NCT05498155: OlympiaN

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

Active, enrolled Phase 2 Last updated 10 June 2025

What this trial tests

Phase 2 trial testing Neoadjuvant Olaparib monotherapy group in Breast Cancer in 50 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

7 November 2022

Primary endpoint
20 November 2024

31 December 2026

Quick facts

Lead sponsor	AstraZeneca
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	7 November 2022
Primary completion	20 November 2024
Estimated completion	31 December 2026
Sites	37 locations across Italy, Belgium, Austria, United Kingdom, Germany, Israel, Australia, United States

Drugs / interventions tested

• Neoadjuvant Olaparib monotherapy group — full drug profile →
• Neoadjuvant combination therapy with olaparib plus durvalumab

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →

Sponsor

AstraZeneca — full company profile →

Who can join

Adults 18 to 130, any sex, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study to learn more about olaparib and olaparib plus durvalumab combination therapy and also to better understand the studied disease, breast cancer, and associated health problems.

Olaparib is a type of drug called a PARP (poly \[adenosine diphosphate-ribose\] polymerase) inhibitor. PARP inhibitors can destroy cancer cells that are not good at repairing DNA damage. Olaparib is also approved by US Food and Drug Administration (FDA), European Medicines Agency (EMA) and in other countries for treating women with BRCA-mutated, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer.

Durvalumab is a type of anticancer drug called immunotherapy that targets cancer cells by blocking the signal that prevents the immune system from seeing the cancer cell. Your immune system can then attack and kill the cancer cells. Durvalumab is approved by the FDA and the EMA for the treatment of patients with locally advanced non-small cell lung cancer after receiving chemoradiation therapy and extensive-stage small cell lung cancer in combination with chemotherapy.

Some parts of this study are experimental, which means that durvalumab and the combination of olaparib and durvalumab are still in the development stage for the treatment of breast cancer, and they are not approved for treatment of breast cancer, except for use in research studies like this.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. BRCA genetic testing and counseling in breast cancer: how do we meet our patients' needs?
   Dubsky P, Jackisch C, Im SA, Hunt KK, et al · · 2024 · cited 19× · PMID 39237557 · DOI 10.1038/s41523-024-00686-8
2. Exploiting DNA Replication Stress as a Therapeutic Strategy for Breast Cancer.
   Zhang J, Chan DW, Lin SY. · · 2022 · cited 12× · PMID 36359297 · DOI 10.3390/biomedicines10112775
3. Therapeutic advances and application of PARP inhibitors in breast cancer.
   Zhou T, Zhang J. · · 2025 · cited 9× · PMID 40359851 · DOI 10.1016/j.tranon.2025.102410
4. PARP Inhibitors in the Neoadjuvant Setting; A Comprehensive Overview of the Rationale for their Use, Past and Ongoing Clinical Trials.
   Habaka M, Daly GR, Shinyanbola D, Alabdulrahman M, et al · · 2025 · cited 9× · PMID 40192976 · DOI 10.1007/s11912-025-01669-z
5. The impact of germline BRCA pathogenic variants in locally advanced, triple negative breast cancer treated with platinum-based neoadjuvant chemotherapy.
   Mutai R, Kuchuk I, Goldshtein A, Yerushalmi R, et al · · 2024 · cited 4× · PMID 38345692 · DOI 10.1007/s10549-024-07247-4
6. Therapeutic applications of germline testing for cancer predisposition genes in Asia in the real world.
   Cheo SW, Ong PY, Ow SGW, Chan GHJ, et al · · 2024 · cited 3× · PMID 38833967 · DOI 10.1016/j.esmoop.2024.103482
7. Computational reactive-diffusive modeling for stratification and prognosis determination of patients with breast cancer receiving Olaparib.
   Schettini F, De Bonis MV, Strina C, Milani M, et al · · 2023 · cited 2× · PMID 37488154 · DOI 10.1038/s41598-023-38760-z
8. Neoadjuvant Immunotherapy in Hormone Receptor-Positive Breast Cancer: From Tumor Microenvironment Reprogramming to Combination Therapy Strategies.
   Tang Z, Huang T, Yang T. · · 2025 · PMID 41373749 · DOI 10.3390/ijms262311596