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 Anchorage, Alaska.

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

Start date
May 20, 2026
Status verified
Jun 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 (5)

FacilityCityStateZIP
Alaska Oncology and Hematology, LlcAnchorageAlaska99508-2974
Cancer Care Specialists For IllinoisO'FallonIllinois62269
Nebraska Cancer SpecialistsOmahaNebraska68130-2042
Astera Cancer Care East BrunswickEast BrunswickNew Jersey08816-4096
Gabrail Cancer Center ResearchCantonOhio44718-2566

Find similar trials in Anchorage, AK

By research site
Alaska Oncology and Hematology, Llc· Anchorage, AKCancer Care Specialists For Illinois· O'Fallon, ILNebraska Cancer Specialists· Omaha, NEAstera Cancer Care East Brunswick· East Brunswick, NJGabrail Cancer Center Research· Canton, OH

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