Last reviewed · How we verify
NCT05485766
Novel Neoadjuvant and Adjuvant Strategy for Germline BRCA 1/2 Mutated Triple Negative Breast Cancer
Phase 2 trial testing Pembrolizumab in Triple Negative Breast Neoplasms in 23 participants. Currently enrolling.
30 June 2028
Quick facts
| Lead sponsor | Okayama University |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 23 |
| Start date | 16 July 2024 |
| Primary completion | 30 June 2028 |
| Estimated completion | 30 September 2028 |
| Sites | 3 locations across Japan |
Drugs / interventions tested
- Pembrolizumab (pembrolizumab) — full drug profile →
- Paclitaxel — full drug profile →
- Carboplatin (Carboplatin) — full drug profile →
- Olaparib (olaparib) — full drug profile →
- Definitive Surgery
Conditions studied
- Triple Negative Breast Neoplasms — all drugs for Triple Negative Breast Neoplasms →
- Triple Negative Breast Cancer — all drugs for Triple Negative Breast Cancer →
- Breast Neoplasms — all drugs for Breast Neoplasms →
- Breast Cancer — all drugs for Breast Cancer →
Sponsor
Okayama University
Who can join
18 and older, any sex, with Triple Negative Breast Neoplasms or Triple Negative Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a Phase II, single-arm, open label study to evaluate Olaparib plus Pembrolizumab following platinum-based chemotherapy plus Pembrolizumab as neoadjuvant therapy for germline BRCA (gBRCA) 1/2 mutated triple negative breast cancer (TNBC). Pembrolizumab in combination with weekly paclitaxel and carboplatin (treatment 1) is followed by Pembrolizumab in combination with Olaparib (treatment 2) in neoadjuvant setting and Pembrolizumab in combination with Olaparib in adjuvant setting will be studied
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Current Treatment Landscape for Early Triple-Negative Breast Cancer (TNBC).
Lee J. · · 2023 · cited 83× · PMID 36836059 · DOI 10.3390/jcm12041524 -
BRCA-mutated breast cancer: the unmet need, challenges and therapeutic benefits of genetic testing.
Arun B, Couch FJ, Abraham J, Tung N, et al · · 2024 · cited 46× · PMID 39215191 · DOI 10.1038/s41416-024-02827-z -
Improving efficacy of TNBC immunotherapy: based on analysis and subtyping of immune microenvironment.
Yang Y, Li H, Yang W, Shi Y. · · 2024 · cited 11× · PMID 39430759 · DOI 10.3389/fimmu.2024.1441667 -
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
Verify or expand the search:
- PubMed search for NCT05485766
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Pembrolizumab
Trials testing the same drug.
- NCT07572123 — Evaluating the Addition of Maintenance Immunotherapy Compared to the Usual Treatment of Chemotherapy and Autologous Stem · Phase 2, PHASE3 · not yet recruiting
- NCT07275216 — Pembrolizumab in Combination With Chemotherapy for the Treatment of Frail Hodgkin Lymphoma Patients Ineligible for Stand · Phase 2 · not yet recruiting
- NCT07302347 — A Study of Pembrolizumab in Japanese Pediatric Participants With Solid Tumors or Lymphomas and Japanese Adult Participan · Phase 1, PHASE2 · recruiting
- NCT06724042 — Study of ISM5939 in Patients With Advanced and/or Metastatic Solid Tumors · Phase 1 · not yet recruiting
- NCT07383441 — Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer · Phase 3 · not yet recruiting
Other recruiting trials for Triple Negative Breast Neoplasms
Currently open trials in the same condition.
- NCT06966700 — A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032) · Phase 3 · recruiting
- NCT06841354 — A Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) as Monotherapy and in Combination With Pembrolizumab (MK-3475) in · Phase 3 · recruiting
- NCT06157892 — A Study of Disitamab Vedotin With Other Anticancer Drugs in Solid Tumors · Phase 2 · recruiting
- NCT06385990 — Utidelone (UTD1) Plus Capecitabine in Non-pCR TNBC After Neoadjuvant Therapy · Phase 2 · recruiting
- NCT06246968 — A Study of Pembrolizumab and Cryoablation in People With Breast Cancer · Phase 1 · recruiting
Other Okayama University trials
Trials by the same sponsor.
- NCT03450200 — Effectiveness of Exercises in Patient With Diabetic Peripheral Neuropathy · NA · completed
- NCT03440203 — Prevalence of Peripheral Neuropathy and Its Impact on Activities of Daily Living in Patients With Type 2 Diabetes · completed
- NCT03129568 — Transcoronary Infusion of Cardiac Progenitor Cells in Pediatric Dilated Cardiomyopathy · Phase 1 · completed
- NCT00253786 — Study for the Effectiveness of Intensive Therapy Aiming at a Remission of Diabetic Nephropathy · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05485766 (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 Okayama University
- Last refreshed: 20 March 2025
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/NCT05485766.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing