Efficacy and Safety of SPH4336 in Combination With Endocrine Therapy in Breast Cancer Patients With Brain Metastases.
- Conditions
- Breast Cancer Brain Metastases
- Interventions
- Drug: SPH4336 Tablets
- Registration Number
- NCT05872347
- Lead Sponsor
- Shanghai Pharmaceuticals Holding Co., Ltd
- Brief Summary
This study evaluated the safety and efficacy of SPH4336 in combination with endocrine therapy in breast cancer Patients with brain metastases.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 52
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SPH4336 Tablets SPH4336 Tablets SPH4336 Tablets; Letrozole tablets; Fulvestrant; Exemestane
- Primary Outcome Measures
Name Time Method Intracranial Objective response rate（iORR） Approximately 3 years Objective response rate according to response assessment in neuro-oncology-brain metastases (RANO-BM) criteria.
- Secondary Outcome Measures
Name Time Method Progression-free survival (PFS) Approximately 3 years measured by RANO-BM and RECIST 1.1
Tmax Approximately 3 years PK (Pharmacokinetics) parameters
Overall Survival (OS) Approximately 8 years Determination of the overall survival times of all patients.
Extracranial Duration of remission (eDOR) Approximately 3 years DoR is measured from the date of first evidence of a confirmed response (CR or PR), as defined by RANO-BM, to the date objective progression or death from any cause.
Cmax Approximately 3 years PK (Pharmacokinetics) parameters
Intracranial Disease control rate (iDCR) Approximately 3 years Percentage of participants with BOIR of CR, PR, or SD: IDCR, as defined by RANO-BM is reported.
Extracranial Objective response rate（eORR） Approximately 3 years Objective response rate according to response assessment in neuro-oncology-brain metastases (RANO-BM) criteria.
Extracranial Disease control rate (eDCR) Approximately 3 years Percentage of participants with BOIR of CR, PR, or SD: IDCR, as defined by RANO-BM is reported.
Intracranial Duration of remission (iDOR) Approximately 3 years DoR is measured from the date of first evidence of a confirmed response (CR or PR), as defined by RANO-BM, to the date objective progression or death from any cause.
Safety and tolerability Approximately 3 years Adverse event type, incidence, correlation with study drug
Trial Locations
- Locations (25)
Liuzhou people's Hospital
🇨🇳Liuzhou, Guangxi, China
Anyang Cancer Hospital
🇨🇳Anyang, Henan, China
Jilin Cancer Hospital
🇨🇳Changchun, Jilin, China
The first hospital of Jilin University
🇨🇳Changchun, Jilin, China
General Hospital of Ningxia Medical University
🇨🇳Yinchuan, Ningxia, China
Chongqing University Three Gorges Hospital
🇨🇳Chongqing, China
Xi'An International Medical Cancer Hospital
🇨🇳Xi'an, China
Anhui provincial hospital
🇨🇳Hefei, Anhui, China
The First Affiliated Hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China
The Fourth Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
Affiliated Cancer Hospital, Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
Harbin Medical University cancer Hospital
🇨🇳Harbin, Heilongjiang, China
The First Affiliated Hospital of Henan University of Science and Technology
🇨🇳Luoyang, Henan, China
Xiangyang Central Hospital
🇨🇳Xiangyang, Hubei, China
Jiangsu Province Hospital
🇨🇳Nanjing, Jiangsu, China
The second people's hospital of neijiang
🇨🇳Neijiang, Sichuan, China
Cancer Hospital of Xinjiang Medical University
🇨🇳Urumqi, Xinjiang, China
The First Affiliated Hospital of Bengbu Medical College
🇨🇳Bengbu, China
Zhejiang cancer Hospital
🇨🇳Hangzhou, Zhejiang, China
Beijing Cancer Hospital
🇨🇳Beijing, China
Peking Union Medical College Hospital
🇨🇳Beijing, China
Tianjin Medical University Cancer Institute & Hospital
🇨🇳Tianjin, China
Guangxi Medical University Cancer Hospital & Guangxi Cancer Institute
🇨🇳Nanning, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
🇨🇳Wuhan, China
Henan Cancer Hospital
🇨🇳Zhengzhou, China