A
Indication details
- Control Arm
- Trastuzumab
- FDA Therapeutic Indication
- Adjuvant treatment of patients with HER2-positive early breast cancer who have residual invasive disease in the breast and/or lymph nodes after neoadjuvant taxane-based and HER2-targeted therapy
- Tumour Sub-type
- Early Breast Cancer
- Tumour Stage
- Adjuvant
- Tumour Sub-Group
- HER2+
- Trial Name
- KATHERINE
- NCT Number
- NCT01772472
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval May 2019
- EMA Approval
- EMA (CHMP) November 2019 EC decision January 2021
Primary Outcome(s)
- Primary Outcome(s)
- iDFS
- Evaluated Outcome
- iDFS
- Form(s)
- Form 1
Outcome Data
- DFS Control
- 3-year: 77.0%
- DFS Gain
- 3-year: 11.3%
- DFS HR
- 050 (0.39-0.64)
Score (after adjustments)
- Curative score
-
A
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 338
- Scorecard version
- 1
- Issue date
- 13.05.2022
- Last update
- 04.12.2023
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.