NEB
Indication details
- Combined Agent(s)
- Standard adjuvant ChT + 1 year of treatment with trastuzumab
- Control Arm
- Placebo + standard adjuvant ChT + 1 year of treatment with trastuzumab
- Therapeutic Indication
- Adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence (node-positive or hormone receptor-negative disease)
- Tumour Sub-type
- Early Breast Cancer
- Tumour Stage
- Adjuvant
- Tumour Sub-Group
- HER2+
- Trial Name
- APHINITY
- NCT Number
- NCT01358877
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA regular approval December 2017
- EMA Approval
- EMA (CHMP) April 2018 EC decision June 2018
- Comment
- Approval based on patients with node-positive or hormone receptor-negative disease: Node positive show absolute benefit of 4.9% iDFS at 8 years HR 0.72 (0.60-0.87) and 8 year survival gain 1.9% (NS). Hormone-receptor negative patients show absolute benefit of 2.3% iDFS at 8 years HR 0.82 (0.64 to 1.06), no OS data presented.
Primary Outcome(s)
- Primary Outcome(s)
- iDFS
- Evaluated Outcome
- iDFS
- Form(s)
- Form 1
Outcome Data
- OS Control
- 8-year: 92.0%
- OS Gain
- 8-year 0.7%
- OS HR
- NS in the third interim (p=0.078)
- DFS Control
- 8-year: 85.8%
- DFS Gain
- 8-year: 2.6%
- DFS HR
- 0.77 (0.66-0.91) in the ITT population
Adjustments
- QoL Comment
-
QoL data pending
- Toxicity Comment
-
Increased grade 3 diarrhoea (9.8% vs 3.7%)
Score (after adjustments)
- Curative score
-
NEB
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 133
- Scorecard version
- 1
- Issue date
- 05.06.2019
- Last update
- 06.12.2024
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.