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NCT05872347 | RECRUITING | Breast Cancer Brain Metastases

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

Condition or disease

Breast Cancer Brain Metastases

Intervention/treatment

SPH4336 Tablets

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 52 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Phase II Study of SPH4336 in Combination With Endocrine Therapy in HR-positive, HER2-negative Breast Cancer Patients With Brain Metastases.
Actual Study Start Date : 2023-09-19
Estimated Primary Completion Date : 2025-12-31
Estimated Study Completion Date : 2025-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
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.
Efficacy and Safety of SPH4336 in Combination With Endocrine Therapy in Breast Cancer Patients With Brain Metastases.

Location Details

NCT05872347

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

China, Anhui

Anhui provincial hospital

Fairy, Anhui, China, 230002

RECRUITING

China, Anhui

The First Affiliated Hospital of Anhui Medical University

Fairy, Anhui, China, 230022

RECRUITING

China, Guangdong

Affiliated Cancer Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China, 510060

RECRUITING

China, Guangxi

Liuzhou people's Hospital

Liuzhou, Guangxi, China, 545026

RECRUITING

China, Hebei

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China, 050011

RECRUITING

China, Heilongjiang

Harbin Medical University cancer Hospital

Harbin, Heilongjiang, China, 150081

RECRUITING

China, Henan

Anyang Cancer Hospital

Anang, Henan, China, 455001

RECRUITING

China, Henan

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, China, 450052

RECRUITING

China, Hubei

Xiangyang Central Hospital

Xiangyang, Hubei, China, 441021

RECRUITING

China, Jiangsu

Jiangsu Province Hospital

Nanjing, Jiangsu, China, 210029

RECRUITING

China, Jilin

Jilin Cancer Hospital

Changchun, Jilin, China, 130012

RECRUITING

China, Jilin

The first hospital of Jilin University

Changchun, Jilin, China, 130061

RECRUITING

China, Ningxia

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, China, 750003

RECRUITING

China, Sichuan

The second people's hospital of neijiang

NE i sauce, Sichuan, China, 641199

RECRUITING

China, Xinjiang

Cancer Hospital of Xinjiang Medical University

Urumqi, Xinjiang, China, 830054

RECRUITING

China, Zhejiang

Zhejiang cancer Hospital

Hangzhou, Zhejiang, China, 310005

RECRUITING

China,

Peking Union Medical College Hospital

Beijing, China, 100730

RECRUITING

China,

Beijing Cancer Hospital

Beijing, China,

RECRUITING

China,

The First Affiliated Hospital of Bengbu Medical College

Bengbu, China,

RECRUITING

China,

Chongqing University Three Gorges Hospital

Chongqing, China, 404031

RECRUITING

China,

Guangxi Medical University Cancer Hospital & Guangxi Cancer Institute

Nanning, China,

RECRUITING

China,

Tianjin Medical University Cancer Institute & Hospital

Tianjin, China,

RECRUITING

China,

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

Wuhan, China,

RECRUITING

China,

Xi'An International Medical Cancer Hospital

XI'an, China,

RECRUITING

China,

Henan Cancer Hospital

Zhengzhou, China,