Clinical Practice Surveillance of the Use of Herceptin® Subcutaneous in Patients With HER2-Positive Early Breast Cancer (HerSCin)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,006
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Pathologic Complete Response (pCR) (For Participants Treated in Neo-Adjuvant Setting), According to Response Evaluation Criteria in Solid Tumor (RECIST), or Modified RECIST, or Cheson Criteria (As per Center Practice)
研究概览
简要总结
This observational study will evaluate the efficacy, safety, tolerability and participant reported quality of life of trastuzumab (Herceptin) subcutaneous (SC) therapy in participants with HER2-positive early breast cancer in routine clinical practice. Data from eligible participants will be collected for the duration of their treatment (approximately 1 year) and for 1-2 years 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
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed adenocarcinoma of the breast
- •HER2-positive tumor
- •Eligible for neo-adjuvant or adjuvant treatment with trastuzumab SC according to the judgement of the physician Note: As of participant recruitment (date of participant informed consent), retrospective documentation is allowed but limited to up to 9 weeks after initial start of therapy with trastuzumab SC
排除标准
- •Contraindications according to the Summary of Product Characteristics of Herceptin SC
- •Pregnant and breastfeeding women
研究组 & 干预措施
HER2 Positive Breast Cancer Participants
Participants with HER2 positive tumors who are considered for treatment with trastuzumab SC according to the judgement of physician and according to the actual summary of product characteristics will be observed for a period of approximately 1 year and will be followed for an additional 2 years.
干预措施: Trastuzumab (Drug)
结局指标
主要结局
Percentage of Participants With Pathologic Complete Response (pCR) (For Participants Treated in Neo-Adjuvant Setting), According to Response Evaluation Criteria in Solid Tumor (RECIST), or Modified RECIST, or Cheson Criteria (As per Center Practice)
时间窗: Baseline up to approximately 3 years (assessed according to routine center practice)
Percentage of Participants Who Were Alive and Disease Free at Year 2 (For Participants Treated in the Adjuvant Setting), According to RECIST, or Modified RECIST, or Cheson Criteria (As per Center Practice)
时间窗: Year 2
次要结局
- Mean Trastuzumab Dose(Baseline up to Year 1)
- Percentage of Participants with Adverse Events(Baseline up to approximately 3 years)
- Percentage of Participants By Reason for Trastuzumab Discontinuation or Interruption(Baseline up to Year 1)
- European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) Scores(Baseline, every 12 weeks up to Year 1)
- European Organization for Research and Treatment of Cancer Breast Cancer Module (EORTC QLQ BR23) Questionnaire Score(Baseline, every 12 weeks up to Year 1)
- Duration of Trastuzumab Treatment(Baseline up to Year 1)
- Percentage of Participants Who Received Concomitant Treatment (Chemotherapy or Any Other Treatment)(Baseline up to Year 1)