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

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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)
August 19, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (108)

Alabama Oncology Princeton

Birmingham, United States

Alaska Oncology and Hematology, Llc

Anchorage, United States

Ironwood Cancer and Research Centers Chandler Ii

Chandler, United States

Genesis Cancer and Blood Institute Hot Springs (Harmony Park)

Hot Springs, United States

Helios Clinical Research the Oncology Institute Fountain Valley

Fountain Valley, United States

Ventura County Hematology Oncology Specialists

Oxnard, United States

Brcr Coral Springs

Coral Springs, United States

Mid Florida Hematology and Oncology Center

Orange City, United States

Florida Clinical Trials Group Plantation

Plantation, United States

Hematology Oncology Associates of the Treasure Coast

Port Saint Lucie, United States

Florida Clinical Trials Group Tamarac

Tamarac, United States

Hope and Healing Cancer Services

Hinsdale, United States

Cancer Care Specialists For Illinois

OFallon, United States

Fort Wayne Medical Oncology and Hematology

Fort Wayne, United States

Mercy Medical Center

Cedar Rapids, United States

Owensboro Health Mitchell Memorial Cancer Center

Owensboro, United States

Metro Minnesota Community Oncology Research Consortium (Mmcorc)

Saint Paul, United States

Nebraska Cancer Specialists St Francis Grand Island

Grand Island, United States

Cancer Partners of Nebraska April Sampson Cancer Center

Lincoln, United States

Nebraska Cancer Specialists

Omaha, United States

Renown Regional Medical Center

Reno, United States

Astera Cancer Care East Brunswick

East Brunswick, United States

Summit Medical Group

Florham Park, United States

New York Cancer and Blood Specialists

Shirley, United States

Pardee Cancer Center

Hendersonville, United States

Carolina Cancer Research Center

Wilson, United States

Gabrail Cancer Center Research

Canton, United States

Dayton Physicians Network

Dayton, United States

Oregon Oncology Specialists

Salem, United States

McGlinn Cancer Institute

West Reading, United States

Ballad Health Cancer Center Kingsport

Kingsport, United States

Virginia Cancer Institute

Richmond, United States

Multicare Cancer Institute Deaconess Medical Office Building 1

Spokane, United States

Multicare Cancer Institute Tacoma General Hospital

Tacoma, United States

Northwest Medical Specialties

Tacoma, United States

Multicare Cancer Institute North Star Lodge

Yakima, United States

Blacktown Cancer and Haematology Centre

Blacktown, Australia

Liverpool Hospital

Liverpool, Australia

Wollongong Hospital

Wollongong, Australia

Sunshine Coast University Private Hospital

Birtinya, Australia

Townsville University Hospital

Douglas, Australia

Peter Maccallum Cancer Centre

Melbourne, Australia

Fiona Stanley Hospital

Murdoch, Australia

One Clinical Research

Nedlands, Australia

Fundacao Pio Xii Hospital de Amor de Barretos

Barretos, Brazil

Icesp Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de Oliveira

São Paulo, Brazil

The First Affiliated Hospital of Chongqing Medical University

Chongqing, China

The Peoples Hospital Affiliated to Fujian University of Traditional Chinese Medicine

Fuzhou, China

Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South)

Guangzhou, China

Cancer Hospital of Shantou University Medical College

Shantou, China

Guangxi Medical University Cancer Hospital Wuxiang Branch

Nanning, China

Hainan General Hospital

Haikou, China

Union Hospital Tongji Medical College Huazhong University of Science and Technologyjinyinhu Branch

Wuhan, China

The First Peoples Hospital of Changde City

Changde, China

Nanchang Peoples Hospitalchaoyang Branch

Nanchang, China

The Second Affiliated Hospital of Xian Jiaotong University

Xi'an, China

Fudan University Shanghai Cancer Center

Shanghai, China

Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital

Chengdu, China

Binhai Hospital, Tianjin Medical University Cancer Institute and Hospital

Tianjin, China

Japan Community Healthcare Organization Kurume General Hospital

Kurumeshi, Japan

National Hospital Organization Hokkaido Cancer Center

Sapporo, Japan

Hyogo Medical University Hospital

Nishinomiyashi, Japan

Social Medical Corporation Hakuaikai Sagara Hospital

Kagoshima, Japan

Tokai University Hospital

Iseharashi, Japan

Nippon Medical School Musashi Kosugi Hospital

Kawasakishi, Japan

Yokohama City University Medical Center

Yokohama, Japan

Mie University Hospital

Tsu, Japan

National Hospital Organization Osaka National Hospital

Osakashi, Japan

The University of Osaka Hospital

Suitashi, Japan

Tokyo Metropolitan Komagome Hospital

Bunkyoku, Japan

Cancer Institute Hospital of Jfcr

Kotoku, Japan

Showa Medical University Hospital

Shinagawaku, Japan

Tokyo Womens Medical University Hospital

Shinjukuku, Japan

Pulau Pinang Hospital

George Town, Malaysia

Hospital Wanita Dan Kanak Kanak Sabah (Hospital Likas)

Kota Kinabalu Sabah, Malaysia

Hospital Kuala Lumpur

Kuala Lumpur, Malaysia

University Malaya Medical Centre

Kuala Lumpur, Malaysia

Sarawak General Hospital

Kuching, Malaysia

Hospital Picaso

Petaling Jaya, Malaysia

National Cancer Institute (Institut Kanser Negara)

Putrajaya, Malaysia

Brcr Global Puerto Rico Hato Rey

San Juan, Puerto Rico

Inje University Haeundae Paik Hospital

HaeundaeGu, South Korea

Dong A University Hospital

Seogu, South Korea

Chungbuk National University Hospital

Cheongju-si, South Korea

Soon Chun Hyang University Cheonan Hospital

Cheonansi, South Korea

Keimyung University Dongsan Hospital

Dalseogu, South Korea

Cha Bundang Medical Center, Cha University

BundangGu SeongnamSi, South Korea

Korea University Ansan Hospital

DanwonGu AnsanSi, South Korea

National Cancer Center (Korea)

IlsandongGu GoyangSi, South Korea

The Catholic University of Korea, St Vincents Hospital

PaldalGu SuwonSi, South Korea

Seoul National University Bundang Hospital

Seongnam-si, South Korea

Inha University Hospital

Jemulpogu, South Korea

Gachon University Gil Medical Center

NamdongGu, South Korea

Chonnam National University Hwasun Hospital

HwasunGun, South Korea

Chung Ang University Hospital

DongjakGu, South Korea

Samsung Medical Center

GangnamGu, South Korea

Korea University Guro Hospital

GuroGu, South Korea

The Catholic University of Korea, Seoul St Marys Hospital

SeochoGu, South Korea

Severance Hospital Yonsei University Health System

SeodaemunGu, South Korea

Korea University Anam Hospital

SeongbukGu, 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

Ulsan University Hospital

Ulsan, South Korea

Ajou University Hospital

Suwon, South Korea

China Medical University Hospital

Taichung, Taiwan

Maidstone and Tunbridge Wells Nhs Trust Kent Oncology Centre Maidstone Hospital

Maidstone, United Kingdom

Trial contact

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.

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