Who is sponsoring NCT05257395?

NCT05257395 is sponsored by Xuanzhu Biopharmaceutical Co., Ltd..

What drugs are being tested in NCT05257395?

Interventions in NCT05257395: XZP-3287+ Letrozole/Anastrozole, Placebo + Letrozole/Anastrozole.

What condition does NCT05257395 study?

NCT05257395 studies Advanced Breast Cancer.

Is NCT05257395 still recruiting?

NCT05257395 is currently active, enrolled. Last updated 17 July 2025.

Last reviewed 2025-07-17 · How we verify

NCT05257395

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

A Study of XZP-3287 in Combination With Letrozole/Anastrozole in Patients With Advanced Breast Cancer

Active, enrolled Phase 3 Last updated 17 July 2025

What this trial tests

Phase 3 trial testing XZP-3287+ Letrozole/Anastrozole in Advanced Breast Cancer in 397 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

14 March 2022

Primary endpoint
5 December 2025

5 September 2030

Quick facts

Lead sponsor	Xuanzhu Biopharmaceutical Co., Ltd.
Phase	Phase 3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	397
Start date	14 March 2022
Primary completion	5 December 2025
Estimated completion	5 September 2030
Sites	1 location across China

Drugs / interventions tested

XZP-3287+ Letrozole/Anastrozole — full drug profile →
Placebo + Letrozole/Anastrozole — full drug profile →

Conditions studied

Advanced Breast Cancer — all drugs for Advanced Breast Cancer →

Sponsor

Xuanzhu Biopharmaceutical Co., Ltd. — full company profile →

Who can join

Adults 18 to 75, female only, with Advanced Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a Phase III clinical trial designed to evaluate the efficacy and safety of XZP-3287 in combination with Letrozole/Anastrozole versus placebo in combination with Letrozole/Anastrozole in patients with HR-positive and HER2-negative recurrent/metastatic breast cancer who have not received systemic anticancer therapy.

Publications & conference data

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

Bireociclib plus fulvestrant for HR+/HER2- advanced female breast cancer progressed on or after endocrine therapy: phase 3 BRIGHT-2 study interim analysis.
Wang J, Zhang Q, Li H, Tong Z, et al · · 2025 · cited 3× · PMID 40204778 · DOI 10.1038/s41467-025-58647-z
Cell-cycle targeted cancer therapy: clinical advances, biological gaps, and the emergence of selective CDK4 inhibitors.
Safaroghli-Azar A, Mekonnen LB, Lenjisa J, Milne R, et al · · 2026 · PMID 41943159 · DOI 10.1186/s13045-026-01794-7

Verify or expand the search:

Other recruiting trials for Advanced Breast Cancer

Currently open trials in the same condition.

NCT07408089 — Study of the Kinesin Oral Molecular Degrader BBI-940 in Subjects With Advanced or Metastatic Breast Cancer · Phase 1 · recruiting
NCT07318805 — A Study to Learn About the Study Medicine Called PF-08032562 in People With Advanced or Metastatic Solid Tumors · Phase 1 · recruiting
NCT07259226 — Optimal Methods to Characterize ADC Resistance in Solid Tumors and Identify Clinically Useful Biomarkers · Phase 2 · recruiting
NCT06982521 — Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PI · Phase 3 · recruiting
NCT07428655 — Acceptability and Feasibility of PSC Model of Serious Illness Communication · NA · active not recruiting

Other Xuanzhu Biopharmaceutical Co., Ltd. trials

Trials by the same sponsor.

NCT07345689 — A Study of the Pharmacokinetics and Safety of Anaprazole Sodium in Special Populations · Phase 4 · not yet recruiting
NCT07330531 — Drug-drug Interaction Study of Rifampin and Anaprazole Sodium · Phase 4 · not yet recruiting
NCT05586568 — Drug-drug Interaction Study of XZP-3621 Tablet · Phase 1 · unknown
NCT05478109 — A Clinical Trial of XZP-3287 for Material Balance · Phase 1 · unknown
NCT05204628 — A Study to Evaluate and Compare the Efficacy and Safety of XZP-3621 Versus Crizotinib · Phase 3 · unknown

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 NCT05257395 (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 Xuanzhu Biopharmaceutical Co., Ltd.
Last refreshed: 17 July 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/NCT05257395.

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