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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 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1056

Last updated 2026-05-22

No results posted yet for this study

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.

Conditions

  • HR+/HER2- Breast Cancer

Interventions

DRUG

BGB-43395

Administered orally.

DRUG

Letrozole

Administered orally.

DRUG

Abemaciclib

Administered orally.

DRUG

Palbociclib

Administered orally.

DRUG

Ribociclib

Administered orally.

Sponsors & Collaborators

  • BeOne Medicines

    lead INDUSTRY

Principal Investigators

  • Study Director · BeOne Medicines

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-20
Primary Completion
2029-04-30
Completion
2037-08-07
FDA Drug
Yes

Countries

  • Australia

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07492641 on ClinicalTrials.gov