Study of Neoadjuvant Olaparib Monotherapy and Olaparib and Durvalumab Combination in HER2 Negative BRCAm Breast Cancer - OlympiaN

Study identifier:D931CC00001

ClinicalTrials.gov identifier:NCT05498155

EudraCT identifier:2021-005231-22

CTIS identifier:N/A

Recruitment Complete

Official 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

Medical condition

Breast Cancer

Phase

Phase 2

Healthy volunteers

No

Study drug

Neoadjuvant Olaparib monotherapy group, Neoadjuvant combination therapy with olaparib plus durvalumab

Sex

All

Actual Enrollment

56

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 07 Nov 2022
Estimated Primary Completion Date: 02 May 2024
Estimated Study Completion Date: 31 Dec 2026

Study design

Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 May 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria