A
Indication details
- Control Arm
- Placebo
- Treatment setting
- Adjuvant treatment of adult patients with germline BRCA1/2-mutations who have HER2-negative, high risk early breast cancer previously treated with neoadjuvant or adjuvant ChT
- Tumour Sub-type
- Early Breast Cancer
- Tumour Stage
- Adjuvant
- Tumour Sub-Group
- gBRCAm HER2-negative
- Trial Name
- OlympiA
- NCT Number
- NCT02032823
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval March 2022
- EMA Approval
- EMA (CHMP) June 2022 EC decicion August 2022
Primary Outcome(s)
- Primary Outcome(s)
- iDFS
- Evaluated Outcome
- iDFS at 4-years
- Form(s)
- Form 1
Outcome Data
- OS Control
- 4-year: 86.4%
- OS Gain
- 4-year: 3.4%
- OS HR
- 0.68 (98.5% CI 0.47-0.97) immature
- DFS Control
- 4-year: 75.4%
- DFS Gain
- 4-year: 7.3%
- DFS HR
- 0.63 (0.50-0.78)
Final Score (after adjustments)
- Final curative score
-
A
- Comment
-
EMA (CHMP) June 2022 EC decision August 2022
FDA approval March 2022
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 331
- Scorecard version
- 1
- Issue date
- 21.04.2022
- Last update
- 10.02.2023
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.