Actively Recruiting
Safety and Efficacy of SPH4336 in Combination With Endocrine Therapy in the Treatment of Locally Advanced or Metastatic Breast Cancer
Led by Shanghai Pharmaceuticals Holding Co., Ltd · Updated on 2026-01-14
254
Participants Needed
22
Research Sites
172 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 the treatment of locally advanced or metastatic breast cancer that progressed on CDK4/6 inhibitor combined with endocrine therapy.
CONDITIONS
Official Title
Safety and Efficacy of SPH4336 in Combination With Endocrine Therapy in the Treatment of Locally Advanced or Metastatic Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who voluntarily participate and sign informed consent
- ECOG performance status of 0 or 1
- Life expectancy of at least 3 months
- Locally advanced or metastatic breast cancer not suitable for surgery or local therapies
- At least one measurable tumor lesion
- Laboratory results meeting organ function requirements
- Agreement to use effective contraception
You will not qualify if you...
- Inflammatory breast cancer
- Unsuitable for endocrine therapy as determined by the investigator
- History of other cancers before study treatment
- Known metastases to the central nervous system
- Taking anti-tumor traditional Chinese patent medicines at consent
- Surgery before study treatment without recovery from side effects
- Participation in other investigational drug trials before study treatment
- Pregnant or breastfeeding women
- History of serious heart conditions or abnormal heart function
- History of ischemic stroke or severe blood clots
- Positive for hepatitis B or C with active infection or known HIV infection
- History of severe allergies or allergy to study drug ingredients
- Conditions affecting drug administration or absorption
- Uncontrolled infections
- History of drug abuse, heavy drinking, neurological or mental disorders
- Other diseases posing excessive risk or making patients ineligible as per investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 22 locations
1
Affiliated Cancer Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510060
Actively Recruiting
2
Liuzhou people's Hospital
Liuzhou, Guangxi, China, 545026
Actively Recruiting
3
Anyang Cancer Hospital
Anyang, He'nan, China, 455001
Actively Recruiting
4
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, He'nan, China, 450052
Actively Recruiting
5
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050011
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6
Harbin Medical University cancer Hospital
Harbin, Heilongjiang, China, 150081
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7
Xiangyang Cancer Hospital
Wuhan, Hubei, China, 441021
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8
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China, 210009
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9
Jiangsu Province Hospital
Nanjing, Jiangsu, China, 210029
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10
Jilin Cancer Hospital
Changchun, Jilin, China, 130012
Actively Recruiting
11
The First Hospital of China Medical University
Shenyang, Liaoning, China, 110002
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12
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China, 750003
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13
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi’an, Shanxi, China, 710061
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14
The second people's hospital of neijiang
Neijiang, Sichuan, China, 641199
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15
Yunnan Cancer Hospital
Kunming, Yunnan, China, 650118
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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
The First Affiliated Hospital of Bengbu Medical College
Bengbu, China
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19
Fujian Cancer Hospital
Fuzhou, China
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20
First Affiliated Hospital of Kunming Medical University
Kunming, China
Actively Recruiting
21
Shenzhen Hospital of University of Hong Kong
Shenzhen, China
Actively Recruiting
22
Tianjin Medical University Cancer Institute & Hospital
Tianjin, China
Actively Recruiting
Research Team
S
Shusen Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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