Advanced Breast Cancer Patients Treated With Oral Vinorelbine: a Prospective and Retrospective, Observational Study - VINOREAL
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 368
- 试验地点
- 5
- 主要终点
- PFS rate in both cohorts.
研究概览
简要总结
This study looks at how well oral vinorelbine works in treating advanced breast cancer. It looks at women who have already had this treatment or are currently having it.
详细描述
This is an international, multicenter, retrospective and prospective, observational study.
The study will comprise of two cohorts:
- Retrospective: Patients who started OV treatment for ABC between 2011 and 2020 will be enrolled in the retrospective cohort study. The observation period for retrospectively included patients will extend from the initiation of OV treatment to the date of death, date of last contact or end date of retrospective observation period, whichever occurs first. The end date of retrospective observation period will be set as the date of the inclusion of the first patient in the study (First Patient In= FPI).
- Prospective: Patients initiating OV treatment and eligible for prospective collection of QoL data and PPQ and WPAI questionnaires will be enrolled in the prospective cohort study. The enrollment period is expected to extend up to 17 months from study start. The study observation period will extend up to 2 years after last patient first visit (around 24 months after treatment initiation).
Due to the observational nature of this study, no additional medical procedures or in person clinical visits beyond routine oncology care will be required for this study.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Female aged ≥ 18 years (≥ 19 years for Algeria as per local regulation) at oral vinorelbine ( OV) -based treatment initiation
- •Confirmed diagnosis of locally advanced or metastatic breast cancer eligible for chemotherapy
- •Initiated OV-based treatment as per SmPC for advanced breast cancer between January 2011 and December 2020 for the retrospective cohort or, initiating oral vinorelbine treatment at enrollment for the prospective cohort
- •Willing and able to complete the QoL questionnaire, PPQ and WPAI questionnaire for the prospective cohort
- •Provision of informed consent or non-opposition to the patient (or next of kin/legal representative, if applicable) for the use of data, according to local regulations
排除标准
- •no exclusion criteria for patients in this study
研究组 & 干预措施
Retrospective Cohort
Patients who initiated an oral vinorelbine treatment for advanced breast cancer over the 2011-2020 targeted enrollment period
干预措施: Vinorelbine Tartrate Oral (Drug)
Prospective Cohort
Patients initiating an oral vinorelbine treatment for advanced breast cancer at or after inclusion in the study and eligible for prospective collection of QoL data and PPQ and WPAI questionnaires
干预措施: Vinorelbine Tartrate Oral (Drug)
结局指标
主要结局
PFS rate in both cohorts.
时间窗: 2-years follow-up
PFS is defined as the time between vinorelbine-based treatment initiation and the first occurrence of progression or death from any cause, with censoring of patients who are lost to follow-up
次要结局
未报告次要终点