KCT0004553招募中未知
HIPEx (HIgh risk ER+HER2- T1-2N0-1 early breast cancer with Palbociclib plus Endocrine Therapy): Single-arm Phase II Study of Palbociclib plus Endocrine Therapy in Patients with High Risk ER-positive/HER2-negative T1-2N0-1 Early Breast Cancer Incorporating GenesWell™ BCT
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 578
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •To be eligible for this trial, patients have to comply with the following eligibility criteria:
- •1.Patient is an adult, = 19 years old at the time of informed consent
- •2.Premenopausal and postmenopausal women or men with primary invasive breast cancer
- •3.De novo primary disease
- •4.Patient who performed surgery with curative aim
- •5.Patient who has negative surgical resection margins
- •6.Patient with histologically confirmed HER2-negative breast cancer
- •7.Patient with histologically confirmed ER positive breast cancer by local laboratory testing
- •8.Pathological node assessment: pN0 or pN1
- •9.Tumor size = 0.5 cm, and T1 or T2
- •10.Clinical High-Risk (Clinical high-risk patients as per the modified Adjuvant! Online guideline in the clinical trial MINADCT(Microarray in Node Negative Disease May Avoid Chemotherapy), refer to section 5.2.1)
- •11.Genomic High-Risk in BCT score (= 4)
- •12.Patients agreed to use effective contraception or not be of childbearing potential.
- •13.Patient has adequate bone marrow and organ function
- •- adequate bone marrow function(= ANC 1,500/uL, = Hemoglobin 9.0g/dL)
- •- adequate kidney function(= serum creatinie 1.5mg/dL or CCr = 50mL/min)
- •- adequate liver function(= serum bilirubin 2.0mg/dL, =3 x ULN of AST/ALT)
- •14.Patient has an Eastern Cooperative Oncology Group (ECOG) performance status = 1
- •15.Patient who is able to swallow and retain oral medication
- •16.A FFPE tumor sample must be available for inclusion. The tumor sample must be taken from the excised primary tumor
- •?For RNA extraction, Tumor cellularity percentage on the H&E stained slide = 30%
- •?Tumor surface area on the H&E stained slide = 3 mm2
排除标准
- •To be eligible for this trial, patients must not meet any of the following criteria:
- •1.Patient with recurred breast cancer
- •2.Patient with histologically confirmed ER negative
- •3.Patient with histologically confirmed HER2-positive
- •4.pN2 or pN3
- •5.Patient who has received neoadjuvant chemotherapy or endocrine therapy
- •6.Patient who has received preoperative treatment with CDK 4/6 inhibitors.
- •7.Patient has received preoperative radiation therapy
- •8.Tumor size less than 0.5 cm
- •9.Patient with low clinical risk group
- •10.Patient who low BCT risk group (BCT score<4)
- •11.Patients with lactose intolerance (example: galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption, and so on)
- •12.Patients with a hypersensitivity to IP and/or components of IP
- •13.Patients with co-administration of anastrozole
- •14.Pregnant women, women of childbearing potential or lactating women
- •15.Patient who has serious underlying co-morbidities which could cause end-organ dysfunction
- •– In case of severe uncontrolled infections
- •- In case of serious medical and mental illness including active heart diseases such as myocardial infarction, angina, uncontrolled arrhythmia within 6 months
- •– In case of having secondary primary malignant tumor
- •– In case of having a medical history of clinically significant liver disease, current alcohol abuse or hepatitis B virus or Known active infection with hepatitis C virus
- •– Immunoactive or HIV-infected
- •16.A FFPE tumor sample is not available
- •?The tumor cellularity on the H&E stained slide < 30%
- •?The tumor surface area on the H&E stained slide < 3 mm2
研究者
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