A
ESMO-MCBS v1.1
Scorecard version: 1
Indication details
- Tumour Type
- Breast Cancer
- Tumour Sub-type
- Early Breast Cancer
- Tumour Sub-Group
- gBRCAm HER2-negative
- Tumour stage
- Adjuvant
- 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
- Trial Name
- OlympiA
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 - Issue date
- 21.04.2022
- Release date
- 21.04.2022
- Last update
- 10.02.2023
ChT; chemotherapy; DFS, disease-free survival; DoR, duration of response; EFS, event-free survival; FFS, failure-free survival; HR, hazard ratio; HRD, homologus recombination deficiency; HRP, homologous recombination proficient; iDFS, invasive disease-free survival; ITT, intention to treat; MFS, metastasis-free survival; NS, not significant; ORR, overall response rate; OS, overall survival; pCR, pathologic complete response/remission; PE, point estimate; PFS, progression-free survival; QoL, quality of life; RFS, relapse-free survival; RR, response rate; rPFS, radiographic progression-free survival; SD, stable disease; SSA, somatostatin analogue; SSTR, somatostatin receptor; TKI, tyrosine kinase inhibitor, TTP, time to progression; WT, wild type