NEB
Indication details
- Control Arm
- Placebo
- Therapeutic Indication
- Extended adjuvant treatment of patients with early-stage hormone receptor-positive HER2-positive breast cancer who completed adjuvant trastuzumab-based therapy
- Tumour Sub-type
- Early Breast Cancer
- Tumour Stage
- Adjuvant
- Tumour Sub-Group
- HR+ HER2+
- Trial Name
- ExteNET
- NCT Number
- NCT00878709
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval July 2017
- EMA Approval
- EMA (CHMP) June 2018 EC decision August 2018
- Comment
- EMA approval is restricted to patients with hormone receptor-positive HER2-positive breast cancer who completed adjuvant trastuzumab-based therapy <1 year. This is based on an unplanned post hoc subgroup analysis and is not eligible for MCBS grading.
Primary Outcome(s)
- Primary Outcome(s)
- iDFS -all
- Evaluated Outcome
- iDFS - No evaluable benefit using ESMO-MCBS v1.1
- Form(s)
- Form 1
Outcome Data
- OS Control
- 8-year: 90.2%
- OS Gain
- 8-year: -0.1%
- OS HR
- 095 (0.75-1.21) Mature OS not significant
- DFS Control
- 5-year:87.7%
- DFS Gain
- 5-year: 2.5%
- DFS HR
- 073 (0.57-0.92)
Adjustments
- QoL Comment
-
After 1st month similar for both arm
- Toxicity Comment
-
Increased grade ≥3 diarrhoea (40% vs 2%)
Score (after adjustments)
- Curative score
-
NEB
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 134
- Scorecard version
- 1
- Issue date
- 05.06.2019
- Last update
- 21.02.2024
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.