NCT06447623招募中3 期
Study of Efficacy of Apatinib Combined With cdk4/6i in First-line Treatment for HR+/HER2- SNF4 Subtype Advanced Breast Cancer (Open, Randomized, Phase III)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 184
- 试验地点
- 1
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
This is a randomized, controlled, open-label, phase III study to explore the efficacy and safety of Apatinib in combination with standard first-line endocrine therapy for the HR+/ HER2-SNF4 subtype of advanced breast cancer. The study was used to explore the efficacy of Apatinib in combination with standard 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
- None
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
- •Inclusion Criteria:
- •Patients need to meet all of the following conditions
- •Patients must be ≥18 and ≤ 75 years of age;
- •Pathologically confirmed breast cancer is HR+/HER2- breast cancer (IHC ER >10%, or/and PR>10%, HER 0 OR +, if HER2++, FISH negative);
- •SNF4 subtype definition: SNF4 subtype confirmed by digital pathology of H&E sections;
- •Locally advanced breast cancer (radical local therapy is not possible) or metastatic breast cancer (without using adjuvant CDK4/6 inhibitors in the past, or one year after adjuvant CDK4/6 inhibitor therapy has ended);
- •No prior therapy (chemotherapy, targeted therapy, etc.) for advanced or metastatic breast cancer;
- •Patients with at least one measurable lesion that has not previously received radiation therapy and can be evaluated repeatedly according to RECIST 1.1;
- •The functions of the main organs are basically normal, and the following conditions are met:
- •Blood routine examination standards should meet: HB≥90g/L (no blood transfusion within 14 days); ANC≥1.5×109/L; PLT≥75×109/L;
- •Biochemical examination shall meet the following standards: TBIL≤1.5×ULN (upper limit of normal value); ALT and AST≤3 x ULN; In case of liver metastasis, ALT and AST≤5×ULN; Serum Cr ≤1.5×ULN, endogenous creatinine clearance > 50ml/min (Cockcroft-Gault formula);
- •ECOG performance status 0 or 1; The expected survival is more than 3 months;
- •Fertile female is required to use a medically approved contraceptive during study treatment and for at least 3 months after the last use of the study drug;
- •Patients voluntarily join the study, sign the informed consent, have good compliance, and cooperate with follow-up.
排除标准
- •Patients with any of the following conditions were excluded from the study
- •Patients with central nervous system metastasis out of control (symptoms need to use glucocorticoids or mannitol).
- •A history of clinically significant or uncontrolled heart disease, including congestive heart failure, angina pectoris, myocardial infarction within the last 6 months, or ventricular arrhythmia;
- •Radiotherapy, chemotherapy, surgery, other targeted therapy, and immunotherapy for advanced HR+/HER2- breast cancer within 4 weeks before the first administration of drugs used in this study.
- •Pregnant or lactating patients;
- •Other malignancies within the previous 3 years, excluding cured skin basal cell carcinoma and cervical carcinoma in situ;
- •Significant comorbid medical conditions, including mental illnesses that the investigator or sponsor believes would adversely affect the patient's participation in the study;
- •Allergic physique, or known allergic history of the drug components of this program; Or allergic to other monoclonal antibodies;
- •The investigator does not consider the patient suitable for participation in any other circumstances of the study.
研究组 & 干预措施
Arm-A
Experimental
Apatinib combined with cdk4/6i and Endocrine therapy.
干预措施: Apatinib (Drug)
Arm-A
Experimental
Apatinib combined with cdk4/6i and Endocrine therapy.
干预措施: CDK4/6 Inhibitor (Drug)
Arm-A
Experimental
Apatinib combined with cdk4/6i and Endocrine therapy.
干预措施: Aromatase inhibitor and Fulvestrant (Drug)
Arm-B
Active Comparator
cdk4/6i and Endocrine therapy.
干预措施: CDK4/6 Inhibitor (Drug)
Arm-B
Active Comparator
cdk4/6i and Endocrine therapy.
干预措施: Aromatase inhibitor and Fulvestrant (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: Approximately 5 years
The interval from randomization until the first occurrence of disease progression (according to RECIST 1.1) or death from any cause, which ever occurs first.
次要结局
- Clinical Benefit Rate (CBR)(Approximately 5 years)
- Objective Response Rate (ORR)(Approximately 5 years)
- Overall Survival (OS)(Approximately 5 years)
- Safety and tolerability(Approximately 5 years)
研究者
Zhimin Shao
Director of General Surgery of Fudan Shanghai Cancer Center
Fudan University
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
2 期
The Study of Apatinib Plus CIK as the Third Line Therapy for Advanced Lung Adenocarcinoma Patients With Wild-Type EGFRAdenocarcinoma of LungNCT02493582The First People's Hospital of Changzhou400
进行中（未招募）
3 期
Phase III Study to Assess AZD9833+ CDK4/6 Inhibitor in HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6)ER-Positive HER2-Negative Breast CancerNCT04964934AstraZeneca315
进行中（未招募）
2 期
The Study of Apatinib Plus CIK as the Third Line Therapy for Patients With Advanced Gastric CancerStomach NeoplasmsNCT02485015The First People's Hospital of Changzhou80
已完成
4 期
A Study of Apatinib Tablets in the Treatment of Advanced or Metastatic Gastric CancerAdvanced Gastric or Gastroesophageal Junction AdenocarcinomaNCT02426034Jiangsu HengRui Medicine Co., Ltd.2,004
进行中（未招募）
3 期
A Study to Evaluate the Efficacy and Safety of Upadacitinib in Participants With Takayasu Arteritis (TAK)Takayasu Arteritis (TAK)NCT04161898AbbVie56