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

Recruiting now · Phase 2

Conditions studied: Breast Cancer Brain Metastases

In brief

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

Key facts

Study ID

NCT05872347

Run by

Shanghai Pharmaceuticals Holding Co., Ltd

People needed

52

Starts

2023-09-19

Expected to finish

2026-12-31

Last updated by the study team

2026-05-05

Who can join

Age: 18 and older, up to 75. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Inflammatory breast cancer.
• Patients unsuitable for endocrine therapy at the investigator's discretion.
• Have a History of other malignancies prior to the start of study treatment.
• Taking anti-tumor traditional Chinese patent medicines at the time of signing the ICF.
• Patients who underwent a surgery prior to the start of study treatment, and have not yet recovered from adverse reactions of the surgery.
• Patients who participated in a clinical trial and received other investigational drugs before the start of study treatment.
• Pregnant or lactating women.
• 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; QTcF≥ 470 ms; left ventricular ejection fraction ≤ 50%.
• History of ischemic stroke or severe thromboembolic disease before the start of study treatment.
• Hepatitis B surface antigen positive and HBV (Hepatitis B Virus) DNA > 2,000 IU/mL or > 10(4) copies/mL; HCV (Hepatitis C Virus) antibody positive and HCV RNA positive; or known HIV infection.
• History of severe allergic diseases, history of severe drug allergies, or known allergy to any ingredient of the investigational product.
• Presence of diseases or conditions that may impact drug administration or gastrointestinal absorption before the start of study treatment.
• Presence of uncontrolled infections before the start of study treatment.
• Known history of drug abuse, excessive drinking, or illegal drug use; history of confirmed neurological or mental disorders.
• 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.

Where it is running

• Anhui provincial hospital — Hefei, Anhui, China (enrolling)
• The First Affiliated Hospital of Anhui Medical University — Hefei, Anhui, China (enrolling)
• Affiliated Cancer Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (enrolling)
• Liuzhou people's Hospital — Liuzhou, Guangxi, China (enrolling)
• Anyang Cancer Hospital — Anyang, He'nan, China (enrolling)
• The First Affiliated Hospital of Henan University of Science and Technology — Luoyang, He'nan, China (enrolling)
• The Fourth Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (enrolling)
• Harbin Medical University cancer Hospital — Harbin, Heilongjiang, China (enrolling)
• Xiangyang Central Hospital — Xiangyang, Hubei, China (enrolling)
• Jiangsu Province Hospital — Nanjing, Jiangsu, China (enrolling)
• Jilin Cancer Hospital — Changchun, Jilin, China (enrolling)
• The first hospital of Jilin University — Changchun, Jilin, China (enrolling)
• General Hospital of Ningxia Medical University — Yinchuan, Ningxia, China (enrolling)
• The second people's hospital of neijiang — Neijiang, Sichuan, China (enrolling)
• Cancer Hospital of Xinjiang Medical University — Ürümqi, Xinjiang, China (enrolling)
• Zhejiang cancer Hospital — Hangzhou, Zhejiang, China (enrolling)
• Peking Union Medical College Hospital — Beijing, China (enrolling)
• Beijing Cancer Hospital — Beijing, China (enrolling)
• The First Affiliated Hospital of Bengbu Medical College — Bengbu, China (enrolling)
• Chongqing University Three Gorges Hospital — Chongqing, China (enrolling)
• Guangxi Medical University Cancer Hospital & Guangxi Cancer Institute — Nanning, China (enrolling)
• Tianjin Medical University Cancer Institute & Hospital — Tianjin, China (enrolling)
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, China (enrolling)
• Xi'An International Medical Cancer Hospital — Xi'an, China (enrolling)
• Henan Cancer Hospital — Zhengzhou, China (enrolling)

Full record on ClinicalTrials.gov

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