NCT05945927已完成不适用
An Observational Study to Evaluate the Safety and Effectiveness of Trastuzumab Emtansine (T-DM1) as Second- or Later-Line Therapy in Chinese Patients With HER2 Positive Advanced Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 178
- 试验地点
- 30
- 主要终点
- Percentage of Participants with Adverse Events
研究概览
简要总结
This study is a post-marketing, observational, multicenter, prospective study. It will investigate the the safety and effectiveness of T-DM1 in the Chinese population in real-world clinical practice.
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
- •Diagnosed with HER2-positive, unresectable locally advanced or metastatic breast cancer before the start of T-DM1 treatment
- •Had prior treatment for breast cancer which must contain a taxane and trastuzumab
- •Get the treatment of T-DM1 for the first time after diagnosis of breast cancer
排除标准
- •Patients not receiving treatment for HER2-positive breast cancer with T-DM1 according to standard of care and in line with the current summary of product characteristics (SPC)/local labeling
- •Has been previously treated with T-DM1 before current clinical visit
- •Currently participating in any clinical trials
- •Previously participated in any clinical trials investigating anti-HER2 drug within 1 year of the initiation of T-DM1
研究组 & 干预措施
Participants with HER2-positive Advanced Breast Cancer
Participants will be prospectively followed from the index date (the first treatment of T-DM1) for up to 1 year.
干预措施: Trastuzumab emtansine (Drug)
结局指标
主要结局
Percentage of Participants with Adverse Events
时间窗: Up to approximately 1 year from index date
次要结局
- Time-to-treatment Discontinuation (TTD)(Up to approximately 1 year from index date)
- Percentage of Participants Exposed to T-DM1 by Dosage(Up to approximately 1 year from index date)
- Percentage of Participants Exposed to T-DM1 by Duration(Up to approximately 1 year from index date)
- Percentage of Participants Exposed to T-DM1 by Line of Therapy(Up to approximately 1 year from index date)
- Percentage of Participants Exposed to T-DM1 by Dose Intensity(Up to approximately 1 year from index date)
- Percentage of Participants Exposed to Prior and Concomitant Medication by WHODrug Anatomical Therapeutic Chemical (ATC) Classification System(Up to approximately 1 year from index date)
- Percentage of Participants Exposed to Prior and Concomitant Surgery/Procedure by Medical Dictionary for Regulatory Activities (MedDRA)(Up to approximately 1 year from index date)
- Real-world Progression Free Survival (rwPFS)(From the index date to the date of first progression of disease as recorded in rwTR or death due to any reason, whichever occurs first (up to approximately 1 year from index date))
研究者
研究点 (30)
Loading locations...
相似试验
终止
不适用
An Observational Study to Evaluate the Safety and Efficacy of Cetuximab in Combination With Platinum-based Chemotherapy in the First-line Treatment of Recurrent or Metastatic Squamous Cell Carcinoma of Head and NeckCarcinoma, Squamous CellNCT01142869Merck KGaA, Darmstadt, Germany133
招募中
不适用
An Observational Post-marketing Study Using Commercially Approved Biosense Webster (BWI) Medical Devices for the Treatment of Participants With Cardiac ArrhythmiasNCT04750798Biosense Webster, Inc.8,000
撤回
不适用
Safety and Effectiveness of the Tornier Simpliciti™ Shoulder System in Shoulder ArthroplastyShoulder OsteoarthritisNCT02452957Stryker Trauma and Extremities
终止
不适用
A Post Marketing Surveillance Study to Assess the Safety and Efficacy of Cetuximab Plus Radiotherapy in Locally Advanced Squamous Cell Carcinoma of the Head and NeckUnresectable Locally Advanced Squamous Cell Carcinoma of Head and NeckLA SCCHNNCT01303237Merck KGaA, Darmstadt, Germany88
已完成
不适用
Evaluate Safety and Efficacy of Pronavi Microcatheter for Use in Endovascular InterventionsPeripheral Arterial DiseaseCoronary Artery DiseaseNCT05747287BrosMed Medical Co., Ltd60