NCT05209529 is a Phase 2 clinical trial of olaparib in TNBC - Triple-Negative Breast Cancer, sponsored by European Organisation for Research and Treatment of Cancer - EORTC.

Who is sponsoring NCT05209529?

NCT05209529 is sponsored by European Organisation for Research and Treatment of Cancer - EORTC.

What drugs are being tested in NCT05209529?

Interventions in NCT05209529: olaparib, Durvalumab.

What condition does NCT05209529 study?

NCT05209529 studies TNBC - Triple-Negative Breast Cancer, BRCA1 Mutation, BRCA2 Mutation.

Is NCT05209529 still recruiting?

NCT05209529 is currently withdrawn. Last updated 23 February 2024.

Last reviewed 2024-02-23 · How we verify

NCT05209529

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Chemo-free BRCA-targeted Neoadjuvant Strategy

Withdrawn Phase 2 Last updated 23 February 2024

What this trial tests

Phase 2 trial testing olaparib in TNBC - Triple-Negative Breast Cancer. Withdrawn.

Timeline

1 February 2024

Primary endpoint
6 September 2028

18 July 2030

Quick facts

Lead sponsor	European Organisation for Research and Treatment of Cancer - EORTC
Phase	Phase 2
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Start date	1 February 2024
Primary completion	6 September 2028
Estimated completion	18 July 2030

Drugs / interventions tested

olaparib (olaparib) — full drug profile →
Durvalumab — full drug profile →

Conditions studied

TNBC - Triple-Negative Breast Cancer — all drugs for TNBC - Triple-Negative Breast Cancer →
BRCA1 Mutation — all drugs for BRCA1 Mutation →
BRCA2 Mutation — all drugs for BRCA2 Mutation →

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC — full company profile →

Who can join

18 and older, any sex, with TNBC - Triple-Negative Breast Cancer or BRCA1 Mutation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a multicenter randomized phase ll clinical trial to evaluate the pathological complete response (pCR) in the tumour burden (primary and lymph nodes) with olaparib alone or in the olaparib and durvalumab arm in TNBC patients candidate for neoadjuvant strategy showing a t/gBRCAmut or BRCAness/HRD profile.

Publications & conference data

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

Triple negative breast cancer: Pitfalls and progress.
Zagami P, Carey LA. · · 2022 · cited 546× · PMID 35987766 · DOI 10.1038/s41523-022-00468-0
The role of DNA damage repair (DDR) system in response to immune checkpoint inhibitor (ICI) therapy.
Shi C, Qin K, Lin A, Jiang A, et al · · 2022 · cited 60× · PMID 36071479 · DOI 10.1186/s13046-022-02469-0
Immune-Based Therapy in Triple-Negative Breast Cancer: From Molecular Biology to Clinical Practice.
Carlino F, Diana A, Piccolo A, Ventriglia A, et al · · 2022 · cited 26× · PMID 35565233 · DOI 10.3390/cancers14092102
BRCA Mutations-The Achilles Heel of Breast, Ovarian and Other Epithelial Cancers.
Loboda AP, Adonin LS, Zvereva SD, Guschin DY, et al · · 2023 · cited 18× · PMID 36902416 · DOI 10.3390/ijms24054982
Facts and Hopes in Immunotherapy for Early-Stage Triple-Negative Breast Cancer.
Nederlof I, Voorwerk L, Voorwerk L, Kok M. · · 2023 · cited 13× · PMID 36622327 · DOI 10.1158/1078-0432.ccr-22-0701
Narrative review on the role of immunotherapy in early triple negative breast cancer: unveiling opportunities and overcoming challenges.
Qian K, Liu Q. · · 2023 · cited 6× · PMID 38751461 · DOI 10.21037/tbcr-23-17
The distinct landscape of tumor immune microenvironment in homologous recombination deficient cancers.
Xu Q, Wen Y, Huang T, Li H, et al · · 2025 · cited 1× · PMID 40830526 · DOI 10.1186/s40364-025-00814-x

Verify or expand the search:

Other trials of olaparib

Trials testing the same drug.

NCT05457257 — Clinical Study to Assess the Efficacy and Safety of Olaparib in Chinese Patients With Metastatic Castration-Resistant Pr · Phase 4 · completed
NCT05870423 — Improving Peptide Receptor Radionuclide Therapy With PARP Inhibitors · Phase 1 · recruiting
NCT05158062 — Pembrolizumab and Bevacizumab With Chemotherapy Followed by Pembrolizumab, Bevacizumab and Olaparib in Recurrent Ovarian · Phase 2 · unknown
NCT05171816 — Study on Olaparib Plus Abiraterone as First-line Therapy in Men With Metastatic Castration-resistant Prostate Cancer (Ch · Phase 3 · active not recruiting
NCT04483544 — Pembrolizumab and Olaparib in Cervical Cancer Patients · Phase 2 · terminated

Other recruiting trials for TNBC - Triple-Negative Breast Cancer

Currently open trials in the same condition.

NCT07351487 — Neoadjuvant Chemotherapy Combined With Sintilimab and Bevacizumab for TNBC (NEOTORCH-BREAST07) · Phase 2 · recruiting
NCT06637306 — Neoadjuvant Dupilumab, Pembrolizumab, Paclitaxel, and Carboplatin in Locally Advanced Triple Negative Breast Cancer · EARLY_PHASE1 · recruiting
NCT07046455 — Trop-2 Targeted PET Probes in Advanced TNBC · NA · recruiting
NCT06627712 — SBRT Combined With PD-1 Inhibitor and Chemotherapy in Early-stage TNBC · Phase 3 · recruiting
NCT06534762 — Milaberon in Advanced Solid Tumors: an Open, Multicenter Clinical Study · Phase 2 · recruiting

Other European Organisation for Research and Treatment of Cancer - EORTC trials

Trials by the same sponsor.

NCT07425808 — FLT3-ITD Targeted Therapy in Fit AML Patients · Phase 2, PHASE3 · not yet recruiting
NCT06978062 — Peri-operative Treatment of Resectable Gastroesophageal Cancer Using Bemarituzumab (BEMA) Plus Perioperative Treatment · Phase 1 · not yet recruiting
NCT06809322 — Vorasidenib Maintenance for IDH Mutant Astrocytoma · Phase 3 · recruiting
NCT06990061 — Radiotherapy for BCG-unresponsive Non-muscle-invasive Carcinoma in Situ (CIS) Bladder Cancer: an Open-label, Single-arm, · NA · not yet recruiting
NCT06783348 — Radiopharmaceutical Treatment of Advanced Kidney Cancer · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05209529 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by European Organisation for Research and Treatment of Cancer - EORTC
Last refreshed: 23 February 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05209529.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing