NCT06341894招募中2 期
Efficacy and Safety of Dalpiciclib With Endocrine Therapy as Adjuvant Treatment in Patients With Hormone Receptor-positive, HER2-negative Early Breast Cancer
The First Affiliated Hospital with Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 1,163 人开始时间: 2023年11月17日最近更新:
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
- 1,163
- 试验地点
- 1
- 主要终点
- invasive Disease-free Survival (iDFS)
研究概览
简要总结
The investigator conduct a phase II multi-center, open-label trial to evaluate efficacy and safety of dalpiciclib with endocrine therapy as adjuvant treatment in patients with medium /high risk hormone receptor-positive, HER2-negative Early Breast Cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patient is ≥ 18 years-old
- •Patient is female with known menopausal status (postmenopausal or premenopausal/perimenopause)
- •Patient with histologically confirmed HR+/HER2- early breast cancer (immunohistochemical ER and/or PR≥10%)
- •Histologically confirmed invasive breast cancer with anatomic stages of IIA-IIIC stage (T2-4N0-3M0), of which stage IIA only included T1N1M0
- •Patients with or without neoadjuvant or adjuvant chemotherapy/ radiotherapy were eligible for inclusion
- •From operation to enrollment should not exceed 12 months
- •Patient has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
排除标准
- •metastatic disease (Stage IV) or inflammatory breast cancer
- •Previous or current history of malignant neoplasms, except for curatively treated:Basal and squamous cell carcinoma of the skin,Carcinoma in situ of the cervix.
- •Clinically relevant cardiovascular disease:Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ≥180/110);
- •A history of allergy to the drugs in this study；
- •Unable or unwilling to swallow tablets
- •History of gastrointestinal disease with diarrhea as the major symptom.
研究组 & 干预措施
Treatment
Experimental
Dalpiciclib and endocrine therapy
干预措施: Dalpiciclib (Drug)
Treatment
Experimental
Dalpiciclib and endocrine therapy
干预措施: Endocrine therapy (Drug)
结局指标
主要结局
invasive Disease-free Survival (iDFS)
时间窗: From enrollment until time of events up to 3 years
Invasive disease-free survival time is defined as the time from date of enrollment until the first disease recurrence or death from any cause
次要结局
- Disease-free Survival (DFS)(From enrollment until time of events up to 3 years)
- AEs and SAEs(From the first administration to one months after the last drug administration，up to one month)
研究者
Liu Xiaoan
Professor
The First Affiliated Hospital with Nanjing Medical University
研究点 (1)
Loading locations...
相似试验
招募中
2 期
Ribociclib And Endocrine Treatment of Physician's Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast CancerLocoregional RecurrenceHormone Receptor-positive Breast CancerHER2-negative Breast CancerNCT05467891Oana Danciu200
已完成
2 期
Palbociclib in Combination With Adjuvant Endocrine Therapy for Hormone Receptor Positive, HER2 Negative Invasive Breast CancerBreast CancerNCT02040857Dana-Farber Cancer Institute162
已完成
2 期
Safety and Efficacy of PD0332991 (Palbociclib), a Cyclin-dependent Kinase 4 and 6 Inhibitor, in Patients With Oligodendroglioma or Recurrent Oligoastrocytoma Anaplastic With the Activity of the Protein RB PreservedOligodendrogliomaOligoastrocytomaNCT02530320Grupo Español de Investigación en Neurooncología34
招募中
2 期
Study of Dalpiciclib Isethionate Plus Pyrotinib Maleate in the Treatment of Advanced Esophageal Squamous Cell CarcinomaEsophageal Squamous Cell CarcinomaNCT06684600Peking University35
招募中
2 期
Dalpiciclib Combination With Fulvestrant and Compound Gossyfol Acetate Tablets in Women With CDK4/6 Inhibitor-refractory HR-positive HER-2 Negtive Metastatic Breast Cancer: a Phase 2 Clinical Trial.Advanced HR-positive and HER2-negative Breast Cancer CDK4/6 Inhibitor Treatment FailedNCT06133088Zhejiang Cancer Hospital53