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
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Osoby powyżej 18 roku życia lub w wieku zgody prawnej.
- •Potwierdzony histopatologicznie zaawansowany lub rozsiany rak piersi HR+/HER2-.
- •Dobry ogólny stan zdrowia (nie więcej niż 1 dzień niesprawności w skali ECOG).
- •Odpowiednia czynność narządów wewnętrznych.
✗ Disqualifies
- •Osoby, które były już leczone systemowo z powodu zaawansowanego lub rozsianego raka piersi.
- •Osoby leczone wcześniej lekami ukierunkowanymi na CDK4 lub CDK2, lub innymi lekami eksperymentalnymi.
- •Osoby z aktywną chorobą opon mózgowych lub nieleczonymi przerzutami do mózgu.
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- June 18, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (30)
Alaska Oncology and Hematology, Llc
Anchorage, United States
Ironwood Cancer and Research Centers Chandler Ii
Chandler, United States
Brcr Coral Springs
Coral Springs, United States
Florida Clinical Trials Group Tamarac
Tamarac, United States
Cancer Care Specialists For Illinois
O'Fallon, United States
Fort Wayne Medical Oncology and Hematology
Fort Wayne, United States
Nebraska Cancer Specialists
Omaha, United States
Astera Cancer Care East Brunswick
East Brunswick, United States
Pardee Cancer Center
Hendersonville, United States
Gabrail Cancer Center Research
Canton, United States
Northwest Medical Specialties
Tacoma, United States
Blacktown Cancer and Haematology Centre
Blacktown, Australia
Wollongong Hospital
Wollongong, Australia
Sunshine Coast University Private Hospital
Birtinya, Australia
Peter Maccallum Cancer Centre
Melbourne, Australia
One Clinical Research
Nedlands, Australia
Cancer Institute Hospital of Jfcr
Kotoku, Japan
Tokyo Womens Medical University Hospital
Shinjukuku, Japan
Hospital Wanita Dan Kanak Kanak Sabah (Hospital Likas)
Kota Kinabalu Sabah, Malaysia
Sarawak General Hospital
Kuching, Malaysia
Inje University Haeundae Paik Hospital
HaeundaeGu, South Korea
Keimyung University Dongsan Hospital
Dalseogu, South Korea
Seoul National University Bundang Hospital
Seongnam-si, South Korea
Inha University Hospital
Junggu, South Korea
Chonnam National University Hwasun Hospital
HwasunGun, South Korea
Severance Hospital Yonsei University Health System
SeodaemunGu, South Korea
Seoul National University Hospital
Seoul, South Korea
Gangnam Severance Hospital, Yonsei University Health System
Seoul, South Korea
Ehwa Womans University Mokdong Hospital
Seoul, South Korea
Asan Medical Center
SongpaGu, South Korea
Trial contact
Study Director
Contact information from ClinicalTrials.gov. Contact in English.
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.