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BGB-43395 with Letrozole for HR+/HER2- Breast Cancer

This study is for people with advanced or metastatic hormone receptor-positive (HR+) and HER2-negative (HER2-) breast cancer who have not yet received treatment for their advanced disease. It compares a new drug, BGB-43395, combined with letrozole, against standard treatments like abemaciclib, palbociclib, or ribociclib, also combined with letrozole. All these medications are taken by mouth. The main goal is to see how long people live without their cancer growing (Progression-Free Survival). You may be able to join if you are at least 18 years old, have confirmed HR+/HER2- breast cancer, and a good general health status (ECOG Performance Status of ≤ 1). The study plans to enroll 1056 participants, but its current status is unclear.

Study design
This study compares two different treatment approaches for breast cancer. It plans to include 1056 participants, but the phase and whether it's blinded are not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The main outcome, Progression-Free Survival, will be measured for up to approximately 4 years.

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NCT07492641

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
BeOne Medicines
~1,056 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:BGB-43395LetrozoleAbemaciclibPalbociclibRibociclib

At a glance

Recruiting sites
108 of 108 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-Free Survival (PFS) Determined by Blinded Independent Central Review (BICR)
Measured over Up to approximately 4 years

Conditions

HR+/HER2- Breast Cancer

Explore related trials

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Where it's being run

108 sites across 61 states
Seoul Teugbyeolsi10
Malaysia7
Florida5
Gyeonggi-do5
Washington4
Tokyo4
Nebraska3
New South Wales3

Study leadership

  • Study Director · STUDY_DIRECTOR · BeOne Medicines

Who to contact

Study Director
[email protected]
877-828-5568
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Progression-Free Survival (PFS) Determined by Blinded Independent Central Review (BICR)Up to approximately 4 years

    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.