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 now · Phase 3

Conditions studied: HR+/HER2- Breast Cancer

In brief

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.

Key facts

Study ID

NCT07492641

Run by

BeOne Medicines

People needed

1056

Starts

2026-05-22

Expected to finish

2037-08-07

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Alaska Oncology and Hematology, Llc — Anchorage, Alaska, United States (enrolling)
• Ironwood Cancer and Research Centers Chandler Ii — Chandler, Arizona, United States (enrolling)
• Genesis Cancer and Blood Institute Hot Springs (Harmony Park) — Hot Springs, Arkansas, United States (enrolling)
• Helios Clinical Research the Oncology Institute Fountain Valley — Fountain Valley, California, United States (enrolling)
• Brcr Coral Springs — Coral Springs, Florida, United States (enrolling)
• Florida Clinical Trials Group Plantation — Plantation, Florida, United States (enrolling)
• Hematology Oncology Associates of the Treasure Coast — Port Saint Lucie, Florida, United States (enrolling)
• Florida Clinical Trials Group Tamarac — Tamarac, Florida, United States (enrolling)
• Hope and Healing Cancer Services — Hinsdale, Illinois, United States (enrolling)
• Cancer Care Specialists For Illinois — OFallon, Illinois, United States (enrolling)
• Fort Wayne Medical Oncology and Hematology — Fort Wayne, Indiana, United States (enrolling)
• Mercy Medical Center — Cedar Rapids, Iowa, United States (enrolling)
• Owensboro Health Mitchell Memorial Cancer Center — Owensboro, Kentucky, United States (enrolling)
• Metro Minnesota Community Oncology Research Consortium (Mmcorc) — Saint Paul, Minnesota, United States (enrolling)
• Nebraska Cancer Specialists St Francis Grand Island — Grand Island, Nebraska, United States (enrolling)
• Cancer Partners of Nebraska April Sampson Cancer Center — Lincoln, Nebraska, United States (enrolling)
• Nebraska Cancer Specialists — Omaha, Nebraska, United States (enrolling)
• Astera Cancer Care East Brunswick — East Brunswick, New Jersey, United States (enrolling)
• Summit Medical Group — Florham Park, New Jersey, United States (enrolling)
• New York Cancer and Blood Specialists — Shirley, New York, United States (enrolling)
• Pardee Cancer Center — Hendersonville, North Carolina, United States (enrolling)
• Carolina Cancer Research Center — Wilson, North Carolina, United States (enrolling)
• Gabrail Cancer Center Research — Canton, Ohio, United States (enrolling)
• Dayton Physicians Network — Dayton, Ohio, United States (enrolling)
• Alabama Oncology Princeton — Birmingham, Alabama, United States (enrolling)

Full record on ClinicalTrials.gov

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