NCT05430399 is a Phase 3 clinical trial of utidelone in Breast Neoplasms, sponsored by Sun Yat-sen University.

Who is sponsoring NCT05430399?

NCT05430399 is sponsored by Sun Yat-sen University.

What drugs are being tested in NCT05430399?

Interventions in NCT05430399: utidelone, docetaxel.

What condition does NCT05430399 study?

NCT05430399 studies Breast Neoplasms, Locally Advanced or Metastatic Breast Cancer.

Is NCT05430399 still recruiting?

NCT05430399 is currently recruiting now. Last updated 13 July 2023.

Last reviewed 2023-07-13 · How we verify

NCT05430399

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

Utidelone Versus Docetaxel in HER2-negative Locally Advanced or Metastatic Breast Cancer

Recruiting now Phase 3 Last updated 13 July 2023

What this trial tests

Phase 3 trial testing utidelone in Breast Neoplasms in 349 participants. Currently enrolling.

Timeline

21 June 2022

Primary endpoint
1 June 2025

1 June 2027

Quick facts

Lead sponsor	Sun Yat-sen University
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	349
Start date	21 June 2022
Primary completion	1 June 2025
Estimated completion	1 June 2027
Sites	2 locations across China

Drugs / interventions tested

utidelone — full drug profile →
docetaxel (Docetaxel) — full drug profile →

Conditions studied

Breast Neoplasms — all drugs for Breast Neoplasms →
Locally Advanced or Metastatic Breast Cancer — all drugs for Locally Advanced or Metastatic Breast Cancer →

Sponsor

Sun Yat-sen University

Who can join

18 and older, female only, with Breast Neoplasms or Locally Advanced or Metastatic Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

It is a phase III trial to explore the efficacy and safety of utidelone versus docetaxel in HER2-negative locally advanced or metastatic breast cancer.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of utidelone

Trials testing the same drug.

NCT06510465 — Neoadjuvant Therapy With Weekly Utidelone Combined With Cisplatin for Patients With Breast Cancer (NeoURANIA) · Phase 2 · not yet recruiting
NCT05403333 — Weekly Utidelone in HER2-negative Inoperable Locally Advanced or Metastatic Breast Cancer · Phase 2 · unknown

Other recruiting trials for Breast Neoplasms

Currently open trials in the same condition.

NCT07214532 — Signatera-Guided CDK4/6 Inhibitor Therapy in Breast Cancer · NA · recruiting
NCT07500428 — Construction of a Benchmark for Breast Ultrasound AI Interpretation and Performance Evaluation of Multimodal AI Models · recruiting
NCT07581834 — Efficacy and Safety of Dalpiciclib Combined With Endocrine Adjuvant Therapy for Early HR +/HER2- Breast Cancer: a Multic · Phase 2 · recruiting
NCT07222215 — PhII Randomized CAPecitabine + ELAcestrant vs. Capecitabine Alone in ER+ Breast Cancer (CAPELA) · Phase 2 · recruiting
NCT07465393 — Facility-Based Multi-Modal Rehab vs. Home-Based Resistance Exercise for Quality of Life in Breast Cancer Survivors · NA · recruiting

Other Sun Yat-sen University trials

Trials by the same sponsor.

NCT07255612 — Bone Marrow Protection, Safety, Efficacy of Trilaciclib and Eribulin in Locally Advanced or Metastatic TNBC(Triple-negat · Phase 2 · not yet recruiting
NCT07371897 — Toripalimab ± Chemo as Neoadjuvant Therapy in LA-HNSCC: A Phase III Trial · Phase 3 · not yet recruiting
NCT07489703 — SHR-A1811 + AK112 in HER2-Altered Advanced/Metastatic NSCLC · Phase 2 · not yet recruiting
NCT07528209 — Neoadjuvant CAPOX With or Without Pucotenlimab Plus Selective Radiotherapy for Locally Advanced Rectal Cancer · Phase 3 · recruiting
NCT07522281 — Evaluation of an Undisturbed Embryo Culture System for Embryo Development in IVF/ICSI Cycles · 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 NCT05430399 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Sun Yat-sen University
Last refreshed: 13 July 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/NCT05430399.

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