OlympiA (GBG 89)
A randomised, double-blind, parallel group, placebo-controlled multi-centre Phase III study to assess the efficacy and safety of olaparib versus placebo as adjuvant treatment in patients with germline BRCA1/2 mutations and high risk HER2 negative primary breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy
News
Status: Recruitment taget reached
-
17.02.2021 OlympiA trial crossed superiority boundary for invasive disease-free survival
IDMC has concluded that OlympiA trial crossed superiority boundary for invasive disease-free survival vs. placebo at planned interim analysis. OlympiA Phase III trial of Lynparza in the adjuvant treatment of BRCA-mutated HER2-negative high-risk early breast cancer will be analysed and reported early.
Design
This is a randomised, double-blind, parallel group, placebo-controlled multi-centre Phase III study to assess the efficacy and safety of olaparib versus placebo as adjuvant treatment in patients with germline BRCA1/2 mutations and high risk HER2 negative primary breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy.
- Arm A: Olaparib 2X täglich (bis), 300 mg (2X150mg), 600mg/d
- Arm B: Placebo 2Xtäglich (bis), 300 mg (2X150mg), 600mg/d
Patientenprofil:
- Triple Negativ
- Bestätigter BRCA-Status
Kontakt
lympgbgd
Fax: +4961027480440
Projektmanagement
Dr. Ioannis Gkantiragas