4
Indication details
- Control Arm
- Dacarbazine
- Therapeutic Indication
- Treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation
- Tumour Type
-
Skin Cancers
- Tumour Sub-type
- Cutaneous Melanoma
- Tumour Stage
- Unresectable or metastatic
- Tumour Sub-Group
- BRAF V600E
- Trial Name
- BREAK-3
- NCT Number
- NCT01227889
- Trial Phase
- Phase III
Approval details
- EMA Approval
- EMA (CHMP) June 2013 EC decision August 2013
Primary Outcome(s)
- Primary Outcome(s)
- PFS (crossover allowed)
- Evaluated Outcome
- PFS
- Form(s)
- Form 2b
Outcome Data
- PFS Control
- 2.7 months
- PFS Gain
- 3.8 months
- PFS HR
- 0.30 (0.18-0.51)
Adjustments
- QoL Comment
-
Improved QoL
Score (after adjustments)
- Preliminary non-curative score
-
3
- QoL adjustment
- 1+
- Non-curative score
-
4
- Comment
-
EMA (CHMP) July 2015 EC decision September 2015
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 86
- Scorecard version
- 1
- Issue date
- 11.12.2018
- Last update
- 12.01.2023
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.