BGB-43395 Plus Letrozole Versus CDK4/6i Plus Letrozole fo... | NCT07492641

Studies
BGB-43395 Plus Letrozole Versus CDK4/6i Plus Letrozole for Patients With Advanced or Metastatic HR+/HER2- Breast Cancer Who Have Not Received Prior Treatment for Advanced or Metastatic Disease

NCT07492641

Sponsor

BeOne Medicines

Status

Recruiting

Last Update Posted

Jul 10, 2026Actual

Enrollment

1,056Estimated

Phase

Phase 3

Conditions

HR+/HER2- Breast Cancer

Interventions

BGB-43395
Letrozole
Abemaciclib
Palbociclib
Ribociclib

Countries

United States
Australia
Japan
Malaysia
South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
2025-523960-19-00	EU Trial (CTIS) Number

Official Title

An Open-Label, Randomized, Multicenter Phase 3 Study Investigating the Efficacy and Safety of BGB-43395 Plus Letrozole Versus CDK4/6 Inhibitors (Abemaciclib, Palbociclib, Ribociclib) Plus Letrozole in Patients With Advanced or Metastatic HR+/HER2- Breast Cancer Who Have Not Received Prior Systemic Anticancer Treatment for Advanced or Metastatic Disease

Status Module

Record Verification Date

Jul 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 22, 2026Actual

Primary Completion Date

Apr 2029Estimated

Completion Date

Aug 7, 2037Estimated

First Submitted Date

Mar 20, 2026

First Submission Date that Met QC Criteria

Mar 20, 2026

First Posted Date

Mar 25, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 9, 2026

Last Update Posted Date

Jul 10, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to investigate the efficacy and safety of BGB-43395 in combination with letrozole compared with investigator's choice of cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) in combination with letrozole in patients with advanced or metastatic hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer (BC) who have not received prior systemic treatment for advanced or metastatic disease.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,056Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm A: BGB-43395 + Letrozole	Experimental	Participants will receive BGB-43395 in combination with letrozole.	Drug: BGB-43395 Drug: Letrozole
Arm B: Cyclin-Dependent Kinase 4/6 Inhibitor + Letrozole	Active Comparator	Participants will receive either abemaciclib, palbociclib, or ribociclib based on the Investigator's choice in combination with letrozole.	Drug: Letrozole Drug: Abemaciclib Drug: Palbociclib Drug: Ribociclib

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BGB-43395	Drug	Administered orally.	Arm A: BGB-43395 + Letrozole
Letrozole

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression-Free Survival (PFS) Determined by Blinded Independent Central Review (BICR)	PFS is defined as the time from first dose until first documentation of progression or death, whichever comes first, as assessed by BICR per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.	Up to approximately 4 years

Secondary Outcomes

Measure	Description	Time Frame
Overall Survival (OS)	OS is defined as the time from the date of randomization until the date of death due to any cause.	Up to approximately 11 years
Overall Response Rate (ORR)	ORR is defined as the percentage of participants who had a complete response (CR) or partial response (PR), as assessed by BICR per RECIST v1.1.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participants must be at least 18 years of age or the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the informed consent.
Participants with histologically confirmed locally advanced or metastatic HR+ HER2- breast cancer.
Participants must have a stable Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1.
Adequate organ function.

Exclusion Criteria:

Participants who have received prior systemic treatment in the advanced or metastatic setting.
Participants who have received prior treatment with any selective cyclin-dependent kinase 4 (CDK4) or cyclin-dependent kinase 2 (CDK2) targeting agent, or any other investigational anticancer drug in any disease setting, except for prior investigational or approved SERDs in the adjuvant setting, provided that disease recurrence occurred more than 12 months after the last dose of endocrine-based therapy.
Participants with active leptomeningeal disease or uncontrolled, untreated brain metastasis.

Note: Other protocol-defined inclusion/exclusion criteria may apply.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Study Director	Contact	877-828-5568		clinicaltrials@beonemed.com

Overall Officials

Name	Affiliation	Role
Study Director	BeOne Medicines	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Alabama Oncology Princeton	Recruiting	Birmingham	Alabama	35211	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved.

BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations.

Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.

Types

Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)

Time Frame

See plan description

Access Criteria

See plan description

URL

https://beonemedicines.com/science/clinical-trials/

ID	Term
D009570	Nitriles
D009930	Organic Chemicals
D014230	Triazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

ID	Term
D000077289	Letrozole
C000590451	abemaciclib
C500026	palbociclib
C000589651	ribociclib