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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

RecruitingPhase 3

Sponsor: BeOne Medicines

Conditions: HR+/HER2- Breast Cancer

Interventions: BGB-43395, Letrozole, Abemaciclib, Palbociclib, Ribociclib

Countries: United States, Australia, China, Japan, Malaysia, Puerto Rico, South Korea

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (74)

Birmingham, Alabama, United States
Anchorage, Alaska, United States
Chandler, Arizona, United States
Fountain Valley, California, United States
Coral Springs, Florida, United States
Plantation, Florida, United States
Port Saint Lucie, Florida, United States
Tamarac, Florida, United States
Hinsdale, Illinois, United States
O'Fallon, Illinois, United States
Fort Wayne, Indiana, United States
Owensboro, Kentucky, United States
Grand Island, Nebraska, United States
Lincoln, Nebraska, United States
Omaha, Nebraska, United States
East Brunswick, New Jersey, United States
Florham Park, New Jersey, United States
Hendersonville, North Carolina, United States
Wilson, North Carolina, United States
Canton, Ohio, United States
Dayton, Ohio, United States
Salem, Oregon, United States
West Reading, Pennsylvania, United States
Richmond, Virginia, United States
Tacoma, Washington, United States
Blacktown, New South Wales, Australia
Wollongong, New South Wales, Australia
Birtinya, Queensland, Australia
Douglas, Queensland, Australia
Melbourne, Victoria, Australia
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