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Safety and Efficacy of SPH4336 in Combination With Endocrine Therapy in the Treatment of Locally Advanced or Metastatic Breast Cancer
Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd
Summary
This study evaluated the safety and efficacy of SPH4336 in combination with endocrine therapy in the treatment of locally advanced or metastatic breast cancer that progressed on CDK4/6 inhibitor combined with endocrine therapy.
Official title: A Phase II/III Study of SPH4336 in Combination With Endocrine Therapy in the Treatment of HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer That Progressed on CDK4/6 Inhibitor Combined With Endocrine Therapy
Key Details
Gender
FEMALE
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
254
Start Date
2023-09-08
Completion Date
2026-12-30
Last Updated
2026-01-14
Healthy Volunteers
No
Interventions
SPH4336 Tablets
SPH4336 Tablets :Administered by oral; Letrozole tablets:Administered by oral; Fulvestrant injection:Administered by intravenous infusion
SPH4336 Tablets Placebo
SPH4336 Tablets Placebo :Administered by oral; Letrozole tablets:Administered by oral; Fulvestrant injection:Administered by intravenous infusion
Locations (22)
Affiliated Cancer Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Liuzhou people's Hospital
Liuchow, Guangxi, China
Anyang Cancer Hospital
Anyang, He'nan, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, He'nan, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Harbin Medical University cancer Hospital
Harbin, Heilongjiang, China
Xiangyang Cancer Hospital
Wuhan, Hubei, China
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Jilin Cancer Hospital
Changchun, Jilin, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi’an, Shanxi, China
The second people's hospital of neijiang
Neijiang, Sichuan, China
Yunnan Cancer Hospital
Kunming, Yunnan, China
Zhejiang cancer Hospital
Hangzhou, Zhejiang, China
Peking Union Medical College Hospital
Beijing, China
The First Affiliated Hospital of Bengbu Medical College
Bengbu, China
Fujian Cancer Hospital
Fuzhou, China
First Affiliated Hospital of Kunming Medical University
Kunming, China
Shenzhen Hospital of University of Hong Kong
Shenzhen, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, China