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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 578
- 试验地点
- 1
- 主要终点
- 3-year event-free survival
研究概览
简要总结
This is a phase II, multi-center, single-arm, open-label trial to evaluate efficacy of palbociclib with endocrine therapy as adjuvant treatment in women with C-high/G-high risk ER-positive/HER2-negative T1-2N0-1 EBC(Early Breast Cancer)
详细描述
The investigators hypothesized that the GenesWell™ BCT may help inform decision about whether or not to have adjuvant chemotherapy to patients with high-risk pN0-N1, ER+/HER2- breast cancer in Korea. While adjuvant therapy for ER-positive EBC is effective in reducing risk of recurrence and improving survival, recurrences are still common, especially in patients with unfavorable factors in terms of clinical, pathological and/or molecular perspectives.
Since the addition of CDK4/6 inhibitor, palbociclib, to endocrine therapy (ET) has proven clinical efficacy with tolerable toxicity profile in ER-positive, HER2-negative advanced BC, its use in the adjuvant setting may decrease risk of recurrences in patients with ER-positive, HER2-negative EBC after surgical resection of the primary tumor by enhancing primary endocrine responsiveness and preventing, or delaying the development of acquired resistance for endocrine therapy.
The purpose of this study is to evaluate the effect of addition of palbociclib to standard adjuvant ET on event-free survival (EFS) in patients with ER-positive, HER2-negative EBC but unfavorable clinicopathological (clinical high risk, C-high) and molecular features (genomic high risk, G-high).
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is an adult, ≥ 19 years old at the time of informed consent
- •Premenopausal and postmenopausal women or men with invasive breast cancer
- •De novo primary disease
- •Patient who performed surgery with curative aim
- •Patient who has negative surgical resection margins
- •Patient with histologically confirmed HER2-negative breast cancer
- •Patient with histologically and cytologically confirmed ER positive breast cancer by local laboratory testing
- •Pathological node assessment: pN0 or pN1
- •Tumor size ≥ 0.5 cm, and T1 or T2
- •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)
- •Genomic High-Risk in BCT score (≥ 4)
- •Patients agreed to use effective contraception or not be of childbearing potential.
- •Patient has adequate bone marrow and organ function
- •Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
- •Patient who is able to swallow and retain oral medication
- •A FFPE tumor sample must be available for inclusion. The tumor sample must be taken from the excised primary tumor
排除标准
- •Patient with recurred breast cancer
- •Patient with histologically confirmed ER negative
- •Patient with histologically confirmed HER2-positive
- •Pathological node assessment: pN2 or pN3
- •Patients has received neoadjuvant chemotherapy or endocrine therapy
- •Patient has received preoperative treatment with CDK 4/6 inhibitors.
- •Patient has received preoperative radiation therapy
- •Tumor size less than 0.5 cm
- •Patients with low clinical risk group (section 5.2.1)
- •Patients who low BCT risk group (BCT score<4)
- •Patients with lactose intolerance
- •Patients with a hypersensitivity to IP and/or components of IP
- •Pregnant women, women of childbearing potential or lactating women
- •Patients who have serious underlying co-morbidities which could cause end-organ dysfunction
- •A FFPE tumor sample is not available
研究组 & 干预措施
palbociclib plus endocrine therapy treatement
- Patients with Clinical high risk/Genomic High risk (in BCT score)-high and ER positive/HER2 negative EBC after Curative Surgery
- Palbociclib at a dose of 125mg, orally once daily on Day 1 to Day 21 followed by 7 days off in a 28-day cycle for a total duration of 2 years
- Standard adjuvant endocrine therapy for a duration of at least 5 years from the start of the treatment.
干预措施: Palbociclib (Drug)
结局指标
主要结局
3-year event-free survival
时间窗: up to 3 years
defined to be time from study entry to first event, where the first event is any type of recurrence
次要结局
- Prognostic and predictive effects of BCT(up to 5 years)
- Exploratory analysis of genomic biomarkers(up to 5 years)
- overall survival(up to 5 years)
- Adverse Events(up to 2 years)
- Quality of Life (QoL)(up to 5 years)
研究者
Yeon Hee Park
Clinical Professor, MD, PhD
Samsung Medical Center