NCT06047184 is a Phase 1 clinical trial of BEBT-209 capsules in Advanced Breast Cancer, sponsored by BeBetter Med Inc.

Who is sponsoring NCT06047184?

NCT06047184 is sponsored by BeBetter Med Inc.

What drugs are being tested in NCT06047184?

Interventions in NCT06047184: BEBT-209 capsules, Letrozole tablets, Fulvestrant.

What condition does NCT06047184 study?

NCT06047184 studies Advanced Breast Cancer.

Is NCT06047184 still recruiting?

NCT06047184 is currently status unknown. Last updated 21 September 2023.

Last reviewed 2023-09-21 · How we verify

NCT06047184

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

Phase I Study of BEBT-209 in Women With Advanced Breast Cancer

Status unknown Phase 1 Last updated 21 September 2023

What this trial tests

Phase 1 trial testing BEBT-209 capsules in Advanced Breast Cancer in 106 participants. Status unknown.

Timeline

15 July 2019

Primary endpoint
20 October 2023

20 November 2023

Quick facts

Lead sponsor	BeBetter Med Inc
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	106
Start date	15 July 2019
Primary completion	20 October 2023
Estimated completion	20 November 2023
Sites	2 locations across China

Drugs / interventions tested

BEBT-209 capsules — full drug profile →
Letrozole tablets — full drug profile →
Fulvestrant (fulvestrant) — full drug profile →

Conditions studied

Advanced Breast Cancer — all drugs for Advanced Breast Cancer →

Sponsor

BeBetter Med Inc — full company profile →

Who can join

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

Sponsor's own description

This clinical study includes a dose escalation trial of BEBT-209 monotherapy in HR +/HER2- advanced breast cancer patients and a Phase 1b trial of BEBT-209 as a single therapy, in combination with letrozole, and in combination with fulvestrant in ER +/HER2- advanced breast cancer in women. To evaluate the safety, tolerability, pharmacokinetic profile, and preliminary efficacy of BEBT-209 as a single therapy, in combination with letrozole, and in combination with fulvestrant. To determine the recommended dose for late clinical studies of monotherapy or combination therapy in patients with HR +/HER2- advanced breast cancer.

Publications & conference data

2 peer-reviewed publications 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
BEBT-209, a primary CDK4 selective inhibitor, for the treatment of HR+/HER2- advanced breast cancer (BECTOP1): a phase 1, multicentre, open-label study.
Hu ZY, Jiang K, Tian C, Zhang F, et al · · 2025 · PMID 40706342 · DOI 10.1016/j.breast.2025.104527

Verify or expand the search:

Other trials of BEBT-209 capsules

Trials testing the same drug.

NCT06685796 — A Study of BEBT-209 in Combination With Chemotherapy for the Treatment of Advanced Triple-Negative Breast Cancer · Phase 2 · recruiting
NCT06998108 — Study of BEBT-209 in Combination With Fulvestrant Versus Placebo in Combination With Fulvestrant in Patients With HR+/HE · Phase 3 · recruiting

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 BeBetter Med Inc trials

Trials by the same sponsor.

NCT07368608 — A Study of BEBT-701 in Patients With Mild to Moderate Hypertension and Elevated Low-Density Lipoprotein Cholesterol（LDL- · Phase 1, PHASE2 · not yet recruiting
NCT07012109 — Study of BEBT-507 Injection in Subjects With Polycythemia Vera (PV) · Phase 1 · not yet recruiting
NCT06792253 — Study Comparing BEBT-908 Combined With R to SOC for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma · Phase 3 · recruiting
NCT06164327 — Study of BEBT-908 Combined With Drugs in the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma · Phase 1 · unknown
NCT06685796 — A Study of BEBT-209 in Combination With Chemotherapy for the Treatment of Advanced Triple-Negative Breast Cancer · Phase 2 · 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 NCT06047184 (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 BeBetter Med Inc
Last refreshed: 21 September 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/NCT06047184.

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