NCT05744687招募中2 期
Randomized, Double-blind, Placebo-controlled, Phase II/III Study of SPH4336 Combined With Letrozole vs Placebo Combined With Letrozole in First-line Treatment of HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer
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
- 374
- 试验地点
- 9
- 主要终点
- response rate (ORR)
研究概览
简要总结
This study is designed to evaluate the safety and efficacy of SPH4336 combined with letrozole in first-line treatment of locally advanced or metastatic breast cancer
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
- Triple (Participant, Investigator, Outcomes Assessor)
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 the study, completely understand the study, and voluntarily sign the informed consent form (ICF).
- •Female, ≥ 18 and ≤ 75 years of age at the time of signing the ICF.
- •ECOG（Eastern Cooperative Oncology Group） performance status 0 or
- •Life expectancy ≥ 3 months.
- •Patients with locally advanced or metastatic breast cancer who are unable to receive radical surgeries/other local therapies, with hormone receptor positive and human epidermal growth factor receptor 2 negative confirmed by tumor histopathology and molecular pathology.
- •No previous systemetic therapy for locally advanced or metastatic diseases that cannot receive radical surgeries/other local therapies.
- •At least one measurable lesion as per the Response Evaluation Criteria in Solid Tumors.
- •Postmenopausal or premenopausal/perimenopausal female patients. Premenopausal or perimenopausal women should consent to receive goserelin therapy during the study.
- •Laboratory test results before randomization meet the relevant requirements for organ function.
排除标准
- •Prior treatment with any CDK4/6 （Cyclin dependent kinase）inhibitor.
- •Inflammatory breast cancer.
- •Patients unsuitable for endocrine therapy at the investigator's discretion.
- •History of other malignancies within 5 years prior to the start of study treatment.
- •Patients with known central nervous system metastases.
- •Taking anti-tumor traditional Chinese medicines at the time of signing the ICF.
- •Having undergone a surgery within 28 days prior to the start of study treatment, and hasn't yet recovered from adverse reactions of the surgery.
- •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; LVEF(Left Ventricular Ejection Fractions)≤ 50%.
- •History of ischemic stroke or severe thromboembolic disease before the start of study treatment.
- •Being receiving potent CYP3A4 inhibitors or inducers at the time of signing the ICF.
- •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.
- •Patients who participated in a clinical trial and received other investigational drugs within 30 days before the start of study treatment.
- •History of severe anaphylactic diseases, history of severe drug allergy, 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, in the opinion of the investigator, makes them an unsuitable candidate for the study.
- •Uncontrolled infections within 2 weeks before the start of study treatment, in the opinion of the investigator, makes them an unsuitable candidate for the study.
- •Pregnant or lactating women.
- •Known history of substance abuse, excessive drinking, or illegal drug addiction; history of confirmed neurological or mental disorders.
- •Presence of other diseases judged by the investigator that the risks of receiving the study treatment outweigh its benefits, or any other reason for which patients are ineligible for the study as assessed by the investigator and the sponsor.
研究组 & 干预措施
SPH4336 Tablets 400mg
Experimental
SPH4336 Tablets； Letrozole tablets
干预措施: SPH4336 Tablets 400mg (Drug)
SPH4336 Tablets Placebo
Placebo Comparator
SPH4336 Placebo； Letrozole tablets
干预措施: SPH4336 Tablets Placebo (Drug)
结局指标
主要结局
response rate (ORR)
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
- Cmax(Approximately 3years)
- Overall Survival (OS)(Approximately 8years)
- Duration of remission (DOR)(Approximately 3years)
- Tmax(Approximately 3years)
- Disease control rate (DCR)(Approximately 3years)
- Incidence of Adverse event(Approximately 3years)
研究者
研究点 (9)
Loading locations...
相似试验
已完成
3 期
A Study of Palbociclib (PD-0332991) + Letrozole vs. Letrozole For 1st Line Treatment Of Postmenopausal Women With ER+/HER2- Advanced Breast Cancer (PALOMA-2)Breast NeoplasmsNCT01740427Pfizer666
已完成
3 期
A Study Of Palbociclib (PD-0332991) + Letrozole VS. Placebo+ Letrozole For 1st Line Treatment Of Asian Postmenopausal Women With ER+/HER2- Advanced Breast Cancer [PALOMA-4]Breast NeoplasmsNCT02297438Pfizer340
进行中（未招募）
3 期
Study of PF-07220060 With Letrozole in Adults With HR-positive HER2-negative Breast Cancer Who Have Not Received Anticancer Treatment for Advanced/Metastatic DiseaseBreast CancerNCT06760637Pfizer1,035
已完成
1 期
Phase I Clinical Study of SPH4336 Tablets in the Treatment of Advanced Solid TumorsAdvanced Solid TumorsNCT05905614Shanghai Pharmaceuticals Holding Co., Ltd29
招募中
1 期
A Study to Efficacy and Safety of SPH4336 Monotherapy or in Combination With Cadonilimab in Patients With Advanced Solid Tumors.Advanced Solid TumorsNCT05944224Shanghai Pharmaceuticals Holding Co., Ltd63