Abemaciclib Combined With Endocrine Therapy or as a Single Agent for the Treatment of Luminal Metastatic breAst caNcer in the Real-life Clinical pracTice in Russia. Prospective, Multicentre, Non-interventional, Observational Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Progression-free Survival (PFS) of patients receiving abemaciclib
研究概览
简要总结
The ATLANT study is prospective, multicentre, non-interventional, observational study. Patients with HR+/HER2-negative metastatic breast cancer received abemaciclib as monotherapy or in combination with endocrine therapy.
详细描述
The ATLANT study is prospective, multicentre, non-interventional, observational study.
136 patients with HR+/HER2-negative metastatic breast cancer received abemaciclib as monotherapy or in combination with endocrine therapy in different line therapy.
The purpose of this study is to better understand how abemciclib combinations are used in real-life conditions and their clinical impact for the treatment of Russian patients affected by (HR+)/ (HER2-) advanced breast cancer (ABC) or metastatic breast cancer (MBC).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Age ≥18 years
- •Patients must have a diagnosis of HR+ breast cancer. To fulfill the requirement of HR+ disease, a breast cancer must express, by immunohistochemistry (IHC), at least one of the hormone receptors (ER, progesterone receptor [PgR]) as defined in the relevant American Society of Clinical Oncology/College of American Pathologists Guidelines: For ER and PgR assays to be considered positive, ≥1% of tumor cell nuclei must be immunoreactive by immunohistochemistry (IHC)
- •Patient has HER2-negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing.
- •Patients with advanced (loco-regionally recurrent, or metastatic) breast cancer not amenable to curative therapy.
- •WHO performance status of 0-2
- •The patient has adequate organ function
- •Any number of prior therapies (including none) is permitted
- •Рatients who will start Abemaciclib as a Single Agent or in combination with endocrine therapy
排除标准
- •Uncontrolled intercurrent illness including, but not limited to, known ongoing or active infection, including HIV, active hepatitis B or C, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia (specifically, atrial fibrillation or ventricular dysrhythmias except ventricular premature contractions), or psychiatric illness/social situations that would limit compliance with study requirements.
- •Participants must not be pregnant or breastfeeding
研究组 & 干预措施
patients with HR+/HER2- ABC/MBC who received abemaciclib based therapy for their ABC/MBC.
干预措施: Abemaciclib (Drug)
结局指标
主要结局
Progression-free Survival (PFS) of patients receiving abemaciclib
时间窗: Up to 5 years
Progression-free Survival (PFS) of patients receiving abemaciclib in combination with endocrine therapy Progression-free Survival (PFS) of patients receiving abemaciclib as a single agent
次要结局
- Frequency of AE/SAE(Up to 5 years)
- Overall Response Rate (ORR)(Up to 5 years)
- Time To Chemotherapy (TTC)(Up to 5 years)
- Time To New Treatment Options (TTN)(Up to 5 years)