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

Официальное название

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

Обзор

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

Вмешательства

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

Первичные конечные точки

• Intracranial Objective response rate（iORR） [Срок оценки: Approximately 3 years]

Вторичные конечные точки (10)

• Intracranial Duration of remission (iDOR) [Срок оценки: Approximately 3 years]
• Intracranial Disease control rate (iDCR) [Срок оценки: Approximately 3 years]
• Progression-free survival (PFS) [Срок оценки: Approximately 3 years]
• Overall Survival (OS) [Срок оценки: Approximately 8 years]
• Extracranial Objective response rate（eORR） [Срок оценки: Approximately 3 years]
• Extracranial Disease control rate (eDCR) [Срок оценки: Approximately 3 years]
• Extracranial Duration of remission (eDOR) [Срок оценки: Approximately 3 years]
• Cmax [Срок оценки: Approximately 3 years]
• Tmax [Срок оценки: Approximately 3 years]
• Safety and tolerability [Срок оценки: Approximately 3 years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 25 центров

• Anhui provincial hospital — Хэфэй
• The First Affiliated Hospital of Anhui Medical University — Хэфэй
• Affiliated Cancer Hospital, Sun Yat-sen University — Гуанчжоу
• Liuzhou people's Hospital — Liuzhou
• Anyang Cancer Hospital — Anyang
• The First Affiliated Hospital of Henan University of Science and Technology — Luoyang
• The Fourth Hospital of Hebei Medical University — Shijiazhuang
• Harbin Medical University cancer Hospital — Харбин
• … и ещё 17 центров

Идентификаторы

NCT: NCT05872347 · SPH4336-202

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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