NCT04465097 (NeoTEE) is a Phase 2 clinical trial of Tucidinostat in Breast Cancer, sponsored by First Affiliated Hospital, Sun Yat-Sen University.

Who is sponsoring NCT04465097?

NCT04465097 is sponsored by First Affiliated Hospital, Sun Yat-Sen University.

What drugs are being tested in NCT04465097?

Interventions in NCT04465097: Tucidinostat, Exemestane, Ovarian function suppression.

What condition does NCT04465097 study?

NCT04465097 studies Breast Cancer.

Is NCT04465097 still recruiting?

NCT04465097 is currently completed. Last updated 17 October 2023.

Last reviewed 2023-10-17 · How we verify

NCT04465097: NeoTEE

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

Neoadjuvant Tucidinostat and Exemestane in Early Breast Cancer

Completed Phase 2 Last updated 17 October 2023

What this trial tests

Phase 2 trial testing Tucidinostat in Breast Cancer in 30 participants. Completed in 1 October 2023.

Timeline

8 July 2020

Primary endpoint
1 October 2023

1 October 2023

Quick facts

Lead sponsor	First Affiliated Hospital, Sun Yat-Sen University
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	8 July 2020
Primary completion	1 October 2023
Estimated completion	1 October 2023
Sites	1 location across China

Drugs / interventions tested

Tucidinostat — full drug profile →
Exemestane (exemestane) — full drug profile →
Ovarian function suppression — full drug profile →

Conditions studied

Breast Cancer — all drugs for Breast Cancer →

Sponsor

First Affiliated Hospital, Sun Yat-Sen University

Who can join

18 and older, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is to evaluate the efficacy of tucidinostat combined with exemestane as neoadjuvant strategy in estrogen receptor-positive early breast cancer patients and explore the genetic model which can predict neoadjuvant endocrine therapeutic results.

Publications & conference data

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

Therapeutic potential of tucidinostat, a subtype-selective HDAC inhibitor, in cancer treatment.
Sun Y, Hong JH, Ning Z, Pan D, et al · · 2022 · cited 58× · PMID 36120308 · DOI 10.3389/fphar.2022.932914
Short-chain acyl post-translational modifications in cancers: Mechanisms, roles, and therapeutic implications.
Wu T, Zhao Y, Zhang X, Wang Y, et al · · 2025 · cited 23× · PMID 40703012 · DOI 10.1002/cac2.70048
The Present and Future of Clinical Management in Metastatic Breast Cancer.
Lin PH, Laliotis G. · · 2022 · cited 14× · PMID 36233758 · DOI 10.3390/jcm11195891
The Present and Future of Neoadjuvant Endocrine Therapy for Breast Cancer Treatment.
Martí C, Sánchez-Méndez JI. · · 2021 · cited 13× · PMID 34064183 · DOI 10.3390/cancers13112538

Verify or expand the search:

Other trials of Tucidinostat

Trials testing the same drug.

NCT06497985 — A Study of Tucidinostat in Combination With Sintilimab and Bevacizumab in MSS/pMMR Colorectal Cancer Patients · Phase 3 · recruiting
NCT05633914 — Tucidinostat and Nab-paclitaxel in Advanced HR+/HER2- Breast Cancer · Phase 2 · unknown
NCT05411380 — Tucidinostat Combined With Metronomic Capecitabine and Endocrine Therapy for Advanced HR-positive, HER2-negative Breast · Phase 2 · unknown
NCT05559008 — A Umbrella Study in R/R PTCL Guided by Molecular Subtypes · Phase 1, PHASE2 · unknown
NCT05390476 — Tucidinostat and Metronomic Capecitabine for Metastatic Triple-negative Breast Cancer:a Multicenter,Open-label, Randomiz · Phase 2 · unknown

Other recruiting trials for Breast Cancer

Currently open trials in the same condition.

NCT06148038 — CBD for Breast Cancer Primary Tumors · Phase 1 · recruiting
NCT07405801 — A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus R · Phase 2 · recruiting
NCT07285993 — Detection and Outcomes in Metastatic Invasive Lobular Breast Cancer Through Novel F-18 FAP PET · Phase 2 · recruiting
NCT07510698 — Same-Day Awake Mastectomy With Immediate Breast Reconstruction for Patients With Breast Cancer · NA · recruiting
NCT06768931 — Biolosion Combined Standard Neoadjuvant Therapy to Treat Triple-negative Breast Cancer · Phase 2 · recruiting

Other First Affiliated Hospital, Sun Yat-Sen University trials

Trials by the same sponsor.

NCT07322835 — Efficacy and Safety of Reperfusion Therapy for Minor Ischemic Stroke in China · not yet recruiting
NCT07322848 — DEB-TACE vs cTACE in HCC After TIPS · Phase 3 · recruiting
NCT07087418 — AI-Driven Multimodal Imaging Integration for Diagnosis and Prognostication of Digestive System Diseases · recruiting
NCT07014475 — Efficacy of the Ranger Drug-Coated Balloon in Treating BTK Lesions in Patients With CLTI · not yet recruiting
NCT06951334 — Clinical Trial of Vildagliptin in Early Parkinson's Disease · NA · 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 NCT04465097 (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 First Affiliated Hospital, Sun Yat-Sen University
Last refreshed: 17 October 2023

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/NCT04465097.

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