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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
BeOne Medicines
Study ID
NCT07492641
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • HR+/HER2- Breast Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BGB-43395 — DRUG
    Administered orally.
  • Letrozole — DRUG
    Administered orally.
  • Abemaciclib — DRUG
    Administered orally.
  • Palbociclib — DRUG
    Administered orally.
  • Ribociclib — DRUG
    Administered orally.

Study Details

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 Dates

First listed
Mar 25, 2026
Start date
May 22, 2026
Status verified
Jul 2026
Primary completion
Apr 30, 2029
Completion
Aug 7, 2037

Study Design

Enrollment
1,056 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: BGB-43395 + Letrozole
    Participants will receive BGB-43395 in combination with letrozole.
  • Active Comparator: Arm B: Cyclin-Dependent Kinase 4/6 Inhibitor + Letrozole
    Participants will receive either abemaciclib, palbociclib, or ribociclib based on the Investigator's choice in combination with letrozole.

Primary Outcome Measure

Progression-Free Survival (PFS) Determined by Blinded Independent Central Review (BICR) [ Time Frame: Up to approximately 4 years ]

Central Contacts

Locations (21)

FacilityCityStateZIPSite coordinators
Alabama Oncology PrincetonBirminghamAlabama35211-
Alaska Oncology and Hematology, LlcAnchorageAlaska99508-2974-
Ironwood Cancer and Research Centers Chandler IiChandlerArizona85224-5665-
Helios Clinical Research the Oncology Institute Fountain ValleyFountain ValleyCalifornia92708-
Brcr Coral SpringsCoral SpringsFlorida33065-
Florida Clinical Trials Group PlantationPlantationFlorida33322-
Florida Clinical Trials Group TamaracTamaracFlorida33321-
Hope and Healing Cancer ServicesHinsdaleIllinois60521-0509-
Cancer Care Specialists For IllinoisO'FallonIllinois62269-
Fort Wayne Medical Oncology and HematologyFort WayneIndiana46804-
Owensboro Health Mitchell Memorial Cancer CenterOwensboroKentucky42303-
Cancer Partners of Nebraska April Sampson Cancer CenterLincolnNebraska68516-
Nebraska Cancer SpecialistsOmahaNebraska68130-2042-
Astera Cancer Care East BrunswickEast BrunswickNew Jersey08816-4096-
Summit Medical GroupFlorham ParkNew Jersey07932-1049-
Pardee Cancer CenterHendersonvilleNorth Carolina28739-
Carolina Cancer Research CenterWilsonNorth Carolina27896-
Gabrail Cancer Center ResearchCantonOhio44718-2566-
Dayton Physicians NetworkDaytonOhio45409-
McGlinn Cancer InstituteWest ReadingPennsylvania19611-2143-
Northwest Medical SpecialtiesTacomaWashington98405-

Find similar trials in Birmingham, AL

By research site
Alabama Oncology Princeton· Birmingham, ALAlaska Oncology and Hematology, Llc· Anchorage, AKIronwood Cancer and Research Centers Chandler Ii· Chandler, AZHelios Clinical Research the Oncology Institute Fountain Valley· Fountain Valley, CABrcr Coral Springs· Coral Springs, FLFlorida Clinical Trials Group Plantation· Plantation, FL

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