Safety and Efficacy of SPH4336 in Combination With Endocrine Therapy in the Treatment of Locally Advanced or Metastatic Breast Cancer

Официальное название

A Phase II/III Study of SPH4336 in Combination With Endocrine Therapy in the Treatment of HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer That Progressed on CDK4/6 Inhibitor Combined With Endocrine Therapy

Обзор

This study evaluated the safety and efficacy of SPH4336 in combination with endocrine therapy in the treatment of locally advanced or metastatic breast cancer that progressed on CDK4/6 inhibitor combined with endocrine therapy.

Вмешательства

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

Первичные конечные точки

• Objective response rate [Срок оценки: Approximately 3years]
• Progression-free survival (PFS) [Срок оценки: Approximately 3years]

Вторичные конечные точки (6)

• Cmax [Срок оценки: Approximately 3years]
• Tmax [Срок оценки: Approximately 3years]
• Disease control rate (DCR) [Срок оценки: Approximately 3years]
• Duration of remission (DOR) [Срок оценки: Approximately 3years]
• Overall Survival (OS) [Срок оценки: Approximately 8years]
• Safety and tolerability of the combination therapy since the start of any study treatment. [Срок оценки: Approximately 3years]

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.
• History of other malignancies prior to the start of study treatment.
• Patients with known metastases to central nervous system.
• 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; mean QTc interval ≥ 470 ms before the start of study treatment; left ventricular ejection fraction ≤ 50% before the start of study treatment.
• 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 > 104 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

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 22 центра

• 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
• Xiangyang Cancer Hospital — Ухань
• Jiangsu Cancer Hospital — Нанкин
• … и ещё 14 центров

Идентификаторы

NCT: NCT05860465 · SPH4336-302

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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