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Recruiting NCT07492641

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

Phase III Interventional HR+/HER2- Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BGB-43395, Letrozole, Abemaciclib, Palbociclib.
Who it may be relevant to
Registry conditions: HR+/HER2- Breast Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia, China, Japan, Malaysia +3
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

An Open-Label, Randomized, Multicenter Phase 3 Study Investigating the Efficacy and Safety of BGB-43395 Plus Letrozole Versus CDK4/6 Inhibitors (Abemaciclib, Palbociclib, Ribociclib) Plus Letrozole in Patients With Advanced or Metastatic HR+/HER2- Breast Cancer Who Have Not Received Prior Systemic Anticancer Treatment for Advanced or Metastatic Disease

Overview

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.

Interventions

  • Drug BGB-43395
    Administered orally.
  • Drug Letrozole
    Administered orally.
  • Drug Abemaciclib
    Administered orally.
  • Drug Palbociclib
    Administered orally.
  • Drug Ribociclib
    Administered orally.

Primary outcome measures

  • Progression-Free Survival (PFS) Determined by Blinded Independent Central Review (BICR) [Time frame: Up to approximately 4 years]
Secondary outcome measures (9)
  • Overall Survival (OS) [Time frame: Up to approximately 11 years]
  • Overall Response Rate (ORR) [Time frame: Up to approximately 4 years]
  • Duration of Response (DOR) [Time frame: Up to approximately 4 years]
  • PFS Determined by Investigator [Time frame: Up to approximately 4 years]
  • Clinical Benefit Rate (CBR) [Time frame: Up to approximately 4 years]
  • Time to Response (TTR) [Time frame: Up to approximately 4 years]
  • Number of Participants with Adverse Events (AEs) [Time frame: From first dose of study drug up to 30 days after last dose, up to approximately 11 years]
  • Change from Baseline in European Organisation for Research and Treatment of Cancer (EORTC)-Item Library (IL)454. [Time frame: Baseline and up to approximately 4 years]
  • Progression-Free Survival 2 (PFS2) [Time frame: Up to approximately 4 years]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 33 centers
  • Alabama Oncology Princeton — Birmingham
  • Alaska Oncology and Hematology, Llc — Anchorage
  • Ironwood Cancer and Research Centers Chandler Ii — Chandler
  • Genesis Cancer and Blood Institute Hot Springs (Harmony Park) — Hot Springs
  • Helios Clinical Research the Oncology Institute Fountain Valley — Fountain Valley
  • Brcr Coral Springs — Coral Springs
  • Florida Clinical Trials Group Plantation — Plantation
  • Hematology Oncology Associates of the Treasure Coast — Port Saint Lucie
  • … and 25 more centers
South Korea · 25 centers
  • Inje University Haeundae Paik Hospital — HaeundaeGu
  • Dong A University Hospital — Seogu
  • Chungbuk National University Hospital — Cheongju-si
  • Soon Chun Hyang University Cheonan Hospital — Cheonansi
  • Keimyung University Dongsan Hospital — Dalseogu
  • Cha Bundang Medical Center, Cha University — BundangGu SeongnamSi
  • Korea University Ansan Hospital — DanwonGu AnsanSi
  • National Cancer Center (Korea) — IlsandongGu GoyangSi
  • … and 17 more centers
Japan · 11 centers
  • Japan Community Healthcare Organization Kurume General Hospital — Kurumeshi
  • National Hospital Organization Hokkaido Cancer Center — Sapporo
  • Hyogo Medical University Hospital — Nishinomiyashi
  • Social Medical Corporation Hakuaikai Sagara Hospital — Kagoshima
  • Tokai University Hospital — Iseharashi
  • Nippon Medical School Musashi Kosugi Hospital — Kawasakishi
  • Yokohama City University Medical Center — Yokohama
  • Mie University Hospital — Tsu
  • … and 3 more centers
Australia · 7 centers
  • Blacktown Cancer and Haematology Centre — Blacktown
  • Wollongong Hospital — Wollongong
  • Sunshine Coast University Private Hospital — Birtinya
  • Townsville University Hospital — Douglas
  • Peter Maccallum Cancer Centre — Melbourne
  • Fiona Stanley Hospital — Murdoch
  • One Clinical Research — Nedlands
Malaysia · 7 centers
  • Pulau Pinang Hospital — George Town
  • Hospital Wanita Dan Kanak Kanak Sabah (Hospital Likas) — Kota Kinabalu Sabah
  • Hospital Kuala Lumpur — Kuala Lumpur
  • University Malaya Medical Centre — Kuala Lumpur
  • Sarawak General Hospital — Kuching
  • Hospital Picaso — Petaling Jaya
  • National Cancer Institute (Institut Kanser Negara) — Putrajaya
China · 5 centers
  • The Peoples Hospital Affiliated to Fujian University of Traditional Chinese Medicine — Fuzhou
  • Cancer Hospital of Shantou University Medical College — Shantou
  • Guangxi Medical University Cancer Hospital Wuxiang Branch — Nanning
  • Hainan General Hospital — Haikou
  • Fudan University Shanghai Cancer Center — Shanghai
Puerto Rico · 1 center
  • Brcr Global Puerto Rico Hato Rey — San Juan
United Kingdom · 1 center

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07492641 · BGB-43395-302 · 2025-523960-19-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗