CORALLEEN: A Phase 2 Clinical Trial of Multi-agent Chemotherapy or Letrozole Plus Ribociclib (LEE011) as Neoadjuvant Treatment for Postmenopausal Patients With Luminal B/HER2-negative Breast Cancer.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 106
- 试验地点
- 21
- 主要终点
- Rate of ROR-low according to the Prosigna test.
研究概览
简要总结
CORALLEEN is a two-arm, randomized, multicentric study in postmenopausal women with primary HR+/HER2 negative Luminal B breast cancer that will explore if the combination of ribociclib with letrozole offers clinical benefit at least comparable to that of standard chemotherapy.
详细描述
This is a parallel, two-arm, randomized 1:1, stratified by tumor size and nodal involvement, open-label, multicenter, exploratory study in postmenopausal women with primary operable HR+/HER2-negative Luminal B breast cancer according to PAM50 intrinsic subtype to evaluate the clinical benefit and biological effects of ribociclib combined with letrozole.
The primary trial objective is to evaluate the ability of each treatment strategy to provide ROR-low score at surgery.
Luminal B patients will be randomized 1:1 to either letrozole plus ribociclib or chemotherapy.Two weeks after the first administration of the assigned treatment, patients will undergo a biopsy to assess early biological response to treatment, at Ki67 protein and gene expression level. After finalization of the assigned neoadjuvant treatment, patients will undergo surgery.
The primary endpoint, Rate of ROR-low (at surgery) after neoadjuvant treatment, according to the Prosigna test will be centrally assessed.
Baseline, Day 15 and post-treatment (surgical) primary breast tumor tissue samples should be available for each patient for molecular characterization A post-surgery visit will be performed within 28 days (7 days) from surgery, and will mark the end of the study for that patient
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Ribociclib + Letrozol
Ribociclib: 600mg, 3-weeks-on/-week-off treatment Letrozole: 2.5mg daily; Six 28 days cycles
干预措施: Ribociclib (Drug)
Ribociclib + Letrozol
Ribociclib: 600mg, 3-weeks-on/-week-off treatment Letrozole: 2.5mg daily; Six 28 days cycles
干预措施: Letrozole 2.5mg (Drug)
Chemotherapy
Chemotherapy treatment will consist of four cycles of AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 every 21 days) followed by weekly paclitaxel during 12 weeks.
干预措施: Doxorubicin (Drug)
Chemotherapy
Chemotherapy treatment will consist of four cycles of AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 every 21 days) followed by weekly paclitaxel during 12 weeks.
干预措施: Cyclophosphamide (Drug)
Chemotherapy
Chemotherapy treatment will consist of four cycles of AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 every 21 days) followed by weekly paclitaxel during 12 weeks.
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Rate of ROR-low according to the Prosigna test.
时间窗: 24 weeks
Rate of ROR-low after neoadjuvant treatment at surgery, according to the Prosigna test,as per central assessment
次要结局
- Tumor Overall response rate (ORR)(24 weeks)
- pCR in the breast and axillary lymph nodes(24 weeks)
- PEPI Score(24 weeks)
- Residual Cancer Burden (RCB)(24 weeks)
- Rate of breast conserving surgery (BCS)(24 weeks)
- Decrease in Ki67 in both treatment arms.(At baseline, in week 2, and pre-surgery)
- Incidence, duration and severity of Adverse Events (AEs)(Up to 24 weeks)