RecruitingPhase 2NCT05872347

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

A Phase II Study of SPH4336 in Combination With Endocrine Therapy in HR-positive, HER2-negative Breast Cancer Patients With Brain Metastases.

Sponsor

Shanghai Pharmaceuticals Holding Co., Ltd

Enrollment

52 participants

Start Date

Sep 19, 2023

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Brain Metastases

Summary

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

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called SPH4336 combined with hormone therapy in people with locally advanced or metastatic breast cancer that is hormone receptor-positive and HER2-negative, focusing on patients who have developed brain metastases (cancer spread to the brain). **You may be eligible if...** - You have locally advanced or metastatic breast cancer that cannot be surgically removed - You have brain metastases that meet specific criteria for this study - Your overall health status is good (ECOG 0 or 1) - Your expected survival is at least 3 months - You have at least one measurable tumour **You may NOT be eligible if...** - Your cancer is HER2-positive or hormone receptor-negative - You are too unwell to tolerate treatment (poor performance status) - You have organ function that does not meet the required levels - You are not willing or able to use effective contraception Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSPH4336 Tablets

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

Locations(25)

Anhui provincial hospital

Hefei, Anhui, China

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Affiliated Cancer Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Liuzhou people's Hospital

Liuzhou, 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 Central Hospital

Xiangyang, Hubei, China

Jiangsu Province Hospital

Nanjing, Jiangsu, 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

The second people's hospital of neijiang

Neijiang, Sichuan, China

Cancer Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

Zhejiang cancer Hospital

Hangzhou, Zhejiang, China

Peking Union Medical College Hospital

Beijing, China

Beijing Cancer Hospital

Beijing, China

The First Affiliated Hospital of Bengbu Medical College

Bengbu, China

Chongqing University Three Gorges Hospital

Chongqing, China

Guangxi Medical University Cancer Hospital & Guangxi Cancer Institute

Nanning, China

Tianjin Medical University Cancer Institute & Hospital

Tianjin, China

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

Wuhan, China

Xi'An International Medical Cancer Hospital

Xi'an, China

Henan Cancer Hospital

Zhengzhou, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT05872347

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