NCT05512780Unknown2 期
An Exploratory Clinical Study of CDK4/6 Inhibitor Dalpiciclib Combined With Letrozole in Neoadjuvant Treatment of Stage Ⅱ-Ⅲ HR-positive/HER2-negative Breast Cancer
Hebei Medical University Fourth Hospital0 个研究点目标入组 30 人开始时间: 2022年9月10日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 30
- 主要终点
- ORR
研究概览
简要总结
This is a single-arm, open-label, exploratory clinical study
详细描述
This is a single-arm, open-label, exploratory clinical study initiated by the investigator to evaluate the objective response rate (ORR), efficacy, and safety of Dalpiciclib combined with letrozole in the neoadjuvant treatment of stage Ⅱ-Ⅲ HR+/HER2- 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
- •Postmenopausal women aged ≥18 years, the definition of postmenopausal:
- •the patients with the history of bilateral oophorectomy, or age ≥ 60 years; or
- •Age <60, natural postmenopausal state (defined as the spontaneous cessation of regular menstruation for at least 12 consecutive months, without other pathological or physiological causes), E2 and FSH at the postmenopausal levels
- •All patients were estrogen receptor (ER) positive (>10%), HER2 -negative invasive breast cancer regardless of PR expression level. Immunohistochemistry (IHC) score of 0+, or 2+ confirmed by pathology laboratory and negative in situ hybridization (ISH) test (HER-2/CEP17 ratio <2.0);
- •Treatment-naive patients with stage Ⅱ-Ⅲ tumors whose tumor staging meets the criteria of the 8th edition of the American Joint Committee on Cancer (AJCC) Staging;
排除标准
- •Received any form of anti-tumor therapy (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.)
- •Concurrently receiving any other anti-tumor therapy that those specified in the protocol;
- •Bilateral breast cancer, inflammatory breast cancer, or occult breast cancer;
- •Stage Ⅳ breast cancer;
研究组 & 干预措施
Dalpiciclib+ letrozole
Experimental
Dalpiciclib combined with Letrozole,28 days as one cycle.
- Dalpiciclib: 150 mg (p.o.) was given once daily for 3 weeks, followed by 1 week off in each 4-week cycle.
- Letrozole: 2.5mg, p.o., once a day, continuous administration.
干预措施: Dalpiciclib (Drug)
结局指标
主要结局
ORR
时间窗: 24 month
Objective response rate
次要结局
未报告次要终点
研究者
相似试验
撤回
2 期
Phase II Safety Single-arm Study of CDK4/6 Inhibition With Palbociclib in Hospitalized, Moderate COVID-19 Cases to Prevent ThromboinflammationCOVID-19NCT05371275biotx.ai GmbH
尚未招募
4 期
An Exploratory Clinical Study of CDK4/6i Dalpiciclib Combined With AI Neoadjuvant Therapy for Stage II-III HR+/HER2- Breast CancerBreast CancerNCT06613373Jiangsu Famous Medical Technology Co., Ltd.30
终止
1 期
Ribociclib&Belinostat In Patients w Metastatic Triple Neg Breast Cancer & Recurrent Ovarian Cancer w Response Prediction By GenomicsRecurrent Ovarian CarcinomaMetastatic Breast CancerNCT04315233University of Utah12
招募中
2 期
Dalpiciclib Combined With Letrozole in HR+/HER2 - Gynecologic Solid TumorsRecurrent Ovarian CarcinomaNCT06243185Fengzhi Feng30
已完成
1 期
A Trial of LEE011 in Patients With Advanced Solid Tumors or Lymphoma.Advanced Solid TumorLymphomasNCT01237236Novartis Pharmaceuticals156