NCT05860465招募中2 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 254
- 试验地点
- 22
- 主要终点
- Objective response rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
排除标准
- •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.
研究组 & 干预措施
SPH4336 Tablets
Experimental
SPH4336 Tablets; Letrozole tablets; Fulvestrant injection
干预措施: SPH4336 Tablets (Drug)
SPH4336 Tablets Placebo
Placebo Comparator
SPH4336 Tablets Placebo; Letrozole tablets; Fulvestrant injection
干预措施: SPH4336 Tablets Placebo (Drug)
结局指标
主要结局
Objective response rate
时间窗: Approximately 3years
tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1.
Progression-free survival (PFS)
时间窗: Approximately 3years
from the start date of study treatment to the date of progression disease or death , whichever occurred first.
次要结局
- Tmax(Approximately 3years)
- Cmax(Approximately 3years)
- Disease control rate (DCR)(Approximately 3years)
- Safety and tolerability of the combination therapy since the start of any study treatment.(Approximately 3years)
- Duration of remission (DOR)(Approximately 3years)
- Overall Survival (OS)(Approximately 8years)
研究者
研究点 (22)
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