A
Indication details
- Control Arm
- Chemotherapy
- FDA Therapeutic Indication
- Patients with HER2-positive early breast cancer following surgery, ChT (neoadjuvant or adjuvant) and RT (if applicable)
- Tumour Sub-type
- Early Breast Cancer
- Tumour Stage
- Early
- Tumour Sub-Group
- HER2+
- Trial Name
- HERA
- NCT Number
- NCT00045032
- Trial Phase
- Phase III
Approval details
- EMA Approval
- EC decision May 2006
Primary Outcome(s)
- Primary Outcome(s)
- DFS
- Evaluated Outcome
- DFS
- Form(s)
- Form 1
Outcome Data
- DFS Control
- 2-years DFS 77.4%
- DFS Gain
- 8.40 %
- DFS HR
- 0.54 (0.43-0.67)
Adjustments
- QoL Comment
-
Not qualified for an ESMO-MCBS credit
Score (after adjustments)
- Curative score
-
A
- Comment
-
Licensed biosimilar formulations are available for this medicine and this may improve accessibility and sustainability
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 1
- Scorecard version
- 1
- Issue date
- 11.12.2018
- Last update
- 03.08.2022
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.