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.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-511096-15-00

Acronym

D081CC00006

Enrollment

864

Registered

2024-03-15

Start date

2014-08-01

Completion date

Unknown

Last updated

2025-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Brief summary

Invasive Disease Free Survival (IDFS)

Detailed description

Overall survival (OS), Distant Disease Free Survival (DDFS), Incidence of new primary contralateral invasive breast cancer, primary contralateral non-invasive breast cancer, new primary ovarian cancer, new primary fallopian tube cancer and new primary peritoneal cancer, Patient Reported Outcomes from FACIT Fatigue and EORTCQLQ-C30 QoL questionnaires, Determination of BRCA mutation status using current and future BRCA mutation assays (gene sequencing and large rearrangement analysis), Exposure to olaparib (in plasma) in patients receiving olaparib as adjuvant therapy, Safety

Interventions

DRUGLynparza 150 mg film-coated tablets

DRUGPlacebo - film-coated tablets

DRUGLynparza 100 mg film-coated tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Invasive Disease Free Survival (IDFS)	—

Secondary

Measure	Time frame
Overall survival (OS), Distant Disease Free Survival (DDFS), Incidence of new primary contralateral invasive breast cancer, primary contralateral non-invasive breast cancer, new primary ovarian cancer, new primary fallopian tube cancer and new primary peritoneal cancer, Patient Reported Outcomes from FACIT Fatigue and EORTCQLQ-C30 QoL questionnaires, Determination of BRCA mutation status using current and future BRCA mutation assays (gene sequencing and large rearrangement analysis), Exposure to olaparib (in plasma) in patients receiving olaparib as adjuvant therapy, Safety	—

Measure

Time frame

—

Countries

Austria, Belgium, France, Germany, Hungary, Iceland, Italy, Netherlands, Poland, Portugal, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026