A Retrospective Study to Characterize Patients With HER2-positive Metastatic or Locally Advanced Breast Cancer, Treated by Herceptin® as 1st Line-therapy and Without Progression for at Least 3 Years Followed by a 1-year Prospective Study for Patients Still Alive
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 78
- 主要终点
- Tumor Hormone Receptor Status of Participants Without Progression
研究概览
简要总结
This observational study will characterize retrospectively patients with HER2-positive metastatic or locally advanced breast cancer who had received treatment with Herceptin (trastuzumab) in 1st line and who were without progression for at least three years. Patients will be followed prospectively for one year.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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 patients, >/= 18 years of age
- •HER2-positive metastatic breast cancer or locally advanced breast cancer
- •Systemic treatment included Herceptin as 1st line therapy
- •Without progression for at least 3 years after the beginning of Herceptin treatment
- •Alive or not alive and treated or not treated with Herceptin at the time of inclusion
排除标准
- •Disease progression <3 years after beginning 1st-line therapy with Herceptin
研究组 & 干预措施
Trastuzumab
Eligible participants with human epidermal growth factor receptor 2 (HER2)-positive metastatic or locally advanced breast cancer, who were treated with trastuzumab as a first-line therapy and were progression-free for at least 3 years after treatment initiation, were included and were followed for one year.
干预措施: Trastuzumab (Drug)
结局指标
主要结局
Tumor Hormone Receptor Status of Participants Without Progression
时间窗: Up to 3 years
The clinical and tumor characteristics including HER2 and Hormone Receptor (HR) status of metastatic breast cancer participants are analysed which are important factors which impact on Progression Free Survival.
Percentage of Participants With Prevalence of Bone Metastases Without Progression for at Least 3 Years After the Beginning of 1st Line Herceptin Treatment
时间窗: Up to 3 years
Bone metastasis occurs when cancer cells spread from their original site to a bone. Percentage of participants with prevalence of bone metastases without progression were reported
次要结局
- Overall Survival(Up to 12 years)
- Progression-free Survival(Up to 12 years)
- Time to Progression(Up to 12 years)
- Dosage Schedule of Herceptin Treatment(Up to 12 years)
- Number of Participants With Antineoplastic Treatment in Combination With Trastuzumab and After Discontinuation of Trastuzumab Treatment(Up to 12 years)
- Number of Participants With Any Adverse Events and Serious Adverse Events(Up to 1 year)
- The Duration of Treatment of Trastuzumab(Up to 1 Year)