Observational, Cross-sectional, Multicenter Descriptive Study of the Patient Clinical Profile That Begins With Disseminated Her 2 + Breast Cancer or Develops a Metastasis After or During the Adjuvant Therapy (PRIMHER)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 129
- 试验地点
- 39
- 主要终点
- The Patient Clinical Profile (General Clinical Data and Breast Cancer Characteristics)
研究概览
简要总结
This is an observational, cross-sectional study that the main objective is to describe the patient clinical profile that begins with disseminated Her 2+ Breast Cancer or develops a metastasis after or during the adjuvant treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Women with 18 years or over
- •Patients with disseminated breast cancer histologically or cytological confirmed, who begins with Her 2+ metastatic breast cancer or develops a metastasis after or during the adjuvant therapy
- •Patients treated in first line treatment in metastatic disease.
- •Patients who have positive Her 2 receptor test
- •Patients who have given their written informed consent
排除标准
- •Patients who are participating in other studies
结局指标
主要结局
The Patient Clinical Profile (General Clinical Data and Breast Cancer Characteristics)
时间窗: 1 day (there is no follow-up, it is a cross-sectional study)
General clinical data: age, weigh, height, Perfomance Status (ECOG Eastern Cooperative Oncology Group, runs from 0 to 5, with 0 denoting perfect health and 5 death), Breast cancer characteristics: familiar history of breast cancer, initial diagnostic (localized or disseminated), age at diagnostic, TNM (tumor node metástasis), tumor size, node involvement, primary tumor surgery, HER2 overexpression, histological Classification (grades I, II and III,determines the urgency and aggressiveness of treatment, as the higher grades do tend to correspond to poorer survival rates and prognosis), time from the primary breast cancer to distant relapse, description and localization of metastasis
次要结局
- Adjuvant Treatment-Node Affectation(one day (there is no follow-up, it is a cross-sectional study))
- Adjuvant Treatment in Primary Breast Cancer: Chemotherapy (Treatment With TAC-Docetaxel, Adriamicine and Cyclophosphamide), Hormonal Therapy Anti-HER Biological Therapy(one day (there is no follow-up, it is a cross-sectional study))
- Disseminated Breast Cancer Treatment-Smoking(one day (there is no follow-up, it is a cross-sectional study))
- Adjuvant Treatment and Age(one day (there is no follow-up, it is a cross-sectional study))
- Adjuvant Treatment-Physical Activity(one day (there is no follow-up, it is a cross-sectional study))
- Disseminated Breast Cancer Treatment-Age(one day (there is no follow-up, it is a cross-sectional study))
- The Pattern of Treatment in Metastatic Breast Cancer: Chemotherapy, Hormonal Therapy Anti-HER Biological Therapy(one day (there is no follow-up, it si a cross-sectional study))
- Disseminated Breast Cancer Treatment-physical Activity(one day (there is no follow-up, it is a cross-sectional study))