OlympiaN
Research type
Research Study
Full title
A Phase II, Multicentre, Open-Label Study to Assess the Efficacy and Safety of Olaparib Monotherapy and Olaparib Plus Durvalumab Combination as Neoadjuvant Therapy in Patients with BRCA Mutations and Early Stage HER2-Negative Breast Cancer (OlympiaN)
IRAS ID
1005728
Contact name
Maria Nieto-Gutierrez
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2021-005231-22
Research summary
The purpose of this study is to find out the efficacy of olaparib monotherapy and olaparib plus durvalumab combination therapy on patients with BRCA mutations and early stage HER2 negative breast cancer and also to better understand the studied disease, breast cancer, and associated health problems.
The research study is planned to go on for 3 years. About 50 participants in approximately 65 sites in 10 countries are due to take part. Study participation will last approximately 3 years. There will be a minimum of (approximately) 28 study visits for the patient. Procedures will include but not limited to physical examination, blood tests, biopsy collection, breast MRI scan and tumor imaging (chest x-ray, CT or MRI scan).
Astrazeneca are funding the research.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
22/NE/0138
Date of REC Opinion
11 Oct 2022
REC opinion
Further Information Favourable Opinion