Phase II Open-label, Multicentre, Exploratory Trial of Neoadjuvant Dalpiciclib in Combination With Exemestane and Trastuzumab Plus Pyrotinib in Early Triple Positive Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- pathological complete response (pCR)
研究概览
简要总结
This is a phase II open-label, multicenter trial assessing the efficacy of combination regimen"Dalpiciclib plus Exemestane plus trastuzumab plus pyrotinib"in early triple positive breast cancer patients.
详细描述
This is a phase II open-label, multicenter trial. The study assesses the treatment of patients with ER-positive /HER2 positive early breast cancer with neoadjuvant Dalpiciclib in Combination With Exemestane and Trastuzumab plus Pyrotinib. Patients were treated with intravenous trastuzumab (8 mg/kg loading dose followed by 6 mg/kg, Q3W) for six cycles plus oral Dalpiciclib (125 mg QD x 21，Q4W) and Exemestane (25 mg po QD ）and oral pyrotinib (320 mg po QD) for 20 weeks. The primary endpoints was pathological complete response.
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
- •18 Years to 75 Years
- •Newly diagnosed clinical stage II or III ER+/HER2+ breast cancer, staging criteria is to be based on AJCC
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- •Primary tumor must have positive estrogen receptor (ER) ≥10%
- •Primary tumor must be HER2-positive (IHC 3+ or FISH/CISH amplification)
- •Baseline LVEF ≥50% measured by Echocardiography (preferred) or MUGA scan
- •Normal organ and marrow function
- •Written Informed Consent (IC) must be signed and dated by the patient and the Investigator prior to randomization.
- •Baseline corrected QT interval (QTcF) < 480 ms
- •All patients must be female.
排除标准
- •Inflammatory breast cancer
- •Evidence of bilateral invasive breast cancer or metastatic disease
- •Received any prior treatment for primary invasive breast cancer
- •Pregnant or lactating women
- •Abnormal baseline hematological values:
- •Abnormal baseline liver function, bilirubin, creatinine and/or INR (international normalized ratio)
- •Subjects with known infection with HIV, HBV, HCV
- •Other investigational drugs while on study
- •Severe or uncontrolled hypertension, history of congestive heart failure or severe coronary arterial disease.
- •Subjects assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol
研究组 & 干预措施
Dalpiciclib in combination with exemestane and trastuzumab plus pyrotinib
Patients are treated with intravenous trastuzumab (8 mg/kg loading dose followed by 6 mg/kg, Q3W) for six cycles plus oral Dalpiciclib (125 mg QD x 21，Q4W) and Exemestane (25 mg po QD ）and oral pyrotinib (320 mg po QD) for 20 weeks.
干预措施: Trastuzumab Pyrotinib Exemestane Dalpiciclib (Drug)
结局指标
主要结局
pathological complete response (pCR)
时间窗: at surgery
Assess the rate of pathological complete response (pCR) defined as ypT0-ypTis ypN0 at surgery
次要结局
- Serial measures of Ki67(baseline before therapy, 2 weeks after and at surgery)
- Objective response(Tumour assessments will be performed by ultrasound and mammography at screening (prior to start of treatment), and before surgery, an expected average of 24 weeks)