Multicenter, Single-Arm, Observational Study of Mean Duration of Trastuzumab (Herceptin) Treatment in Patients With HER2-Positive Early or Metastatic Breast Cancer in Romanian Population
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Treatment Duration With Trastuzumab in the Routine Clinical Practice
研究概览
简要总结
This single arm observational study will assess the duration and safety of treatment with trastuzumab in routine clinical practice in participants with early or metastatic HER2-positive breast cancer. Data will be collected from female participants treated with trastuzumab according to the Summary of Product Characteristics and local protocols. Duration of observation for each participant is from therapy initiation until permanent discontinuation for any cause.
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
- •HER2-positive breast cancer
- •Treated with trastuzumab in accordance with Summary of Product Characteristics and local protocols
- •Written informed consent to data collection
排除标准
- •Any contraindication to trastuzumab
- •Clinically relevant cardiovascular disorder or disease
研究组 & 干预措施
Participants with Breast Cancer
Participants with early or metastatic HER2-positive breast cancer who were receiving treatment with trastuzumab according to local standard of care and in line with the current summary of product characteristics/ local guidelines, will be observed. Dosing and treatment duration of the trastuzumab will be at the discretion of the treating physician.
干预措施: Trastuzumab (Drug)
结局指标
主要结局
Treatment Duration With Trastuzumab in the Routine Clinical Practice
时间窗: Baseline up to 5 years
次要结局
- Percentage of Participants Who Discontinued Trastuzumab Therapy According to Reasons for Discontinuation(Baseline up to 5 years)
- Percentage of Participants Who Had Surgical Procedure for Breast Cancer(Baseline up to 5 years)
- Percentage of Participants Who Received Previous Neoadjuvant Therapy(Baseline up to 5 years)
- Percentage of Participants Who Received Trastuzumab as Adjuvant Therapy of HER2 Positive Breast Cancer(Baseline up to 5 years)
- Progression Free Survival(Baseline uo tp 5 years)
- Percentage of Participants by the Site of First Disease Progression(Baseline up to 5 years)