A Prospective Registry Study in Patients With Unresectable Locally Advanced or Metastatic Breast Cancer (MBC)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,867
- 试验地点
- 40
- 主要终点
- Number of patients with the different breast cancer subtypes and real distribution of them.
研究概览
简要总结
This study is a prospective, multicenter non-interventional cohort study designed to develop a registry in unresectable locally advanced or metastatic disease.
详细描述
The target population for inclusion in this study is breast cancer patients recently diagnosed (from January 2016) with unresectable locally advanced or metastatic disease (either after a recurrence or as first diagnosis). No treatment regimen will be protocol specified. This is an observational study in which clinical decisions concerning the optimum management strategy for a particular patient are taken independently of and/or prior to, any decision by the physician to invite a patient to participate in the study. The treating physician will make all treatment decisions according to his/her regular clinical practice independent of this study. Patients enrolled on the study are free to withdraw their informed consent for the use and disclosure of health information at any time and when asked, patients are not obliged to provide a reason. Patients may request discontinuation from the study at any time.
The date and the reason for withdrawal or discontinuation from the study must be recorded in the electronic case report form (eCRF). An attempt will be made to determine the date of discontinuation and final status (i. e. withdrawal of consent, loss to follow-up, death) of any patient who discontinues from the study. However, the treating clinician is encouraged to follow the patient as long as possible, until patient death or through study end. The Sponsor has the right to terminate the study at any time. The Sponsor will notify the investigator if the study is placed on hold or if the Sponsor decides to discontinue the 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
- All
- 接受健康志愿者
- 否
入选标准
- •Patients (males or females) diagnosed with unresectable locally advanced or MBC (either after a recurrence or as first diagnosis) from January 2016 onwards.
- •Patients who died are allowed to be included on the study.
- •Able and willing to provide written informed consent if they are alive.
- •Age ≥ 18 years.
- •Availability to medical records access and all data related to the disease management.
排除标准
- 未提供
结局指标
主要结局
Number of patients with the different breast cancer subtypes and real distribution of them.
时间窗: 8 years
Number of patients with the different breast cancer subtypes (Luminal A-like, Luminal B-like \[HER2 negative\], Luminal B-like \[HER2 positive\], HER2-enriched and Triple Negative) of the unresectable locally advanced or metastatic disease
次要结局
- Differences in the development disease in the group of male vs female patients.(8 years)
- Influence of timing of primary tumor surgery in patients with metastatic disease as first diagnosis(8 years)
- Number of participants with specific biomarkers on tumor and blood samples.(8 years)
- Patient and tumor characteristics and frequency of breast cancer with heredofamiliar risk.(8 years)
