A Multicenter, Non-interventional Retrospective Study to Describe the Real-world Treatment Patterns and Associated Outcomes in Patients of China With HER2-positive Unresectable or Metastatic Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 865
- 试验地点
- 5
- 主要终点
- Percentage of Participants Receiving Local and Regional Treatment for Metastasis (Radiotherapy and/or Surgery) and Osteoprotective Therapy
研究概览
简要总结
This is a multicenter, non-interventional, retrospective, real-world study that enrolled patients diagnosed with HER2-positive unresectable or metastatic breast cancer. This study will be conducted to understand the treatment pattern and sequencing of therapies, survival outcomes, and associated burden of toxicities with line of treatment in the real world.
详细描述
The treatment landscape has changed dramatically with the lack of real-world evidence for usage and the efficacy of newly approved drugs in China. This multicenter, retrospective, non-interventional study will include patients newly diagnosed with HER2-positive unresectable or metastatic breast cancer, or first recurrent from early breast cancer.
The primary objective of this real-world study is to describe the treatment patterns of HER2-positive unresectable or metastatic breast cancer in China. Secondary objectives will include describing the demographic and clinicopathological characteristics of patients, efficacy of different treatment regimens, treatment options and efficacy of brain metastases, and safety and tolerability of different treatment regimens in patients with HER2-positive unresectable or metastatic breast cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Male or female patients ≥ 18 years of age at the time of diagnosis of unresectable or metastatic breast cancer
- •Participants with first diagnosis of unresectable or metastatic breast cancer, or first recurrence of HER2-positive breast cancer since January 1,
- •Participants were eligible if they were HER2-positive in the early operable stage and HER2-negative in the advanced stage. HER2 positive was defined with the reference to the Chinese guidelines for HER2 positive breast cancer at the time of testing
- •Participants have received at least one systemic therapy for advanced breast cancer
排除标准
- •Participants with concomitant cancer at the time of diagnosis of HER2-positive unresectable or metastatic breast cancer, except for the non-metastatic non-melanoma skin cancers, or in situ or benign neoplasms; a cancer is considered concomitant if it occurs within 5 years of HER2-positive breast cancer diagnosis.
- •Participants who are/were currently/previously enrolled in a clinical trial and have not been unblinded during the data collection interval of the study
- •Participants with critical missing data from their medical records or other patients deemed by the investigator to be ineligible for inclusion
结局指标
主要结局
Percentage of Participants Receiving Local and Regional Treatment for Metastasis (Radiotherapy and/or Surgery) and Osteoprotective Therapy
时间窗: Assessed over a 2 year, 8 month time period
Treatment Sequence Since the Time of Diagnosis of HER2-positive Unresectable or Metastatic Breast Cancer
时间窗: Assessed over a 2 year, 8 month time period
Percentage of Participants Receiving Each Regimen in Each Treatment Line
时间窗: Assessed over a 2 year, 8 month time period
Percentage of Participants Receiving Endocrine Therapy if Breast Cancer is Hormone Receptor Positive
时间窗: Assessed over a 2 year, 8 month time period
次要结局
- Duration of Treatment (DoT) in Participants With HER2-positive Unresectable or Metastatic Breast Cancer(Assessed over a 2 year, 8 month time period)
- Percentage of Participants With Brain Metastases Per Line of Treatment in Participants With HER2-positive Unresectable or Metastatic Breast Cancer(Assessed over a 2 year, 8 month time period)
- Percentage of Participants With Adverse Events (AE) Leading to Treatment Discontinuation or Dose Modification(Assessed over a 2 year, 8 month time period)
- Percentage of Participants With HER2-positive Unresectable or Metastatic Breast Cancer, Based on Demographic and Clinicopathological Characteristics(Assessed over a 2 year, 8 month time period)
- Time to Next Treatment (TTNT) in Participants With HER2-positive Unresectable or Metastatic Breast Cancer(Assessed over a 2 year, 8 month time period)
- Percentage of Participants Receiving Radiotherapy or Surgery in Participants With HER2-positive Unresectable or Metastatic Breast Cancer(Assessed over a 2 year, 8 month time period)
- Real-world Progression-free Survival (rwPFS) in Participants With HER2-positive Unresectable or Metastatic Breast Cancer(Assessed over a 2 year, 8 month time period)
- Real-world Disease Control Rate (rwDCR) in Participants With HER2-positive Unresectable or Metastatic Breast Cancer(Assessed over a 2 year, 8 month time period)
- Real-world Duration of Response (rwDoR) in Participants With HER2-positive Unresectable or Metastatic Breast Cancer(Assessed over a 2 year, 8 month time period)
- Percentage of Participants With HER2-positive Unresectable or Metastatic Breast Cancer, Based on Clinical Characteristics of Brain Lesions(Assessed over a 2 year, 8 month time period)
- Time to Next Treatment (TTNT) After Diagnosis of Brain Metastases in Participants With HER2-positive Unresectable or Metastatic Breast Cancer(Assessed over a 2 year, 8 month time period)
- Real-world Objective Response Rate (rwORR) in Participants With HER2-positive Unresectable or Metastatic Breast Cancer(Assessed over a 2 year, 8 month time period)
- Treatment Pattern After Diagnosis of Brain Metastases in Participants With HER2-positive Unresectable or Metastatic Breast Cancer(Assessed over a 2 year, 8 month time period)
- Real-world Progression-free Survival (rwPFS) After Diagnosis of Brain Metastases in Participants With HER2-positive Unresectable or Metastatic Breast Cancer(Assessed over a 2 year, 8 month time period)