NCT06605690尚未招募不适用
An Exploratory Clinical Study of Dalpiciclib an&Amp;#39;d Letrozole Combined With Anlotinib Neoadjuvant Therapy in Stage II-III Postmenopausal HR+/HER2- Early Breast Cancer
Liu Shu0 个研究点目标入组 30 人开始时间: 2024年10月31日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 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 and letrozole combined with Anlotinib in the neoadjuvant treatment of stage Ⅱ-Ⅲ Postmenopausal 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 female patients, the definition of menopause:
- •(1) previous bilateral oophorectomy, or age ≥60 years; or(2) Age <60, natural postmenopausal status (defined as spontaneous cessation of regular menstruation for at least 12 consecutive months without other pathological or physiological causes), E2 and FSH in postmenopausal levels.
- •All patients had estrogen receptor (ER) positive (> 10%), HER2 receptor-negative invasive breast cancer regardless of PR expression level. Follow 2018 Asc-cap HER2 negative Interpretation guidelines. Immunohistochemical (IHC) score 0,1 + or 2+ and in situ hybridization (ISH) confirmed by pathology laboratory The test was negative (HER-2/CEP17 ratio < 2.0);
- •Patients with initial treatment of stage II-III whose tumor stage meets AJCC 8th edition standard;
- •No known severe hypersensitivity to chemical compounds or endocrine therapy similar to dalpiciclib or dalpiciclib excipients; Known against anlotinib or anlotinib Compounds with similar excipients had no severe hypersensitivity
- •The patient must have the ability to swallow oral drugs;
- •The level of organ function must meet the following requirements:
- •Bone marrow function ANC ≥ 1.5×109/L (no granulocyte stimulating factor was used within 14 days); PLT ≥ 100×109/L (no corrective therapy used within 7 days); Hb ≥ 100 g/L (no corrective therapy used within 7 days);
- •Liver and kidney function TBIL≤1.5×ULN;ALT and AST≤3×ULN (ALT and AST≤5×ULN in patients with liver metastasis);BUN and Cr≤1.5×ULN and creatinine clearance ≥50 mL/min (Cockcroft-Gault formula)
- •12-lead electrocardiogram QT interval ≤480 ms;
- •Able to accept 2 puncture biopsies required by the protocol (puncture at the first diagnosis and puncture on the 15th day of medication)
- •Voluntarily participate in this study, sign informed consent, have good compliance and be willing to cooperate with follow-up.
排除标准
- •Previously received any form of anti-tumor therapy (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.);
- •At the same time receive any anti-tumor treatment other than that prescribed in other protocols;
- •Bilateral breast cancer, inflammatory breast cancer or ocessive breast cancer;
- •Stage IV breast cancer;
- •Other malignant tumors have appeared in the past 5 years;
- •Severe heart, liver, kidney and other vital organ dysfunction;
- •Inability to swallow, chronic diarrhea, and intestinal obstruction, with multiple factors affecting drug use and absorption;
- •Known allergic history of the drug components of this protocol; Have a history of immunodeficiency, including HIV positive, HCV, active viral hepatitis B, or Have other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation;
- •Pregnant and lactating women, women who are fertile and have a positive baseline pregnancy test or are unwilling to take effective treatment during the entire test period Female patients of reproductive age using contraceptives;
- •Concomitant diseases (including but not limited to uncontrollable drugs) that, in the judgment of the investigator, seriously endanger the patient's safety or interfere with the patient's completion of the study Severe hypertension, severe diabetes, active infection, etc.);
- •People with large risk of hemoptysis, such as patients with refractory hypertension; Blood system diseases such as idiopathic thrombocytopenic purpura, thrombocytopenia, etc.;Lung diseases such as active pulmonary tuberculosis and bronchiectasis; Patients with chronic liver disease such as cirrhosis, portal hypertension, etc., and other diseases that may present with massive hemoptysis disease;
- •Have a clear history of neurological or mental disorders, including epilepsy or dementia. The investigator did not consider the patient suitable for participation in any other condition of the study.
研究组 & 干预措施
experimental
Experimental
Dalpiciclib and Letrozole Combined With Anlotinib
干预措施: Dalpiciclib and Letrozole Combined With Anlotinib (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
Liu Shu
Chief physician
The Affiliated Hospital Of Guizhou Medical University
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