NCT01777958已完成不适用
Noninterventional Study - Advanced HER2-positive Breast Cancer (Metastatic or Locally Recurrent, Inoperable): First-Line Treatment With PERJETA After Adjuvant Herceptin Therapy (HELENA)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- Median progression-free survival in routine clinical practice
研究概览
简要总结
This observational study will evaluate the efficacy, safety and patient reported quality of life of palliative first-line Perjeta (pertuzumab) in combination with Herceptin (trastuzumab) in patients with HER2-positive advanced breast cancer (metastatic or locally recurrent, inoperable) who relapsed after completed adjuvant Herceptin therapy. Additionally, information on selection criteria of breast cancer patients treated first-line with Perjeta, Herceptin and chemotherapy and their treatment duration will be collected and analyzed. Data will be collected from eligible patients for up to 20 months of treatment and 24 months of follow-up.
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 adult patients, >/= 18 years of age
- •HER2-positive advanced breast cancer (metastatic or locally recurrent, inoperable) relapsing after completed adjuvant Herceptin therapy
- •Indication for first-line treatment with Perjeta in combination with Herceptin and chemotherapy according to the Summary of Product Characteristics
- •Prior Herceptin therapy as systemic adjuvant treatment (postoperative treatment in a potentially curable setting); additional upfront neoadjuvant Herceptin therapy is allowed
- •No prior chemotherapy and/or immunotherapy for advanced (metastatic or locally recurrent, inoperable) HER2-positive breast cancer
排除标准
- •Pregnant or breastfeeding women
- •Contraindications to Perjeta, Herceptin or concomitant chemotherapy according to the Summary of Product Characteristics
- •No Herceptin treatment for early breast cancer in the adjuvant setting
结局指标
主要结局
Median progression-free survival in routine clinical practice
时间窗: approximately 7.5 years
次要结局
- Dosage/schedule: Initiation/duration/modification/discontinuation of Perjeta administration(approximately 7.5 years)
- Clinical/demographic patients characteristics at initiation of treatment(approximately 7.5 years)
- Safety: Incidence of adverse events(approximately 7.5 years)
- Patient reported outcome: Quality of life (FACT B questionnaire)(approximately 7.5 years)
研究者
研究点 (1)
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