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

NCT05872347 | Recruiting Phase 2

• 1 other identifier: SPH4336-202
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 25

Brief Summary

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

Conditions

Breast Cancer Brain Metastases

Outcome Measures

Primary Outcomes (1)

• Intracranial Objective response rate（iORR）

  Objective response rate according to response assessment in neuro-oncology-brain metastases (RANO-BM) criteria.

  Approximately 3 years

Secondary Outcomes (10)

• Intracranial Duration of remission (iDOR)

  Approximately 3 years

• Intracranial Disease control rate (iDCR)

  Approximately 3 years

• Progression-free survival (PFS)

  Approximately 3 years

• Overall Survival (OS)

  Approximately 8 years

• Extracranial Objective response rate（eORR）

  Approximately 3 years

Study Arms (1)

SPH4336 Tablets

EXPERIMENTAL

SPH4336 Tablets; Letrozole tablets; Fulvestrant; Exemestane

Drug: SPH4336 Tablets

Interventions

SPH4336 Tablets DRUG

SPH4336 Tablets ：Administered by oral; Letrozole tablets：Administered by oral; Fulvestrant injection：Administered by intravenous infusion; Exemestane：Administered by oral.

SPH4336 Tablets

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Shanghai Pharmaceuticals Holding Co., Ltd: lead

Study Sites (25)

Anhui provincial hospital

Hefei, Anhui, 230002, China

RECRUITING

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230022, China

RECRUITING

Affiliated Cancer Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

RECRUITING

Liuzhou people's Hospital

Liuzhou, Guangxi, 545026, China

RECRUITING

Anyang Cancer Hospital

Anyang, He'nan, 455001, China

RECRUITING

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, He'nan, 450052, China

RECRUITING

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050011, China

RECRUITING

Harbin Medical University cancer Hospital

Harbin, Heilongjiang, 150081, China

RECRUITING

Xiangyang Central Hospital

Xiangyang, Hubei, 441021, China

RECRUITING

Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China

RECRUITING

Jilin Cancer Hospital

Changchun, Jilin, 130012, China

RECRUITING

The first hospital of Jilin University

Changchun, Jilin, 130061, China

RECRUITING

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, 750003, China

RECRUITING

The second people's hospital of neijiang

Neijiang, Sichuan, 641199, China

RECRUITING

Cancer Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, 830054, China

RECRUITING

Zhejiang cancer Hospital

Hangzhou, Zhejiang, 310005, China

RECRUITING

Peking Union Medical College Hospital

Beijing, 100730, China

RECRUITING

Beijing Cancer Hospital

Beijing, China

RECRUITING

The First Affiliated Hospital of Bengbu Medical College

Bengbu, China

RECRUITING

Chongqing University Three Gorges Hospital

Chongqing, 404031, China

RECRUITING

Guangxi Medical University Cancer Hospital & Guangxi Cancer Institute

Nanning, China

RECRUITING

Tianjin Medical University Cancer Institute & Hospital

Tianjin, China

RECRUITING

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, China

RECRUITING

Xi'An International Medical Cancer Hospital

Xi'an, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, China

RECRUITING

Central Study Contacts

Shusen Wang

CONTACT

0086-020-87343811; wangshs@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2023
• First Posted: May 24, 2023
• Study Start: September 19, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 5, 2026

Record last verified: 2025-08

Locations

CN (25)