A Phase II Study of SPH4336 in Combination With Endocrine Therapy in HR-positive, HER2-negative Breast Cancer Patients With Brain Metastases.
Status: Recruiting
Location: See all (25) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
This study evaluated the safety and efficacy of SPH4336 in combination with endocrine therapy in breast cancer Patients with brain metastases.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Patients who voluntarily participate in this study, completely understand this study, and voluntarily sign the informed consent form (ICF).
• ECOG (Eastern Cooperative Oncology Group) performance status score of 0 or 1.
• Life expectancy ≥ 3 months.
• Patients with locally advanced or metastatic breast cancer who are unable to receive radical surgeries/other local therapies.
• At least one measurable lesion .
• Laboratory test results meet the relevant requirements for organ function.
• Subjects who agree to take effective contraceptive measures.
Locations
Other Locations
China
Anyang Cancer Hospital
RECRUITING
Anyang
Beijing Cancer Hospital
RECRUITING
Beijing
Peking Union Medical College Hospital
RECRUITING
Beijing
The First Affiliated Hospital of Bengbu Medical College
RECRUITING
Bengbu
Jilin Cancer Hospital
RECRUITING
Changchun
The first hospital of Jilin University
RECRUITING
Changchun
Chongqing University Three Gorges Hospital
RECRUITING
Chongqing
Affiliated Cancer Hospital, Sun Yat-sen University
RECRUITING
Guangzhou
Zhejiang cancer Hospital
RECRUITING
Hangzhou
Harbin Medical University cancer Hospital
RECRUITING
Harbin
Anhui provincial hospital
RECRUITING
Hefei
The First Affiliated Hospital of Anhui Medical University
RECRUITING
Hefei
Liuzhou people's Hospital
RECRUITING
Liuzhou
The First Affiliated Hospital of Henan University of Science and Technology
RECRUITING
Luoyang
Jiangsu Province Hospital
RECRUITING
Nanjing
Guangxi Medical University Cancer Hospital & Guangxi Cancer Institute
RECRUITING
Nanning
The second people's hospital of neijiang
RECRUITING
Neijiang
The Fourth Hospital of Hebei Medical University
RECRUITING
Shijiazhuang
Tianjin Medical University Cancer Institute & Hospital
RECRUITING
Tianjin
Cancer Hospital of Xinjiang Medical University
RECRUITING
Ürümqi
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
RECRUITING
Wuhan
Xi'An International Medical Cancer Hospital
RECRUITING
Xi'an
Xiangyang Central Hospital
RECRUITING
Xiangyang
General Hospital of Ningxia Medical University
RECRUITING
Yinchuan
Henan Cancer Hospital
RECRUITING
Zhengzhou
Contact Information
Primary
Shusen Wang
wangshs@sysucc.org.cn
0086-020-87343811
Time Frame
Start Date: 2023-09-19
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 52
Treatments
Experimental: SPH4336 Tablets
SPH4336 Tablets; Letrozole tablets; Fulvestrant; Exemestane
Related Therapeutic Areas
Sponsors
Leads: Shanghai Pharmaceuticals Holding Co., Ltd