BGB-43395-302
Research type
Research Study
Full 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
IRAS ID
1013972
Contact name
Shehri Lafon
Contact email
Sponsor organisation
BEONE MEDICINES UK, LTD.
Clinicaltrials.gov Identifier
Research summary
Protocol Number: BGB-43395-302
The purpose of this study is to compare the effectiveness (how well a treatment works) and safety of two combinations of anticancer drugs in treating hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer. The first combination is BGB-43395 and letrozole, while the second combination is a cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) in combination with letrozole. BGB-43395 is an oral drug (tablets taken by mouth) that selectively inhibits a protein called cyclin dependent kinase 4 (CDK4). CDK4 is a type of protein that regulates cell growth and division. The CDK4/6i will be either abemaciclib, palbociclib, or ribociclib and will be chosen by the study doctor. The aim of the study is to determine which combination of treatments may be more effective in controlling advanced or metastatic HR+/HER2- breast cancer (breast cancer that has spread beyond the breast, to other parts of the body).
Participants must be at least 18 years old and not previously received CDK4/6 inhibitors to treat advanced or metastatic HR+/HER2- breast cancer.
About 1056 participants will take part in this study globally. In the UK, around 24 participants will take part at approximately 6 study centers.
This study is conducted and funded by BeOne Medicines I GmbH.REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
26/EM/0096
Date of REC Opinion
8 Jun 2026
REC opinion
Further Information Favourable Opinion