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
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
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.
Inclusion Criteria:
Exclusion Criteria:
Note: Other protocol-defined inclusion/exclusion criteria may apply.
clinicaltrials@beonemed.com877-828-5568
Chandler, Arizona 85224-5665, United States
Hot Springs, Arkansas 71913, United States
Fountain Valley, California 92708, United States
Port Saint Lucie, Florida 34952-7596, United States
OFallon, Illinois 62269, United States
Saint Paul, Minnesota 55101-2502, United States
Grand Island, Nebraska 68803, United States
Lincoln, Nebraska 68516, United States
Spokane, Washington 99204, United States
São Paulo, 01246-000, Brazil
Chongqing, Chongqing Municipality 630014, China
Fuzhou, Fujian 350009, China
Guangzhou, Guangdong 510245, China
Wuhan, Hubei 430048, China
Chengdu, Sichuan 610071, China
Tianjin, Tianjin Municipality 300453, China
Kurumeshi, Fukuoka 830-0013, Japan
Nishinomiyashi, Hyōgo 663-8501, Japan
Kagoshima, Kagoshima-ken 892-0833, Japan
Iseharashi, Kanagawa 259-1193, Japan
Kawasakishi, Kanagawa 211-8533, Japan
Osakashi, Osaka 540-0006, Japan
Suitashi, Osaka 565-0871, Japan
Bunkyoku, Tokyo 113-8677, Japan
Kotoku, Tokyo 135-8550, Japan
Shinagawaku, Tokyo 142-8666, Japan
Shinjukuku, Tokyo 162-8666, Japan
Kota Kinabalu Sabah, 88996, Malaysia
HaeundaeGu, Busan Gwang'Yeogsi 48108, South Korea
Cheonansi, Chungcheongnam-do 31151, South Korea
Dalseogu, Daegu Gwang'Yeogsi 42601, South Korea
BundangGu SeongnamSi, Gyeonggi-do 13496, South Korea
DanwonGu AnsanSi, Gyeonggi-do 15355, South Korea
IlsandongGu GoyangSi, Gyeonggi-do 10408, South Korea
PaldalGu SuwonSi, Gyeonggi-do 16247, South Korea
Jemulpogu, Incheon Gwang'Yeogsi 22332, South Korea
NamdongGu, Incheon Gwang'Yeogsi 21565, South Korea
HwasunGun, Jeonnam-Gwangju S.M. City 58128, South Korea
DongjakGu, Seoul Teugbyeolsi 06973, South Korea
GangnamGu, Seoul Teugbyeolsi 06351, South Korea
GuroGu, Seoul Teugbyeolsi 08308, South Korea
SeochoGu, Seoul Teugbyeolsi 06591, South Korea
SeodaemunGu, Seoul Teugbyeolsi 03722, South Korea
SeongbukGu, Seoul Teugbyeolsi 02841, South Korea
Seoul, Seoul Teugbyeolsi 06273, South Korea
SongpaGu, Seoul Teugbyeolsi 05505, South Korea