Breast Cancer RElapsed in Patients Treated With Adjuvant CDK4/6 Inhibitors: Evaluation in the Real-world Setting
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 750
- 试验地点
- 23
- 主要终点
- Invasive-disease free survival (IDFS)
研究概览
简要总结
This is a multicenter observational study with both retrospective and prospective phase, designed to evaluate the clinico-pathologic characteristics and outcomes of patients with HR+/HER2- EBC at high risk of recurrence treated with ribociclib or abemaciclib in combination with ET in the adjuvant setting.
详细描述
The study will also evaluate clinico-pathologic characteristics, patterns of recurrence, therapeutic choices and outcomes of the subgroup of patients relapsed during or within 12 months after adjuvant therapy with CDK4/6 inhibitors in combination with ET.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female (regardless of menopausal status) or male ≥18 years of age;
- •The patient has confirmed HR+, HER2-, early-stage resected invasive breast cancer candidate to adjuvant CDK4/6 inhibitors (abemaciclib or ribociclib);
- •ER and PgR positivity is defined as evidence of immunohistochemical staining ≥ 1% according to ASCO/CAP recommendations; HER2 negativity is defined as expression of the membrane protein in immunohistochemistry 0 or 1+ or with a 2+ in situ hybridization (ISH) test negative as per ASCO/CAP recommendations;
- •Patients who are initiating or have initiated adjuvant treatment with a CDK4/6 inhibitor (abemaciclib or ribociclib) in combination with endocrine therapy (ET). Treatment must have started on or after January 1,
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;
- •Consent to data treatment according to the local regulation.
排除标准
- •Current participation in any other HR+/HER2- EBC study with any investigational products;
- •Patients who have already received adjuvant treatment with a CDK4/6 inhibitor as part of a clinical trial;
- •Patients unable to comply with the requirements of the study or who, in the judge of the study physician, should not be included in the study;
- •Patients with a history of previous BC, with the exception of Ductal carcinoma in situ (DCIS) treated by locoregional therapy alone ≥5 years ago;
- •Patients with a history of any other cancer (except non-melanoma skin cancer or carcinoma in situ of the cervix), unless in complete remission with no therapy for a minimum of 5 years from the index date, will be excluded, as well.
研究组 & 干预措施
Group 1
Patients undergoing treatment with CDK4/6 inhibitors
结局指标
主要结局
Invasive-disease free survival (IDFS)
时间窗: 3 years
Invasive disease-free survival (IDFS) will be defined as the time from surgery to invasive loco-regional recurrence, metastasis, other primary non-breast carcinomas, or death from any cause, whichever occurs first.
次要结局
- Distant relapse-free survival (DRFS)(5 years)
- progression-free survival (PFS)(5 years)
- Overall survival (OS)(5 years)