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Efficacy and Safety of SPH4336 in Combination With Endocrine Therapy in Breast Cancer Patients With Brain Metastases.
Led by Shanghai Pharmaceuticals Holding Co., Ltd · Updated on 2026-05-05
52
Participants Needed
25
Research Sites
171 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study evaluated the safety and efficacy of SPH4336 in combination with endocrine therapy in breast cancer Patients with brain metastases.
CONDITIONS
Official Title
Efficacy and Safety of SPH4336 in Combination With Endocrine Therapy in Breast Cancer Patients With Brain Metastases.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who voluntarily agree to participate and sign the informed consent form.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Life expectancy of at least 3 months.
- Locally advanced or metastatic breast cancer patients who cannot have surgery or local therapies.
- At least one measurable tumor lesion.
- Laboratory tests showing adequate organ function.
- Agreement to use effective contraception during the study.
You will not qualify if you...
- Inflammatory breast cancer.
- Patients not suitable for endocrine therapy as judged by the investigator.
- History of other cancers before starting study treatment.
- Using anti-tumor traditional Chinese patent medicines at study entry.
- Recent surgery without recovery from side effects before treatment start.
- Participation in other clinical trials with investigational drugs before treatment.
- Pregnant or breastfeeding women.
- History of serious heart conditions including myocardial infarction, unstable angina, severe arrhythmia, symptomatic heart failure (NYHA Class II or higher), QTcF ≥ 470 ms, or left ventricular ejection fraction ≤ 50%.
- History of ischemic stroke or severe blood clot diseases before treatment.
- Positive for Hepatitis B surface antigen with high viral load, positive for Hepatitis C antibody and RNA, or known HIV infection.
- History of severe allergic reactions or allergy to any study drug ingredients.
- Conditions affecting drug administration or absorption.
- Uncontrolled infections.
- History of drug abuse, heavy alcohol use, illegal drug use, or neurological/mental disorders.
- Any other condition that makes participation unsafe or unsuitable as judged by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 25 locations
1
Anhui provincial hospital
Hefei, Anhui, China, 230002
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2
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China, 230022
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3
Affiliated Cancer Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510060
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4
Liuzhou people's Hospital
Liuzhou, Guangxi, China, 545026
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5
Anyang Cancer Hospital
Anyang, He'nan, China, 455001
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6
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, He'nan, China, 450052
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7
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050011
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8
Harbin Medical University cancer Hospital
Harbin, Heilongjiang, China, 150081
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9
Xiangyang Central Hospital
Xiangyang, Hubei, China, 441021
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10
Jiangsu Province Hospital
Nanjing, Jiangsu, China, 210029
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11
Jilin Cancer Hospital
Changchun, Jilin, China, 130012
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12
The first hospital of Jilin University
Changchun, Jilin, China, 130061
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13
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China, 750003
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14
The second people's hospital of neijiang
Neijiang, Sichuan, China, 641199
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15
Cancer Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China, 830054
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16
Zhejiang cancer Hospital
Hangzhou, Zhejiang, China, 310005
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17
Peking Union Medical College Hospital
Beijing, China, 100730
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18
Beijing Cancer Hospital
Beijing, China
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19
The First Affiliated Hospital of Bengbu Medical College
Bengbu, China
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20
Chongqing University Three Gorges Hospital
Chongqing, China, 404031
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21
Guangxi Medical University Cancer Hospital & Guangxi Cancer Institute
Nanning, China
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22
Tianjin Medical University Cancer Institute & Hospital
Tianjin, China
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23
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
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24
Xi'An International Medical Cancer Hospital
Xi'an, China
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25
Henan Cancer Hospital
Zhengzhou, China
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Research Team
S
Shusen Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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