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RECRUITING
NCT05872347
PHASE2

Efficacy and Safety of SPH4336 in Combination With Endocrine Therapy in Breast Cancer Patients With Brain Metastases.

Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd

View on ClinicalTrials.gov

Summary

This study evaluated the safety and efficacy of SPH4336 in combination with endocrine therapy in breast cancer Patients with brain metastases.

Official title: A Phase II Study of SPH4336 in Combination With Endocrine Therapy in HR-positive, HER2-negative Breast Cancer Patients With Brain Metastases.

Key Details

Gender

FEMALE

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

52

Start Date

2023-09-19

Completion Date

2025-12-31

Last Updated

2025-08-17

Healthy Volunteers

No

Interventions

DRUG

SPH4336 Tablets

SPH4336 Tablets :Administered by oral; Letrozole tablets:Administered by oral; Fulvestrant injection:Administered by intravenous infusion; Exemestane:Administered by oral.

Locations (25)

Anhui provincial hospital

Hefei, Anhui, China

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

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 Central Hospital

Xiangyang, Hubei, China

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Jilin Cancer Hospital

Changchun, Jilin, China

The first hospital of Jilin University

Changchun, Jilin, China

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, China

The second people's hospital of neijiang

Neijiang, Sichuan, China

Cancer Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

Zhejiang cancer Hospital

Hangzhou, Zhejiang, China

Peking Union Medical College Hospital

Beijing, China

Beijing Cancer Hospital

Beijing, China

The First Affiliated Hospital of Bengbu Medical College

Bengbu, China

Chongqing University Three Gorges Hospital

Chongqing, China

Guangxi Medical University Cancer Hospital & Guangxi Cancer Institute

Nanning, China

Tianjin Medical University Cancer Institute & Hospital

Tianjin, China

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, China

Xi'An International Medical Cancer Hospital

Xi'an, China

Henan Cancer Hospital

Zhengzhou, China