Clinical trial NCT05872347: Efficacy and Safety of SPH4336 in Combination With Endocrine Therapy in Breast Cancer Patients With Brain Metastases.
Official title: A Phase II Study of SPH4336 in Combination With Endocrine Therapy in HR-positive, HER2-negative Breast Cancer Patients With Brain Metastases.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Breast Cancer Brain Metastases
Lead sponsor: Shanghai Pharmaceuticals Holding Co., Ltd
Sponsor class: INDUSTRY
First posted: 2023-05-24
Enrollment: 52
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

1. Patients who voluntarily participate in this study, completely understand this study, and voluntarily sign the informed consent form (ICF).
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:

1. Inflammatory breast cancer.
2. Patients unsuitable for endocrine therapy at the investigator's discretion.
3. Have a History of other malignancies prior to the start of study treatment.
4. Taking anti-tumor traditional Chinese patent medicines at the time of signing the ICF.
5. Patients who underwent a surgery prior to the start of study treatment, and have not yet recovered from adverse reactions of the surgery.
6. Patients who participated in a clinical trial and received other investigational drugs before the start of study treatment.
7. Pregnant or lactating women.
8. 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%.
9. History of ischemic stroke or severe thromboembolic disease before the start of study treatment.
10. 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.
11. History of severe allergic diseases, history of severe drug allergies, or known allergy to any ingredient of the investigational product.
12. Presence of diseases or conditions that may impact drug administration or gastrointestinal absorption before the start of study treatment.
13. Presence of uncontrolled infections before the start of study treatment.
14. Known history of drug abuse, excessive drinking, or illegal drug use; history of confirmed neurological or mental disorders.
15. 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.

Primary outcomes:
measure: Intracranial Objective response rate（iORR）
timeFrame: Approximately 3 years
Secondary outcomes:
measure: Intracranial Duration of remission (iDOR)
timeFrame: Approximately 3 years
measure: Intracranial Disease control rate (iDCR)
timeFrame: Approximately 3 years
measure: Progression-free survival (PFS)
timeFrame: Approximately 3 years
measure: Overall Survival (OS)
timeFrame: Approximately 8 years
measure: Extracranial Objective response rate（eORR）
timeFrame: Approximately 3 years
measure: Extracranial Disease control rate (eDCR)
timeFrame: Approximately 3 years
measure: Extracranial Duration of remission (eDOR)
timeFrame: Approximately 3 years
measure: Cmax
timeFrame: Approximately 3 years
measure: Tmax
timeFrame: Approximately 3 years
measure: Safety and tolerability
timeFrame: Approximately 3 years
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui provincial hospital
state: Anhui
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University
state: Anhui
city: Guangzhou
country: China
facility: Affiliated Cancer Hospital, Sun Yat-sen University
state: Guangdong
city: Liuzhou
country: China
facility: Liuzhou people's Hospital
state: Guangxi
city: Shijiazhuang
country: China
facility: The Fourth Hospital of Hebei Medical University
state: Hebei
city: Harbin
country: China
facility: Harbin Medical University cancer Hospital
state: Heilongjiang
city: Anyang
country: China
facility: Anyang Cancer Hospital
state: Henan
city: Luoyang
country: China
facility: The First Affiliated Hospital of Henan University of Science and Technology
state: Henan
city: Xiangyang
country: China
facility: Xiangyang Central Hospital
state: Hubei
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Changchun
country: China
facility: Jilin Cancer Hospital
state: Jilin
city: Changchun
country: China
facility: The first hospital of Jilin University
state: Jilin
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
state: Ningxia
city: Neijiang
country: China
facility: The second people's hospital of neijiang
state: Sichuan
city: Urumqi
country: China
facility: Cancer Hospital of Xinjiang Medical University
state: Xinjiang
city: Hangzhou
country: China
facility: Zhejiang cancer Hospital
state: Zhejiang
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Beijing
country: China
facility: Beijing Cancer Hospital
city: Bengbu
country: China
facility: The First Affiliated Hospital of Bengbu Medical College
city: Chongqing
country: China
facility: Chongqing University Three Gorges Hospital
city: Nanning
country: China
facility: Guangxi Medical University Cancer Hospital & Guangxi Cancer Institute
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute & Hospital
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
city: Xi'an
country: China
facility: Xi'An International Medical Cancer Hospital
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
Study officials:
References: