Safety and Efficacy of SPH4336 in Combination With Endocrine Therapy in the Treatment of Locally Advanced or Metastatic Breast Cancer
NCT ID: NCT05860465
Last Updated: 2026-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
254 participants
INTERVENTIONAL
2023-09-08
2026-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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SPH4336 Tablets
SPH4336 Tablets; Letrozole tablets; Fulvestrant injection
SPH4336 Tablets
SPH4336 Tablets ：Administered by oral; Letrozole tablets：Administered by oral; Fulvestrant injection：Administered by intravenous infusion
SPH4336 Tablets Placebo
SPH4336 Tablets Placebo; Letrozole tablets; Fulvestrant injection
SPH4336 Tablets Placebo
SPH4336 Tablets Placebo ：Administered by oral; Letrozole tablets：Administered by oral; Fulvestrant injection：Administered by intravenous infusion
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
2. ECOG (Eastern Cooperative Oncology Group) performance status score of 0 or 1.
3. Life expectancy ≥ 3 months.
4. Patients with locally advanced or metastatic breast cancer who are unable to receive radical surgeries/other local therapies.
5. At least one measurable lesion.
6. Laboratory test results meet the relevant requirements for organ function.
7. Subjects who agree to take effective contraceptive measures.
Exclusion Criteria
2. Patients unsuitable for endocrine therapy at the investigator's discretion.
3. History of other malignancies prior to the start of study treatment.
4. Patients with known metastases to central nervous system.
5. Taking anti-tumor traditional Chinese patent medicines at the time of signing the ICF.
6. Patients who underwent a surgery prior to the start of study treatment, and have not yet recovered from adverse reactions of the surgery.
7. Patients who participated in a clinical trial and received other investigational drugs before the start of study treatment.
8. Pregnant or lactating women.
9. History of myocardial infarction, unstable angina pectoris, severe arrhythmia, and symptomatic congestive heart failure before the start of study treatment; ≥ NYHA (New York Heart Association) Class II; mean QTc interval ≥ 470 ms before the start of study treatment; left ventricular ejection fraction ≤ 50% before the start of study treatment.
10. History of ischemic stroke or severe thromboembolic disease before the start of study treatment.
11. Hepatitis B surface antigen positive and HBV (Hepatitis B Virus) DNA \> 2,000 IU/mL or \> 104 copies/mL; HCV (Hepatitis C Virus) antibody positive and HCV RNA positive; or known HIV infection.
12. History of severe allergic diseases, history of severe drug allergies, or known allergy to any ingredient of the investigational product.
13. Presence of diseases or conditions that may impact drug administration or gastrointestinal absorption before the start of study treatment.
14. Presence of uncontrolled infections before the start of study treatment.
15. Known history of drug abuse, excessive drinking, or illegal drug use; history of confirmed neurological or mental disorders.
16. Presence of other diseases that the risks of receiving the study treatment outweigh its benefits, as determined by the investigator, or any other reason for which patients are ineligible for the study as assessed by the investigator.
18 Years
75 Years
FEMALE
No
Sponsors
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Shanghai Pharmaceuticals Holding Co., Ltd
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Bin Yu
Role: primary
Jing Sun
Role: primary
Xinshuai Wang
Role: primary
Cuizhi Geng
Role: primary
Qingyuan Zhang
Role: primary
Yuehua Wang
Role: primary
Jifeng Feng
Role: primary
Yongmei Yin
Role: primary
Ying Cheng
Role: primary
Yue'e Teng
Role: primary
Xinlan Liu
Role: primary
Jin Yang
Role: primary
Xujuan Wang
Role: primary
Jianyun Nie
Role: primary
Zhanhong Chen
Role: primary
Chunmei Bai
Role: primary
Jun Qian
Role: primary
Weiwei Huang
Role: primary
Jinxian Qian
Role: primary
Haiman Jing
Role: primary
Yehui Shi
Role: primary
Other Identifiers
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SPH4336-302
Identifier Type: -
Identifier Source: org_study_id
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