NCT05077449进行中（未招募）3 期
A Phase III Study to Evaluate the Efficacy and Safety of XZP-3287 in Combination With Fulvestrant Versus Placebo Combined With Fulvestrant in Patients With HR Positive and HER2 Negative Recurrent/Metastatic Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Investigator-assessed progression free survival (PFS)
研究概览
简要总结
This is a phase III clinical trial to evaluate the efficacy and safety of XZP-3287 in combination with Fulvestrant versus placebo combined with Fulvestrant in Patients who have HR positive and Her2 negative recurrent/metastatic breast cancer and have received prior endocrine therapy are eligible for study.
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
- Quadruple (Participant, Care Provider, 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
- •Female patients aged ≥18 years and ≤75 years old;
- •Patient is in the menopausal state；
- •Pathologically-confirmed HR positive and Her2 negative Breast Cancer;
- •Locally advanced stage, recurrence or metastasis breast cancer; 4.1 Disease progression after previous endocrine therapy； 4.2 One previous line of chemotherapy for advanced/metastatic disease is allowed in addition to endocrine therapy;
- •At least one measurable lesion (based on RECIST v1.1) or only bone metastases;
- •Patient has an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
- •Adequate organ and marrow function;
- •Patient of childbearing age must undergo a serum pregnancy test within 14 days before randomization, and the result is negative; patient is willing to use a medically approved high-efficiency contraceptive method during the study period and within 6 months after the last study drug treatment;
- •Patient with acute toxic reactions caused by previous anti-tumor treatments or surgical operations were alleviated to grade 0 to 1 (NCI-CTCAE v5.0), or to the level specified by the enrollment criteria;
- •Patient has signed informed consent before any trial related activities.
排除标准
- •Patient with visceral crisis, inflammatory breast cancer, or brain metastases, except for patient with stable brain metastases;
- •Patient had clinically significant pleural effusions, ascites effusions, or pericardial effusions in the 4 weeks before enrollment;
- •Patient who received prior treatment with mTOR inhibitors, CDK4/6 inhibitors or fulvestrant;
- •Participation in a prior treatment of major surgery, chemotherapy, radiotherapy, and any anti-tumor treatment within 14 days before enrollment；
- •Patient who participated in other clinical trials within 14 days before enrollment or within 5 half-lives of the trial drug, whichever is longer;
- •Patient used CYP3A4 potent inhibitors or potent inducers within 14 days before enrollment or within 5 half-lives of the drug, whichever is longer;
- •Patient who used bisphosphonates or RANKL inhibitors within 7 days before enrollment, patient who have started treatment during the study should not change the method of use;
- •Any other malignant tumor has been diagnosed within 3 years before randomization;
- •Patient is in the active stage of HBV, HCV or co-infected with HBV, HCV, or Patient with positive HIV antibody;
- •Patient with severe infection within 4 weeks before enrollment, or unexplained fever> 38.5℃ during screening/before enrollment;
- •Patient with heart function impaired or clinically significant heart disease within 6 months before enrollment;
- •Cerebrovascular accident occurred within 6 months before enrollment, including history of transient ischemic attack or stroke; symptomatic pulmonary embolism;
- •Inability to swallow, intestinal obstruction or other factors that affect the taking and absorption of the drug;
- •Patient with a known hypersensitivity to any of the excipients in this study;
- •A prior history of autologous or allogeneic hematopoietic stem cell transplantation;
- •A prior history of psychotropic drug abuse or drug use;
- •Pregnant or breastfeeding;
- •The researchers considered that there were some cases that were not suitable for inclusion.
研究组 & 干预措施
XZP-3287+Fulvestrant
Experimental
干预措施: XZP-3287+Fulvestrant (Drug)
Placebo + Fulvestrant
Placebo Comparator
干预措施: Placebo + Fulvestrant (Drug)
结局指标
主要结局
Investigator-assessed progression free survival (PFS)
时间窗: Up to approximately 24 months
An interim analysis will be performed in this study. The primary endpoint of the study is PFS. An interim analysis is scheduled upon the collection of 70%(approximately 125) PFS events, and the final PFS analysis will be conducted after 178 PFS events have been collected.
次要结局
- Objective response rate (ORR)(Up to approximately 24 months)
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0(Up to approximately 24 months)
- Time to Maximum Plasma Concentration [Tmax](Up to approximately 4 months)
- Overall survival (OS)(Up to approximately 5 years)
- Duration of response (DoR)(Up to approximately 24 months)
- Number of participants with treatment emergent adverse events as assessed by CTCAE v5.0(Up to approximately 24 months)
- BICR-assessed progression free survival (PFS)(Up to approximately 24 months)
- Area under the time-concentration Curve [AUC](Up to approximately 4 months)
- Disease control rate (DCR)(Up to approximately 24 months)
- Clinical benefit rate (CBR)(Up to approximately 24 months)
- Overall survival rate(OSR)(Up to approximately 5 years)
- Maximum Plasma Concentration [Cmax](Up to approximately 4 months)
研究者
研究点 (1)
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