0.2 months
- OS HR
- 0.85 (0.67-1.07) Not significant (mature)
Adjustments
- QoL Comment
-
QoL was an exploratory endpoint
Score (after adjustments)
- Preliminary non-curative score
-
3
- Non-curative score
-
3
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 165
- Scorecard version
- 1
- Issue date
- 20.04.2020
- Last update
- 26.04.2024
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: