Recruiting

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

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.

ClinicalTrials.gov IDNCT07492641

PhasePHASE3

Enrollment1056

SponsorBeOne Medicines

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

HR+/HER2- Breast Cancer

About this study

Interventions

Drug: BGB-43395 — Administered orally.
Drug: Letrozole — Administered orally.
Drug: Abemaciclib — Administered orally.
Drug: Palbociclib — Administered orally.
Drug: Ribociclib — Administered orally.

Primary outcomes

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

Eligibility information

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.

Study locations

Alabama Oncology Princeton, Birmingham, Alabama 35211 United States
Alaska Oncology and Hematology, Llc, Anchorage, Alaska 99508-2974 United States
Fairbanks Cancer Care Physicians Pc, Fairbanks, Alaska 99701 United States
Pioneer Research Center, Bullhead City, Arizona 86442 United States
Ironwood Cancer and Research Centers Chandler Ii, Chandler, Arizona 85224-5665 United States
Genesis Cancer and Blood Institute Hot Springs (Harmony Park), Hot Springs, Arkansas 71913 United States
Helios Clinical Research the Oncology Institute Fountain Valley, Fountain Valley, California 92708 United States
California Research Institute, Los Angeles, California 90027 United States
Ventura County Hematology Oncology Specialists, Oxnard, California 93030 United States
Brcr Coral Springs, Coral Springs, Florida 33065 United States

Showing 10 of 162 reported sites. See the official listing for all locations.

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.