C
Indication details
- Combined Agent(s)
- Trastuzumab + docetaxel
- Control Arm
- Trastuzumab + docetaxel
- FDA Therapeutic Indication
- Neo-adjuvant HER2 overexpressed invasive ductal breast
- Tumour Sub-type
- Early Breast Cancer
- Tumour Stage
- Neoadjuvant
- Tumour Sub-Group
- HER2+
- Trial Name
- NeoSphere
- NCT Number
- NCT00545688
- Trial Phase
- Phase II
Approval details
- FDA Approval
- FDA approval October 2013
- EMA Approval
- EMA (CHMP) December 2012 EC decision February 2013
Primary Outcome(s)
- Primary Outcome(s)
- pCR
- Evaluated Outcome
- pCR
- Form(s)
- Form 1
Outcome Data
- PFS HR
- NS
- pCR Control
- 29%
- pCR Gain
- 16.8%
Adjustments
- QoL Comment
-
Not qualified for an ESMO-MCBS credit
Score (after adjustments)
- Curative score
-
C
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 2
- Scorecard version
- 1
- Issue date
- 11.12.2018
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.