NCT05851014 is a Phase 3 clinical trial of GB491 combined with Letrozole in Breast Cancer, sponsored by Genor Biopharma Co., Ltd..

Who is sponsoring NCT05851014?

NCT05851014 is sponsored by Genor Biopharma Co., Ltd..

What drugs are being tested in NCT05851014?

Interventions in NCT05851014: GB491 combined with Letrozole, Placebo combined with Letrozole.

What condition does NCT05851014 study?

NCT05851014 studies Breast Cancer.

Is NCT05851014 still recruiting?

NCT05851014 is currently recruiting now. Last updated 9 May 2023.

Last reviewed 2023-05-09 · How we verify

NCT05851014

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

A Study of GB491 in Combination With Letrozole in Patients With HR Positive and HER2 Negative Advanced Breast Cancer

Recruiting now Phase 3 Last updated 9 May 2023

What this trial tests

Phase 3 trial testing GB491 combined with Letrozole in Breast Cancer in 350 participants. Currently enrolling.

Timeline

14 January 2022

Primary endpoint
30 January 2026

30 January 2027

Quick facts

Lead sponsor	Genor Biopharma Co., Ltd.
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	350
Start date	14 January 2022
Primary completion	30 January 2026
Estimated completion	30 January 2027
Sites	52 locations across China

Drugs / interventions tested

GB491 combined with Letrozole — full drug profile →
Placebo combined with Letrozole — full drug profile →

Conditions studied

Breast Cancer — all drugs for Breast Cancer →

Sponsor

Genor Biopharma Co., Ltd. — full company profile →

Who can join

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

Sponsor's own description

The main purpose of this study is to evaluate the efficacy and safety of GB491 combined with Letrozole versus placebo combined with Letrozole in the treatment of HR+/HER2- locally advanced or metastatic breast cancer without prior systemic antitumor therapy

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

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 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 Genor Biopharma Co., Ltd. trials

Trials by the same sponsor.

NCT05860582 — A Study of [14C]GB491 in Male Healthy Subjects · Phase 1 · completed
NCT05332574 — A Safety, Tolerability, PK and Preliminary Activity Study of GB263T in Advanced NSCLC and Other Solid Tumor · Phase 1, PHASE2 · unknown
NCT05054751 — GB491 Combined With Fulvestrant for HR+ HER2- Locally Advanced or Metastatic Breast Cancer · Phase 3 · completed
NCT04923048 — A Safety, Tolerability, Pharmacokinetics and Efficacy Study of GB261 in B-Cell NHL and CLL. · Phase 1, PHASE2 · unknown
NCT05337657 — A Phase Ib Study of GB491 Plus Letrozole in Patients With Advanced Breast Cancer · Phase 1 · 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 NCT05851014 (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 Genor Biopharma Co., Ltd.
Last refreshed: 9 May 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/NCT05851014.

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